ASME BPE-2022
(Revision of ASME BPE-2019)
Bioprocessing
Equipment
AN INTERNATIONAL STANDARD
&
The American Society of
~ Mechanical Engineers
ASME BPE-2022
(Revision of ASME BPE-2019)
Bioprocessing
Equipment
AN INTERNATIONAL STANDARD
&
The American Society of
~ Mechanical Engineers
Two Park Avenue • New York, NY • 10016 USA
Date of lssuance: April 29, 2022
The next edit ion of t his Standard is scheduled for publication in 2024. This Standard will become effective 6 months after the
Date of lssuance .
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The American Society of Mechanical Engineers
Two Park Avenue, New York, NY 10016-5990
Copyright ~ 2022 by
THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS
Ali rights reserved
Printed in U.S.A.
CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
xiii
Statement of Policy on the Use of the ASME Single Certification Mark and Code Authorization in Advertising
xv
Statement of Policy on the Use of ASME Marking to ldentify Manufactured ltems . . . . . . . . . . . . . . . . . . .
xv
Committee Roster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • . . . . . . . . .
xvi
Correspondence With the BPE Committee . . . . . . . . . . . . . . . . • . . . . . . . . . • . . . . . . • . . . . . . • . . • . . .
xxi
Summary of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
xxiii
Chapter 1
lntroduction, Scope, and General Requirements ....... . ......... . .. . ..... .
1
Part GR
General Requirements ............. . .. . ......... . ... . .. . . ........... .
1
GR-1
lntrod uction ...................... . ...... . ... . ...... . . ......... . .. .
1
GR-2
Seo pe of the ASM E BPE Standard ................. . .............. . ... . .. .
1
GR-3
Manufacturer's Quality Assurance Program ... . ...... . ... . ... . ...... . ... . .. .
2
GR-4
Examination, lnspection, and Testing ........ • .. • . . ..... .... . • . .• .... . .. ..
2
GR-5
Documentation ........................ . ...... . .......... . ...... . .. .
6
GR-6
U.S. Customary and SI Units .... . ... . ... . ... . ... . ... . ... . ... . ....... . .. .
8
GR-7
References . . . .... . . . .... . . . .... . . . .... . . . ...... . . ..... . . ...... . .. .
8
GR-8
Terms and Definitions .............. . .......... . ... . ..... . .... . ... . .. .
10
GR-9
Nomenclature ......... • .......... . .......... • ... . .......... • ... . ...
19
Chapter 2
Certificatlon . . .... .. ...... . . . . . .. ...... . . ............... . .. . .... . .
20
Part CR
Certificatlon Requirements ........... . ... . ......... . ... . . .. ...... . .. .
20
CR-1
Purpose and Scope ............ . ...... . .. . ...... . ...... . ...... . .. . .. .
20
CR-2
Chapter 3
Part MM
MM-1
General ................... . .. . ............ . ............ . .. . ..... .
20
Materials .......... . ... . ............. . ........ . ... . ... . ... . ... . .. .
23
Metallic Materials .... . ...... . ............. . ...... . ...... . ...... . .. .
23
Purpose and Scope ..... . ............. . .. . ...... . ...... . ...... . .. . .. .
23
MM-2
Alloy Designations .... . ..... . . . ......... . ... . . . . . ... . .. . ..... . . . . . .. .
23
MM-3
Uses of Specifications . .. . . .• ...... .. .... • .. • . . ..... .... . • . .• .. • . . .. ..
23
MM-4
Referenced Specifications ..................... . ... . ... . ... . ........... .
27
MM-5
Base Metals and Filler Materials ........ . ... . .............. . ......... . .. .
29
MM-6
Mechanical Pr operties and Leak Testing . . . . ........... . . . ...... . ...... . .. .
37
MM-7
Positive Material ldentification .......... . ....... . ... . ... . ..... . ..... . .. .
37
MM-8
Corrosion-Resistance Requ irements ............ • .. . ......... • .. . .. • ......
37
MM-9
Mínimum Requirements for Alloys in Part MM .... . . .. . .. . .. . . . ........... . .
39
Part PM
Polymeric and Other Nonmetallic Materials ..... . . .. .. . .. . .... . ......... .
41
PM -1
Purpose and Scope ............................. . ...... . ...... . .. . .. .
41
PM -2
Materials .................... . ......... . ....... .. . ......... . ..... .
41
PM-3
Properties and Performance ...... . ... . ................ . ... . ........... .
46
PM-4
Applications ................ . ...... . ...... . ...... . ...... . ...... . .. .
48
Chapter 4
Design for Multiuse ............................. . ... . ....... . ... . .. .
52
¡¡¡
Part SO
Systems Design for Multiuse ... . ........ . . . ...... . ..... . . ..... . .... . . .
52
SD-1
Purpose and Scope ............. . ... • .. . .. . ...... . ... • .. . ...... • .. . ..
SD-2
General Guidelines ...................... • .. . .. • ............ • .. . .. • ..
52
52
SD-3
Process Components and Equipment ......................... . . . .. . ..... .
SD-4
Process Utility Systems .................... . ...... . ...... . ......... . . .
SD-5
Process Systems .............. . ...... . ...... . ...... . ...... . ...... . . .
SD-6
Process Support Systems ..... . ... . .......... . ... . .............. . ..... .
131
SD-7
Design Conformance Testing ........ . . . .......... . . . . ............ . .. . . .
154
Chapter 5
Process Components for Multiuse ........................ . .......... . . .
Dimensions and Tolerances for Process Components .............. . ..... . . .
156
Part DT
DT-1
Purpose and Scope ...... . . . .... . ...... . . .. ...... . ... .. . . .... . .... . . .
DT-2
Pressure Rating ........ • ... • .................... • . . . • .............. .
DT-3
Wall Thickness .... . ...... . ...... . ...... . .......... . ...... . ...... . . .
DT-4
Dimensions ........ . ... . ... . ... . ... . ... . .................. . ....... .
DT-5
Materials ... . .......... . . . ....... . ...... . .. . ...... . . . . ...... . .. . . .
156
156
156
156
157
DT-6
Tests •••••••••••• • ••• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
Tolerances ........ . ...... . ...... . ...... . ....................... • ..
DT-7
DT-8
DT-9
Weld Ends ............ • ................ • ...... • .. · · · · · · · · · · · · · · • · ·
Hygienic Clamp Unions ........... . ..... • ...... • . . ....... . ... .. .... • ..
DT-10
Mínimum Examination Requirements ...... . ...... . ...... . ...... . ...... . . .
DT-11
Marking .............................. . ...... . ...... . ... . ...... . . .
DT-12
Packaging . . . ........................ . ..... . ........ . ... . ... . ..... .
Part PI
Process Instrumentation for Multiuse ............. . ... . .......... . ... . . .
PI-1
Purpose and $cope ....................... . ............. . ......... . . .
PI -2
Process Instrumentation General Requirements ...... . ... . . . . . ............ . . .
PI-3
lnstrument Receiving, Handling, and Storage ........ • ... • ... • ...............
Pl-4
Flowmeters .................................... . ... . .............. .
PI -5
Level lnstruments ....... . ..... . .... . ... . ..... . .... . ......... . .... . . .
PI -6
Pressure lnstruments . . . . ..... . .......... . . . . .... . ..... . .... . .. . .. . . .
PI-7
Temperature Sensors and Associated Components .... . .. • .... • .... . .... . ....
PI-8
Analytical lnstruments ............................ • ...................
PI-9
Optical ... . .... . .......... . ... . .......... . ...... . ... . . . ........ . . .
Part MC
Componcnts for Multiuse ............. . .. . ............... . .. . .. . .. . . .
MC-1
Purpose and Scope ............. . ...... . .. . ...... . ...... . ......... . . .
MC-2
Sealing Component Types ........................ . .............. . .. . . .
MC-3
Sealing Components General Design Requirements (General Provisions) ........... .
MC-4
Seal Performance Requirements .................................. . ..... .
MC-5
Seal Applications . . . ............. . . . ............. . . . ...... • ...... . ...
Chapter 6
Part MJ
Fabricatíon, Assembly, and Erection for Multluse ... . . . .... . . . . ...... . .. . . .
Matcrials Joining for Multiuse .................. . ... . ... . ... . ... . ..... .
MJ-1
Purpose and Scope ............. . ...... . .. . ...... . ...... . ......... . . .
56
102
107
156
157
157
157
157
158
159
159
194
194
194
197
197
202
203
206
211
215
219
219
219
237
243
245
248
248
248
248
249
MJ-2
Materials ........................ . ...... . .. . ...... . .. . ...... . .. . . .
MJ-3
Joint Design and Prepararion ........ . ...... . ...... . .......... • ...... . ..
MJ-4
Joining Processes and Procedures ..... • ............. . .. . .. . .. • ..... • ....
252
MJ-5
Procedure Qualifications .. . .... . ......... • .. • ......... • ............ • ..
252
iv
MJ-6
MJ-7
MJ-8
MJ-9
MJ-10
MJ-11
Part SF
SF-1
Performance Qualifications . . . . ... . . . . .. . . . . .. . . . ..... . ........... . ... .
Examination. lnspection, and Testing ..... . .. . .. . ...... . .. . .. . .. . .. . ..... .
Acceptance Criteria ........................ . .......... . .......... . .. .
)oining of Polymeric Materials .... . ...... . ......... . ...... . ...... . .. . .. .
Documentation Requirements ..... . .. . .. . ............................. .
Passivation ................................. . .............. . ... . .. .
Process Contact Surface Finishes for Multiuse ....... . . . ............ .. ... .
Purpose and Scope ...................... . ...... . ...... . . . .... . .. . .. .
Metallic Applications ........ . .......... . ... . ...... . ... . .......... . .. .
Polymeric Applications ..... . ............ . .. . .................. . ..... .
SF-2
SF-3
Chapter 7
Design for Single-Use ............................ . .. . .............. .
Part SU
Systeros Design for Single-Use ..................................... . .. .
SU-1
SU -2
SU-3
General ...................... . ............ . ............ . .. . ..... .
SU-4
su-s
SU -6
SU-7
SU-8
SU -9
SU-10
SU-11
Chapter 8
Part se
SC·l
SC-2
SC-3
SC-4
Chapter 9
Part SJ
SJ · 1
S) -2
SJ -3
General Guidelines . . ................ . .. . .. . ............ . . . . ........ .
lntegrity ...... . ........ . ... . . . . . ..... . ....... . . ...... . . ... . . . . . .. .
Biocompatibility .............. . ... . .. . ...... . .. . ... . .. . ... . .. . .. . .. .
Extractables a nd Leachables .... . .. . .. . .. . .. . .. . ..... . ................ .
ldentification . .. ............ . .. . ......... . .. . ............ . .. . ..... .
Certifica te of Conformance ......... . ............................... . .. .
lnspection and Packaging ............................................ .
Sterilization (Bioburden Control) ......... . ................. . ........ . .. .
Shelf Life, Storage, and Expiration Date . . .......... . .. . ......... . . ....... .
252
253
254
255
270
270
272
272
272
275
277
277
277
277
277
277
277
278
278
278
278
278
Particulates ................................... . ... . ... . ........... .
279
Process Components for Single-Use ........ . ... . ... . ... . ............... .
280
Components for Sillgle-Use ............ . .. . . ..... . ...... . ......... . .. .
280
Steam-Through and Steam-To Connectors ... • ................ • ...... • .. • ...
Aseptic Connectors ...................... . ...... . ...... . ......... . .. .
280
Flexible Bioprocess Containers (Bags) ............. . .. . ......... . . ....... .
Polymeric Hygienic Unions ... . ........... . ........... . ........... . ... .
Fabrication, Assembly, and Erection for Single-Use ..... . ... . ... . ... . ... . .. .
Joining Methods for Single-Use ................... . ...... . ...... . .. . .. .
General ...................... . ............ . ............ . .. . ..... .
Mechanical Hose Barb Connections .................. . ... . ... . ........... .
Thermal Welding of Thermoplastic Elastomer Tubing .......... . .. . .. . ....... .
280
280
281
282
282
282
282
282
Mandatory Appendices
1
11
111
IV
Submittal of Technical lnquiries to the Bioprocessing Equipment (BPE) Committee ... .
Standard Units .................... . .. . ........ . .............. . .. . . .
Single-Use Components and Assemblies ................ . .. . .............. .
Nomenclature ............................... . ... . .......... . ... . .. .
284
285
286
287
Nonroandatory Appendices
A
8
C
Commentary: Slag and Oxide lsla nds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Material and Weld Examination/ lnspection Documentation . . . . . . . . . . . . . . . . . . . . .
Slope Measurement and )oint Misalignment . . . . . . . . . . . . . . . . . • . . • . . . . . . . . . . .
V
289
290
294
D
Rouge and Stainless Steel ....... . ............. . .. . .. . .. . . . . .. . . . . .. . . .
295
E
Passivation Procedure Qualification .... . .. . .. . ......... . .. . .. . .. . .. . .. . . .
F
Corros ion Testing .................... . ...... . ...... . ...... . ...... . . .
303
311
G
Ferrite ........ . .......... . .... . ...... . ...... . .......... . ...... . . .
314
H
Electropolishing Procedure Qualification ........................ . ... . ..... .
1
Vendor Documentation Requirements for New lnstruments ............... . .. . . .
315
317
K
L
Standard Process Test Conditions (SPTC) for Sea! Performance Evaluation ......... .
Standard Test Methods for Polymers ... . . . ...................... . . . . .. . . .
320
330
M
Spray Device Coverage Testing ......................................... .
333
N
Commentary: UNS S31603 Weld Heat-Affected Zone Discoloration Acceptance Criteria .
335
o
Guidance When Choosing Polymeric and Nonmetallic Materials ................. .
p
General Background/Useful l nformation for Extractables and Leachables .......... .
336
337
Q
Temper ature Sensors and Associated Components ...................... . ... .
340
R
lnstrument Receiving, Handling, and Storage .... . ... . ... . ... . ...... . ....... .
342
s
Application Data Sheet ......... . ................ . ..... . . . ... . . . . .. . . .
343
T
Guidance on Polymer Applications: Chromatography Columns and Filtration ...... . . .
345
u
w
Guidance for the Use of U.S. Customary and SI UnitS .................... . .. . . .
348
Positive Material ldentification . . . . ............... . ... . ....... . ... . ..... .
350
y
Procuren1ent Sources ... .. ................... . .. . ..... . .. . .. . . .. .. . . .
353
z
Quality Management System ............................ . .. . .. . .. . .. . . .
AA
Static Seals Application Guide for Compendia! Water Systems .................. .
354
358
BB
Mechanical Sea! Face Material Selection for Compendia! Water Pumps ... . ... . . ... .
361
ce
Examination, lnspection, and Testing Cross-References ................ . ...... .
363
DD
Conductivity Sensor Selection Guide ................................... . . .
366
EE
FF
Vessel Flange, Agitator, and Mechanical Sea! Design for Bottom-Mount Agitators ... . . .
368
Leak Test Methods for Single-Use Components and Assemblies ................. .
378
GG
Single-Use Mechanical Hose Barb Design Recommendations .......... . ... . ..... .
383
Figures
CR-1-1
The ASME Single Certification Mark With the BPE Certification Designator ..... . .. . .
20
SD-3.1.1 -1
Flat Gasket Applications ........................................ . .. . . .
57
SD-3.1.2.2·1
Accepted Point-of-Use Designs .......... . ..... . . .......... . .......... . . .
61
SD-3.1.2.3-1
Double Block-and-Bleed Valve Assembly ..... . .............. . ... . ... . ..... .
SD-3.2.1-1
flexible Hygienic Hose Design ................... . ...... . .. . ...... . .. . . .
62
64
SD-3.3.2.2-1
Pump lmpeller Configurations ......... . ......... . ...... . .. . .... . . . .. . . .
65
SD-3.3.2.2-2
Acceptable lmpeller Attachments ......... . ...... . ...... . ...... . ...... . . .
66
SD-3.3.2.2-3
Casing Drain Configurations ................. . ... . ... . ... . ... . . .. . ..... .
67
SD-3.3.2.2·4
Casing Drain Lid Ratios . .......... . . . ............. . . . ............. . .. .
68
SD-3.3.2.4· l
Rotary Lobe Pump Rotor Attachment ......... . .......... . . . .... . ...... . . .
69
SD-3.4.2-1
Nozzle Design ........................ . ... . .................. . ..... .
70
SD-3.4.2-2
Side and Bottom Connections ............... . ... . ... . ... . .............. .
71
SD-3.4.2-3
Sidewall Nozzles ............ . .......... . ... . . . .... . ... . ..... . .... . . .
72
SD-3.4.2-4
Vessel Design Tangential Nozzles ........ . ...... . .......... . .......... . . .
73
SD-3.4.2-5
Typical Nozzle Detail .............. . ... . ... . ... . ... . ... . ... . ... . ... . . .
73
SD-3.4.3· 1
Accepted Nozzle Penetrations ... • .. • .. • ..... • .............. • ...........
75
vi
SD-3.4.3 -2
Interna! Components .......... . . . . . ..... . ....... . . ... . ... . ... . . . . . .. .
76
SD-3.4.6-1
Síght Glass Design (Accepted) ........ . .. . .. . .. . .. . .. . .. . ......... . .. . . .
77
SD-3.5.1-1
Agitator Mounting Flanges ...... . ... . ... . .................. . ... . ... . .. .
79
SD-3.5.2 -1
Shaft Coupling Construction . . ......... . ............ . ... . ... . ... . ... . .. .
SD-3.5.2 -2
Shaft Coupling Seal Arrangements .................... . .. . .. . ..... . ..... .
80
81
SD-3.5.2 -3
Fastener Sea! Arrangements: Alternative Bolting Designs ............ . ...... . .. .
83
SD-3.5.5-1
Shaft-Steady Bearing ...................................... . ...... . .. .
84
SD-3.5.5-2
Magnetically Coupled Mixer (Typical Bottom-Mount) ....... . ... . . . ........ . .. .
85
$D-3.6.2 -1
Double Tubesheet Heat Exchanger Bonnet Design ....... . ...... . ......... . .. .
86
SD-3.7.1-1
Transfer Panel Looped Headers .................... . ...... . ......... . .. .
88
SD-3.7.2 -1
Transfer Panel Tolerances ......... . . . .... . ........ . ........ . ... . .. . .. .
SD-3.7.4-1
Transfer Panel )umpers ............. • .......... • ... • .......... • . .. • ...
89
91
94
95
96
SD-3.9.1· 1
Dynamic Spray Device: Single Axis .......... . ...... . .......... . ...... . .. .
SD-3.9.1 -2
Two-Axis Dynamic Spray Device .................. . . .. . .. . .. . .. . ....... .
SD-3.9.2.1-1
Static Spray Device ... . ...... . ............. . ...... . . ..... . . ...... . .. .
SD-3.9.2.1-2
Flow Rate Guideline for Vertical Cylindrical Vessels ....... . ....... . ... . ... . .. .
SD-3.9.2.1-3
Flow Rate Guideline for Hor izontal Cylindrical Vessels .............. . ...... . . .
96
97
SD-3.9.2 .3· 1
lmpact Pattern Buildup ...... . .......... .. .......... . . . .... . ...... . .. .
98
SD-3.12 ·1
Steam Traps for Clean Steam Systems .. . ........... .. .. • .. . .. • ...........
SD-3.17.1-1
Example Strainer Types ............... . ... . ... . ... . ... . ... . ... . ... . .. .
99
100
SD-4.1.2.1-1
Point-of-Use Piping ..................... . .......... . ...... . ...... . .. .
103
SD-4.1.2.2-1
Physical Break in Point-of-Use Piping .... . ..... . .... . ...... . ... . ...... . .. .
104
$D-4.2.2-1
Typical Clean Steam System lsometric ..... . ............................. .
105
SD-4.2.2-2
Clean Steam Point-of-Use Design ........ . .. . ............... . ..... . ..... .
106
SD-5.1.4.4-1
Gas Sparging Assembly -
Lance ........... . .. . ...... .. ....... . .. . . . ... .
SD-5.1.4.4-2
Gas Sparging Assembly -
Sintered ..................... . ........... . ... .
108
109
SD-5.1.4.4-3
Gas Sparging Assembly -
Ring ........... . ......... . .. . ......... . ..... .
110
SD-5.1.4.4-4
Gas Sparging Assembly - Single Orífice ..... . . . ........ . ... . . . .... . ... . .. .
111
SD-5.1.4.7-1
Exhaust Gas Condenser ............. . . . ...... . ...... . ...... . ...... . .. .
113
SD·S.1.4.7-2
Exhaust Gas Heater ........................... . ... . ....... . .. . ... . .. .
113
SD-5.1.4.7-3
Electr ically Heat Traced Filter Housing ............. . ... . .......... . ... . .. .
114
SD-5.1.5 -1
Fermentor Sterile Envelope . .... . ...... . . . .... . ...... . ...... . ...... . .. .
115
SD-5.1.5-2
Bioreactor Sterile Envelope .................... . ......... . ...... . .. . .. .
116
SD-5.2.1-1
Cell Disruptor Process Flow Schematic Diagram .............. . .. . .. . ....... .
118
SD-5.4.5.1-1
Tank/Vessel Vent Fillers ....... . ..................... . ......... . ..... .
123
SD-5.6.4-1
Typical Lyophilizer Component Assembly ......... . ...... . ...... . ...... . .. .
125
$D-5.6.5 -1
Lyophilízer Sterile Boundary .......................... . ......... . ..... .
129
SD-6.3.4.1.1-1
Conical Vessel With Reduced Bottom Outlet, or Tulip Tank . .. .. .. . . ...... • .....
SD-6.3.4.2-1
CIP Looped Header (Supply or Return) ............ ... ............. . . . . . .. .
137
138
SD-6.3.4.2-2
Zero-Static Chain ................... . ............................ . .. .
139
SD-6.3.4.2-3
Swíng Elbow Arrangement ........ . ... . ... . ... . ... . ................ . .. .
139
SD-6.3.4.2-4
Mix-Proof Valve Array ......................... . ......... . .... . ... . .. .
140
SD-6.4.1.1-1
Example of HTST Process Flow Schematic Diagram ....................... . .. .
143
SD-6.4.1.1-2
Example of Direct Steam lnj ection UHT Process Flow Schematic Diagram .......... .
144
SD-6.4.4.5· 1
Example of Additional Retention Tube Length Required to Account for Axial Mixing .. .
146
vii
SD-6.5.4.2-1
DT-9.4-1
Pl-2.2.1-1
Pl-2.2.2-1
Pl-4.1.3.2-1
Pl-4.1.3.3-1
Pl -4.1.4.3-1
Pl-4.1.4.4-1
Pl-4.2.2-1
Pl -5.1.2.1-1
Pl -5.1.3.3-1
Pl-6.1.2-1
Pl -7.3-1
Pl-7.3.4 -1
Pl-7.3.4 -2
Pl-7.3.5-1
Pl-7.3.5-2
Pl-8.1.2-1
Pl-8.1.3.2-1
Pl-8.1.3.4· 1
Pl -8.2.2 -1
Pl-8.2.3.3-1
Pl-9.1.3.2-1
Pl -9.1.3.4·1
Pl -9.1.3.4-2
MC-2.2.2-1
MC-2.2.2-2
MC-2.2.2-3
MC-2.2.2-4
MC-2.2.2-5
MC-2.3.1.2·1
MC· 2.3. l.2· 2
MC-2.3.1.2-3
MC-2.3.1.2•4
MC-2.3.1.2-5
MC-2.3.1.3-1
MC-2.3.1.4·1
MC-2.3.1.S·l
MC· 2.3.l.7·1
MC· 2.3.l.8· 1
MC-2.3.1.9·1
MC-2.3.1.10-1
MC-2.3.2.2-1
MC-2.3.2.2-2
lmme rsion Tank Side Nozzle Design ...... . ....... . .... . . .. . ... . ... . ..... .
Clamp Conditions at lnstallation ...................... . ... . ... . ... . ... . . .
ln-Line a nd At-Line lnstrument lnstallation Examples ..... . .................. .
Accepted lnsertion Device lnstallation Examples ............................ .
Manifold or Flow Splitter for Dual-Tube Construction Flowmeters a nd Pote ntial for Product
Holdup ..... . . . . . . ...... . ... . . . . . . . . .... · ..... · · · · · · · · · · · · · · · · · ·
Concentrically Reducing Process Connection ........ . ...... . ...... . ...... . . .
198
198
Vertical lnstallation . . . . ..... . . . ...... . . . ... . ......... . ........ . ..... .
Mínimum Angle of lnclination, a ..... . ........... . ........... . ......... .
200
200
Typical Turbine Flowmeters ............................... . .......... .
Bulb, Horn, Isolated Horn, and Rod-Style Antenna ....... . ...... . .......... . . .
Dead Band, Measuring Range, and Mounting Location ..... .... .... . .. • . .. .. • ..
Accepted Orientation and Flow .................... . , . . ..... . .......... .
Typical Installation Styles .................................... . .. . .. . . .
201
203
204
Accepted Elbow Orientations and Flow Directions .......... . .......... . ..... .
Accepted Nonintrusive Orientations and Flow Directions . ...... . .. . . . .... . .. . . .
Sensor lnsertion Lengths for Tee lnstallations ............ . ... . ... . ... . ..... .
Sensor lnsertion Lengths for Elbow lnstallations .... . .......... . .......... . . .
Conductivity Sensor Components .................... . .... .... ..... . .. • . .
Acceptable Orientations for Conductivity Sensors .. . .. . . .. . . .... . . . .. . . .. . . . .
lnstallation Clearance Requirements ............ . .............. . ... . ..... .
pH Sensor Components ............ . ...... . .......... . ...... . ...... . . .
Accepted Mounting Orientations ... . ..... . ... . ....... . ... . .. . ... . ... . ... .
Vessel Light Glass Design and Mounting ........ . ....................... . . .
ln-Line lnsertion Length ........................ . .. . ............ . .. . . .
lnsertion Probe Length ........................ • . . ....... . ... .... .. • ..
Hygienic Union per Table DT-7.1·1 ..... . ... . . . ... . . . . . ... . . ..... . ....... .
Hygienic Clamp Union per Table DT-7.1•1 ... . .. . ....... . .......... . ...... .
Hygienic Union per DIN 11864 ........................................ .
Hygienic Clamp Union per DIN 11864 ... . . . . . .. . .. . .. . .................. .
Nonhygienic Connections ............................... . ... . ......... .
Weir Valves ................... . .. . ...... . .. . ...... . .. . ...... . .. . . .
Radial VaJves . . .. ... ..... . .... . . . . . .. .... . ......... . . . . ...... . .. . . .
Weirless Diaphragm Valve ............ . ... . .......... . .......... . ... . . .
Linear Control Valves ................ . ......... . .. . ............ . .. . . .
Regulator Valve ........ . ... . ................ . ... . ... . .............. .
Ball Valves .. . ...... . ...... . ................. . ........ . .. . . . .... . . .
149
192
195
196
205
206
207
208
209
210
212
213
213
214
215
217
218
218
220
220
221
221
222
224
224
225
225
226
226
Rising Stem Single, Double-Seat Mix-Proof, and Need le Valves ... . .. . ........... .
Butteríly Valve .................................................. . . .
Back Pressure Control Valve ......... • . .. .. • ...... ..... .... . .. • . .. .. • ..
Pinch Valve ....... . . . . . ..... . ...... . ....... . . . . . . . . . ...... . ....... .
Pressure Relief and Check Valves ....... . ... . .......... . .............. . . .
227
Plug Valve ........................... . ............ . ......... . .. . . .
Single Mechanical Sea! ..... . . . ......... . ..... . ............. . . . . . ..... .
Single Seal for Top-Entry Agitator .................. . ..... . .. . .. . ..... . . .
230
231
231
viii
227
227
228
229
MC-2.3.2.3-1
Dual Mechanical Seal-Pressurized for Pumps ... . ..... . ..... . . .. . .. . ....... .
231
MC-2.3.2.3-2
Dual Mechanical Seal-Pressurized for Top-Entry Agitator ..... . .... . . . .... . . . . .
231
MC-2.3.2.3-3
Dual Mechanical Seal- Unpressurized for Pum ps .................... . ....... .
232
MC-2.3.2.4-1
Flush Plan 01 ................................ . ..... . .... . ...... . .. .
233
MC-2.3.2.4-2
Flush Plan 02 ....... . ...... . .......... . ...... . .......... . ...... . .. .
233
MC-2.3.2.4-3
Flush Plan 03 ....... . ...... . .......... . ...... . .......... . ...... . .. .
233
MC-2.3.2.4-4
Flush Plan 11 ....... . ...... . .......... . ...... . .......... . ...... . .. .
234
MC-2.3.2.4-5
Flush Plan 32 ............. . . .......... . . . .... . .......... . ...... . .. .
234
MC-2.3.2.4-6
Flush Plan 52 for Pump ........................................... . .. .
234
MC-2.3.2.4-7
Flush Plan 52 for Top-Entry Agitator ....... . ......... . .. . ......... . ..... .
235
MC-2.3.2.4-8
Flush Plan BPE52 for Pump ..... . . . ............. . . . . ... . ... . ... . . . . . .. .
235
MC-2.3.2 .4·9
Flush Plan 53 for Pump ......... . ............... . ............... . . • ...
235
MC-2.3.2.4-10
Flush Plan 53 for Top-Entiy Agitator ....... . ......... . .. . ......... . ..... .
235
MC-2.3.2.4-11
Flush Plan 54 for Pump . . ............... . ............... . ......... . .. .
236
MC-2.3.2.4-12
Flush Plan 54 for Top-Entry Agitator ....... . ......... . . . . ......... . . . ... .
236
MC-2.3.2.4-13
Flush Plan SS for Pump ................... . ... . ... . ....... . ... . ... . .. .
236
MC-2.3.2.4-14
Flush Plan SS for Top-Entry Agi tator ....... . ......... . .. . ......... . ..... .
236
MC-2.3.2.4-15
Flush Plan 74 for Pump ............. . ............... . ............. . . . .
MC-2.3.2.4-16
Flush Plan 74 for Top·Entry Agitator ....... . ......... • .. . ... .. .... • ......
237
237
MC-3.3.2.2·1
Examples of Static O-Ring Grooves ......... . ... . ...... . ... . .......... . .. .
MC-3.3.2.3-1
Seals for Rising Stem Valves .......................................... .
239
241
MC-4.2-1
Typical Hygienic Clamp Union: Allowable Gasket lntrusion .. . ............... . . .
244
MJ-3.2 -1
Unacceptable Pressure Vessel and Tank Head-to-Shell Join t Confígurarions ....... . . .
250
MJ-3.2-2
Acceptable Pressure Vessel and Tank Head -to -Shell Joint Configurations ........... .
251
MJ-8.4·1
Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube· to-Tube Butt
Joints .............. . ............. . .............. . . . ........... .
262
MJ-8.4-2
Discoloration Acceptance Criteria for Welds and Heat•Affected Zones on Electropolished
UNS S31603 Tubing .............................................. .
263
MJ-8.4-3
Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically
Polished UNS S31603 Tubing ........................................ .
264
MJ-8.4-4
Acceptable and Unacceptable Metallic Weld Bead Width and Meander on Non- Process
Contact Surfaces of Groove Welds on Tube-to-Tube Butt Joints ............... .
265
M/-8.5-1
Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds .. . . . ... . ..... .
268
M/-9.7.1-1
Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds ...... . .. .
271
K-1.3.2.1-1
Weir-Style Diaphragm ............................................ . .. .
322
K· l.3.2.1·2
Weir·Style Body ............... . ... .. .... . ...... . . . . ......... . . . ... .
325
K-1.3.2.1·3
Radial·Style Body ...... . .... • ............ • ........ . • ......... • . . ....
325
K-1.3.2.1-4
K-1.3.2.1-5
Manual Bonnet ...... . .......... . ...... . ...... . .......... . ...... . .. .
326
Pneumatic ....................................................... .
326
P-4-1
339
BB-1-1
Flowchart ofBioprocessing Equipment/Component Evaluation Related to Extractables and
Leachables Characterization ........ . ... . ........... . ............... . .
Mechanical Sea] Face Material Selection for Compendia] Water Pumps .... . ..... . . .
DD-2.1.1·1
Conductivity Scale ........................................... . ... . .. .
367
EE-3·1
Direct-Mount Agitator ......... . ...... . ...... . ...... . ...... . ...... . .. .
369
EE·3· 2
EE-3.1 -1
Pedestal·Mount Agitator .. . . . .... .. .... . . .. .... . .. . ...... . .. . .. . . . .. . .
370
Registered Fit to Ensure Concentricity: Sea] Housing-to-Drive Pilot ... . . . ........ .
371
ix
361
EE-3.2-1
Dual Mechanical Seal Assembly . . . ............. . .. . . . ..... . .... . .. . .. . . .
372
EE-3.2-2
Sea! Assembly to Flange 0-Ring Detail ..... . .. . .. . ......... . .. . .. . .. . .. . . .
373
EE-3.3-1
Vessel Flange With Piloted Bore ........................................ .
375
EE-3.3-2
Vessel Flange Tolerance Parameters .......................... . .... . ..... .
376
GG-1.2-1
Typical Polymeric Single-Use Hose Barb Featuríng Mono-Barb Design ........... . .
383
GR-4.2-1
Quality lnspector's Delegate Capabílities ...... . ..... . .... . ......... . .... . . .
3
CR-1-1
Types of ASM E BPE Certificares ........................ . ...... . ...... . . .
20
MM-2.1-1
Wrought Stainless Steels: Nominal Compositions (wt. %) ........ . ... . ......... .
24
Tables
MM-2.1-2
Wrought Nickel Alloys: Nominal Composítions (wt. %) . ....... . .. .. ... . ...... .
25
MM-2.1-3
Staínless Steel and Nickel Alloy Cast Designations ........... . . . ........... • . .
26
MM-2.1-4
Wrought Copper: Nominal Composítions (wt. %) (Cleaned for Oxygen Service) ...... .
27
MM-5.2.1.1 -1
Predícted Ferrite Number (FN) Ranges for Various Austenitíc Stainless Steel Product Form s
and Welds .... . .......................... . . . ................... .
29
MM-5.2.5-1
Materials for· OEM Equípment .............. . .... . .......... . .. . . . . .. . . .
30
MM-5.3-1
Fíller Metals for Austenitic Stainless Steels .......... . . . ....... . ...... . .. . . .
31
MM-5.3-2
Fíller Metals for Superaustenitic Sta inless Steels .... . .. . .. . ............ . .. . . .
MM-5.3-3
Filler Metals for Duplex Stainless Steels ....... . . . ........... . . • .. • .. • .. • . .
33
34
MM-5.3-4
Filler Metals for Nickel Alloys ... . . . .... . ... . . . . . .. . . ... . . . . . .. . .. . .. . . .
35
MM-5.3.4-1
Brazing Filler Metals for Copper ........................................ .
38
MM-5.3-5
Consumable lnserts for Superaustenític and Duplex Staínless Steels .............. .
36
MM-5.4-1
Solution Anneal Heat Treatment Requírements for Superaustenític and Duplex Staínless
Steels ................ . . . ...................................... .
39
PM-2.1.1-1
Common Thermoplastic Polymers and Applications ..... . ... . .......... . ... . . .
42
PM-2.1.2-1
Common Thermoset Polymers and Applications ............ . .. . ............ .
42
PM-2.1.3-1
Examples of Nonmetallícs . .. . . . ....... . .. . . . .... . .. . ... . . . .... . .... . . .
43
PM-2.2.1-1
Content Requíred on the Certíficate of Conformance ......................... .
44
PM -2.2.3.2-1
Change Levels and Mínimum Change Notification Requirements ... . ... . ... . ..... .
45
PM -4.2.1-1
Size Comparison of Common Thermoplastic Sízing Standards ........... . ... . ... .
49
SD-2.4.3.1-1
Slope Designatíons for Drainable Lines ..... . ....... . ...... . .............. .
55
SD-3.1.2.2-1
L/d Dimensions for Flow-Through Tee: Full-Síze Standard Straight Tee Wíth Blind Cap .
58
SD-3.1.2.2-2
J,fd Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Bli nd Cap ... .
59
SD-3.4.3-1
Annular Spacing Recommendations for Hygieníc Dip Tubes . . .. ........ . . .. .... .
74
SD-6.3.5.2.1 -1
Flow Rates to Achíeve 5 h/sec (1.5 m/s) ....... . .......... . ...... • ..... • ..
141
DT-2-1
Metallic Fittíngs: Rated Interna! Working Pressur e .......................... .
159
DT-3-1
Final Tolerances for Mechanícally Políshed Fíttings and Process Components, Excluding
T ube ... . .... . . . ........... .. ........... . . . ................... .
160
DT-3-2
Final Tolerances for Electropolished Fittings and Process Components, Excluding Tube .
161
DT+l
Nominal O.O. Tubing Sizes ............................................ .
161
DT-4.1 -1
Tangent Lengths ........................... . ........ .. . .......... . . .
162
DT-4.1.1-1
Automatic Tube Weld: 90-deg Elbow . ......... . .......... . ............ • ..
162
DT-4.1.1-2
Automatic Tube Weld: Hygíenic Clamp Joint. 90-deg Elbow .... . .. . ............ .
163
DT-4.1.1-3
Hygieníc Clamp foint: 90-deg Elbow .................... . ... . .......... . . .
163
DT-4.1.1-4
Automatic Tube Weld: 45-deg Elbow ................. . ............. . .. . . .
164
DT-4.1.1-5
Automatic Tube Weld: Hygíenic Clamp Joint, 45-deg Elbow ... . . .. . ............ .
164
X
DT-4.1.1-6
Hygienic Clamp Joint: 45-deg Elbow ... . .... . ......... . . ... . . . ...... . . . .. .
165
OT-4.1.1-7
Automatic Tube Weld: 180-deg Return Bend . . . • ... • ... . ... . ... . .... • ... • ...
165
DT-4.1.1-8
Hygienic Clamp Joint: 180-deg Return Bend .. . . . .. • . . . ... . ..... ... ... . .....
166
DT-4.1.1-9
Automatic Tube Weld: 88-deg Elbow . . .. . . .. . . . . . . .. . . .. . . .. . .. . . . . . . .. . .
166
DT-4.1.1-10
Automatic Tube Weld: 92 -deg Elbow ........... . ............... . .. . ..... .
167
DT-4.1.2-1
Automatic Tube Weld: Straight Tee and Cross ........................... . .. .
DT-4.1.2-2
Automatic Tube Weld: Short•Outlet Hygienic Clamp Joint Tee ..... .. . ....... . . . .
167
168
DT-4.1.2-3
Hygienic Mechanical Joint: Short-Outlet Run Tee ... . ............. . . ...... . .. .
168
OT-4.1.2-4
Hygienic Clamp Joint: Straight Tee and Cross . .. . . .. . .. . .. . .. . .. . .......... .
169
OT-4.1.2-5
Hygienic Clamp Joint: Short-Outlet Tee .. . . . . . .. . . . . . . . . . ... . . . . . . . . .. . . . . .
169
DT-4.1.2-6
Automatic Tube Weld: Reducing Tee . . .. . .. . .. . .. .. . . .. .. . .. . .. . .. . .. . .. .
170
DT-4. 1.2-7
Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee . . . • .. • . ....
171
DT-4.1.2-8
Hygienic Clamp Joint: Reducing Tee ......................... . ..... . .. . .. .
172
DT-4.1.2-9
Hygienic Clamp Joint: Short-Outlet Reducing Tee ......................... . .. .
DT-4.1.2-10
Automatic Tube Weld: lnstrument Tee . . . . .... . . . .... . . . .... . . . ...... . . .. .
173
173
OT-4.1.2-1 1
Hygienic Clamp Joint: lnstrument Tee ..... .. . ... . . . . . . . . . . . . .. • ... • ... . ...
174
DT-4.1.2-1 Z
Automatic Tube Weld: Standard Outlet Hygien ic Clamp Joint Tee .......... • . .....
174
DT-4.1.2-13
Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Reducing Tee . . . . . . . . . .
175
DT-4. 1.3-1
Automatic Tube Weld: Concentric and Eccentric Reducer . . . . . ... . . . . . . . . . . . . . . .
176
DT-4.1.3-2
Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer ..... . .. . ..... .
177
DT-4.1.3-3
Hygienic Clamp Joint: Concentric and Eccentric Reducer ........ . ........ . .... .
178
DT-4.1.4-1
Automatic Tube Weld: Ferrule ............. . . . ............... . ...... . .. .
179
OT-4.1.5-1
Automatic Tube Weld: Cap .. . .. .. ... ................................. .
179
OT-4.1.5-2
Hygienic Clamp Joint: Solid End Cap ... . . .. . . . . . . . ... . . . . . . . . . . . . . . .. . . . . .
180
DT-4.4.1-1
Hygienic Clamp Joint: Two-Way, Weir-Style Diaphragm Valve . . . . .. . . ... . . . . . . . . .
181
DT-4.5.1-1
Tapered Locking Tab Retainer : Recessed . ... . ........ . ... . . • . . • . . • .. . . ....
182
DT-4.5.2-1
Tapered Locking Tab Retainer : Externa! ........ . ............. . ........ . .. .
183
DT-7.1-1
Metallic Hygienic Clamp Ferrule Standard Oimensions and Tolerances ... . ...... . . .
184
DT-7.1-2
Polymeric Hygienic Clamp Ferrule Standard Oimensions and Tolerances . .. . . . .. . . .
187
OT-7.3-1
Transfer Panel and Jumper Tolerances . . . . .. . . . . . .. . . . . .. . . . . . .. . .. • .. . ...
190
DT-9.3-1
Hygienic Clamp Ferrule: Design Cr iteria . . . . . . ... .. ... . • . . . ...... . . . • . .....
191
DT-11.1.l·l
Mínimum Required Marking lnformation .. . .. . .. . .. .. . .. . .. . .. . .. .. . .. . .. .
193
MJ-6.3-1
Metallic Tube/Pipe Diameter Limits for Orbital GTAW Perfor mance Qualification .... .
Metallic Weld Thickness Limits for Orbital GTAW Performance Qualification ........ .
253
MJ-6.3-2
MJ-8.2-1
Visual Examination Acceptance Criteria for Welds on Metallic Pressur·e Vessels and Tanks
256
M/-8.3-1
Visual Examination Acceptance Criteria for Welds on Metallic Pipe ..... . ........ .
258
MJ-8.4-1
Visual Examination Acceptance Criteria for Groove Welds on Metall ic Tube-to-Tube Butt
Joints ..... .. ...... .. .... ... ......... . .. . . . ...... .. . . .. . . . ..... .
260
MJ-8.5 -1
Visual Examinarion Acceptance Criteria for Metall ic Tube-Attachment Welds . . .... . .
266
MJ-9.7.1-1
Visual Examination Acceptance Criteria for Polymeric Pipe Beadless Welds . . . . . . . . .
270
SF-2.2-1
Acceptance Cr iteria for Metallic Process Contact Surface Finishes . .. . . . . . . . . .. . . . .
273
SF-2.2-2
Additional Acceptance Criteria for Electropolished Metallic Process Contact Surface Finishes
273
SF-2.4.1-1
R., Readings for Metallic Process Contact Surfaces ........................... .
274
SF-2.6-1
Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes . . . . . . . .
275
SF-3.3-1
Acceptance Criteria for Polymeric Process Contact Surface Finishes . ... ... ... .. . . .
276
xi
253
SF-3.4-1
11-1
D-2-1
R0 Readings for Polymeric Process Contact Surfaces ... . ... . ...... . . .. . ...... .
Standard Units .................................................... .
Considerations That Affect the Amount of Rouge Formation During the Fabrication of a
System ........................................................ .
276
285
D-2-2
ConsiderationsThatAffect the AmountofRouge For mation During the Operation ofa System
D-3.1-1
Process Fluid Analyses for the ldentification of Mobile Constituents of Rouge ... . . . . .
D-3.2 -1
Solid Surface Analyses for the ldentification of Surface Layers Composition ........ .
D-4.1-1
Rouge Remediation Processes Summary ................................ . . .
297
298
299
300
301
E-3.2-1
Mínimum Surface Requirements for Process Qualification Samples .... . ....... . . . .
304
E-3.2-2
Passivation Processes .......................................... . .. • ..
305
E-5-1
Test Matrix for Evaluation of Cleaned and Passivated Surfaces ..... . ...... . ... . . .
307
F-1-1
ASTM Corrosion Tests ............................................... .
312
F-3-1
PRE Numbers for Stainless Steels as per Table MM-2.1-1 and for Nickel Alloys as per Table
MM-2.1 -2 ...................................................... .
313
H-3.3-1
Mínimum Surface Requirements for Process Qualification Samples ............... .
316
J-1.1-1
Vendor Documentation Requirements for New lnstruments: Section 1, VDR Definitions .
318
J-1.2-1
Vendor Documentation Requirements forNew lnstruments: Section 2, lnstrumentTypesand
Required Documents ..... . ................. . ............ . ......... .
319
L-3-1
Thermoset Polymer Test Properties ......... . ........ . .... . .... . ...... . . .
331
L-4-1
lnter pretation of T hermoset Material Property Changes ......... • ... . ... . ... • ..
332
AA-1-1
Static Seals for Use in Compendia! Water Systems (MC-2.2.1) .... • . . ............
359
DD-2.6-1
Technological Considerations ................ ... ............ ... .. . ... . . .
367
EE-3.3-1
Vessel Flange Bore per Shaft Diameter ............... . .......... . ...... . . .
374
EE-3.3-2
Vessel Flange Fabrication Tolerance Guidelines ............ . .......... . ... . . .
377
FF-1
Leak Test, Nondestructive Methods ................. . ................... .
379
FF-2
Leak Test, Destructive Methods ..... . . . .................... . ......... . . .
381
GG-2-1
Typical Retention Devices by Tubing Type and Operating Pressure ... . . . . . . . . . .. .
384
Forms
MEL-1
Material Examination Log ....... . ............ . .. . ............ . .. . .... .
291
MER-1
Material Examination Record .............. . .......... . .......... . ... . . .
292
WEL-1
Weld and Examination lnspection Log ... . .. . .. . .. . .. . . . . .. . .. . .. . . . . .... .
S-1
Application Data Sheet ....................... . .. • .. . .. . .. . .. • .. . .....
293
344
lndex
385
xii
FOREWORD
At the 1988 ASMEWinte r Annual Meeting (WAM), many individuals expressed inte rest in developing standards for the
design of equipment and components for use in the biopharmaceutical industry. As a result of this interest, the ASME
Council on Codes and Standards (CCS) was petit ioned to approve this as a project. The initia l scope was approved by the
CCS on ¡,me 20, 1989, with a directive to the Board on PressureTechnology to initiate this projectwith the following initial
scope:
Th is standard is intended for design, materials, construction, inspection, and testing of vessels, piping, a nd
related accessories such as pum ps, valves, and fittings for use in the biopha rmaceutica l ind ustry. The rules
provide for the adoption of other ASME and related nationa l standards, a nd when so referenced become part
of the standard.
(a) At the 1989 WAM, a n a d hoc committee was formed to assess the need to develop further the seope and action plan.
The committee met in 1990 and there was consens us concerning the need to develop standards tha t would meet the
requirements of operational bioprocessing, including
(1) the need for equipment designs that are both cleana ble and sterilizable
(2) the need for special e mphasis on the quality of weld s url'aces once the required s trength is present
(3) the need for s tandardized definitions that can be used by materia l s uppliers, designers/fabricators, and users
(4) the need to integrate existing s ta ndards covering vessels, piping, appurte nances, and other equipment necessary
for the biopharmaceutical industry without infringing on the scopes of those standards
(b) The BPE Main Committee was s tructured with six functioning s ubcommittees and an executive committee
comprising the main committee cha ir and the s ubcommittee chairs. The initial s ubcommittees were
(1) General Requirements
(2) Design Relating to Sterility and Cleanability of Equipment
(3) Dimensions and Tolerances
(4) Mate rial Joining
(5) Surface Finis hes
(6) Seals
(e) Throughout the development ofthe Standard, close lia ison was made with the European CEN, ASTM, and the 3-A
Da iry Standards. The purpose was to develop an ASME standard that would be distinctive, germane, a nd not in conflict
with other industry standards. Wherever possible, the Committee strived to reference existing s tandards that are ap plicable to biopharmaceutical equipment design and fabrication.
{d) Th is Standard representS the work of the BPE Standards Comm ittee, and this edition incl udes the following:
Chapter l. lntroduction, Scope, and General Requirements
Part GR, General Requirements
Chapter 2, Certification
Part CR, Certification Requirements
Chapter 3, Materia ls
Part MM, Metallic Materials
Part PM, Poly meric and Other Nonmetallic Mate rials
Chapter 4, Design for Multiuse
Part SD, Systems Design for Multiuse
Chapter 5, Process Components for Multiuse
Part DT, Dimensions and Tolerances for Process Components
Part PI, Process lnstrumentation for Multiuse
Part MC, Components for Multiuse
xiii
Chapter 6, Fabrication, Assembly, a nd Erection for Multiuse
Part MJ, Mate rials Joini ng for Mul tiuse
Part SF, Process Contact Surface Finishes for Multiuse
Chapter 7, Design for Single -Use
Part SU, Syste ms Design for Single-Use
Chapter 8, Process Compone nts for Single-Use
Part SC, Components for Single-Use
Chapter 9, Fabrication, Assembly, a nd Erection for Single-Use
Part SJ, Joini ng Methods for Single-Use
The first edition of this Sta ndard was approved as an American National Standard on May 20, 1997. This edition was
a pproved by ANSI on March 21, 2022.
xiv
STATEMENT OF POLICY ON THE USE OF THE ASME SINGLE
CERTIFICATION MARK AND CODE AUTHORIZATION IN
ADVERTISING
ASME has established procedures toauthorize qua lified organizations to perform various activities in accordance with
the requirements ofthe ASME Codes and Standards. lt is the a im of the Society to provide recognition of organizations so
authorized. An organization holding authorization to perform various activities in accordance with the requirements of
the Codes and Standards may state this capability in its advertising literature.
Organizations that are authorized to use the ASME Single Certification Mark for marking items or constructions that
have been constructed and inspected in compliance with ASME Codes and Standards are issued Certificates of Authorization. lt is the aim of the Society to maintain the standing of the ASME Single Certification Mark for the benefit of the
users, the enforcement jurisdictions, and the holders of the ASME Single Certification Mark who comply with ali requirements.
Based on these objettives, the following polity has been established on the usage in advertising of facsímiles of the
Certificates of Authorization and references to Codes or Standards const:ruction. The American Society of Mechanical
Engineers does not "approve; "certify;' •rate," or "endorse" any ítem, construction, or activity and there shall be no
statements or implications that might so indicate. An organization holding the ASME Single Certification Mark and/or a
Certificate ofAuthorization may state in advertising literat:ure thatitems, constructions, or activities "are built (produced
or performed) or activities condutted in accordance with the requirements ofthe applicable ASME Code or Standard." An
ASME corporate logo shall not be used by any organization other than ASME.
The ASME Single Certification Markshall be used only forstamping and nameplates asspecifically provided in the Code
or Standard. However, facsímiles may be used for the purpose offostering the use of such construction. Such usage may be
by an association or a society, or by a holder of the ASME Single Certification Mark who may also use the facsímile in
advertising to show that clearly specified items will carry the ASME Single Certification Mark. General usage is permitted
only when ali of a manufacturer's items are constructed under the rules of the applicable Code or Standard.
STATEMENT OF POLICY ON THE USE OF ASME MARKING TO
IDENTIFY MANUFACTURED ITEMS
The ASME Codes and Standards provide rules for the const:ruction of various items. These include requirements for
materials, design, fabrication, examination, inspection, and stamping. ltems const:ructed in accordance with ali of the
applica ble rules of ASME are identified with the ASME Single Certification Mark described in the governing Code or
Standard.
Markings such as ·ASME" and "ASME Standard" or any other marking including ·ASME" or the ASME Single Certificat:ion
Markshall not be used on any item that is not construtted in accordance with ali of the applicable requirements ofthe Code
or Standard.
lte ms shall not be described on ASME Data Report Forms nor on similar forms referring to ASME which tend to imply
that ali requirements have been met when in fact they have not been. Data Report Forms covering items not fully
complying with ASME require ments should not refer to ASME or they should clearly identify a li exceptions to the
ASME requirements.
ASME's certification related to products means that the capabil ity by the supplier to fulfill requirements in the ap plicable standard has been reviewed and accepted by ASME. The s upplier is responsible for ens uring that products meet,
and if applicable continue to meet, the requirements.
XV
ASME BIOPROCESSING EQUIPMENT COMMITTEE
(The following is the roster of the Committee a t the time of approval of this Standard.)
STANDARDS COMMITTEE OFFICERS
K. O. Khnbrel, Chair
O. J. Matbien, Vice Chair
P. O. Stumpf, Secretary
STANDARDS COMMITTEE PERSONNEL
J, Ankers, Ocean Alloys, LLC
M. Mcfeeters, The 8ioProcess lnstitute
R. A, Michalak, Eli Lilly and Co,
M, Pelletier, CRB
J, Rau, Dockwcillcr AG
L. J. Peterman, Unltcd Industries, lnc.
W. L. Roth, Wcldlng Enginec-rlng Consultants
S. Sharon, BioMarin Pharmaceutícal, In<:.
R, A, Snow, Sanofi Global
P. O. Stumpf. The American Society of Mechanical Engineers
P. L. Sturgill, Sturgill Weldi ng and Code Consulting
C. A. Trumbull, Paul Mueller Co.
M. Oda, Delegare, Hitachl Plant Scrviccs Co., Ltd.
R. Cosentlno, DelegtJte, Soleri do Brasil, Ltda.
2. Cu, Delegate, Shanghai Morimatsu
E. A. Benway, Contributl119 Member, l ronwood Speci alist, l nc.
A. P. Cirillo, Co11tribut1119 Member, Cirillo Consulting Services, LL.C
E. B. Fisher, Contributing Member, Fisher Engineering
M. M. Gonzalez, Contributing Member, Consultant
R. Hansel ka, Co11tributblg Member, Consultant
O. K. Henon, Contributln9 Member, Consultant
M. A. Hohrnann, C<Jnl'ribuUng Member, Consultant
R. Mc.-Gregor, Contributing Member, Titan Research Group
S. M.urakami, Contriburing Member, Hitachi, Ltd.
M. L. Salmer, Mer ck
P. H. Banes, Astr o Pak Corp.
B. A. Billmyer, Central Statcs Industrial Equipmcnt
W, H, Cagney, JSG, LLC
R, O, Campbell, Bechtel
T. Cook, T&C Stainless, l nc.
R. A~Cotter, Cotter Brothers Corp.
J, R, Daniels, ITT Engineered Valves, LLC
J. Ovorscek, Vessel and \\feld lnspection Services, LLC
A. O. Oyrness, Trinity Consult.mts, ADVENT Life Sdences
M, Embury, ASEPCO
l .. T. Hutton, Plastícwelding.. LLC
C. A. Johnson, Genentech_., lnc.
M. W. Johnson, Entegris
C. Kettermann, United Industries
K. 0 , Kimbrel, VNE Corp,
O. T. Klees, Consultant
M. Knox, W. L. Gorc and Associates
G. Kroehnert_, Ncumo
A. Larnore, Burkert Fluid Control Systems. Ltd.
J. T. Mahar, 3M Pttrification
0, M, Marks, O'Neal, lnc,
O. J. Mathien, Behringer Corp.
EXECUTIVE COMMITTEE
O. J. Matlden, Chair, Behringer Corp.
K. O. Kimbrel, Vice Chair, VNE Corp.
¡, Ankers, Ocean Alloys, LLC
P. H. Banes, Astr o Pak Corp.
B. A. Bilhnyer, Central $tates Industrial Equípment
R, O, Carnpbell, Bechtel
T, ¡, Cook, T&C Stainless, lnc,
R. A~Cotter, Cotter Brothers Corp.
¡, R. Daniels, ITT Engineered Valves, LLC
J. Ovorscek, Vessel and \\feld lnspection Services. LLC
A. Oyrness, Tr inity Consultants, AOVENT Life Sciences
M, Embury, ASEPCO
M. Knox, W. L. Gore and Associates
A. Lamore, Burkcrt Fluid Control Systcms, Ltd.
D. M. Mark...~, O'Neal, lnc:.
M. Mcfeeters, The BioProcess lnstitute
M, Pelletier, CRB
J. Rau, Dockweiler AG
P. L. Sturgill, Sturgill Weldi ng and Code Consulting
A. P. Cirillo, Co11tributi119 Member, Cirillo Consulting Services, LLC
xvi
SUBCOMMITTEE ON GENERAL REQUIREMENTS ANO EDITORIAL REVIEW
M. Pelletier, CRB
K. Seibe,~, ABEC, l nc.
M. Embury, Chair, ASEPCO
J. W. Minor , Vice Chair, Paul Mucllcr Co.
1, L. Bradl ey, Eli Lllly and Co.
W. P. Burg, DECCO, lnc.
W. H. Cagney, JSG, LLC
R. O. Campbell, Bechtel
R. B. Fitts, Spraying Systems Co.
w. M. Huitt, W. M. Hu itt Co .
V. L. Norton, T&C Stainless, lnc.
S. Sharon, BioMarin Pharmaceutical, lnc.
P. 1,, Sturglll, Sturgill Welding and Code Consulting
T. J. Winter, Winter Technologies
E. A. 8enway, Cont1ibuting Member, lronwood Specialist. lnc.
A. P. Cirillo, Contributin9 Member, Cirillo Consulting Services, LLC
M. A. Hobmann, Contributi119 Member, Quality Coalescence
D. Kwil osz, Co11tributitlg Member, EH Lilly and Co.
SUBCOMMITTEE ON SYSTEMS DESIGN
J. T. Mahar, 3M Purifkation
A. D. Dyrness, Chair, Tr inity Consultants, ADVENT Life Sciences
M. L. Balmer, Vice Chair, Mcrck
B. Jensen, Vice Chair. AJFa Laval
J. W. Mlnor, Setrél'ú,y, Paul Mueller Co.
1, Ankers, Otean Alloys, LLC
l. Mak, Trlnlty Consultants, ADVENT Ufe Scienccs
R. Manser, DCI, lnc.
O. P. McCune, Allegheny Bradford Corp.
K. 8 . Mekhiors, Jacobs F,:ngi neeríng Group, lnc.
J. f . Monachello, Sí-> Industries
f . P. Armstrong, Cotter Brothers Corp.
P. Barrie, Sani·Matic
R. Berk, Hyde Engineering and Consulting
J. L. Bradley, EII Lilly and Co.
T. Bremner, AGC Biologics
C. Chaprnan, GEMU Valves
l. Conley, OPS Engineering
R. A. Cotte r, Cotter Brothers Corp.
M. Mortensen, NN E A/S
M. Pelletier, CRB
A. Powell, Consultant
L Rappl, BioMarin Pharmaceutical, lnc.
T. E. Roblllard, F'eldmeier Equipment,, l nc.
S. Sharon, BioMarín Pharmaceutical, l nc.
R. Snow, Sanofi Global
J. Craig. Holloway America
J. Crawley, Jacobs Engineering Group, lnc~
R. Warn, Operational Readiness Partners, lnc.
K. J. Westin, Roplan Sales, lnc.
J. Daly, BSI Engineerlng, lnc.
K. Ouncan, Duncan Enterprises, 11\c.
M. Embury, ASEPCO
J. Feldman, Yul a Corp.
T. Canty, Contrlbutlng Member, IM Canty, lnc.
X. Chen, Contributfn9 Member, lntegratcd Product Scrvkcs, LLC
J. Dvorscek, Contrlbutíng Member~ Vessel and Weld l nspectl on
Services, LLC
G. P. Foley, Contributing Member, PBM, lnc.
R. F. Foley, Contributin9 Member, OPS Engineering
J. Fortin, Contributing Member, Catalent
R. Hansel ka, Contributlng Member. Consultant
J. Fisher, Amgen, lnc.
J. W. Franks, El ectro( Specialties Co.
R. Gerra, Shire Pharmaceuticals
Z. Gu, Shanghai Morimatsu
M. Cutt?.ett. Bayer AG PharmaceutíéálS
T. L Hoblck, Holland Applied Te<hnologies
M. lnoue, Fujiki n, lnc.
S. M. Hartner, ContribuUng Member, Baxalta US, lnc.
C. Johnson, Genentech, lnc.
A. Kaiser, CRB
O. Hogensen, Contributíng Member, Amgen_, lnc:.
C. Kelleher, Contrlbuting Member~ Janssen Supply Chai n
D. 1\1. Marks, Contributing Member, O'Neal, lnc.
R. A. Michalak, Contributi119 Member, Eli Lilly and Co.
A. MorgenthaJer, Contributin9 Member, Wild Type, lnc.
P. M. Kubera, ABEC., lnc.
R. Lalonde, BFC Technologies, lnc.
1, Lorenz, Bristol Myer s S<¡uibb
C. N. Pacheco, Contrtbuting Member, Scaooast Mushrooms
S. Yang. Contributing Member, Sanl•Matk
R. J. Zlnkowskl, Contributing Member, RJZ Alliances, LL.C
J. Janousek, Abbott L.aboratories
xvii
SUBCOMMITTEE ON DIMENSIONS ANO TOLERANCES
B. A. Billmyer, Chair, Central States Industrial Equipment
J. Kendrick, Advanced Couplings, Ltd.
O. J. Mathien. Vice Chair, Bchringer Corp.
G. Montgomery, Vice Chair, Tank Component:s Industries
G. Krochnert, Ncumo
F. 1- Mannlng, VNE Corp.
P. L. McClune, fr., ITT Pure-Flo
8 . Munn, Consultant
L. J. Peterman, United Industries, lnc.
M. Thomas, Eppendorf Manufacturing Corp.
C. Chapman, SecrettJry, Ge.mu Valves
O. V. Anderson. Alfa Laval Kolding A/S
R. Bottorff, Dockweiler AG
O. Brockmann, United Industries, lnc.
R. Ca nell, Steel and O'Brien Manufacturing
C. C. Conn, Stecl and O'Brien Manufacturing
K. R. Davis, Nordson Mcdlcal
P. M. Dunbar, VNE Corp.
J. f'isher, Amgen, lnc.
R. 8 . fitts, Sprayi ng Systems Co.
J. Georgen, VNE Corp.
S. Henry, Advanced Coupling.,, Ltd.
R. Vermillion, Advance Fittings Corp.
F. G. Villela, Stockval Tecno Comercial,, Ltda.
T. Whitaker, 80
T. 1. Wlnter, Wi nter Technologie.s
R. Cosentino, Contribudng Member, Soleri do Brasil, Ltda.
R. f·. f'oley, Contribueing Member, DPS Enginee1i ng
M. Manfredi, Contributing Member, MC&P Equipamentos
SUBCOMMITTEE ON COMPONENTS FOR MULTIUSE
J. R. Oaniels, Chair, ITT Engi neered Valves, LLC
J. Pouliot, Vice Chair, Amgen
K. J. Westin, Vice Chair, Roplan Sales, lnc.
S. Haman, Setretary, Fristam Pumps
C. Ahrens, GEMO Valves, lnc.
M. Atklnson, Flowserve
J. A. BlumenthaL Perceptual focus, LLC
P. Oay, Fisher Controls Jnternational, lnc.
O. Oonnelly, Chemring Group PLC
M. Embury, ASEPCO
P. Esbensen, Alfa Laval Kolding A/S
J. Giffen, PBM, lnc.
B. O. Gregg. Steel and O'Brien Manufocturing, l nc.
J. Heaven, Crane Process Flow 'fechnology, Ltd.
M. lnoue, Fujikin, l nc.
O. lrish, Carten
C. A. Johnson, Genentech., lnc.
C. Kelleher, Jans.sen Biologtcs
8. Kennedy, GEMO Gebr. Müller Apparatebau GmbH
J. Kerr, PBM. lnc.
P. M. Kubera, ABEC, Jnc.
N. Marcum. A·T Controls, lnc.
J. Mar shall, Perrlgo, lnc.
M. Mcfeeters, The. BioProcess lnstitute
K. B. Mekhlor s, Jacobs Engineering Group, lnc.
A. R. Obertanec, Clark•Re.liance Corp.
A. Ogle, Huhnseal Mechanical Seals
c. N. Pacheco, Seacoast Mushrooms
M. Patterson, Huhnseal Mechanical Seals
S. Pitolaj, Garlock Scallng Tcchnologlcs
A. L. Powell, Consultant
R. Rleger, John Cr.me, lnc.
W. R. Sams, Richards l ndustrials
8 . Schipull, Emerson Automation Solutions
R. P. Schroder, Newman Sanitary Gasket Co.
S. Tanner, Gar lock Sealing Technologies
J. Vitti, Consult:ant
J. O. Vogel, The BioProces.s l nstitute
D. Wlse, John Crane, l nc.
R. J. 21nkowsk1, Contribut-íng Member, RJZ Alliance.s, LLC
SUBCOMMITTEE ON MATERIALS JOINING
J. Dvorscek, Chaír, Ve.sse.l and Weld lnspectíon Services, LLC
w. M. Huln, w. M. Huilt Co.
K. Bhaila, Vice Chair, ITT Engineered Val ves, LL.C
W. L. Rotb, Vice Chair, Welding Engineering Consultants
W. P. 8urg, Secretary, DECCO, l nc.
N. K. Bickel, Boehringer lngelheim
K. A. Brown, Feldmeler Equipmcnt, lnc.
R. D. Campbell, Bechtcl
T. 1. Cook, T&C Stainl•ss, lnc.
R. Cotter, Cotter Br others Corp.
R. A~Cotter, Cotter Brothers Corp.
J. Craig. Holloway Americ.a
C. W. E1kins, Central States Jndustrial Equipment
J. D. Fritz, JDF Metal Consulti ng
E. L. Gay er, Holloway America
J. Hammer, Pr octe.r & Gamble
L. T. Hutlon, Plasticwelding. LLC
O. Juritsch, Zeta GmbH
K. J. Matheis, Sr., Complete Automation, lnc.
N. s. McCauJey, A and B Process Systems
T. M. O'Connor, Central Statcs Industrial Equipmcnt
G. Placide, Pall Corp.
P. L. SturgJII, Sturgill Weldi ng and Cod• Consulti ng
G. R. Tabor, Oiamond T
C. A. Trumbull. Paul Mueller Co.
C. Weeks, RGD Project Management
E. A. Benway, Contributin._q Member, l ronwood Specialist. lnc..
R. Hanselka, Co11tributing Member, Consultant
B. K. Henon, Contributfn9 Member, Consultant
H. Relnhold, Conrributing Member, AM Technical Solutlons
xviii
SUBCOMMITTEE ON SURFACE FINISH
P. H. Banes, Chair, Asn·o Pak Corp.
T. J. Cook. Vice Cllair, T&C Stalnlcss, lnc.
1, Hamllto n, Vice Chair, Rohrbogen AG
N. Walter, Setretary, Central $tates Industrial Equipment
N. K. BickeL Boehringer l ngelheim
M. Bosley, L. J. Star, l nc.
K. A. Brown, Feldmeier Equipment, Jnc.
K. Chih·Feng, King Lai Group
C. C. Conn, Stcel and O'Brlcn Manufacturlng, lnc.
J. R. Daniels, ITI Enginccrcd Valves, LLC
C. W. Elk:lns, Central $tates Industrial Equipment
E. L. Gayer, Holloway America
J. Georgen. VNE Corp.
L. Hamilton, Steriflow Valve
S. T. Harrison, lfarrlson Elcctropolishlng, LP
D. Juritsch, Zeta GmbH
K. D. Kimbrel, VNE Corp.
G. Kroehnert. Neumo
M. Lovelace, Steel and O'Brlcn Manufacturing, lnc.
N. Marcum, A-T Controls, l nc.
R. McGonigle, Consultant
A. Navabi, Massachusetts Oivision of L. J. Star of Ohio
L. J. Peterman, United Industries, l nc.
P. A. Petrillo, Millenium Facilities Resources, Jnc.
J. Rau, Dockweiler AG
J. Schaecher, Astro Pak Corp.
P. D. Sedivy, RathGlbson
C. A. Trumbull, Paul Mueller Co.
T. J. Wi nter, Elkhorn Electropolish
R. E. Avery, Conr,ibuting Member, Nickel lnstitute
M. M. GonzaJez, Contributi119 Member, Consul rant
B. K. Henon, Contrlbuting Member. Consultant
F. J. Manning, Contributfng Member, VNE Corp.
R. K. Raney, Contrlbuting Member. UltraClean Electropollsh, lnc.
SUBCOMMITTEE ON POLYMERIC AND OTHER NONMETALLIC MATERIALS
M. Knox. Chair, W. L. Gore and Assoc-lates
). Ananl, Vice Chair, [MD Millipore
G. Eva ns, Vice Chair/SecreUJry, Ate Sanitary
M. McFeeters, Vice Ch(Jir, The BioProcess lnstitute
M. Allard, Venair
B. Allen, Sartorius
T. Andrews, CPC
C. J. cartson, E:xyte, lnc.
J. Carter, Cytiva
K. R. Oavl s, Nor dson Medical
P. C. Galvin, G~ Piping Systems, LLC
S. Hanstke, Genentech
J. R. Harp, Avantor
R. Hayes, BioMarin Pharmaceutical. Jnc.
L. T . Hutton, Plasdcwcldlng, LLC
M. W. Johnson, Entcgris
T. Lark1n, Jr., Mass Biologics
J. T. Mahar, 3M Purification
A. Palovcak, Arkema, lnc.
J. Pouliot, Amgen
P. Priebe, Qosina
R. Schroder, Ne¾rinan Sanitary Gasket Co.
T. Seelert, MMR Consulting
D. A. Seiler, Arkcma., lnc.
H. Slnkovlch, Meissner
R. A. Snow, Sanofi Gl obal
M. Thomas, Eppendorf Manufacturing Corp.
J. D. Vogel, The BioProcess lnstitute
T. Whitaker, 8D
A. Witmer, Rcgencron
SUBCOMMITTEE ON METALLIC MATERIALS
J. Rau, Chair, Dockweiler AG
J. Hammer, Secrerary, Procter & Gamble
T. Kobayashi, JGC Corp.
K. J. Matheis, Sr., Complete Automation, lnc.
D. P. McCune, Allcghcny Bradford Corp.
T. M. O'Connor, Central $tates Industrial E<¡uipment
D. L. Rol~ Astro Pak Corp.
W. L. Roth. Wel di ng Engineering Consultants
N. A. Schmidt, Boccar d Life Sciences
P. Sturgill, Sturgill \\felding and Code Consulting
R. E. Avery, Contrlbuting Member. Nickcl lnstitutc
N. Alms, RathGibson
P. Anderson, Samuel Pressur e Vessel Group
R. D. Campbell, Bechtel
J. W. Frnnks, El ectro! Speci alties Co.
J. D. Fritz, JOF Metal Consul ting
S. T. Harrison, Harrison Electropolishing, LP
W. M. Huitt, W. M. Hultt Co.
C. Ketterman, Unltcd Industries
xix
SUBCOMMITTEE ON CERTIFICATION REQUIREMENTS
T. J. Cook, Chair, T& C Stainless, lnc,
N. Bickel, Vice Chair, Bochringcr lngelhclm
W. M. Huitt, Vice Ch(Jír, W. M. Huitt Co.
S. Sharon, Vice Chair, BioMari n Phannaceutical, lnc:.
T. L. Hobick, Holland Applied Technologies
M. A. Hohmann, Consultant
L. T. Hutton, Plastic¾•elding. LLC
K. D. Klmbrel, VNE Corp.
B. A. Billmyer, Central $tates Industrial Equipment
O. Brockma nn, United Industries, lnc.
T. Larkin, Jr., Mass Biologics
R. D. Campbel~ Bechtel
R. Cohen, EGMO, Ltd,
W. F. Daprilc, EII Lilly and Co.
P. M. Dunbar, VNE Corp.
J. Dvorscek.i Vessel and Weld l nspection Services, LLC
E. L. Gayer, Holloway America
A. R. Obertanec, Clark·Reliance Corp.
K. J. Matheis, Sr., Complete Atttomation, lnc.
L. Rappl, BioMarin Phan naceutical, l nc.
W. L. Roth, Wcldlng Enginec-rlng Consultants
P. L. Sturgill, Sturgill Welding and Codo Consulting
M. M. Gonzafoz, C<Jnl'ribuUng Member, Consultant
SUBCOMMITTEE ON PROCESS INSTRUMENTATION
O. Kresge_. CRB Consulting F,:ngi neers
D. Kwllosz, Eli Lllly and Co.
R. Large, Gannett fleming
M. Muth, WJKA l nstruments, LP
J. R. Nerstad, Pure Supply, l nc.
V. Pai, Advent Englnccring Serviccs, lnc.
C. Perehnan, CRB Consulting Engineers
P. A. Pe trlllo, Millennium Facilities Resources, lnc:.
R. Shankar, RSE
G. Tischler, Vega Americas
G. Woods, CrossPoint Engi neering
J. Wynn, Paul Mueller Co.
J. Zipp, WIKA Alcxander Wiegand SE and Co. KG
J. Ankers, Contributfn9 Member, Occan AJloys, LLC
K. Renger lng, Contrlbutlng Member, Jacobs
A. Lamore, Chair, Burkert Fluid Control Sys1.ems, l,td.
V. Gorbls, Vice Chair, Genente<h/Roche
C. Placide, Vice Chair, Pall Corp.
J. Sipka. Secrew,y, Brooks lnstniment
J. A. Blumenthal. Perceptual Focus. LLC
R. Bond, Anderson lnstrument Co.
C. 1, Bragg. Bum s Engíneering. lnc.
T. Canty, JMCanty Associates, lnc.
R. Cosentino, Soleri do Brasil, Ltda.
J. W. Defeo, Hoffer f low Controls, lnc.
J. M. Featherston, KROHNE INOR
O. Fennell. TQ Constructors, l nc.
J. Gleeson, Hamilton Co.
A. Kalantari, Mcttlcr•Tolcdo
S. J. K.annenglesze r, Brooks l nsl.rument
O. T. Klees, Consultant
XX
CORRESPONDENCE WITH THE BPE COMMITTEE
General. ASM E Standards are developed and maintained with the inte nt to re present the consensus of concerned
interests. As s uch, users of this Standard may inte ract with the Committee by requesting interpretations, proposing
revisions or a case, a nd attending Committee meetings. Correspondence should be addressed to:
Secretary, BPE Standards Committee
The American Society of Mechanical Engineers
Two Park Avenue
New York, NY 10016-5990
http://go.asme.org/l nquiry
Proposlng Revlslons. Revisions are made periodically to the Standard to incorporate changes that appear necessary
or desirabie, as demonstrated by the experience gained from the application of the Standard. Approved revisions will be
published periodically.
The Committee welcomes proposals for revisions to this Standard. Such proposals should be as specific as possible,
citing the paragraph number(s}, the proposed wording, and a detailed description of the reasons for the proposal,
including any pertinent documentation.
Proposing a Case. Cases may be issued to provide alternative rules when justified, to permit early implementation of
an approved revision when the need is urgent, or to provide rules not covered by existing provisions. Cases are effective
immediately upon ASME approval and shall be posted on the ASME Committee web page.
Requests for Cases shall provide a Statement of Need and Background lnformation. The request should identify the
Standard and the paragraph, figure, or table nu mber(s}, and be written as a Question and Reply in the same format as
existing Cases. Requests for Cases should also indicate the appl icable edition(s) of the Standard to which the proposed
Case applies.
lnterpretatlons. Upon request, the BPE Standards Committee will render an interpretation ofany requirement ofthe
Standard.) nterpretations can only be rende red in response to a written request sent to the Secretary ofthe BPE Standards
Committee.
Requests for interpretation should pre ferably be submitted through the online lnterpretation Submittal Form. The
form is accessible at http://go.asme.org/lnterpretationRequest. Upon s ubmittal ofthe form, the lnquirer will receive an
automatic e-mail confirming receipt.
lf the lnquirer is unable to use the online form, he/she may mail the request to the Secretary of the BPE Standards
Committee at the above address. The request for an interpretation should be clear and unam biguous. lt is further recommended that the lnquirer s ubmit his/her request in the following format:
Subject:
Edition:
Question:
Cite the applicable paragraph number(s) and the topic of the inquiry in one or two words.
Cite the applicabie edition of the Standard for which the interpretation is being requested.
Phrase the question as a request for an interpretation of a specific requireme nt suitable for
general understanding and use, notas a requestfor an approval ofa proprietary design or
situation. Ple ase provide a condensed and precise question, composed in s uch a way that a
"yes" or ·no" reply is acceptable.
Proposed Reply(ies):
Provide a proposed reply(ies} in the form of ·ves" or "No; with explanation as needed. lf
entering replies to more than one question, please number the questions a nd replies.
Background lnformation: Provide the Committee with any background information that will assist the Committee in
understanding the inquiry. The lnquirer may also include a ny plans or drawings that are
necessary to explain the question; however, they should not conta in proprieta1y na mes or
information.
xxi
Requests that are notin the formal described above may be rewritten in the appropria te forma l by the Committee pr ior
to being a nswered, w hich may inadvertently change the intent of the original request.
Moreover, ASME does not act as a consultan! for s pecific engineering problems or for the genera l application or
understanding of the Sta ndard requirements. lf, based on the inquiry informa tion s ubmitted, it is the opinion of
the Committee t ha t the lnquirer s hould seek a ssistance, the inquiry will be retu rne d with the recommenda tion
that s uch assistance be obtained.
ASME procedures provide for reconsideration of any inte rpretation when or if additional information that might affect
a n inte rpretation is available. Further, persons aggrieved by an interpretation may appeal to the cognizant ASME
Committee or Subcommittee. ASME does not "approve," "certify," "rare;· or •endorse" a ny item, construction, proprieta ry
device. or activity.
Attending Committee Meetings. The BPE Standards Committee regularly holds meetings a nd/or telephone conferences thatare open to the public. Pe rsons wishing to attend any meeting and/or telephone conference should contact the
Secretary of the BPE Standards Committee.
xxii
ASME BPE-2022
SUMMARY OF CHANGES
Followingapproval by theASME BPE Committee andASME, andafterpublic review,ASME BPE -2022 was approved by the
American National Standards lnstitute on March 2 1, 2022.
In ASME BPE-2022, Part SG has been redesignated as Part MC, its title has been revised, and ali related cross· references
have been updated throughout. In addition, ASME BPE-2022 includes the following changes identified by a ma rgin note,
(22).
Page
locaCion
Change
1
1
2
2
Chapter 1
GR-2
GR-4.l
GR-4.2
GR-4.2.1
Table GR-4.2-1
GR-4.2.3
GR-5.3
GR-5.3.1
Title revised
First a nd last paragraphs revised
Subparagraph (b) revised
Revised
First sentence revised
Title revised
Subparagra ph (d) reví sed
2
3
6
7
7
7
7
8
8
GR-5.3.2
GR-5.3.3
GR-5.3.4
GR-7
10
GR-8
Title revised
Last sentence added
Revised
Revised
Revised
(1) First paragraph revised
(2) AWS 0182, ASQ/ANSI 2 1.4,ASTM 0199,ASTM 0499 1, ASTM
E499,ASTM ES l S, ASTM E1003, ISO 1402, ISO 2859-1, and PPI
Standard ES-SO added
(1) Oefinitions of animal-derived ingredients (AD/), animal•
derived products (ADP), audit, audit (as performed by ASME or
their designee 011 ASME BPE Certificate Holders and Applicants),
compliance, conformance, conformity, drainable, looped header,
multiuse, process equipmen~ process system, repeated use,
single-use, special process, strainer, strainer body, strainer
element, surveillance, survey, survey (as performed by ASME or
their designee on ASME BPE Certificate Holders and Applicants),
and swing elbow added
(2) Oefinitions of blind weld, clean steam, Quality lnspector's
Delegate, Material Test Report (mil/ report or MTR), process
componen~ pure steam, testing (as it relates to pressure vessels),
testing (as it relates to process equipment), testing (as it relates to
process piping), a nd testing (as it relates to vessels not rated for
pressure service) revised
(3) Defin ition of selfdraining deleted
20
23
23
Chapter 2
MM-2.1
MM-3.1
Former Chapter 6 redesignated a nd revised in its e ntirety
Revised
Revised
xxiii
Page
location
Change
23
MM-3.2
(1) First par agraph revised
(2) Third and fourth paragraphs deleted
23
MM-3.3
Revised
24
Table MM-2.1· 1
"JIS Designation" column and data added
25
Table MM-2.1· 2
(1) · uNS Number" and · EN Designation" column heads revised
(2) "J IS Designation" column and data added
(3) For N10276 and N06022, · other" data revised
26
Tab le MM-2.1-3
27
MM -3.5
"JIS Designation" columns and data added
Revised
27
MM-3.6
Deleted
27
MM-4.1
First paragraph revised
27
MM-4.2
(1) Title revised
(2) ASTM A213/A213M, AST M A249/A249M, ASTM A269/
A269M, ASTM A270/A270M, ASTM A312/A312M, ASTM
A511/A5 11M, ASTM B619/B619M, and ASTM B690/B690M
revised
(3) JIS G 3447, JIS G 3459, and JIS G 4903 added
28
MM-4.3
(1) ASTM A351/A351 M, ASTM A743/A743 M, and ASTM A890/
A890M revised
(2) JIS G 5121 added
28
MM-4.4
(1) ASTM A182/A182M, AST M 8462, and ASTM 8564 revised
(2) JIS G 32 14 and JI$ G 4319 added
28
MM -4.5
(1) ASTM A240/A240M, ASTM A666, ASTM B443, ASTM B575,
and ASTM B688 revised
(2) JIS G 4304, JIS G 4305, JIS G 43 12, and JIS G 4902 added
28
MM -4.6
(1) Title, first paragraph, ASTM A276/A276M, ASTM B574, and
ASTM B691 revised
(2) EN 10263· l , EN 10263-5, and last paragraph deleted
(3) JIS G4303, )IS G4308, JIS G4311,J ISG4901, JIS H 4553,and )IS
H 4554 added
29
MM -4.7
Deleted
29
MM -5.2.1
(1) Title revised
(2) MM -5.2.1.1 added
(3) Former M-5.2.1.1 revised and redesignated as MM-5.2.1.l(a)
(4) Former MM-5.2.1.2 revised and redesignated as
MM -5.2.1.l(b)
(5) Fonner MM-5.2.2 revised and redesignated as MM -5.2.1.2
(6) Former MM-5.2.3 revised and redesignated as MM -5.2.1.3
29
Table MM-5.2.1.l· l
For mer Table MM-5.2.1.2 ·1 redesignated
30
MM -5.2.2
Added
30
MM-5.2.3
Former MM-5.2.4 redesignated
30
MM-5.2.4
Former MM-5.2.5 revised and r edesignated
30
MM-5.2.5
Former MM-5.2.6 revised and redesignated
30
Table MM-5.2.5-1
(1) Former Table MM-5.2.6-1 redes ignated
(2) Note (3) revised
30
MM -5.2.6
For mer MM -5.2.7 revised and redesignated
30
MM -5.3
(1) Cross-r eferences to tables updated
(2) Paragraph following subpara. (b) revised
(3) Last paragraph added
xxiv
Page
location
Change
31
Table MM -5.3-1
(1) Title revised
(2) "JIS Designation." "JIS Z 3221 Designation; and "JIS Z 3321
Designarion" colum ns and data added
(3) Under SMAW, "ISO 14343-A" revised to "ISO 3581-A"
33
34
Table MM -5.3-2
Added
Table MM-5.3-3
Added
35
Table MM-5.3-4
Added
36
Table MM -5.3-5
Former Table MM -5.3-2 redesignated
37
MM-5.3.1
Last sentence added
37
MM-5.3.2
Revi sed
37
MM-5.3.3
Added and subsequent paragraph redesignated
37
MM-5.3.4
Former MM-5.3.3 revised
38
37
Table MM-5.3.4-1
Former Table MM -5.3.3· 1 redesignated
MM-5.4
Last paragraph revised
39
Table MM-5.4· l
Revised
37
MM-6
(1) Title revised
(2) MM-6.1 deleted and subsequent paragraphs redesignated
(3) In MM -6.2 (former MM -6.3), first paragraph revised
(4) In MM-6.3 (former MM -6.4), cross-reference updated
(5) In MM -6.4 (former MM -6.5), cross-reference updated
37
MM-8.1
First paragraph added
39
MM-9.1
First paragraph revised
39
MM-9.1.1
Subparagraph (d) revised
39
MM-9.1.2
Subparagraph (e) revised
42
Table PM-2.1.1-1
Revised
43
PM-2.2
First paragraph revised
43
"Compliance" revised to "conformance" throughout
44
PM-2.2.1
Table PM-2.2.1-1
Title and General Note revised
44
PM-2.2.3.1
Revised
48
PM-4.1
Revi sed in its entirery
48
PM-4.2.l
Penultimate sentence revised
so
so
so
PM-4.2.S
Last sentence revised
PM-4.3.2.S
Subparagraph (b) revised
PM -4.3.3.3
51
PM -4.3.5
In subpara. (a). last sentence revised
Title revised
51
PM-4.3.5.1
"Compliance" revised to "conformance" throughout
51
PM-4.3.5.2
Title and first sentence revised
51
PM-4.4
(1) Sections PM-4.4 and PM-4.5 deleted and fonner section
PM-4.6 redesignated
(2) Cross-references in current PM-4.4.2, PM-4.4.2.1, and
PM-4.4.2.2 revised
52
Chapter 4
(1) Former Chapter 2 redesignated
(2) Title revised
52
Part SD
Title revised
52
SD -1
Last sentence revised
52
SD -2
Revised
XXV
Page
location
Change
52
52
53
53
53
53
54
54
54
55
55
55
55
55
56
56
56
63
63
63
63
63
64
65
65
69
70
72
S0-2.2
SD-2.3
S0-2.3.1
SD-2.3.1.1
SD-2.3.1.1.1
SD-2.3.1.1.2
SD-2.4.1.1
S0-2.4.2
S0-2.4.3.1
SD-2.4.3.2
SD-2.4.3.3
Table SD -2.4.3.1-1
SD-2.4.3.4
SD-2.4.4.2
S0-2.6
S0-3
SD-3.1.1
SD-3.1.2.4
SD-3.1.2.4.1
SD-3.1.2.4.2
SD-3.2.1
S0-3.2.2
SD-3.3.1
SD-3.3.2.2
SD-3.3.2.4
SD-3.4
Figure SD-3.4.2 -1
Figure SD-3.4.2-3
76
77
Figure $0-3.4.3-2
Figu re $0-3.4.6-1
78
SD-3.5.1
82
82
82
82
85
86
87
87
89
90
SD-3.5.3
SD-3.5.4
SD-3.5.5
SD-3.5.6
SD-3.6
Figure S0-3.6.2-1
SD-3.7.1
SD-3.7.2
Figure SD-3.7.2-1
SD-3.7.3
Revised in its e ntirety
Revised in its e ntirety
Revised
Revised
Subparagraph (b} revised
Subparagraphs (t) through (h} added
Last paragraph revised
Subparagraph (b)(2) revised
Revised
Subparagraphs (b) and (e) and the last paragraph revised
Revised
Title revised
Revised
Subparagraph (e) revised
Added
Title revised
Subparagraph (e) revised
Subparagraph (a} revised
Revised
Subparagraph (a) revised
Subparagraphs (a) and (d) revised
Subparagraph (e) revised
Subparagraphs (a), (e), (d), a nd (t) revised
Subparagraph (t) revised
Subparagraph (e) revised
Revised in its e ntirety
lllustration (a) revised
(1) Title, illustrations, a nd Note (1) revised
(2) Notes (2) through (4) added
Title and illustration (d) revised
(1) lllustration (b) revised
(2) Note (1) added
(1) Subparagraphs (a), (b), and (e) revised
(2) Subparagraphs (g) and (k) added and former subparas. (g)
through (i) redesignated
Subparagraphs (t) and (g) revised
Subparagraph (d} revised
Subparagraphs (b) through (d), (t), and (g) revised
Subparagraph (e) added
Revised in its e ntirety
Former Figure S0-3.6.1-1 redesignated
Subparagraph (e) revised
Subparagraphs (e) and (g) revised
Title, illustration, and Notes revised
Revised
x:xvi
Page
90
90
90
90
93
94
94
95
97
98
99
99
100
100
101
location
SD-3.7.4
SD -3.7.5
SD -3.7.6
SD -3.8
SD -3.9.1
SD -3.9.2
SD -3.9.2.1
SD -3.9.2.2
SD -3.9.2.3
SD -3.13
SD -3.15
SD -3.16
SD -3.17
Figure SD-3.17.1-1
SD-3.18
102
102
102
102
102
104
104
104
107
107
107
112
112
112
114
114
117
117
SD-4
SD -4.1.1
SD -4.1.2.1
SD-4.1.2.2
SD -4.2.1
SD -4.2.2
SD-4.2.3
SD -4.3.1
SD -5.1.4.3
SD -5.1.4.4
SD -5.1.4.7
SD -5.1.4.11
SD -5.1.4.13
$D-5.1.4.14
SD-5.l.S
SD -5.1.5.1
SD -5.1.5.2
SD-5.1.5.4
117
119
121
123
123
123
123
124
124
SD -5.2
SD -5.3
SD-5.4
Figure SD-5.4.5.1-1
SD ·S.5
SD -5.5.1
SD -5.5.3
SD -5.5.5.2
SD -5.6
Change
Subparagraphs (bl through (d) revised
Subparagraph (e) revised
Subparagraphs (b) and (e) revised
Revised in its entirety
First sentence and subpara. (!)(2)(-a) editorially revised
Subparagraphs (a), (b), (e), a nd (j) revised
Subparagraphs (b) and (f) revised
Subparagraphs (a) a nd (e) revísed
Subparagraphs (a) a nd (f) revised
Subparagraphs (b) and (e) revised
Subparagraphs (e), (f) through (h), and U) revised
Subparagraphs (a) a nd (e) revised
Added
Added
(1) Former PM-4.4 relocated and redesignated
(2) SD-3.18.6 title revised
(3) SD-3.18.6.2 revised
Title revised
Subparagraph (e) revised
First sentence and sentence following subpara. (b) revised
Subparagraphs (a), (b), (j), (1), and (n) revised
Subparagraph (e) revised
Subparagraphs (e), (g), and (h) revised
Subparagraphs (a) a nd (d) revised
Subparagraphs (a), (e), and (f) revised
Subparagra ph (e) editorially revised
Subparagraph (d) revised
Subparagraph (f) editorially revised
Subparagraph (b) revised
Subparagraph (b) revised
Subparagraphs (bl and (e) revised
Subparagraph (e) revised
Subparagraphs (e) through (g) revised
Subparagraphs (d) and (f) revised
(1) Subparagraph (e) editorially revised
(2) Subparagraph (f) added
Revised in its entirety
Revised in its entirety
Revised in its entirety
Former Figure SD-5.4.4-1 redesignated
Revised
Added
Added
Revised
Revised in its entirety
xxvii
Page
125
129
130
131
131
131
132
132
132
133
133
133
133
133
133
134
134
135
135
135
135
137
138
139
139
140
141
142
142
145
145
145
147
148
148
148
148
149
149
149
150
151
152
153
location
Figure SD-5.6.4-1
Figure SD-5.6.5-1
SD-5.7.1
SD-6.1.3.1
SD-6.1.4
SD-6.1.4.1
SD-6.1.4.4
SD-6.1.4.6
SD-6.1.4.7
SD-6.1.4.8
SD-6.1.4.9
SD-6.1.4.10
SD-6.1.S
SD-6.1.5.2
SD-6.l.S.3
SD-6.1..7.3
SD-6.2.4
SD-6.2.4.1
SD-6.2.4.6
SD-6.2.4.10
SD-6.3
Figure SD-6.3.4.1.1-1
Figure SD-6.3.4.2-1
Figure SD-6.3.4.2 -2
Figure SD-6.3.4.2-3
Table SD -6.3.4.2-4
Table SD -6.3.5.2.1-1
SD-6.4.1.1
SD-6.4.3.2
SD-6.4.4.1
SD-6.4.4.4
SD-6.4.4.5
SD-6.5.1
SD-6.5.3
SD-6.5.4
SD-6.5.4.1
SD-6.5.4.2
SD-6.5.4.3
SD-6.5.5.1
SD-6.5.5.2
SD-6.5.7.1
SD-6.6.4
SD-6.6.4.7
SD-6.6.4.9
Change
Former Figure SD-5.6.2-1 redesignated
Former Figure SD-5.6.3·1 redesignated
First sentence revised
Subparagraph (b)(2) revised
Subparagraphs (a)(l), (a)(4), (a)(5), and (b) revised
Subparagraph (b) revised
Subparagraph (c)(S) revised
First paragraph revised
Subparagraphs (a) and (e) revised
Subparagraphs (b) and (e) revised
Subparagraph (a) revised
Subparagraph (a) revised
Subparagraph (b) revised
Subparagraph (e) revised
Subparagraphs (e) and (f) revised
First sentence revised
Revised
l.ast sentence revised
Revised
Subparagraph (a) revised
Revised in its e ntirety
Added
Former Figure SD-6.3.4.6· 1 redesignated
Former Figure SD-6.3.4.6·2 redesignated
Former Figure SD-6.3.4.6-3 redesignated
Added
FormerTable SD-6.3.5.2-1 redesignated and revised in its entirety
Definitions of cooling equipment and heating equipment revised
Revised
First paragraph and subpara. (b) revised
Revised
Subparagraphs (e) and (f) revised
Definition of general load immersion basket/rack revised
Subparagraphs (e) and (g) revised
Subparagraph (a) revised
Subparagraph (e) revised
Subparagraph (g) revised
Subparagraphs (a) and (b) revised
Subparagraph (b) revised
first sentence a nd last paragraph revised
Subparagraphs (b) and (d) revised
Subparagraph (b) revised
Last paragraph revised
First sentence revised
x:xviii
Page
153
153
155
156
location
SD -6.6.4.11
SD -6.6.5.1
SD -7.4
Chapter 5
156
156
156
156
156
156
157
157
DT-2
DT-3
DT-4
DT-4.1.1
DT-4.1.2
DT-4.1.4
DT-4.4
DT-4.4.1
157
157
157
158
158
158
158
159
DT-4.6
DT-7
DT-8
DT-9.2
DT-9.3
DT-9.4
DT-10.3
DT-11.1
159
DT-11.1.1
159
159
160
DT-11.2
Table DT-2-1
Table DT-3-1
192
161
Figure DT-9.4· l
Table DT-3·2
161
166
167
170
172
174
175
181
184
187
Table DT-4-1
Table DT-4.1.1-9
Table DT-4.1.1-10
Table DT-4.1.2-6
Table DT-4.1 .2-8
Table DT-4.1.2·12
Table DT-4.1.2·13
Table DT-4.4.1-1
Table DT-7.1-1
Table DT-7.1-2
190
193
Table DT-7.3-1
Table DT-11.1.1 -1
Change
First paragraph revised
Revised
Revised in its entirety
(1) Former Chapte r 4 redesignated
(2) Title revised
Revised in its entirety
Second paragraph revised
First sentence revised
Revised
Revised
Revised
Second paragraph deleted
(1) Title revised
(2) Last sentence added
Added
Revised in its entirety
First paragraph revised
Revised
Revised
Subparagraph (e) revised
Second and fourth paragraphs revised
(1) Title, first paragraph, a nd subpara. (a) revised
(2) Subparagraph (e) added and s ubsequent subparagraphs
redesignated
(1) Subparagraph (a) revised
(2) Subparagraph (e) added
Section DT-11.2 deleted and former section DT-11.3 redesignated
Revised in its entirety
(1) Title revised
(2) General Note (f) added
Former Figure DT·2·1 redesignated
(1) Title revised
(2) General Note added
General Note revised
Added
Added
Revised
Revised
Added
Added
Title revised
Table DT-7-1 redesignated
(1) Former Table DT-7-2 redesignated
(2) lllustrations and data in "Face Offset, H"columns revised
Table DT-7-3 revised and redesignated
Added
XJ<U(
Page
location
Change
194
194
194
194
197
200
Part PI
Pl-2
Pl-2.1.1
Pl-2.1.3
Pl-2.2.3
Pl-4.2.2.1
201
202
Figure Pl-4.2.2-1
Pl-4.2.3.1
202
202
211
214
215
Pl-4.2.4
Pl-4.2.S
Pl-8.1
Pl-8.2
Pl-9.1.3
217
218
218
220
220
223
230
Figure Pl-9.1.3.2-1
Figure Pl-9.1.3.4-1
Figure Pl-9.1.3.4-2
Figure MC-2.2.2-1
Figure MC-2.2.2-2
MC-2.3.1.9
MC-2.3.2.1
230
MC-2.3.2.3
231
231
232
232
237
237
237
238
238
239
Figure MC-2.3.2.3-1
Figure MC-2.3.2.3 -2
Figure MC-2.3.2.3-3
MC-2.3.2.4
MC-3.1
MC-3.2
MC-3.3.1
MC-3.3.2.1
MC-3.3.2.2
MC-3.3.2.3
241
MC-3.3.2.4
242
243
243
244
MC-3.4.l
MC-3.4.3
MC-4.1
MC-4.3.1
Title revised
First two paragraphs dele ted
First paragraph revised
First sentence revised
Revised
(1) Subparagraph (e) and last paragraph deleted
(2) Former subpara. (f] redesignated as (e)
Revised
Former Pl-4.2.3.1 and Pl-4.2.3.2 deleted and Pl-4.2.3.3
redesignated
Former Pl-4.2.4 deleted a nd Pl-4.2.5 redesignated
Former Pl-4.2.6 revised and redesignated
Revised in its e ntirety (including figures)
Revised in its e ntirety (including figures)
Former Pl-9.1.3.1 deleted and s ubsequent paragraphs
redesignated
Former Figure Pl-9.1.3.3-1 redesignated
Former Figure Pl-9.1.3.5-1 redesignated
Former Figure Pl-9.1.3.5-2 redesignated
Cross-reference in title revised
Cross-reference in title revised
Subparagraph (a) revised
(1) Subparagraph (a) reformatted as first paragraph
(2) Subparagraph (b) deleted
Subparagraphs (a), (a)(l), (a)(3), (a)(S) through (a)(7), (b),
(b)(l), (b)(3), (b)(6), and (b)(7) revised
Title revised
Title revised
Title revised
Subparagraphs (1) through (k) revised
Revised in its e ntirety
Revised in its e ntirety
Subparagraphs (a) and (f] revised
Subparagraph (b) revised
Subparagraphs (c)(7)(·b)(-2) a nd (c)(7)(-c) revised
(1) Subparagra phs (a)(l), (a)(3), (a)(6), (b)(2), (b)(3), (e), (c)(3),
(e), (f], (h), and (k) revised
(2) Subparagraphs (a)(S), (a)(lS), a nd (a)(l 6) deleted a nd
s ubsequent subparagraphs redesignated
(3) Subparagraph (a)(l4) added
Subparagraphs (a)(8), (a)(l0), (e), (c)(l) th rough (c)(7), (d), a nd
(d)(l) through (d)(7) revised
Revised
Revised
First paragraph revised
First paragraph revised
Page
location
Change
244
MC-4.3.1.1
Second paragraph revised
244
MC-4.3.2.1
Subparagraph (d) revised
245
MC-5.1.1
Revised
246
MC-5.3
Subparagraph (a) revised
248
Chapter 6
(1) former Chapter 5 redesignated
(2) Title revised
248
Part MJ
249
M)-3.1
Title revised
Revi sed
249
MJ-3.2
Added
250
Figure M)-3.2-1
Added
251
Figure M) -3.2-2
Added
249
M)-3.2.1
(1) Former MJ -3.2 redesignated
(2) Ti tle revised
249
M)-3.2.2
253
MJ-7.2.2
Added
Revised
253
MJ-7.2.3
Revi sed
253
M)-7.2.4
Revised
253
M)-7.2.5
Revised
253
M)-7.2.6
(1) First paragraph revised
(2) Subpa ragraphs (a) and (b) and last paragraph deleted
255
M)-8.3
(1) First paragraph revised
(2) Second paragraph added
255
M)-8.4.2
256
Table M)-8.2-1
Subparagraph (d) added
Revised
258
Table MJ-8.3-1
260
Table MJ-8.4-1
Revised
Revi sed
262
Figure MJ-8.4-1
Labels revised
263
264
Figure M) -8.4-2
Text underneath figure revised
Figure M)-8.4-3
Text underneath figure revised
265
Figure M) -8.4-4
266
Table M)-8.5-1
Labels for illustrations (b) and (e) revised
Revised
268
Figure MJ -8.5-1
Labels revised
269
MJ-9.6.2.1
Revised
269
M)-9.6.2.2
(1) First paragraph revised
(2) Subparagraphs (a) and (b) and last paragraph deleted
269
M)-9.7.l
Revised in its entirety
270
Table MJ -9.7.1 -1
Added
271
Figure M) -9.7.1-1
272
Part SF
Labels and illustration (d) r evised
Title revised
272
SF-2.2
Revised
273
Table SF-2.2-1
Revi sed
272
SF-2.3.2
Cross-reference updated
273
SF-2.4.1
Last sentence revised
274
Table SF-2.4.1·1
General Note ( d) reví sed
274
SF-2.6
Revised
xxxi
Page
location
Change
275
274
276
276
277
280
282
284286
287
294296
296
297
298
Table SF-2.6-1
SF-2.8
Table SF-3.3· 1
Tab le SF-3.4-1
Chapter 7
Chapter 8
Chapter 9
Mandatory Appendix 1
Mandatory Appendix 111
Mandatory Appendix IV
C-2
D-4.3
D-4.4
Table D-2-1
Table D-2-2
299
300
301
303
303
304
304
Table D-3.1-1
Table D-3.2 -1
Table D-4.1 •l
E-1
E-2.2
E-3.1
E-3.2
304305
306
307
311
312
E-4.1
Table E-3.2·2
E·S.1
Table E-5-1
F-3
Table F-1-1
313
318
320
320
Table F-3-1
Table J-1.1 -1
K-1.1
K-1.2
353
354
355
Z-2
Z-3.2
General Note (a) revised
Second paragraph revised
Revised
General Note (b} revised
Added
Added
Added
Deleted
lnformation revised and relocated to Parts SU, SC. and SJ
1,ast l/d cross·reference updated
Subparagraph (b} revised
First sentence revised
First paragraph revised
Considerations for ·Anoy composition·· revised
(1) Variable • High-shear/velocity environment (pump impeller,
sprayball, tees, etc.)" revised
(2) Considerations for "Operating temperature and temperatu re
gradients" revised
Revised
Revised
"Conditions of Process" column and Note (3) revised
First paragraph revised
First sentence added
Third paragraph revised
Subparagraph (a}(2} deleted and s ubsequent subparagraphs
redesignated
First paragraph revised
Revised
Title and first sente nce revised
Revised
First sentence revised
"Purpose ofTest" revised for ASTM A262, Practice C; ASTM A923,
Method C; and ASTM G48, a li methods
Revised in its e ntirety
Revised in its e ntirety
First paragraph revised
(1) First paragraph revised in its entirety
(2) In K-1.2.1.subparas. (b), (c)(l) through (c)(5), (d), (e), and (g)
revised
(3) K-1.2.2 deleted and subsequent paragraphs redesignated
(4) K-1.2.3.2 deleted
(5) In K-1.2.3 (formerly K· 1.2.4), first paragraph revised and
subpara. (e) added
)IS procurement contact information added
Revised
Subparagraphs (b) a nd (c}(8} revised
Nonmandatory Appendix Y
xxxii
Page
355
location
Z-3.5
356
Z-3.8
357
363
Z-3.12
Nonmandatory Appendix CC
366
368
378
383
385
DD-2
Nonmandatory Appendix EE
Nonmandatory Appendix FI'
Nonmandatory Append ix GG
lndex
Change
(1) Second paragraph revised
(2) Third paragraph added
(1) Subparagraphs (b)(l), (b)(l)(-a), and (b)(2) revised
(2) Subparagraph (b)(2)(-e) added
Subparagraph (e) revised
Title and ·cenera!, Personnel, and Procedures• and "lnspection"
sections of table revised
Title corrected by errata
Added
Added
Added
Updated
xxxiii
INTENTIONALLY LEFT BLANK
xxxiv
ASME BPE-2022
CHAPTER 1
INTRODUCTION, SCOPE,
ANO GENERAL REQUIREMENTS
(22)
PART GR
GENERAL REQUIREMENTS
GR-1 INTRODUCTION
men tal principies of t his Standard. Such judgmen ts
shall not be used to override mandatory regulations or
specific prohibitions of this Standard.
New editions of the ASME BPE Standard may be used
beginning with the date of issuance and become effective
6 months after the date of issua nce.
The ASM E Bioprocessing Equipment (BPE) Standard
was developed to aid in the design and construction of
new fluid processing equ ipment used in the manufacture
ofbiopharmaceuticals, where a defined level of purity and
bioburde n control is required.
The Standard typically applies to
(a) components that are in contact with the product,
raw materials, or product intermediates during manufacniring, development, or scale-up
(b) systems that a re a critica! part of product manufacture [e.g., water-for-injection (WFI}, clean steam, filt ration, and intermediate product storage]
The General Requirements Part states the scope of the
ASM E BPE Standard and provides references and definitions that apply throughout the Sta ndard.
When operating unde r pressure conditions, syste ms
shall be cons tructed in acco rda nce wit h t he ASME
Boiler and Pressure Vessel Code (BPVC}, Sectio n VIII,
and/or ASME B31.3 Process Piping Code or applicable
local, national, or inte rnational codes or standards. The
owne r/user may stipulate additional or alternative specí·
fications and requirements.
This Standard shall govern the design and construction
of piping systems for hygienic service. For process piping
systems designed and constructed in accordance with
ASME B31.3, it is the owner's responsibility to selecta
fluid service category for each fluid service. Should any
fluid service meet the definition of high-pu rity flu id
service (ASME B31.3, Chapter X) it is recommended
that such flu id service be selected and the requirements
of this Standard a nd ASME B31.3, Chapter X be met.
When a n application is covered by laws or regulations
iss ued by an e nforcement authority (e.g., municipa l,
provincial, state, or federal), the final construct ion requirementS shall conform to these laws.
ltems or re quireme nts tha t are not specifícally
addressed in this Sta ndard are not prohi bited. Engineering judgments must be consistent with the funda-
GR-2 SCOPE OF THE ASME BPE STANDARD
The ASME BPE Standa rd provides requirements for
syste ms and com ponents that are subject to cleaning
and sanitization a nd/or st erilization including systems
t hat are cleaned in place (CIP'd) and/or stea med in
place (SIP'd) and/or other suitable processes used in
the manufacturing of biopharmaceuticals. This Standard
also provides requirements for single-use systems and
compone nts used in the a bove listed applications. This
Standard may be used, in whole or in part, for other appli·
cations where bioburden risk is a concern.
This Standard applies to
(a) new system (and component) des ign and fabrication
(b) defin ition of system boundaries
(e) specific metallic, polymeric, a nd elastomeric (e.g.,
seals a nd gaskets) materials of construction
{d) component dimensions and tolerances
(e) surface finishes
(f) materials joining
(9) examinations, inspections, and testing
(h) certification
This Standard is inte nded to apply to new fabrication
and construction. 1f the provisions of this Standard are
op tionally applied by an owner/user to existing, inservice equipment, other considerations may be necessary. For insta llations between new construction and
an existing, in-service system, such as a retrofit, modification, or repair, the boundaries and requirements must be
agreed to among the owner/user, engineer, installation
contractor, and inspection contractor.
1
(22)
ASME BPE-2022
The own er/ user determines which requirements oí the
Standard a re applicable to individual components, equipment, or systems based on in tended service. However, for
a compo n ent, equipme nt, o r sys te m to be BPEconforming, adherence to ali applicable requirements
oí this Standard is mandatory.
(e) Pipin9 and Tubin9. Examiner, defined as a person
who performs quality control examinations for a manufactureras a n employee of the ma nufactureras defined in
ASME B31.3, para. 341.1.
When local regulations require that pressure equipment be designed and constructed in accordance with
stan dard s oth e r tha n ASM E codes/standards, t he
inspector in this Standard is defined as one who is accept·
able to the relevant regulatory authority.
GR-3 MANUFACTURER'S QUALITY ASSURANCE
PROGRAM
The manufacturer shall impleme nt a qua lity assurance
program describing the systems, methods, a nd procedures used to control materials, drawings, specifications,
fabrication, assembly techn iques, and exam ination/
inspection used in the manufacturing of bioprocessing
equipment.
Nonma ndatory App e ndix Z, Quali ty Management
Syste m, provides guida n ce o n quality assurance
programs. This is only required for orga nizations tha t
are ASME BPE Certifica re Holders or applicants (see
Part CR). However, it may be used by any organization
that implements this Standard.
GR-4,2 Quality lnspector's Delegate
(22)
Quality lnspector's Delegate qualifications s hall be in
accordance with the requirements listed herein. The
employer of the Quality lnspector's Delegare shall have
docu mente d tra ining and q ua lifi cation programs to
ensure the qualifications and capabilities oí personnel
are met.
The capa bi l it ies requirements are listed i n
Table GR-4.2-1. lt is required that a capability listed
for a lower leve) of qualification is a lso required for· subsequent higher levels of qualification.
GR-4 .2.1 Levels ofQualífication. There a re four levels (22)
of qualification for Quality lnspector's Delegate. Examinatio n person nel qual ificatio ns are not covered in this
section but s hall be in acco rdance with ASME 831 .3,
para. 342.
(a) Trainee. An individual who is notyetcertified toany
leve! s hall be considered a trainee. Tra inees shall work
under the direction of a certified Quality Jnspector's Delegare and s hall not independently conduct any tests or
write a report of test results.
(b) Quality lnspector's Delegate 1 (QID-1). This individual shall b e qua lified to properly perform specific calibrations, specific inspections, and specific evaluations for
acceptance or rejection according to written instructions.
A Ql D-1 may perform tests and inspections according to
the capabilities' require ments under the supervision of, at
a mínimum, a QID-2.
(e) Qua/ity lnspector's Delegate 2 (QID-2). This individ·
ual s hall be qualified to set up and calibrate equipment and
to interpret and evaluare results with respect to applicable
codes, standards, and s pecifications. The QID-2 s hall be
thoroughly familiar with the scope and limitations of
the inspection they are performing and s hall exe rcise
assigned responsibility for on-the·j ob training and
guidance of trai nees and QID · l personnel. A QID -2
may perform tests and inspections according to the
capabilities' requirements.
(d) Quality JnspecUJr's Dele9ate 3 (QJD-3). This individual s hall be capa ble of esta blishing techniques and proce·
dures; inte rpreting codes, standards, specifications, a nd
procedures; and designating the particular inspection
methods, tech niques, a nd procedures to be used. The
QID-3 shall have sufficient practica! background in applicable materials, fabrication, and product technology to
GR-4 EXAMINATION, INSPECTION, AND TESTING
The examination, inspection, and testing req uirements
are specified in each Part oí this Standard. If a n inspection
or examination plan is required, it shall be developed a nd
agreed to by t he owner/user, contractor, inspe ction
contractor, a nd/or engineer e ns uring that the systems
and components meet this Standard .
As it relates to pressure vessels, vessels not rated for
pressu re service, process piping and tubing, and process
contat"t equipment, this Standard uses the terms examination, inspection, and testing and oth er forms of these
terms in a manner consistent with the uses in ASME
8PVC, Section VIII, and ASME 831.3. References for examination, ins pection,and testing per this Sta ndard are listed
in Nonmandatory Appendix CC. These requi rementsare in
addition to the requirements of ASME 8PVC, Section VIII,
a nd ASME 831.3. Th is Standa rd also uses the common
la nguage meaning of these terms. Be aware of the differences between the usage as defi ned in GR -8 vers us
common usage.
(22) GR-4.1 lnspector/ Examiner
Inspector and examiner in this Standard shall be defined
for the following:
(a) Pressure Vessels. Authorized lnspector,as defined in
ASME 8PVC, Section VIII.
{b) Pipin9, Tubin9, and Non -Code Vessels. Owner's
Inspecto r, as defined in ASME 831.3, paras. 340.4(a)
and 340.4(b). Quality lnspector's Delegate, as defined
in GR-8, meets t he additional requirements listed in
GR-4.2.
2
ASME BPE-2022
Table GR-4.2-1
Quality lnspector's De!egate Capabilities
Capablllty
Trainee
QID-1
(22)
QID-2
QID-3
Materials
(al Jdentify materials
(1J Fitti ng type
X
(2) Tube/pipe
X
(3) Filler materials
X
(4) Elastomers
X
X
(5) Process components
(b) Ve1ify material marking to standard
X
(e) Mcasurc material dlmensions
X
(d) Measure material surface finish
X
(e) Verify material documentation
(1) Material Test Reports ( MTR)
X
( 2) Certlflcatcs or Conformancc (C or Cs)
X
(3) lnstrument calibration records
(4) Elastomers
X
X
(f) Evaluatc to acccptance c-riteria
(g) Verify material conformance to specification
(h) Verify mate1ial storage/handling conformance
X
X
X
Equipment Use
(a) Mirrors/magnifiers
X
(b) Measuring devices
(1) Steel rule
X
( 2) Calipers (dial, digital)
X
X
(3) Flllet gaugc
(4) Rad ius gauge
X
(5) Temperature·sensitive crayon (tempilstick)
X
( 6JSlope Jevcl
X
(7) Undercut gauge
X
X
(e) Borescope/ftberscope
(d) Profilometer
X
(e) Positive material identifical:ion (PMI)
(f) Calibration records (inspection equipment)
X
X
Knowledge and Skllls
Understand inspection fttndame ntals
(a) Effective oral and written communication
X
(b) Quality procedures
(1) Prepare documentation control requirements
(2) Develop inspection procedures
X
X
X
(e) Rcvicw or spcclflcatlons
(d) Codes and Standard; (training)
(1) ASME BPE
GR/DT/SF
MJ/SD 3.12
( 2) ASME B3 1.3
X
Chaptcr VI
X
(3) ASME BPVC, Section IX
(e) Jnterpret welding symbols and drawings
X
(1) Detall drawings (mechanical)
X
( 2) P&JD
(3) Single line isometric drawings (weld maps)
X
3
X
ASME BPE-2022
Table GR-4.2-1
Quality lnspector's Delegate Capabilities (Cont'd)
Capablllty
Tralnee
QID-1
QID-2
QID-3
Knowledge and Skllls (Cont'd)
( 4) lsometric drawings (slope maps)
X
(5) Gcncral/fabrlcatlon an-angcmcnt drawlngs (dctalls)
X
(6) lnterpret welding symbols
X
(t) Prepare documents/reports in ac.cordance with GR-5,3
(lJ Material cxami nation lag
X
(2) Nonconformance rep0rts
X
(3) Visual weld inspection
X
(4) Slopc vcrillcation ( lsomctr lc)
X
(S) Pressure test
X
(g) Turnover package
(1) Assemble
X
(2) Review
(h) Basic understanding of NDT/NDE
(1) PT
X
X
(2) UT
X
(3) RT
X
( 4) Eddy current
X
(5) Pressure/lcak tcstlng
X
lnspectlon
(a) Perfonn visual inspection (other than weld inspection)
X
(b) Pcrform wcld l nspcctlon
X
X
(e) Evaluate weld lnspection re.sults
(d) Perform slope verification
X
(e) Wimcss pressure tests
X
(f) Verífy insr>e<:tlon conformance
X
(g) Review inspection repo1ts
X
(h) Verlfy nonconfonnancc dispositlon
X
(1) Perform installation verifkatíon
(1) lnstallation per P&ID
X
(Z) Check for cold sp,i ng
X
X
(3) Hanger veñficatiOn
X
(4) Component i nstallation per manufacturer's
recommendations
Vessel Inspection (addltional to above)
(a) Verify surface finish
X
(bl Verify drainability
X
(e) Clcanabillty (CIP/rlbonavln/sprayball tesdng)
X
(d) Verify d lmensi(>nS and orientation
X
X
(e) Confo,mance with ASME Code (U-1)
X
(f) Documcntatlon r cvlcw
Welding Procedure Qualification
X
Vcrify wcldlng procedurcs (WP5/PQRJ conformance
Welder and/or Welding Operator Performance Qualification
X
Verify weldér and/or welding operator perfonnance
qualiíkation conformance
4
ASME BPE-2022
Table GR-4.2-1
Quality lnspector's Delegate Capabilities (Cont'd)
Capablllty
Tralnee
QID-1
QID-2
QID-3
Project Plannlng
(a) Review contract requirements
X
X
X
(b) Prepare wcld ins pcction crltcrla
(e) Revlew speclfications
(d) Prepare purchase specific.ations
X
X
(e) Dcvelop inspecdon plan
Training
X
X
(a) Provlde on•the-job tralning for Quallty lnspcctors
(b) Malnt:ain record$()( lrniníng
Audit
(a) Pe rform vendor audits
X
(b) Perfom1 fabricator audits
X
X
(e) Prepare audit and surveillance plan
establish techniques a nd to assist in establishing acceptance criteria when non e are otherwise available. The QID3 shall be capable oí tra ining personnel. A QID-3 may
perform tests a nd inspections according to the capabilities' requirements.
(2) receivea mínimum ofl 6additional hr ofrelevant
documented training (mínimum total = 24 hr), including
as a mínimum the requirements s hown in Table GR-4.2-1
(3) pass a written test a nd practica! performance exa mination, including as a mínimum the requ irements
shown in Table GR-4.2-1 for this level
(e) QID-2. To be considered as a QID -2, personnel s hall
meet the following:
(1) be a QID-1 for a mínimum oí 6 months of documented relevant indus try experience. Alternate meth ods
for meeting the work experience requirement are at least
one of the following:
(•a) prior or current certification as a QID-2
(·b) completion with a passinggrade oí at least 4 yr
of engineering or science study in a unive rsity, college, or
technical school
(•e) possess an AWS CWI ce rtificate 1 or ACCP Level
11 VT certificate2 or international equivalent
(·d) 2 yr of documented relevant experience in
inspection, exami nat ion, or testing activities of h ighpurity/ hygienic systems
(2) receivea mínimum of16additional hr ofrelevant
documented training (minimum total = 40 hr), including
as a mínimum the requirements s hown in Table GR-4.2 -1
(3) pass a written test a nd practica! performance exa minatio n, including as a mínimum the req uirements
shown in Table GR-4.2-1 for this leve)
(d} QID-3. To be considered as a QI D-3, personnel shall
meet the following:
(1) be a QID-2 for a mínimu m of24 months of documented relevant industry experience. Alternate methods
for meeting the work experience requirement are a t least
one of the following:
(-a) prior or current certification as a QID-3
GR-4.2.2 Qualification Requirements. The quali fication requirements listed herein shall be met prior to
consideration for examination/certification.
(a) Trainee
(1) be a high school graduate or hold a state or military approved high school equivalency diploma
{2} receive a mín imum oí 8 hr oí relevant documented training (total 8 hr), including as a mínimum
the requirements s hown in Table GR-4.2-1
(b) QID-1. To be considered as a QID-1, personnel s hall
meet the following:
{1) be a trainee for a mínimum of 6 months of documented relevant indus try experience. Alternate methods
for meeting the work experience requirement are at least
one oí the following:
(-a) prior or current certification as a QID-1
(-b) completion with a passinggrade of at least 2 yr
oí engineering or science study in a university, college, or
technical school
(-c) possess an AWS CWl certificate 1 or ACCP Level
11 VT certificate 2 or inte rnational equivalent
(·d) 2 yr oí documented relevant experience in
inspection, examination, or testing activities
1
Certifications from the American Welding Society (AWS). (:AWI is a
Certified Associate Welding Inspector, and CWJ is a Certifled Welding
I nspector.
2 Certifications from the American Society or Nondestructlve Testing
(ASNT). ACCP is the ASNT Central Certific.ation Program.
5
ASME BPE-2022
(-b) 3 yr of documented releva nt experience in
inspection, exam ination, or t esting activi ties of hig hpurity/hygienic systems
(2) receive a mínimum of 40 additional hrofrelevant
documented training ( mínimum total = 80 hr), including
as a mínimum the requirements shown in Table GR-4.2-1
(3) pass a written test and practica! performance exa mination, includ ing as a mí nimum the requirements
shown in Table GR-4.2-1 for this leve!
(22)
GR-4.3.l Pressure Vessels. The responsibilities of the
owner's Inspector· shall be the same as the inspector in
ASME BPVC, Section VIII.
GR-4.3.2 Piping, Tubing, and Non- Code Vessels. The
responsibilities ofthe owner/user's Inspector shall be in
accordance with ASME B31.3, para. 340.2.
GR-4.4 Access for lnspectors
Manufacturers ofbioprocessing equipment and components shall allow free access to owner/user and authorized inspection personnel at ali times while work on the
equipment or components is being performed. The noti·
fication of an impending inspection should be mutually
agreed to by t he manufact urer and the ins pector.
Access may be limited to the area of the manufacturer's
facility where assembly, fabrication, welding, and testing
of the specific equipment o r com ponents are being
performed. lnspectors shall have the right to audit any
examination, to inspect components using any examina·
tion method specified in t he Des ign Specificatio n
(includ ing Purchase Order), and to review ali certifications a nd records necessary to satisfy the requ irements
of GR-5. Th e ma nufactu re r shall provide the Inspector
with work progress updates.
GR-4.2.3 Certification. The e mployer is responsible
for tra ining, testing, a nd certification of e mployees. The
e mployer shall establish a written practice in accorda nce
with the guidelines of ASNT SNT-TC-lA including
(a) the requirements listed in Table GR-4.2-1
(b) training programs
(e) certification testing requirements
(d) eye examinations as follows:
{1) Near Vision Acuity. The individual shall have
na tural or corrected near distance acu ity in at leas t
one eye such that the individual is capable of reading a
mínimum o f a Jaeger Number 2 or equivalent type and
size lette r at a dista nce designated on the chart but no
less than 12 in. (305 mm). This test shall be administered
initially and at least annually thereafte r.
(2) Color Controst The individual shall demonstrate
the capab ility of d ist inguis hing and d iffe rentiat ing
contrast among colors. This test shall be administered
initially and, thereafter, at intervals not exceeding 3 yr.
These examinations shall be ad ministered by an
ophthalmologist, optometrist, medical doctor, registered
nurse or nurse practitioner, certified physician assistant,
orotherophthalmic medical personnel, and the documen·
tation shall include the state or province (or applicable
jurisdictional) license number.
(e) certification documentation
The owner/ user is responsible for verifying the require·
me nts of this section a re me t.
GR·S DOCUMENTATION
GR-5.1 General
Documentation requirements shall be agreed to at the
beginning of a design project a nd shall be made available
upon request or submitted at the agreed-upon time to
suppo rt the req uirements of this Sta ndard, as agreed
to by the owner/user and manufacn,re r/contractor.
GR-5.2 Document Requirements
Material Test Reports (MTRs) for ali metallic process
components shall be verified to be in conformance to
the appl icable specification. Certificates of Conformance
(C of Cs) for ali polymeric a nd other nonmetallic process
components shall be provided. In addition, the following
documentation shall be provided to the owner/user or
their designee.
GR- 4.2.4 Recertlficatlon. A QID-1, QID -2, or QID-3
whose employment has been tenninated may be recerti·
fied to t heir former level of q ualification by a new o r
former employer based on examination, provided ali of
the following requirements are met:
(a) The e mployee has proof of prior certification.
(b) The employee was working in the capacity to which
certified within 6 months of termination.
(e) The employee is being recertified within 6 months
of termination.
lf the employee does not meet the listed requirements,
additional training as deemed appropriate by the owner's
Inspector shall be required.
GR-5.2.1 General List of Documents
GR-5.2.U Metalllc Materlals
GR-5.2.1.1.1 Turnover Package Documentatíon.
Documentation required for current Good Manufacturing
Prac tices (c GMP)-vali dated di stributio n syste ms,
incl udi ng t he vesse ls, t ubing systems on mod ules,
s uper skids, sk ids, t he s hop o r field fabricatio n of
tubing, etc.. includes the following:
(a) Materials Documentation
(1) Material Test Reports
(2) Certificates of Conformance
GR-4.3 Responsibilities
The responsibilities of inspection personnel are defined
in GR-4.3.1 and GR-4.3.2.
6
ASME BPE-2022
GR-5.2.1.1.2 Technical s upport informat ion to
s upport the design, operation, and maintenance of equipment may include, but is not limited to, the following,
(a) material handling procedures
(b) mechanical and electropolishing procedures
(e) shop passivation procedures
(3) Material Examination Logs
(4) ldentification of the filler metal or consumable
insert used
(b) Weldin9, lnspection, and Examination Qualiftcation
Docwnentation (not required forstandard fittings, valves,
a nd componen ts un less s pecifi cally required by t he
owner/user)
(1) Welding Procedure Specifications/Parameters
(WPS/P)
(2) Procedure Qualification Records (PQRs}
(3) Welder Performance Qualifications (WPQs}
(4) Welding Operator Performance Qualifications
(WOPQs)
(5) Examiner qualifications
(6) documentation of approval of the above by the
owne r/user's representative prior to welding
(7) lnspettor qualifications
(8) docu mentation of the approval of (7) by the
owner/user prior to welding
(e) Weld Documentatíon (not required for standard
fi tt ings, valves, and com ponen ts u nless specifically
required by the owner/user)
(1) weld maps
(2) weld logs
(3) weld examination a nd inspection logs
( 4) coupon logs
(d) Testing and Examination Documentaeion (as applicable)
( 1) passivation reports
(2) spray device cove rage testing
(3) pressure testing
(4) final slope check documentation
(5) calibration verification documentation
(6) purge gas ce rtifications
(7) signature logs
(8) number of welds - both manual and automatic
(9) number of welds inspected expressed as a percentage (%)
(10) heat numbers of components tha t must be identified, documented, and fully traceable to the insta lled
system
(11) surface finish C of Cs
(12) NDE (nondestructive examination} re ports
(e) 5ystem/Equipment
(1) standard operating a nd maintenance procedures
and manuals
(2) installation procedures
(3) piping a nd instrumentation diagrams
(4) detail mechanical drawings and layouts
(5) technical specification sheets of components and
instrumentation
(6) original equipment manufacture r's data
(7) manufacturer's data a nd test reports
(8) any documentation that is specifically needed for
the owner/user's qualification of a syste m
GR-5.3 Material Test Reports/Certiflcates of
Conformance
(22)
GR-5.3.1 Metallic Materials. The combination of docu- (22)
ments, including C of Cs and MTRs. for ali valves and
fittings having process contact surfaces s hall include
the following information, as a mínimum;
(a) ASME BPE Standard, including year
(b) material type
(e) heat number or code traceable to the original heat
(d) chemical composition
(e) AWS classification of fille r metal, if used
(!) alloy d esignation and mat erial specification of
insert, if used
(9) postwe ld heat treatrnent documentation, if applica·
ble
(h) mechanical properties are not required, but if
included must be accurate to the raw material specifica·
tion
MTRs for other components made to a material s pecification s hall con ta in the mínimum infor mation specified
by the material specification incorporated by reference.
MTRs for tubing shall a lso state the year edition of the
ASME BPE Standard.
GR·S.3.2 Polymeric and Other Nonmetallic Material (22)
Components. The manufacturer of polymeric a nd other
nonm etallic co mponents shall issue a Certificate of
Conformance that the components meet requirements
as shown in Table PM-2.2.l· l.
GR·S.3.2.1 Seal Documentation. Seal manufacturers
shall provide, upon owner/user request, documentation
(test report} ofthe USP <88> Bíological Reactivity Test In
Vivo, Class VI and the USP <87> Biological Reactivity Test
In Vitro testing on final manufactured seals.
A Certificare of Conformance shall be issued by the seal
manufacturer to certify conformance to this Standard
when requi red by the owner/user. The Certificate of
Confor mance shall contain the information list ed in
Table PM -2.2.1-1.Additional agreements may be required.
GR·S.3.2.2 Sealed Unions. The seal manufacturer
shall provide, upon request of the owner/user, a certifica te of design conformance that the sealed union meets
the intrusion requirements of MC-4.2.
GR-5.3 .3 Electropolishing. The electropolishing (22)
vendor, if requested by the owner/user, s ha ll provide
a Certificate of Confo rmance with each type of compo·
nent(s) that shall incl ude, b ut is no t limí ted to, t he
following,
7
ASME BPE-202 2
(a) vendor's company
(b) owner/user's name
(e) description of component(s)
(d) identification of the electropolishing procedure
used
(e) final s urface finish report (R,, if required by the
owner/user)
(22)
(3) acceptance/rejection
(4) initia ls
(g) inspection
(1) date
(2) type of examination
(3) acceptance/rejection
(4) initia ls
(h) identification of blind weld s
(i) identification of manua l welds
(j) basis of rejection
In add ition, hea t n umbers (o r other ide ntificatio n
sys te m for mat eria l t raceability) and slo pe shall be
recorded on the Weld and Examination/lns pection Log,
an isome tric drawing. or other owner/user -approved
document.
GR-5.3.4 Passivation. The passivation provider shall
s upply a Certificate of Conformance for each system or set
(type) of component(s) that s hall include, b ut not be
li mited to, the following:
(a) owner/user's name
(b) description of system or component(s)
(e) service provider's company name
(d) qualified passivation method used
(e) documentation of passivation process, as follows:
(1) written qualified procedure
(2) docume nta tion of process control of essential
variables
(3) instr ument calibration records
(4) certificares of a nalysis for a li chemicals used
(5) process testing and verification
{j) postpassivation verification method(s) used
(g) for materia l ma nufacture rs/suppliers of components w hose surfaces have been e lectropolished and/
or passivated, a Certificate of Confonnance for Passivation
a nd/or Electropolishing s ta ting that standard industry
practices, such as ASTM A967 or ASTM 8912, as applicable, have been used. lf required by the owner/ user, the
manufacturer or supplier may be required to demonstrate
the effectiveness oftheir procedure by a method mutually
agreed upon.
GR-5.5 Records Retention
GR-5.5.l Vessel Documentatlon. l'or ali Bioprocessing
ASME Code-stamped vessels, National Board registration
is recommended to maintain vessel data on file. Manufacturing documentation shall be mainta ined throughout the
design and manufacture for each component, assembly,
part, or unit.
Ali documentation s hall be retained by the owner/user.
As agreed to by the own er/user and manufacturer, documentation from the manufacturer will be reta ined for the
agreed-upon duration of time but not less than 3 yr after
manufacture.
GR-5.5.2 Welding Documentation
(a) Piping and Tubing. Records and rete ntion ofrecords
associated with piping and tubing s hall be in accorda nce
with ASME 831.3.
(b) Pressure Vessels and Tanks. Records and rete ntion
of records for code vessels s hall be in accordance with
ASME BPVC, Section VIII.
GR-5.4 Weld and Examination/lnspection Log
The results of the welding. examination, a nd inspection
s hall be recorded on a Weld and Examination/lnspection
Log. The information required to be on the Weld Log may
be in a ny formar, written or tabular, to fit the needs ofthe
manufacturer/supplie r. installing contractor, inspection
contractor, a nd owner/user as long as ali required information is includ ed or refere nced. Fonn WE L-1 (see
Nonma ndatory Append ix 8) has bee n pr ovi ded as a
guide for the Weld a nd Exami nation/ lnspection Log.
This form includes the require d data plus sorne other
information that is not required. The mínimum requirements are as follows:
(a) isometric d rawing number (includ ing revision
number)
(b) weld number
(e) date welded
{d) welder and/or welding opera tor identification
(e) size
{j) examination
(1) date
{2} type of examination
GR- 6 U.S. CUSTOMARY AND SI UNITS
Th is Standard uses sta n dard un its listed i n
Mandatory Appendix 11. Nonmandatory Appendix U has
been provided as a guide fo r U.S. Customary an d SI
unit conversion.
GR-7 REFERENCES
Material specifications for metallic materia Is a re listed
by product form in Part MM. For this Standard, the most
recent approved version of the following referenced standards shall apply:
3-A, Sanitary Standards
Publisher: 3-A Sanitary Standards, lnc., 6888 Elm Street,
Suite 2D, McLean, VA 22101 (www.3-a.org)
ANSI/FCI Standard 70-2, Control Valve Seat Leakage
8
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ASME BPE-2022
Publishe r: Fluid Controls lnstitute (FCI}, 1300 Sumner
Aven u e, C l eveland, OH 441 1 5 - 2851
(www.fluidcontrolsinstitute.org}
ASTM D624, Sta ndard Test Method for Tear Strength of
Conventional Vulcan ized Rubber a nd Thermoplastic
Elastomers
ASTM D1599, Standard Test Method for Resistance to
Short-Time Hydraulic Press ure o f Plas tic Pipe,
Tubing, a nd Fittings
ASTM D2240, Standa rd Test Method for Rubber Property - Duromete r Hardness
ASTM D2657, Standard Practice for Heat Fusion Joining of
Polyolefin Pipe and Fittings
ASTM D4991, Standard Test Method for Leakage Testing
of Empty Rigid Containers by Vacuum Method
ASTM E112, Test Methods for Dete rmining Average Grain
Size
ASTM E220, Standard Test Method forCalibration ofThermocouples by Comparison Techniques
ASTM E230/E230M,StandardSpecification and Tempera ·
ture· Electromotive Force (emf) Tables for Standardized
Thermocouples
ASTM E499, Standard Practice for Leaks Using the Mass
Spectrometer Leak Detector in the Detector Pro be Mode
ASTM ESlS, Standard Practice for Leaks Using Bubble
Emission Techniques
ASTM E644, Standard Test Methods for Testing Indus trial
Resistance Thermometers
ASTM El003, Standard Practice for Hydrostatic Lea k
Testing
ASTM El137 /El 137M, Standard Specification for Ind ustrial Platinum Resistance Thermometers
ASTM E2500. Standard Guide for Specification, Design,
and Verífication of Pharmaceutical and Biopharmaceutical Manufacturing Systems a nd Equipment
Pub lisher: American Society for Testing a nd Materials
(ASTM lnternationa l}, 100 Barr Harb or Orive, P.O.
Box C700, Wes t Co n s ho hocke n, PA 19428-2959
(www.astm.org)
AWS A3.0M/A3.0, Sta ndard Welding Terms and Definitions
AWS B2.4, Speci fication fo r Wel ding Proced ure a nd
Performance Qualification for Thermoplastics
AWS D18.2, Guide to Weld Discoloration Levels on lnside
of Austenitic Stainless Steel Tube
AWS Gl.lOM, Guide forthe Evaluation ofHotGas, HotGas
Extrusion, and Heated Tool Butt Thermoplastic Welds
AWS QCl, Standard for AWS Certification of Welding
lnspectors
Publis her: American Welding Society (AWS), 8669 NW 36
Street, No. 130, Miami, FL 33166 (www.aws.org)
ASME B31.3, Process Piping
ASME B46.1, Surface Texture (Surface Rough ness. Waviness. and Lay)
ASME Boiler and Pressure Vessel Code, Section V, Nondestructive Examination
ASME Boiler a nd Pressure Vessel Code, Section VIII, Rules
for Construction of Pressure Vessels
AS ME Boiler an d Pressu re Vessel Code, Section IX,
Welding, Brazing, a nd Fusing Qualifications
ASME CA-1, Conformity Assessment Requirements
ASME MFC-22, Measurement of Liquid by Turbine Flowmeters
ASME PTC 19.3 TW, Thermowells
ASME PVH0-1, Safety Sta ndard for Pressure Vessels for
Huma n Occupa ncy
Publis her: The American Society of Mecha nical Engineers
(ASME}. Two Park Avenue, New York, NY 10016-5990
(,,vww.asme.org)
ASQ/ANSI Zl.4, Sampling Proced ures and Tables for
lnspection by Attributes
Publis her: American Society for Quality (ASQ), 600 Plan·
ki nton Avenue, Mílwaukee, WI 53203 (www.asq.org}
DVS 2202 -1, lmperfections in Thermoplastic Welding
Joints; Features, Descriptions, Evaluation
Publis her: DVS-Verlag GmbH (German Welding Society},
Aachene r Strasse 172, 40223 Dusseldo rf, Germa ny
(w,,vw.d ie -verbindungs-spezialis ten.de}
ASTMA380, Practice for Cleaning, Descaling, a nd Passivation of Stainless Steel Parts, Equipment, a nd Systems
ASTM A967, Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts
ASTM A1015, Sta ndard Guide for Videoborescoping of
Tubular Products for Sanitary Applications
ASTM 8912, Standa rd Specification for Passiva tion of
Stainless Steels Using Electropolishing
ASTM D395, Standard Test Methods for Rubber Prop•
erty - Compression Set
ASTM D412, Standa rd Test Methods fo r Vu lca nized
Rubber and Thermoplastic Elastomers - Tension
ASTM D471, Standard Test Method for Rubber Property Effect of Liquids
EN 12266· l. Industrial valves - Testing of metallic valves
European Hygienic Engineering & Design Group (EH EDG),
Document No. 18 - Passivation of Stainless Steel
Publishe r: Eu ropean Com mittee for Sta ndard ization
(CEN}, Avenue Marn ix 17, B-1000, Brussels, Belgium
(w,,vw.cen.eu}
FDA, 21 CFR. Parts 210 and 211, Curren! Good Manufacturing Practices
GMP: Current Good Manufacn,ring Practices, Title 21 of
the Food a nd Drug Administration
Publisher: U.S. Food a nd Drug Admi nis tration (FDA),
10903 New Ham ps hire Avenue, Silver Spring, MD
20993 (www.fda .gov}
9
ASM.E BPE-2022
IEC 60751, Industrial Platinum Resistance Thermometers
and Platinum Temperature Sensors
Publisher: lnternational Electrotechn ical Commission
(IEC), 3, ruede Varembé, Case Postale 131, CH-1211,
Geneva 20, Switzerland/Suisse (www.iec.ch)
Publisher: Internacional Organization for Standardization
(ISO), Central Secretariat, Chemin de Blandonnet 8, Case
Postale 401, 1214 Vernier, Geneva, Sw itzer land
(www.iso.org)
ISPE Baseline® Pharmaceutical Engineering Cuide for
Water and Steam Systems - Volume 4
Publisher: lnternational Society for Pharmaceutica l Engi•
neering (ISPE), 3109 W. Dr. Martin Luther King. Jr. Blvd.,
Tampa, FL 33607 (www.ispe.org)
IEST-RP-CCOOl.6, Conta mination Control Division Recommended Practice 001.6, HEPA and ULPA f ílters
Publísher: lnstitute of Environmental Sciences and Technology (1 EST), 1827 Walden Office Square, Schaumberg,
IL 60173 (www.iest.org)
MSS-SP-67, Butterfly Valves
MSS-SP-72, Ball Valves with Flange or Butt-Welding Ends
for General Service
MSS-SP-88, Diaphragm Valves
MSS-SP-110, Ball Valves Threaded, Socket-Weldi ng,
Solder Joint, Grooved and Flared Ends
Publisher: Manufacturers Standardization Society of the
Valve and Fittings lndustry, lnc. (MSS), 127 Park Street,
NE, Vienna, VA 22180 (www.msshq.org)
ISO 34-1, Rubber, vulcanized or thermoplastic - Determination of tear strength - Part l : Trouser, a ngle a nd
crescent test pieces
ISO 34-2, Rubber, vulcanized or thermoplastic - Determination of tear s trength - Part 2: Small (Del~) test
pieces
ISO 37, Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties
ISO 48, Rubber, vulcanized or thermoplastic - Determination of hardness (hardness bet\Veen 10 IRHD and 100
IRHD)
ISO 815-1, Rubber, vu lcanized or thermoplastic - Determination of compression set - Part 1: At ambient or
elevated temperatures
ISO 815-2, Rubber, vu lcanized or thermoplastic - Determination of compression set - Part 2: At low temperatures
ISO 816, Superseded by ISO 34· 2
ISO 1402, Rubber and plastics hoses and hose assemblíes
- Hydrostatic testing
ISO 1817, Rubber, vulcanized - Determination of the
effect of líquids
ISO 2859-1, Sampling procedures for inspection by attributes
ISO 10648-2, Containment enclosures - Part 2: Classification according to lea k tightness and associated
checking methods
ISO 10790, Measurement of fluid flow in closed conduits
- Guidance to the selection, installation and use of
Coriolís flowmeters (mass flow, density and volume
flow measurements)
ISO 10993, Biologícal evaluation of medica! devices
ISO 11137, Sterilízation ofhealth care produtts - Radiation - Part l : RequirementS for development, valídation, and routine control of a sterilization process for
medica! devices
ISO 14644·1, Cleanrooms and associated controlled environments - Part 1: Classification of a ir cleanliness by
part icle concentration
ISO 14644-7, Cleanrooms and associated controlled environments - Part 7: Separative devices (clean a ir hoods,
gloveboxes, isolators and mini-environments)
NIH (BL-1/BL-4), Biohazard Containment Guidelines
Publisher: National lnstitutes ofHealth (NIH), 9000 Rock•
vílle Pike, Bethesda, MD 20892 (www.nih.gov)
PFI Standard ES·SO, Interna! Oxidation for Piping Welds
Publisher: Pipe Fabrication lnstitute (PFI), 5901 Coastal
Hwy #27, Ocean City, MD 21842
(www.pfi -institute.org)
Recommended Practice (RP) No. SNT-TC-lA, Personnel
Qualification and Certification in Nondestructive
Testing
Publis her: American Society for Nondestructive Testing
(ASNT), 1711 Arlingate Lane, P.O. Box 28518,
Columbus, OH 43228 (www.asnt.org)
United States Pharmacopeia and Nationa l formu lary
(USP-Nf)
Publis her: U.S. Pharmacopeia Conve ntion (USP), 12601
Twinbrook Parkway, Rockvíl le, MD 20852 -1790
(www.usp.org/usp•nt)
GR-8 TERMS AND DEFINITIONS
animal-derived in9redíents {AD/): products or ingredients
derived from tissues or secretions of animals susceptible
to transmissible spongiform encephalopathies (TSEs),
primari ly cattle's bovine spongiform e ncephalopathy
(BSE).
animal-deríved products (ADP): products made from
animal-derived ingredients (ADI).
annealíng: a treatment process for steel for reducing hard·
ness, improving machinability, facilitating cold working,
or producing a desired mechanícal, physica l, or other
property.
10
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ASM E BPE-2022
anomaly: a localized surface area that is out of specificat ions to the su rrou nding area, and is class ified as
abnormal.
nant culture-derived proteins, and cultured cells and
tissues.
bioprocess: technique or operation used in the manufacture and/or purification of biopharmaceuticals or other
biological materials, such as products derived from microbial fermentation (e.g., yeast, mold, bacteria), cell culture
(e.g., insect, mammalian, plant), tissue culture, blood, or
milk fractionation.
are gap: for orbital GTAW, the nominal distance, measured
prior to welding, from the tip of the e lectrode to the s urface
of the weld joint or insert.
are strike: a discontinu ity consisting of a ny local ized
reme lted metal, heat-affected metal, or cha nge in the
surface profile ofany part of a weld or base metal resulting
from an are, generated by the passage of e lectrical current
between the surface of the weld or base material and a
current source, such as a welding electrode, magnetic
particle prod, or electropolishing electrode.
bioprocessin9: see bioprocess.
bioprocess/119 equipment: equipment, systems, or facilities
used in the creation ofproducts utilizing living organisms.
blind weld: a weld joint by design that cannot feasibly be
visually examined internally.
aseptic: free of pathogenic (causing or capable of causing
disease) microorganisms.
blister (polymeric): a localized imperfection on a polymer
surface, containing a pocket of fluid.
aseptic processin9: operating in a manner that prevents
contamination of the process.
audit: an ASME Certificate Holder's documented evaluation of a s upplier performed to verify, by examination of
objective evid ence, that those selecte d elements of a
previously approved quality management system have
been developed, documented, and implemented in accordance with specified requirements. Asurveillance is notan
audit.
audit (as performed by ASME or theirdesi9nee on ASM E BPE
Certificate Holders and Applican ts): see ASME CA-1.
blistering (metallic): a localized delamination within the
meta l that has an appearance of chipped or flaked-off
areas. Per SEMI F019-0304, section 4.2.1.
borescope: generic term for a group of optical instruments
for visual examinations. This includes rigid borescopes
and flexible borescopes (fiberscopes). Often a camera
chip is mounted to the borescope. (See also videsoscope.)
break: a discontinuity in the face of a fitting.
buffin9: a meta l fi nis hing process for smoothi ng the
surface using a grease-s uspended abrasive.
burn-through: excessive melt-through or a hole through
the root bead of a weld.
autogenous fil/et weld: a fillet weld tha t is prod uced
without the addition of filler metal. (See also sea/ weld.)
autogenous weld: a weld made by fusion ofthe base mate·
rial without the addition offiller. (See alsogas tungsten-arc
welding {GTAW).)
burr: excess material protruding from the edge typically
resulting from operations such as cutting or facing.
butt joint: a joint between two members lying approxi mately in the same plane.
automatic welding: welding with equipment that performs
the welding operation without adjustment ofthe controls
by a welding operator. The equipment may or may not
perform the loading and u nloading of the work. (See
also machine welding.)
cartridge sea/: a self-contained seal assembly.
cavitotion: a condition of liquid flow where, after vaporiiation of the liquid, the s ubsequent collapse of vapor
bubbles can produce s urface damage.
barrier fluid: a fluid used to separate environment from
product s uch as water or condensate in a dual mechanical
seal.
Certijicate:a Certificate of Authorization or Quality System
Certificate issued by ASME.
Certiftcate Holder: an organization holding a Certificate of
Authorization ora Quality System Certificate issued by the
Society upon satisfactory completion of evaluation of its
capability to conform to therequirements ofthis Standard.
bioburden: the nu mber of viable contaminating organisms
per product unit.
biofílm: a film of microorganisms or cell components
adhering to s urfaces s ubmerged in or subjected to
fluid e nvironments.
Certiftcate of Authorization: a document issued by ASME
that authorizes the application of the ASME Single Certification Mark with the BPE certification designator for a
specified time and for a s pecified scope of activity.
bio/09/cs: therapeutic or d iagnostic products generated
and purified from natural sources.
biopharmaceuticals: pharmaceuticals manufacture d by
biotechnology methods, with the products having biological sources, usually involving live organisms or their
active componen ts. Biopharmaceu ti cals generally
include recombinant proteins, (monoclonal) antibodies,
vaccines, blood/plasma -derived products, nonrecombi-
certification: documented testimony by qualified authori ties that a system qualification, calibration, validation, or
revalidation has been performed appropriately and that
the results are acceptable.
11
ASM.E BPE-2022
consumable insert: a ring of metal placed between the two
elements to be welded tha t provides filler for the weld,
when performed wi th fusion welding eq uipmen t. A
consumable insert can also be used for the root pass
in a multiple-pass weld with the addition of filler wire
(also called insert ring) .
convexity: a condition in which the surface of a welded
joint is extended relative to the surface of the tube or
pipe. Convexity is measured as a maximu m dista nce
from the outsi d e or insi d e dia me ter s urface of a
we lded join t along a line perpendicu lar to a li ne
joining the weld toes.
corrosion: a chem ica l or electrochem ical interaction
between a metal and its environment, which results in
changes in the property of the metal. This may lead to
impairment ofthe function of the metal, the environment,
and/or the technical system involved.
cracks: fracture-type discontinuities characterized by a
sharp tip an d hig h r a ti o of length and width to
opening displacement. A crack may not be detected
with a stylus. Alinear crack will produce a liquid penetrant
indication during liquid penetration inspet"tion, X-ray, or
ultrasound.
cGMPs: curren t Good Manufacturing Practices. Current
design and operating practices developed by the pharmaceutical industry to meet FDA require ments as published
in the Code of Federal Regula tions, Chapter 1, Title 21,
Parts 210 and 211.
chroma1:1J9raphy: the purification of substances based on
the chemical, physical, and biological properties of the
molecules involved.
clean: a condition achieved by re moval of dirt, residues,
detergents, or other surface contaminants.
cleaning: operations by which dirt, residues, detergents, or
other surface contaminants are removed to achieve predetermined surface attributes.
clean-in-place {CIP}: cleaning of process contact surfaces
oía system orcomponentwithoutdisassembly beyond the
re moval of single-use components.
clean st.eam: see pure steam.
closed head: for orbital GTAW, a welding head thatencap·
sulates the entire circumference of the tube/pipe during
welding and that contains the shielding gas.
cloudiness: the appearance of a milky white hue across
some portian of a surface resulting from the electropolish
process.
crat.er: a depression at the terminat ion of a weld bead.
cluster of pits: two or more pits, t he closest distance
crat.er cracks: cracks that form in the crater, or e nd, of the
between each being less than the d iamete r of any one pit.
weld bead.
cluster porosity: porosity that occurs in clumps or cluste rs.
creep: a time-dependent permanen t d efo rmation that
occurs under stress levels below the yield stress.
dead leg: a space where system design and operating conditions result in insufficient process fluid flow, presenting
a risk for particulate, chemical, or biological contamination.
compendia/ water: purported to conform to USP and/or
any other acknowledged body of work related to the
quality, manufacture, or distribution of high-purity water.
compliance: performing a function oroperation in a recog·
nized way to abide by a law or legislative requirement
such as complying with the Code of Federal Regulations
(CFR). Compliance is externally imposed. Noncompliance
is the failu re to adhere to a n act or law or regulation.
defects: discontin uities that by nature or accumulated
effect (e.g., total crack length) render a part or product
unable to meet mínimu m appl icable acceptable standards
or specifications. This term designates rejectabil ity. (See
also discontinuir:y.l
deionized wat.er: a grade of purified wate r produced by the
exchange of cations for hydrogen ions and anions for
hydroxyl ions.
compression set: permanent deformation of rubber after
subscription in compression for a period of time, as typically determined by ASTM D395.
concavity: a condition in which the surface of a welded
joint is depressed relative to the surface of the tube or
pipe. Concavity is meas ured as a ma ximum d ista nce
from the outside or ins ide diameter s urface of a
we lded joint along a li ne perpendicular to a li ne
joining the weld toes.
delamination: separation into constituent layers.
demarcation: a localized area that is dissimila r to t he
surrounding areas with a defined boundary.
dent: a la rge, s moo th-bot to med depression whose
diameter or width is greater than its depth and that
will not produce an indication.
conformance: see conformity.
conformity: the state of meeting, acting. or behaving in
acco rda nce with a specificatio n, procedu re, method,
stated rule, or standard such as the ASME BPE Standard.
Nonconformity is the state when a process or at"tion or
system does not conform to a stated quality requirement,
specification requirement, procedure, or standard such as
the ASME BPE Standard.
descalíng: the removal of heavy, tightly ad herent oxide
fil ms res ulting fro m hot-fo r min g, hea t- treatmen t,
weldi ng, and othe r high -temperatu re operations such
as in steam systems.
12
ASME BPE-2022
direct visual examination: a visual examination whe re
there is an uninterrupted optical path from the observer's
eye to the area to be examined. This can be either unaided
or aided via mirrors, tenses, etc.
end grain effect: a surface discontinuity of small diameter
(or linear} cavities located perpendicular to the rolling
direction of the material and appearing after electropolishing.
dirty: a relative term indicating the condition of being
contam inated.
etch/119: the process of removing a !ayer of metal from its
surface using a chemical and/or electrolytic process.
discoloration: any change in surface color from that of the
base metal. Usually associated with oxidation occurringon
the weld a nd heat-affected zone on the outside diameter
and inside diameter of the weld jointas a result of heating
the metal during welding. Colors may range from pale
bluish-gray to deep blue, and from pale straw color to
a black crusty coating.
ethical pharmaceutical: a controlled substance for the
diagnosis or treatment of disease.
examination: as it relates to pressure vessels, vessels not
rated for pressure service, process piping, and process
contact equi pm e nt, the quality control fu nctions
carried out by the manufacture r, fabricator, or erector
in accordance with ASM E BPVC, Section VIII.
discontinuity: interruption of the typical structure of a
weldment, such as a lack of homogeneity in the mechanical, metallurgical, or physical characteristics of the mate·
rial or weldment. A discontinuity is not necessarily a
defect.
excessive penetration: weld penetration that exceeds the
acceptance limit for inside diameter convexity. (See also
convexity.)
expiration date: the dateafter which the shelflife has been
exceeded.
distribution system: central ized syste m for the delivery of
tluids from point of generation or supply to point of use.
extractables (po/ymeric): chemicals that can be removed
from polyme ric articles using appropriate solvents.
downslope: that part of an a utomatic orbita l weld
sequence during which the welding curren! is gradually
reduced prior to extinguishing of the welding are. The
downslope portion of a welded joint is seen as a tapering
of the end of the weld bead with a reduction of penetration
from the beginning to the end of the downslope so that the
final weld bead is small with minimal penetration.
fermentation: the biochem ica l syn thesis of organic
compounds by microorganisms or cultivated cells.
fermentar (ferme11te1): a vessel for carrying out fermenta tion.
finishing marks: a ny surface texture or pattern resulting
from cutting, machining, form ing. grind ing. poli shi ng,
and/or other finishi ng methods.
drainable: a designed characteristic of a componen!,
equipment, or system that enab les the removal of
water by means of grav ity except for that wh ich
rema ins due to surface adherence. Dra in pa ths that
become blocked due to surface-adhered water are not
considered drainable.
duplex stainless steel: a group of stainless steels whose
chemical composition is designed to produce a roomtemperature microstructure that is a mixture of a ustenite
and ferrite.
fixture marks: a n area on an electropolished componen!
where the electrical connection was made for the processing of the componen!..
flash electropolish: an electrochemical process done for a
very short duration of time with a low current density,
which neither significantly alters the surface ofthe material nor meets t he acceptance criteria as set forth in
Nonmandatory Appendix H, Table H-3.3-1.
fluoropolymer: polymer material having a carbon chain
either partially or completely bonded to tluorine atoms.
durometer: measurement of hardness related to the resistance to penetration of a n indenter point in toa material as
typically determined by ASTM D2240.
f/11shin9 (rinsing): the tlowing of water over the process
contact surfaces of system components for the removal of
particulates or water-soluble contaminants.
dynamic sea/:seal with a componen! that is in motion relative to a second surface.
ful/ penetration: a weld joint is said to be fully penetrated
when the depth of the weld extends from its face into the
weld joint so thatthe joint is fully fused. Fora tube-to-tube
weld, no unfused portions of the weld joint shall be visible
on the inside diameter of a fully penetrated weld.
dynamic spray device: a moving device, designed to
produce a nonstationary spray pattern.
elastamer: rubber or n 1bberlike material possessing elasticity. (See also elastomeric material.)
elastameric material: a material that can be stretched or
compressed repeatedly and, upon immediate release of
stress, will return to its approximate original size.
fusion: the melting together offiller metal and base metal,
or of base metal only, that results in coalescence.
fusion weldin9: weld ing in which the base material is fused
togetherwithout the addition of filler material to the weld.
[See also gas tungsten -arc welding (GTAW}.J
e/ectropolishing: a con trolled electrochemical process
u tilizing acid electro lyt e, d irect curren!, anode, and
cathode to smooth the surface by removal of metal.
13
ASM.E BPE-2022
gasket: static sea l made from deformab le ma teria l
compressed benveen l\VO mating surfaces.
hygienic clamp joint: a tube ou tside diameter u nio n
consisting of two neutere d ferrules having flat faces
with a concentric groove and mating gasket that is
secured with a clamp, providing a nonprotruding, recessless process contact surface.
hygienic joint: a tube outside diameter union providing a
nonprotruding, recessless process contact surface.
gas tungsten-arc we/ding (GTAW): an are welding process
that produces coalescence of metals by heating them with
an are between a tungsten (nonconsumable) e lectrode
and the work. Shielding is obtained from a gas or gas
mixtu re. (This process is sometimes called TIG
welding. a nonpreferred term.) GTAW may be performed
by adding filler material to the weld, or by a fusion process
in which no filler is added.
/cicles: localized regions of excessive penetration, which
usually appear as long, narrow portio ns of weld metal on
the weld u nde rbead. (See a lso convexity and excessive
penetration.)
inclusions: particles of foreign material in a metallic or
polymer matrix.
GMP facility: a facility designed, constructed, and operated
in accordance with cGMP guide lines established by the
FDA.
grain boundary: an interface separating l\vo grains, where
the orientation ofthe latticestructure changes from thatof
one grain to thatofthe other. PerSEMI F0l 9-0304, section
4.8.2.
incompletefusion (or lackoffusion): a weld discontinuity in
which fusion did not occur between weld metal and faces
or between adjoi ning weld beads. Also, in weld ing of
tubing. when the weld fully penetrates the wall thickness
but misses the joint, leaving sorne portion of the inn er
(inside diameter) weld joint with unfused edges.
harvesting: the separation of ce lis from growth med ia. This
can be accomplished by filtration, precipitation, or centrifugation.
haze: a loca lized diminis hed s urface brightness,
commonly produced by gassing or variations ofthe essential variables during electropolishing.
incomplete penetration (or lack ofpenetration): a groove
weld in which the weld metal does not extend complete ly
through the joint thickness.
indication: a condition oran a no maly of a localized a rea
that has not been classified as being accepted or rejected.
heat-affected zone: that portio n of the base metal o r
polymer that has not been melted, but whose microstructure or mechan ical properties have been altered by the
heat of welding or cutting.
inspection (as it relates to pressure vessels): functions or
actions carried out by an ASME-accredited Authorized
Inspector; normally a regular employee of an ASME-accredited Authorized lnspection Agency (or equivalen!
for other applicable codes or standards) in accordance
with ASME BPVC, Section VIII.
heat number: an alphanumeric identification of a stated
tonnage of metal obtai ne d from a continuous melting
in a furnace.
heat tint: coloration of a metal s urface through oxidation
by heating. (See also discoloration.)
inspection (as it relates to process piping, tubing, and
process contact surfaces): functions performed by t he
owner's lnspectorto verify that ali required exam inations
and testing have been completed and to eva lu ate the
physical attributes of the piping to the extent necessary
to be satisfied that it conforms to ali applicable requirements.
High Efficiency Particulate Air (HEPA} filter: a type of a ir
fil te r that removes 99.97% of particles 0.3 µ and larger in
diameter.
higher alloy: a metal containing various alloying constitu ents formulated to provide enhanced corrosion resistance
and possibly improved mechanícal properties beyond
those that are typícally observed in UNS S31603 stainless
steel.
holdup volu me: the volume of liquid remaining in a vessel
or piping system after it has been a llowed to drain.
hydrotest: a pressure test of piping, pressure vessels, or
pressure-containing parts, us ually performed by pressurizing the interna) volume with water at a pressure determined by the applicable code.
interrupted electropolish: a break in the continuity of the
electropolished s urface appearance, due to a change of
electropolishing conditions at the overlapping boundaries, which may occur when s urfaces are electropolished
by zones. lt may be visible as haze, cloudiness, orvariance
in luster across these overlapping boundaries.
ISO class 1-9: clean room classifications based on air particulate concentration as defined by the lnternational Organization for Standardization in ISO 14644-1..
joint penetration: the depth that a weld extends from its
face into a joint, exclusive of reinforcement.
hygienic:of or pertaining to equi pmentand pipingsystems
that by design, materia ls of construction, a nd operation
provide for the main tenance of clea nline ss so th at
products produced by these systems will not adversely
affect human or animal health.
lack of fusion after reftow: a discontinuity in welding of
tubing where, after a reflow or second weld pass has
been made, the original joint has still not been consumed,
14
ASME BPE-2022
leaving the weld joint with unfused edges on the inner
surface.
/amellar tears:terrace-like fractures in the base metal with
a basic orientation parallel to the wrought surface; caused
by the high st ress in the thickness direction that results
from welding.
meandering: of or pertaining to a weld bead tha t deviates
from side to side across the weld joint rather than cracking
the joint precisely.
mechanical polishing: a process by which abrasive media is
applied to a surface untíl the specífied surface roughness
(R0) is achieved.
laminations: elongated defects in a finished metal product,
resu lt ing from the roll ing of a we lded or othe r pa rt
containing a blowhole. Actually, the blowhole is stretched
out in the direction of rolling.
mechanical sea/: a device used for sealíng fl uids with
rotating shafts. A mechanical sea! is a prefabricated or
packaged assembly that forms a running seal benveen
tlat surfaces.
leachables (polymeric): typically a subset of extractables,
these chemicals migrate from polymeric articles into the
product or process tluid.
micron (1 µ) or micrometer (1 µm): one-millionth oí a
meter.
misalignment (m ismatch): ax ial offset of the jo in t
members.
línear porosity: porosity that occurs in a linear pattern.
Linear porosity generally occurs in the root pass from
inadequate joint penetration.
miter: two or more straight sections of tube matched and
joined in a pla ne bisecting the angle of junction so as to
produce a change of direction.
liquid penetrantindication: refer to ASME BPVC, Section V,
T-600, for testing an anomaly oran indication.
molded sea/: a seal that is manufactured by forming in a
mating cavity.
looped header: a piping ring with multiple branches for
inlet or outlet. The branches on the ring can be closed
by valves, caps, or other means of tlow isolation.
mold flash: excess material t ha t is grea te r t ha n t he
designed geo metry of a part t hat is formed in t he
molding process.
multiuse: a term describing process contact components,
equipment, a nd systems that a re designed to be cleaned,
sanitized, or sterilized and used multiple times (also
referred to as repeated use).
luster: the state or quality of shining by retlecting light.
(See also variance in luster.)
machine welding: welding with equipment that performs
the welding operation under the constant observation and
control of a welding operator. The equipment mayor may
not perform the loading and unloading ofthe works. (See
also automatic welding.)
nick: a surface void anomaly caused by material removal
or compression from the surface, whose bottom surface is
usually irregular.
nominal outside diameter: a numerical identificatíon of
outside dia meter to which tolerances apply.
manual welding: weld ing in which the entire welding
operation is performed and controlled by hand.
material manufacturer: an organization responsible for
the p rod uction of p roducts meeting the requirements
of the material specification(s).
nominal wa/1 thickness: a numerical identification of wall
thickness to which tolerances apply.
Material Test Report (mil/ test report or MTR): a document
in which the results oí tests, examinations, repairs, or
treatments required by the material speciíication to be
reported are recorded. This document includes those
oí a ny supplementa ry requ irements or other req uirements stated in the order for the material. This document
may be combined with a Certificate of Conformance as a
single document.
material type: a commercial designation for a given chem•
istry range.
nonsliding sea/: a seal that does not have transverse or
rotaciona l move me nt between t he seal a nd mating
surface(s).
maximum working pressure: the pressure at which the
system is capable of operati ng fo r a sustained period
of time.
maximum working temperature: the temperature at which
the system must operate for a sustained period of time.
The maximum working te mperature should relate to the
maximum working pressure and the tluids involved.
open head: for orbital GTAW, a welding head that is open to
the atmosphere externa! to the tube/p ipe being welded
and that does not e ndose the shield ing gas, which is still
provided through the torch.
nonuniform mechanical polishing marks: a loca lized
surface polishing pattern that is dissimílar to t he
surrounding area.
off angle: a measurement of face-to-face squareness.
off plane: a measurement oí t he offset between part
centerlines or two planes.
orange pee/: large-featured, roughened type of surface
visible to the una ided eye whose surface appearance
patte rn ís like that of an orange peel.
15
ASM.E BPE-2022
orbital welding: a utomatic or machine welding of tubes or
pipe in-place with the electrode rotating (or orbi ting)
around the work. Orbital welding can be done with the
addition of filler mater ial or as a fusion process
without the addition of filler.
0-ring: ring sea) of circular cross section.
outboard sea/: a seal that is outside the product a rea in the
outermost part of a mechanical seal assembly.
overlap: the protrusion of weld metal beyond the weld toes
orweld root. Also, in an orbital weld, that amount by which
the end of the weld bead overlaps the beginning of the
weld bead (not including the downslope) on a singlepass weld.
owner/user: the body on which final possession or use
rests.
oxidation: a common form of electrochemical reaction tha t
is the combining of oxygen with various elements and
compounds.
oxide island: a concentration of nonmetallic impurities
(often oxides or nitrides) that may form in the weld
pool and solidify on the underbead or weld top surface.
oxide /ayer: an area usually located in the heat-affected
zone of the weldment where an oxida tion reaction has
taken place.
packin9: a type of shaft sea) formed into coils, spirals, or
rings that is compressed into the sea) cavity.
particulates (single-use): small, solid, a nd mobile matter.
passivation: removal of exogenous iron or iron from the
surface of stainless steels and higher alloys by means of a
chemical dissolution, most typically by a treatment with
an acid solution that will re move the surface contamination and enhance the formation of the passive )ayer.
passive /ayer: a ch romium-enriched oxide layer on a stainlesssteel surface that improves thecorrosion resistanceof
the base metal.
passivity: the state in which a stainless steel exhibits a very
low corrosion rate; the loss (or minimizing) of chemical
reactivity exhibited by certain metals and alloys unde r
special environmental conditions.
PE: polyethylene, polymer material composed of carbon
and hydrogen.
penetration: see ful/ penetration, incomplete penetration,
and joint penetration.
personal care products: prod ucts used for persona l
hygiene or cosmetic care.
PFA: perfluoroalkoxy, copolymer of tetraíluoroethylene
a nd perfluorovinyl ether.
pharmaceutical: relating to the useand/or manufacture of
medica) drugs or compounds used to diagnose, treat, or
prevent a medica] condition.
pickling: a chemical process for cleaning and descaling
stainless steel and other alloy parts, equipmen t, and
systems.
pipe: pipe size is determined by diamete r and schedule,
series,or SOR. For bioprocessingequipment, pipe does not
include tube.
pit: a small surface void resulting from a localized loss of
base material.
pitch: to cause to be set at a particular angle or slope;
degree of slope or elevation.
polymer: a molecule consisting of many smaller groups.
Polymers can be synthesized either through chain reactions or by templating. Sorne examples of polymers are
plastics, proteins, DNA, and dendrimers.
polymeric material: a natural or synthetic material whose
molecules are linked in a chain.
polypropylene (PP): polymer material composed of carbon
and hydrogen.
porosity:cavity-type discontinuities formed bygasentrapment during solidification.
pressure rating: pressure at which a system is designed to
operate, allowing for applicable safety factors.
process component: a constituent part of equipment or a
system that contacts the product or process fluid. Examples of process components include, but are not lim ited to,
tube, fittings, gaskets, valves, and instruments.
process contact surface: a surface under design operating
conditions that is in contact with, or has the potential to be
in contact with, raw mate rials, in-process materia Is, APls,
clean utilities (e.g., WFI, CJP, pure steam, process gases), or
components (e.g., stoppers) and where there is a potential
for the surface to affect product safety, quality, identity,
strength, or purity.
processequipment: a n assemblyof components that, when
combined, provides the platform for one or more process
operatio ns incl uding, b u t no t lim ited to, storage,
momentum transfer, heat transfer, mass transfer, and separation. Examples of process equipment include, but are
not limited to, pumps, vessels, heat exchangers, chromatography colum ns, centrifuges, and filter housings.
process ~stem: an assembly of components, equipment,
and subsystems that, when integrated, provides a plat•
fonn for one or more process operations to produce
an output within predefined specifications. Examples of
process syste ms include, but are not limited to, bioreactor,
chromatography, CIP, and purified wate r systems.
productcontactsurface: a process contactsurface that is in
contact with, or has the potential to be in contact with, a
product whe re product is defined by the owner/user.
Examples of product contact surfaces may include the
interior surfaces of bioreactors, transfer tub ing,
16
ASM E BPE-2022
chro matography col umns, vesse ls, a nd reci rculating
segments of CIP systems.
proftlometer: a n instrument for the measurement of the
degree of surface roughness.
Class II rouge: a localized form of active corrosion. lt
occ urs in a spectru m of colors (o range, re d, blue,
purple, gray, black). lt ca n be the result of chl oride or
other halide a ttack on the surface of the stainless steel.
Class III rouge: a surface oxidation condition occurring
in high -temperature environments such as pure steam
systems. The system's color transitions to gold, to blue,
to va rious shades of black, as the )ayer thicke ns. This
su rface ox ida tion ini t ia tes as a stab le )ayer a nd is
ra rely particulate in nature. lt is a n extremely sta ble
form of magnetite (iron sesquioxide, Fe3 0,).
progressive polishing: a mecha nical grinding procedure
where a coarse grit material is used first and the successive operations use a fi ner and fi ner grit until the desired
surface roughness is ach ieved.
PTFE: polytetrafluoroethylene, homopolymer material of
tetrafluoroethylene.
pure steam: also known as clean steam, steam that is
produced by a steam generator th at, when condensed,
meets requirements for water-for-injection (WFI).
sanitary : see hygienic.
sanita,y (hygienic) weld: generally considered to be a
groove weld in a square butt joint made by the CTAW
(or plasma) process as a fusion weld without the addition
of filler material. A sanita ry weld must be completely
penetrat ed on the weld inside d iamete r (I. D.), with
little or no discoloration due to oxidation, and be otherwise without defects that would interfere with mainte•
nance in a clean and sterile condition.
purifted water (PW): a classification of water according to
compendia) standards.
PVDF: polyvinylidene fluoride, homopolymer, and/or
copo ly mer mate rial co mposed of ca rbon, hydroge n,
and fluorine.
pyrogen: a fever-producing substance.
schedule: d imensional standard for pipe as defi ned by
ASTM.
Quality lnspector's Delegate: a person who is delegated by
an owner's Inspector to perform inspection functions as
referenced in ASME 831.3, para. 340.4(c).
scrat.ch: an elongated ma rk or groove cut in the surface by
mechanical means, not associated with the predominan!
surface texture pattern.
SDR: standa rd di mension rat io, a s izi ng system for
polymer pipi ng systems tha t relates wall thickness to
pressure rating as defined by ISO.
Quality System Certiftcate: a document issued by ASME
that a uthorizes the use of an ASME Certificate number
on Certificates of Conformance for a specified time and
for a specified scope of activity.
R,,: log of the arithmetic mean of the surface profile.
sea/ chamber: see stufftn9 box.
R0 max.: the highest value of a series of R0 readings.
sea/ Jace: surface point on which a sea) is achieved.
reflow: a second weld pass made to correcta lack of fusion
or missed joint.
reinforcement: see convexíty.
sea/ point: location of process boundary created by components in contact (seal), having sufficient contact stress/
load to create media or e nvironmental isolation.
remote visual examination: a visual examination where
there is a n interrupted optical path from the observer's
eye to the a rea to be exa min ed. This covers the use of
photography, video systems, videoscopes, and borescopes.
sea/ weld: a weld used to obtain fluid tightness as opposed
to mechanical strength. (See also autogenous fil/et weld.)
seat leakage: a qua ntity of test fluid passing through an
assembled valve in the closed position under the defined
test conditions.
repeated use: see multiuse.
SEM: scanning electron microscope.
semi-automatic are weldi119: are welding with equipment
that controls only the filler metal feed. The advance of the
welding is manually controlled.
rouge: a general term used to describe a variety of d iscolorations in high-purity sta inless steel biopharmaceutical
systems. lt is composed of metallic (prima rily iron) oxides
and/or hydroxides. Three types of rouge have been categorized.
Class I rouge: a rouge that is predominantly particulate
in nature that tends to migrate downstream from its origination poin t a nd can deposit on process contact surfaces.
lt is generally orange to red-orange in color. These particles can be wiped off a surface and are evident on a wipe.
Surface composition under the rouge remains unchanged.
servíce life: the li fe expectancy or number of cycles for
which the unit will maintain itS performa nce.
she/flife: the duration, under specified storage conditions,
from the date of ma nufacture to the last date the product
can be placed in service without having an unaccepta ble
effect on performa nce.
she/1 leakage: a qua ntity of test fluid passing from the
inside of a component exte rnally to atmosphere under
the defin ed test conditions.
17
ASME BPE-2022
si9niftcanc chan9e (polymeric): a change that may affect
form, fit, or function.
strainer body: the s ubcomponent of a strainer that holds or
houses the strainer element. Astrainer body can be part of
th e process piping in which the strainer is installed (e.g.,
gasket strainer).
single-use: a term describing process contact components,
assemblies, a nd syste ms that are designed to be u sed once,
and not to be cleaned or sterilized for reuse.
strainer element: the s ubcomponent of a strainer with
openings (e.g., perforations, slots) . This subcomponent
provides the straining of suspended solid part iculates.
sizeclassification: the size of surface deficits is class ified in
two groups as follows:
(a) macro: referring to ind ications that can be seen in
adequate lighting without magnification.
(b) micro: referring to indications that can be seen only
with the aid of magnification.
stringer indication: a linea r vo id resulti ng from the
removal of an elongated nonmetallic incl us ion o r
secondary phase.
stuffing box: in shaft sea Is, the casingcontaining the sealing
material; seal chamber for s haft seals. (See a lso packing.)
slag: a nonmeta llic product resulting from the mutua l
dissolution of flux and nonme tallic impurities in some
welding a nd brazing operations.
superaustenitic stainless steel: a subgroup of a ustenitic
stainlesssteels having elevated levels of nickel, chromium,
and mo lybdenum compared with standa rd austen itic
stai nl ess steels (e.g., UNS S31603) and that may have
other additions (e.g., ni trogen and/or copper) to increase
strength a nd resistance to pitting corrosion and stress
corrosion cracking in the presence of chlorides.
slidin9 sea/: a seal that has transverse or rotationa l movement between the seal and mating s urface(s).
slope: a n incline or deviation from the horizontal. A tube or
pipe installed in the horizontal plane is said to slope if one
end is positioned higher than the other.
super duplex stainless steel: those duplex sta inless steels
whose chemical composition is designed to result in a
pilting resistance equivale nt number (PREN) ofa l least 40.
sparger: a device used to agitate, oxygenate, or aerate a
liquid by meaos of compressed a ir or gas.
spacter: the metal particles expelled during welding tha t
do not form part of a weld.
surface finish : a li s urfaces as defi ned by Part SF of the
current ASME BPE Standard a nd/or the owner/ user or
manufacturer a nd expressed in R0 inches or meters.
special process: a process, the results of which are highly
dependent on the control of the process or the skill of the
operators, or both, a nd in which the s pecified quality
cannot be readily determined by inspection or test of
the product
surface inclusion: particles offoreign mate rial in a metallic
matrix. The particles are usually compounds such as
oxides, s ulfides, or silicates, but may be a substance
fore ign to and essentially insoluble in the matrix.
spot electropolishi119: a localized electrochemical process
that is capa ble of producing the correct Cr to Fe ratios on
the surface of a materia l and meeting the requirements of
Nonmandatory Appendix H, Table H-3.3-1.
surface residual: a fore ign s ubstance that adheres to a
surface by chemical reaction. ad hesion, a dsorption, or
ion ic bonding (e.g., corrosion, rouging. and staining).
spray device: d ev ice fo r t he directe d dis trib ution
(delivery) of liquids to defined process contact surfaces
of equipment. (See also dynamic spray device and static
spray device.)
surveillance: tl1e act of an ASME Certificate Holder's monitoring or observing a supplier's in-process production
activities at the location of work to verify whether an
íte m conforms to specified require ments.
square cut: a tube end cut perpendicu lar to the tangent
plane.
static spray device: a stationary d evice designed to
produce a fixed directional spray pattern.
survey: an ASME Certificate Holder's documented evaluation of a supplier's ability to s upply items to meet specified
requ iremen ts as verified by a determina tion of the
adeq uacy of the organization's quality manage ment
system for the items to be procured and by review of
the implementation of that quality management system
at the location of work.
steam-in-place (SIP): the use of steam to sanitize or sterilize a piece of equipment without the use of a n autoclave.
survey (as performed by ASME or their designee on ASME
BPE Certificare Holders and Applicants): see ASME CA-1.
stem sea/: a seal eleme nt that is used on a shaft.
swing elbow: a movable elbow used to connect and reconfigure flow paths.
squareness: face-to -face perpendicularity.
st.atic sea/: a stationary sealing device.
sterile: free from living organisms.
system volume: total volume of liquid in the system,
including equipment, piping, valving. and instrumentation.
sterility: the absence of ali life forms.
strainer: a component that mechanically separa res and
re tai ns suspended salid particulates from a process
fluid. (See also strainer body a nd strainer e/ement.)
tack weld: a weld made to hold parts of a weldment in
proper alignment until the final welds are made.
18
ASME BPE-2022
testing (as it relates to pressure vessels): a function of the
manufacturer or fabricator, as witnessed by the examiner
or ASME Authorized Inspector· and verified or witnessed
by the owner's Inspector or the Quality lnspector's Delegate including written documentation in accordance with
ASME BPVC, Section VIII (or equivalent for other applicable codes or standards).
Ulcra-low Parliculate Air {ULPA} filter: a type of air fil ter
that removes 99.999% of particles 0.1 µ and larger in
diameter.
unacceptable leakage: leakage leve! above which the
system performance is considered unacceptable by the
system user and applicable regulating body.
testing (as it relates to process contact equipment): a funct ion of the manufact urer, fabricator, or erecto r, as
witnessed by the examiner a nd may be verified or
witnessed by the owner's Inspector or the Quality lnspec·
tor's Delegate including written documentation in accordance with ASME BPE.
underfi/1: a depression on the weld face or root surface
ex te nding below the adjacent surface of t he base
metal. (See also concavity.)
undercut: a groove melted into the base metal adjacent to
the weld toe or weld root a nd left: unfilled by weld metal.
uniformlyscactered porosity: porosity that is distributed in
a weldment in a uniform pattern.
testing (as it relates to process piping): a function of the
manufacturer, fabricator, or erector, as witnessed by the
examiner or Inspector· and verified or witnessed by the
owner's Inspector or the Qua lity lnspector's Delegate
including written documentation in accordance with
ASME 831.3.
user: see owner/user.
validation: establishing documented evidence that the
system does what it purports to do.
variance in luster: the appearance of a different shine or
retlectivity resulting from the examination or inspection
technique or from the preconditioning or conditioning of
the electropolished sur·face.
testing (as it relates to vessels not rated for pressure
service): a function of the manufacturer, fabricator, or
erector, as witnessed by the examiner and verified or
witnessed by the owner's Inspector orthe Quality lnspec·
tor's Delegate including written documentarion.
videoscope: a type of borescope with a carnera chip
mounted to the instrument for taking pilotos or videos
of the area of examination.
thermoplastic: long-chain polymers that are usually not
connect ed by cross links. Once formed, these mate rials
can be reshaped.
waviness: undulations or rippling of the surfaces.
welding operator: onewho operates machi ne orautomatic
welding equipment.
thermoset: long-c hain po lymers that are usua lly
connected by cross links. Once formed, these mate rials
cannot be reshaped.
weld joint design: the shape, dimensions, and configuration of the weld joint.
weld whicening: a difference in appearance oí grain structure between weld metal and base metal after electropolishing.
cransfer panel: a panel to which process and/or utilities
are piped that mechanically precludes erroneous crossconnections.
wbe: tube is sized by its nominal outside diameter. For
bioprocessing equipment, tube does not include pipe.
WFI: water-for-injection, a classification of water
according to compendia) standards.
tungsten inc/usions: tungsten parricles transferred into the
weld deposit by occasional touching of the tungsten electrode used in the gas tungsten-a rc process to the work or
to the molten weld metal. These inclus ions a re often
considered defects that must be removed and the weld
repaired prior to final acceptance. Tu ngsten inclusions
may be invisible to the unaided eye, but are readily identified in a radiograph.
GR-9 NOMENCLATURE
Dimensional and mathematical symbols used in this
Standard are listed in Mandatory Append ix IV with defi nitions for each symbol given in addition to their point-ofuse location(s) with in the Standard. Uppercase and lowercase English letters a re listed alphabetically, followed by
Greek letters.
19
ASME BPE-2022
CHAPTER 2
CERTIFICATION
(22)
---------------------PART CR
CERTIFICATION REQUIREMENTS
CR-1 PURPOSE ANO SCOPE
CA-1. An ASME BPE Certificate Holder s hall have a QMS in
conformance w ith Nonma ndatory Appendix Z. The essentia l controls ofthe QMS ens uring the components' conforma nce with the ASME BPE Sta ndard shall be documented
in a QMS Manual. Decisions to issue, renew, s uspend, withhold, or withdraw an ASME Certificate are made by ASME
based upon surveys, audits, and investigations conducted
by an ASME team. A list of ASME BPE Certificate Holders
can be found on the ASME website.
(b] ASME s urveys a re conducted by an ASME team to
evaluate the capability of an organization to manufacture
components in conformance with the requirements of its
QMS and the ASME BPE Standard. Surveys a re conducted
as part of the ASM E decision process for the issuance or
renewa l of a n ASME Certificate. ASME Certificares a re
issued a nd renewed with a n expiration date by which
t ime t he Certifica re Ho lders shall have t hei r QMS
Ma nual and its implementation s urveyed by ASME.
Duri ng the term of the ASME Cert ificate, Cert ificare
Holde rs a re s ubject to a pla nn ed a ud it program by
ASME. Additional a ud its may be conducted based upon
the resul ts of past surveys and a ud its or complaintS.
(e) Certificate Holders who manufacture components
under a Certificate of Authorization s hall provide designated ove rs ight of the ir ac tiviti es and the proper
Part CR establis hes the requirements for an organization manufacturing components in accorda nce with the
ASME BPE Standard to certify the components under
a n ASME Certificate of Authorization or a n ASME
Quality Syste m Certifica te. The type o f certi fica te
issued is based on the type of components manufactured,
as identified in Table CR-1-1.
Application of the ASME Single Certification Mark with
the "BPE" certification designator (see Figure CR-1-1) to
components or documentation that fulfills the require ments of the ASME BPE Standard is granted by ASME
under a Certificate of Authorization.
An ASME Quality System Certificate is issued to a manufacturer to identify the acceptance of its Quality Manage·
ment System (QMS) by ASME. That manufacturer may
then issue a Certifica te of Conformance, bearing its Certificare number, with componentS that fulfill the requirementS of the ASME BPE Standard.
Both programs are volun tary certification progra ms;
however, o rgan izations seek ing to apply the ASME
Single Certification Mark or issue the Certificate of Conformance shall conform with the requirements of Part CR.
In Part CR, the term "components" s hall be li mited to
those listed in Table CR-1-1.
CR-2 GENERAL
Figure CR-1-1
The ASME Single Certification Mark
With the BPE Certification Designator
(a) Toobta in, maintain, and renewan ASME Certificate,
applicants and Certificate Holders shall conform with the
conformity assessme nt require mentS addressed in ASME
Table CR-1-1
Types of ASME BPE Certificates
Component
Meta11ic fittings
Mctallic tubing
Polyrneric Sta.tic
seals
Certificate of
Authorization
Quality System
Certifica te
X
X
BPE
X
20
ASME BPE-2022
(9) qua lifying and approving s upp lie rs o f s ubcontracted work
utilization of the ASMESingle Certification Mark. Thisshall
be perfonned by a Certified Individual (CI). The CI shall be
an employee of the Certificate Holder and shall be qualified and certified by the Certifica te Holder. The Certificare
Holder's qualification and certification program for the CI
s ha ll be s ubject to evaluation a t the time of the ASME
CR-2.2 .2 Organízations manufacturing components
u nder an ASME BPE Certíficate of Author ization are
also respons ible for the followíng:
(a) ensuríng that the BPE certification desígnator is
used in conjunction w ith the ASME Single Certifícation
Mark. The BPE certification des ig nator shall be t he
respons ibility of the Certificate Holder. The BP E certification designatorshall cons istofthe uppercase letters "BPE"
and shall be of a design having similar proportions to that
shown in Figure CR-1-1 . The BPE certification designator
shall be legible and located immediately beneath the ASME
Single Certification Ma rk.
(b) establishi ng a nd defining competency requ irements for the qua lifica tion and certification of a CI.
(e) establishing a nd defining the duties for the CI.
(d) providing a uthorization forthe CI to perform duties
that protect the integr ity of the ASME Single Certification
Mark with the BPE certification designator.
(e) providing authorization for the CI to notify ASME
when the ASME Single Certification Mark with the BPE
ce rti fica tion d es ig nator is be ing ina p pro pri ately
controlled or misused.
survey.
(d) Certificare Holders who ma nufacture components
under a Quality System Certificate a re not required to use a
CI to provide designated oversight of their actívities.
CR-2.1 ASME BPE Certificate Holders
(a) An ASME BPE Certificate Holder shall have a QMS
that has been reviewed and accepted by ASM E a nd shall
have demonstra ted their capability to fulfill the requirements of the ASME BPE Standard for the scope of work
identified on the ASM E Certificate.
(b) ASME BPE Certificate Holders s hall be iss ue d a
Ce rtificate number to be used to attest to the valid ity
of their certification s tatements on data reports, Certificates of Conformance, or both.
(e) Written references indicating that an organizatíon
is a n ASME BPE Ce rtíficate Holder s hall not be valid
wíthout reference to the Certificate number.
(d) ASME BPE Certificate Holders shall be authorized
under a valid Certificate of Authorization to mark compo·
nents, documentation, or both, traceable to the compo·
nents, with the ASME Single Certification Ma rk wit h
the BPE certífication designator and t heír Certífícate
number, as appropríate.
CR-2.2.3 Ali Certificate Holders s hall be respons ible
for proper use of ASME marki ngs, i.e., the ASME Single
Certificatio n Mark, "ASME," o r t he ASME Ce rtificate
nu mbe r. These ma rk ings shall cert ify co nforma nce
w ith the ASME BP E Standard and shall clearly indicate
by stampings, labels, nameplates, data reports, or Certifícates of Confonnance that the componen! is certified by
the name of the Certi ficate Holder as it appears on the
ASM E BPE Certificate.
CR-2.2 ASME BPE Certificate Holder's
Responsibilities
CR-2.2.l
Ali Certífícate Holders shall be responsible
CR-2.3 Certified Individual Requirements Under a
Certificate of Authorization
for
(a) obtainíngan ASME BPE Certificate issued by ASME
in accordance with Table CR-1·1
(b) conformance to the latest edition of ASME CA-1 as
applicable to the ASME BPE Certification Program
(e) conformance to a li requirements ofthe ASME BPE
Standard, as applicable, for the scope ofwork identified on
the ASME BPE Certi ficate
{d} establ ish in g a nd mai nta ini ng an effective QMS
under Part CR
(e) documenting the QMS as follows:
{1} The QMS Manual s hall provide a detailed descri ption of the items and services tha t are bei ng provided
under the company's AS ME BP E Ce rtifi ca t e a n d
address the essential controls for each element identified
in Nonmandatory Appendix Z.
(2) The Certifica te Holder shall prepare procedures,
work instructions, forms, and other implementing documents specified by the QMS.
(/) fili ng a controlled copy of the QMS Manua l with
ASME
Certificate Holders performing work under a Certificate
of Authorization shall have aCI providing designated overs ight of the proper utilization of the ASME Single Certification Mark with the BPE certification d esignator.
CR-2.3.l Competency Requírements. The Certificate
Holder shall establis h and define the competency requirements for an individual to qualify and be certified as a CI.
(a) Ata m ínimum, the competency requ irements s hall
require the individual to
{1} be a n employee of the Certificate Holder w ith a uthorization to ensure the ASME Single Certification Mark
w ith the BPEcertification designator is not misusedand to
contact ASME on matters concerning the integrity of the
Mark
(2) have knowledge of the applicable requirements
of the ASME BPE Standard for the application ofthe ASME
Single Certification Mark with the BPE certification designator
21
ASM.E BPE-2022
(3) have knowledge of the Certificate Holder's QMS
(4) have train ing commensurate with t he scope,
complexity, or special nature of the activities to which
oversight is to be provided
(b) The individual meeting the established competency
requirements under the Certificate Holder's qualification
and certifica tion program shall be certified by the Certificate Holder to be able to perform the duties of a CI.
(e) The Certifica te Holder s hall maintain a record ofthe
qualifications and training of the CI.
{1} the scope of the ASME Certificate of Authoriza-
tion
(2) a valid and current ASME Certificate of Authorization
(3) the QMS Manual on file with ASME
(b) signing the appropriate data report, Certificate of
Conformance, or both prior to release of the BPE componen t. The signature shall attest to the component being in
conformance with the ASME BPE Standard.
(e) terminating the application of the ASME Single
Certification Mark with the BPE certification designator
on components that do not conform with the QMS or
the ASME BPE Standard.
(d) notifying ASME w hen the QMS, or any portion
thereof, is not being effectively implemented.
(e) being present during ASME surveys, audits, and
investigations.
CR-2.3.2 Duties of the Certified Individual. The duties
of the CI shall include, but are not limited to
(a) verifying that each component to which the ASM E
Single Certification Mark with the BPE certification designator is applied conforms with both the QMS on file with
ASME and the applicable requirements of the ASME BPE
Standard. Verifica tion activi ties include, but are not
limited to, ensuring the component is manufactured in
accordance with
22
ASME BPE-2022
CHAPTER 3
MATERIALS
PART MM
METALLIC MATERIALS
MM-1 PURPOSE AND SCOPE
provided they meet ali requirements of those specifications.
Austenit ic stain less st ee l t ube s hall be ca pab le of
passing t he weld decay test in ASTM A249 / A249M,
Supplement S7 and either the intergranular corrosion
test in ASTM A270/A270M , Supple ment Sl o r ISO
3651-2 Method B.
Materials used in applications governed by this Standard shall conform to a specification listed in MM-4.2
through MM -4.6, except as provided in MM -3.3.
The purpose of this Part is to identify metallic materia Is
considered acceptable for use in hygienic service. lt identifies ma te rial specifications, grades and alloys, appropriate filler metals. and other a ttributes necessa ry for
t his service. lt also spec ifies t he data t ha t m ust be
subm itted to the MM Subcommittee for a ny new or
unlisted alloy that is proposed for inclusion in Part MM.
MM-2 ALLOY DESIGNATIONS
{22)
MM-3.3 Unlisted Specifications
MM-2.1 General
Alloys in specifications not listed in MM -4.2 through
MM -4.6 may be used for a pplications governed by this
Standard provided they conform to a published specification covering composition, physical a nd mechanical properties, me tho d and process of manufacture, heat
treatment, and quali ty control, and otherwise meet the
chemical composition requirements of one of the speci·
fications listed in MM -4.2 through MM-4.6. Alloys not
listed in Tables MM -2.1 -1 through MM-2.1-4 may be
used for applications governed by this Standard provided
the following requirements are met:
(a) The applicable requirements of MM -9 are met
(bJ The specific written permission of the owner/user
is obtained.
Materials listed in MM-5.2.S are exempt from the require mentS of MM-3.3.
This Part identifies those metallic materials that have
demonstrated the ability to meet welding and surface
finish criteria as set forth in other Parts of this Standard.
Jt is the responsibility of the owner/user to e nsure that
any metallic materials selected for use from those listed in
Tables MM-2.1-1 through MM-2.1-4 a re appropriate for
the intended application.
The guidelines and criteria listed in this Part indicate a
general acceptability for use and do not address the specifics of fabrication or require ments of any given service.
MM-3 USES OF SPECIFICATIONS
(22)
MM-3.1 General
The specifications listed in MM-4.2 t hrough MM-4.6
may contain references to codes, sta ndards, or specifications not listed in this Part. Such unlisted codes, sta ndards,
or specifications are to be used only in the context of the
listed documents in which they a re referenced. Where
specifications listed in MM-4.2 through MM-4.6 contain
design rules that are in conflict with this Sta nda rd, the
design rules of this Standard shall govern.
(22)
MM-3.4 Unknown Materials
Mate ria Is of unknown origin or specification shall not be
used in hygienic service.
MM-3.2 Usted Specifications
Materials ma nufactured to specifications listed in the
appropria te sections of MM-4.2 through MM-4.6 may
be used for applications gove rned by th is Standard,
23
(22)
ASME BPE-2022
Table MM-2.1-1
Wrought Stainless Steels: Nominal Compositions (wt. %)
(22)
UNS
N1tmber
(Note (1)]
EN
JIS
Oesig:nation
Designation
e
Mn
N
Cr
Ni
Mo
Cu
Austenitic Stainless Steels
0.07
0.07
S30400
1.4301
SUS304
S30403
1.4307
1.4306
SUS304L
S31600
1.4401
SUS316
S31603
1.4404
1.4435
SUS316L
0.10
0.10
17.5-19.5
8.0-10.5
0.08
2.00
2.00
2.00
17.5- 19.5
18.0-20.0
8.0- 10.5
8.0- 10.5
0.030
2.00
0.10
0.030
0.030
0.030
2.00
2.00
2.00
0.10
0.10
17.5-19.5
17.5-19.5
8.0-12.0
8.0-10.5
18.0- 20.0
18.0-20.0
10.0- 13.0
9.0-13.0
0.08
2.00
0.10
0.07
0.08
2.00
2.00
0.10
16.0-18.0
16.5-18.5
10.0-14.0
10.0-13.0
2.00-3.00
2.00-2.50
16.0- 18.0
10.0- 14.0
2.00- 3.00
0.030
0.030
2.00
2.00
0.10
0.10
0.030
0.030
2.00
2.00
0.10
16.0- 18.0
16.5-18.5
17.0-19.0
10.0- 14.0
10.0-14.5
1 2.5-15.0
2.00- 3.00
2.00-2.50
2.50-3.00
16.0- 18.0
12.0- 15.0
2.0- 3.0
Superaustenitic Stainless St eels
N08904
1.4539
N08367
S31254
0.020
0.020
2.00
2.00
0.10
0.15
19.0-23.0
19.0-21.0
23.0-28.0
24.0-26.0
4.0-5.0
4.0-5.0
1.0-2.0
1.20-2.00
0.030
2.00
0.18-0.25
20.0-22.0
23.5-25.5
6.0-7.0
0.75
0.020
1.4547
0.020
1.00
1.00
0.18-0.25
0.18-0.25
19.5-20.5
19.5-20.5
17.5-18.5
17.5-18.5
6.0-6.5
6.0-7.0
0.50-1.00
0.50-1.00
0.020
0.020
2.00
1.00
0.15- 0.25
1.4529
19.0- 21.0
19.0-21.0
24.0- 26.0
24.0-26.0
6.0- 7.0
6.0-7.0
0.5- 1.5
0.50-1.50
0.040
0.20-0.25
0.20-0.25
21.0-22.0
21.0-22.0
l.35- 1.70
1.35-1.70
0.10-0.80
0.10-0.80
0.10-0.80
0.10-0.80
0.14-0.20
22.0-23.0
4.5-6.5
3.0-3.5
0.10- 0.22
21.0- 23.0
4.5- 6.5
2.50-3.5
N08926
0.15-0.25
Duplex Stalnless Steels
S32101
1.4162
0.04
4.00-6.00
4.0-6.0
1.4462
0.030
0.030
2.00
2.00
S32205
GENERAL NOTES:
Cal Maxi mum. unless range or minimum is i ndicated.
(b) Values listed i n this Table ar e primary elements only and ar e not complete chemical compositions as listed in specific product type material
specifications. Alloy composition is typically at the low end of the ranges indicated above. Refer to approp1i ate product type material
specification for complete material composition requirements.
(e) Alloys listed between horizontal lines ar e not equivalent, but comparable.
NOTE: (1) For cross-rcferencing of the UNS numbers Usted above to common alloy names, r cFer to SAE Metals and Alloys In the Unlflcd
Numbcr lng Systcm. latcst cdltion.
24
ASME BPE-2022
Table MM-2.1-2
Wrought Nickel Alloys: Nominal Compositions (wt. %)
UNS
Number
(Note (1)]
EN
JIS
De.signation Oesignation
N0662S
e
Cr
Ni
Mo
0.10
20.0-23.0
58.0 min.
8.0-10.0
(22)
Cu
Otber
Fe: S.O max.
(Nb + Ta) : 3.1S-4.1S
2.48S6
0.03- 0.10
20.0-23.0
58.0 mln.
8.0- 10.0
o.s
Fe: 5.0 max.
(Nb + Ta): 3.15-4.15
Ti: 0.4-0 max.
NCF62S
N! 0276
2.4819
O.JO
20.0-23.0
58.0 min.
8.0-10.0
Fe: S.00 max.
(Nb + Ta): 3.JS-4.!S
TI: 0.40 max.
0.01
14.S- !6.S
Balance
lS.0 - 17.0
0.01
'14.5-16.S
Balance
'IS.0-17.0
W: 3.0 -4.S
Fe: 4.0-7.0
Co: 2.5 max.
Mn: 1.0 max.
W: 3.0-4.S
Fe: 4.0-7.0
o.s
Co: 2.5 max.
Mn: 1.0 max.
NW0276
0.010
14.S-16.S
Balance
IS.0-17.0
W: 3.00-4.SO
Fe: 4.00-7.00
Co: 2.50 max.
Mn: 1.00 max.
N06022
2.4602
O.OJS
20.0 -22.5
Balance
12.5- 14.5
0.01
20.0-22.S
Balance
12.5-14.S
W: 2.S- 3.S
Fe: 2.0-6.0
Co: 2.5 max.
Mn: O.SO max.
W: 2.S-3.S
Fe: 2.0-6.0
Co: 2.5 max.
Mn: 0.50 max.
NW6022
0.015
20.0-22.5
Balance
12.5-14.5
W: 2.50-3.50
Fe: 2.00-6.00
Co: 2.50 max.
Mn: O.SO max.
GENERAL NOTES:
(a) Maximum, unless range or minimum is i ndic.ated.
(b) Values Listed in this 'fa ble are primar-y elements only and are not complete chemical compositions as listed in speciftc product type material
specifications. Alloy composition is typicaJJy at the low end of the ranges i ndicated above. Refer to appropriate product type material
specification for complete material comp<>sl tion requlrements.
(c:) A1loys Usted between horizontal Unes are not e<¡uivalent, but compardble.
NOTE: (1) For cross•rcíercncing of thc UNS numbers listcd abovc to common alloy names. refor to SAE Mctals and Alloys In t hc Unitied
Numbering System, latest edition.
25
ASM.E BPE-2022
Table MM-2.1-3
Stainless Steel and Nickel Alloy Cast Designations
(22)
Approx1mate Wrought Equivalent
UNS
ACI
EN
JIS
UNS
EN
11s
Oesignation
Designation
Oesignation
Oesignation
Oesignation
Oesignation
Oesignation
J92600
Cf8
Austenjtic Stainless Steels
S30400
1.4308
1.4301
ses 13A
J92500
CF3
SUS304
S30403
1.4309
1.4307
1.4306
ses 19A
J92900
CFSM
SUS304L
S3 1600
1.4408
1.4401
ses 14A
J92800
eFJM
SUS316
S3 1603
1.4409
l.4404
1.4435
ses 16A
SUS316L
Superaustenitic Stainless Steels
194651
eN3MN
J93254
CK3MeuN
N08367
S3 1254
1.4557
1.4547
Ouplex Stainless Steels
J92205
C03MN
S32205
1.4470
1.4462
Nickel-Based Alloys
N26625
ew6Me
N06625
N30002
CW12MW
Nl0276
N26455
CW2M
N10276
2.4856
2.4819
2.4610
2.48 19
N30107
CW6M
Nl0276
N26002
CX2MW
N06022
2.4819
2.4602
GENERAL NOTE: Alloys listed between horizontal lines are not equivalent, but comparable.
26
ASME BPE-2022
Table MM-2. 1-4
Wrought Copper: Nominal Compositions (wt. %)
(Cleaned for Oxygen Service)
UNS
Number
EN
Oeslgnatlon
p
Cu + Ag
99.95
Cl2000
99.90
0.008- 0.0 12
Cl2200
99.90
0.01S-0.040
0.015-0.040
99.90
Tubing, piping, and hollow bar manufactured in accordance with the following s pecifications may be used :
o
ASTM A213/A213M. Standard Specification for Seamless
Ferritic and Austenitic Alloy-Steel Boiler, Superheater,
and Heat-Exchanger Tubes
ASTM A249/A249M, Standard Specification for Welded
Austenitic Steel Boiler, Superheate r. Heat-Exchanger,
and Condenser Tubes
ASTM A269/A269M, Standard Specification for Seamless
and Welded Austen it ic Stainless Stee l Tu bing for
General Service
ASTM A270/A270M, Standard Specification for Seamless
and Welded Austenitic and Ferritic/Austenitic Stainless
Steel Sanitary Tubing
ASTM A312/A312 M, Standard Specification for Seamless,
Welded, a nd Heavily Cold Worked Austenitic Stainless
Steel Pipes
ASTM A511/A511M, Standard Specification for Seamless
Stainless Steel Mechanical Tubing and Hollow Bar
ASTM A789/A789M, Standard Specification for Seamless
and We lded Ferritic/Austenitic Stainless Steel Tubing
for General Service
ASTM A790/A790M, Standard Specification for Seamless
and Welded Ferritic/ Aus tenitic Stainless Pipe
ASTM B619/B619M, Standard Specification for Welded
Nickel and Nickel-Cobalt Alloy Pipe
ASTM 8622, Standa rd Specification for Seamless Nickel
and Nickel-Cobalt Alloy Pipe and Tube
ASTM 8626, Specification for Welded Nickel a nd NickelCoba lt Alloy Tube
ASTM B675, Specification for UNS N08367 Welded Pipe
ASTM 8676, Specification for UNS N08367 Welded Tube
ASTM 8690, Sta ndard Specification for lron-Nickel-Chromium-Molybdenum Alloy (UNS N08367) Seamless Pipe
and Tube
ASTM 8819, Standard Specification for Seamless Copper
Tube for Medica) Gas Syste ms
DIN 17744, Wrought nickel alloys with molybdenum and
chromium - Chemical composition
DIN 17751, Tubes ofwrought nickel alloys - Properties
EN 10216·5, Seamless steel tubes for pressure purposes
- Technical delive ry conditions - Part 5: Stainless
steel tubes
EN 10217-7, Welded steel tubes for pressure purposes Technical delivery conditions - Part 7: Stainless steel
tubes
EN 10312, Welded stainless steel tubes forthe conveyance
of water and other a queous liquids - Technical delivery
conditions
EN 13348, Copper and copper alloys - Seamless. round
copper tubes for medica) gases or vacuum
JIS G 3447, Stainless s teel sanitary pipes
JIS G 3459, Stainless s teel pipes
JI$ G 4903, Seamless nickel-chromium-iron alloy pipes
0.00010 max.
Cl0200
C.W024/I
MM-4.2 Tubing, Pi ping, and Hollow Bar
GENERA~ NOTES:
(a) Minimum, unless range or maximum is indic.1ted.
(b) Coppergrades listed between horizontal li nes are not equivalent,
but comparable.
(22) MM-3.5 Reclaimed Materlals
Reclaimed process components, equipment, or both
may be used with owner /user authorization, provided
they a re properly identified as conforrning to a published
specifica tion listed in MM-4.2 through MM-4.6 orto a
published specifica tion not listed in t hose paragraphs
and otherwise meeting the míni mum requiremen ts of
MM-9. When reclaiming s uperaustenitic or duplex s tainless s teel components, refer specifically to MM-5.2.1.2 or
MM-5.2.1.3, respectively.
(22) MM-3.6 Designation of Alloy and Fluid Services
DELETED
MM-4 REFERENCED SPECIFICATIONS
(22) MM-4 .1 General
Standards and specifications adopted by reference in
th is Standa rd are lis ted by product form in t hi s
section. lt is not considered practica) to identify the specific ed ition of each s ta ndard a nd specification in the
followi ng lists; therefore, the most current ed ition is
implied. Sources for procuring a ny of the listed material
specifications are found in Nonmandatory Appendix Y.
Ma teria l manufactured in accordance with ea rlier
editions o f the referenced standards that in ali othe r
respects conforms to this Sta ndard will be considered
to be in conformance with this Standard.
The ASME Boiler and Pressure Vessel Code (BPVC) has
adopted many of the lis ted ASTM material specifications.
Mate rials furnis hed to the latest edition of these ASME
specifications are a lso considered to be in conformance
with this Standard.
When preparing a Material Test Report (MTR), a mate·
rial manufacturer may transcribe data produced by other
organizations, provided he accepts responsibility for the
accuracy and authenticity of the data.
27
(22)
ASM.E BPE-2022
(22)
ASTM A240/A240M, Standard Specification for Chromi um and Chromium -Nickel Sta inless Steel Plate,
Sheet, and Strip for Pressure Vessels and for General
Applications
ASTM A666, Standard Specification for Annealed or ColdWorked Austenitic Stainless Steel Sheet, Strip, Plate, and
Flat Bar
ASTM B443, Standard Specification for Nickel-ChromiumMolybdenum-Columbium Alloy and Nickel-ChromiumMolybdenum-Silícon Alloy Plate, Sheet, and Strip
ASTM B575, Standard Specifícatio n for Low-Carbon
Nickel-Chromium-Molybdenum, Low-Carbon NickelChromium-Molybdenum-Copper, Low-Carbon NickelChromium -Molybden um-Tantalum, and Low-Carbon
Nickel-Chromium-Molybdenum-Tungsten Alloy Plate,
Sheet, and Strip
ASTM B688, Standard Specífication for Chromium-NickelMolybdenum-lron (UNS N08367) Plate, Sheet, and Strip
DIN 17744, Wrought nickel alloys with molybdenum and
chromium - Chemical composition
DIN 17750, Strip and sheet of nickel and wrought nickel
alloys - Properties
EN 10028-1, Flat products made of steels for pressure
purposes - Part 1: General requirements
EN 10028-7, Flat products made of steels for pressure
purposes - Part 7: Stainless steels
EN 10088-2, Stainless steels - Part 2: Technical deli very
conditio ns for sheet/p late a nd strip of corrosio n
resisting steels for general purposes
EN 10095, Heat resistant steels and nickel alloys
JIS G 4304, Hot-rolled stainless steel plate, sheet and strip
JIS G 4305. Cold- rolled stainless steel plate, sheet and strip
JIS G 4312, Heat-resisting steel plate, sheet and strip
JIS G 4902, Corrosion-resisting and heat-resisting superalloy pla tes and sheets
MM-4.3 Castlngs
Castings manufactured in accordance with the
following specifications may be used:
ASTM A351/A351M, Standard Specification for Castings,
Austenitic, for Pressure -Containing Parts
ASTM A494/A494M, Standard Specification for Castings,
Nickel and Nickel Alloy
ASTM A743/A743M, Standard Specification for Castings,
lron -Chromium, lron -Chromium -Nickel, Corrosion
Resistant, for General Application
ASTM A744/A744M, Standard Specification for Castings,
lron-Chromium-Nickel, Corrosion Resistant, for Severe
Service
ASTM A890/A890M, Standard Specífication for Castings,
lron-Chromium -Nickel -Molybdenum Corrosion-Resistant, Duplex (Austenitic/Ferritic) for General Applica·
tion
ASTM A995/A995M, Standard Specífication for Castings,
Austenitic-Ferritic (Duplex) Stainless Steel, for Pressure -Containing Parts
EN 10213, Steel castings for pressure purposes
EN 10283. Corrosion resistant steel castings
JIS G 5121, Corrosion-resistant cast steels fo r general
applications
(22)
MM-4 .4 Forgings
Forg in gs ma nu factured in acco rdance w ith the
following specifications may be used:
ASTM A182/A182M, Standard Specification for Forged or
Rolled Alloy and Sta inless Steel Pipe Flanges, Forged
Fittings, and Valves and Parts for High -Temperature
Service
ASTM B462, Standard Specification for Forged or Rolled
Nickel Alloy Pipe f langes, forged fittings, and Valves
and Parts for Corrosive High-Temperature Service
ASTM B564, Standard Specification for Nickel Alloy
Forgings
EN 10222-5, Steel forgings for pressure purposes - Part
5: Martensitic, aus tenitic, and aus tenitic-ferritic stainless steels
EN 10250-4, Open die s teel forgings for general engi neering purposes - Part 4: Stainless steels
JIS G 3214, Stainless steel forgings for pressure vessels
JIS G 4319, Stainless steel blooms and billets or forgings
(22)
MM-4.6 Shapes, Rods, and Bars
Shapes, rods, and bars manufactured in accordance
with the following specifícations may be used:
ASTM A276/A276M, Standard Specifícation for Stainless
Steel Bars and Shapes
ASTM A479/A479M, Standard Specifícation for Stainless
Steel Bars and Shapes for Use in 8oílers and Other Pressure Vessels
ASTM B574, Standard Specífícation for Low-Carbon
Nickel-Chromium-Molybdenum, Low-Carbon Nickel·
Molybdenum -Chromi um -Tan talum, Low -Carbon
Nickel-Chromium -Molybdenum -Copper, and LowCa rbon Nickel • Ch rom iu m -Mo lybden um -Tungsten
Alloy Rod
ASTM B649, Standard Specífication for Ni -Fe-Cr-Mo-Cu -N
Low-Carbon (UNS N08925, UNS N08031. UNS N08034,
UNS N08354, and UNS N08926), a nd Cr-Ni -Fe- N
MM-4.5 Plate, Sheet, and Strip
Plate, s heet, and s trip manufactured in accordance with
the following specífícations may be used:
28
(22)
ASME BPE-2022
(b) Delta Ferrite. lf specific d elta ferrite levels in austenitic stainless steels are deemed necessary to maintain
certain properties, the owner/user s ha ll specify required
delta ferrite ranges separately for the base metal, for welds
in the solution-a nnealed condition, and for welds left in
the as-welded condition. As a general rule, ma terial with
low Cr-to-Ni ratios show lower delta ferrite levels in the
base me t a l a nd subsequen t to we lding. See
Ta ble MM-5 .2.1.1-1 for pred icte d ferri te n u mber
ranges for various austenitic stai nless steel p roduct
forms. These ar e not acceptance crit eria. The listed
ferrite numbers refer to as-solidified austenitic stainless
steels a nd therefore indicate predicted delta ferrite levels
of the respective a utogenous welds, welds with fi ller
meta l, or castings. Additional informa tion regardi ng
delta ferrite can be found in Nonmandatory Appendix G.
Low-Carbon Alloy (UNS R20033) Bar and Wire, and NiCr-Fe-Mo-N Alloy (UNS N08936) Wire
ASTM B691, Standard Specification for lron-Nickel-Chromium-Molybdenum Alloy (UNS N08367) Rod, Bar, and
Wire
DIN 17744, Wrought nickel alloys with molybdenum and
chromium - Chemical composition
DIN 17752, Wrought nickel a nd nickel alloy rods and bars
- Requirements and testing
EN 10088-3, Stainless steels - Part 3: Technical delivery
conditions for semi-finished products. bars. rods, wire,
sections and bright products of corros ion resisting
steels for general purposes
EN 10095, Heat resistant steels a nd nickel a lloys
EN 10272, Stainless steel bars for pressure purposes
)IS G 4303, Stainless steel bars
)IS G 4308, Stainless steel wire rods
)IS G 4311. Heat-resisting steel bars a nd wíre rods
)IS G 4901, Corrosion-resisting a nd heat-resistíng s uperalloy bars
)IS H 4553, Nickel and nickel alloy bars
)IS H 4554, Nickel and nickel alloy wíre a nd drawingstock
MM-5.2.1.2 Superaustenitlc Stainless Steels. The
s uperaustenitic sta inless steels in Tables MM-2.1-1 and
MM-2.1-3 are prone to the precipitation of undesirable
secondary inte rmeta llic p hases such as sigma and chi.
Thís p recipitatio n typically occurs in t he range o f
1.000ºF to 1,900º F (540ºC to 1 040ºC) . This is a
concern du ring weldi ng and other thermomechanical
processes. including solution annealing. lt is, the refore,
(22) MM-4 .7 Copper Alloy Fittings
DELETED
Table MM-5.2.1.1-1
Predicted Ferrite Number (FN) Ranges for Various
Austenitic Stainless Steel Product Forms and Welds
MM-5 BASE METALS AND FILLER MATERIAL$
MM-5.1 General
Th is section provides requi rements and recommendations forthe base metals listed in Tables MM-2.1-1 through
MM-2.1-4. The use ofbase metals other than those listed in
this section is pennitted with the owner/user's written
approval (see MM-3.3).
This section a lso recommends filler meta Is and consumable inserts for welding these alloys in arder to produce
weldments whose weld metal has corrosion resista nce
consiste nt with that of the base metal. Details necessary
for welding are provided in Part MJ.
Product Form
Wrought product forms w lth sulfur
levels less than 0.005%
Wrought. product forms w ith a
sulfur range of 0.005% to
1.0 to 6
0.017%
MM-5.2 Base Metals
(22)
Expected FN
0.5 to 4
GMAW/GTAW uslng ER316L
[Note ( J) ]
4 to 12 [Note (2)]
SMAW using E316L [Notes ( 3),
4 to 10 [Note (5))
(4)1
CFtlM and CF3M castlngs
5 to 15
GENERAL NOTE: FN ranges determined from D. J. Kotecki and T. A.
Siewart, "'WRC·1992 Constitution Oiagram for Stainless Steel Weld
MM-5.2.1 Stainless Steels
Metals: A Modificati on o f the WRC -1988 Oiagram; We ldin9
journal 71(5), p. 171-s, 1992.
MM-5.2.1.1 Austenitic Stainless Steels
NOTES:
( 1) SFA 5.9/S.9M, Sp<lcification for Ban, Stainless St.eel Welding Electrodcs and Rods.
(a) Weld Ends of Process Componencs. Weld end s of
process co mpo ne nts tha t are to be a utoge nous ly
we lde d s h al l h ave a s u lfur con t en t between
0.005 wt. % and 0.017 wt. % (see a lso MJ- 2.1.l(a)].
This requiremen t applies to the a ustenit ic stainless
steels listed in Tables MM -2.1 -1 an d MM-2.1-3. This
requirement does not apply to ma terials u sed in the ma nufacture of process components, only to the weld ends of
process components in their final form.
( 2) Nitrogen pickup or wcld metal dilution could result in a 3 FN to 4
FN loss in the as-deposited weld metal,
(3) SFA S.4/S.4M, Specific~tion for Stai nless Steel Electrodes for
Shielded Metal Are Welding.
(4) Rlettrodes wíth a restritted FN usually require a spedal order,
w ith t.he exception ()f 2 FN maxim um produc-t for cryogenic
tempera tu res.
( 5) FN in the as•dcposlted weld is lnfluenccd by welding tcchniquc
and is lowcred by nltrogcn pickup or weld metal dilutlon.
29
(22)
ASME BPE-2022
desirable to keep exposure time within this temperature
range to a mínimum.
Exposure time to undesira ble tempera tures reached
during high-temperatu re service, hea t treatmen t, o r
joining should be minimized. The material manufacn,rer
should be consulted for speci fic instructions regarding
heat treatment.
MM-5 .2.5 Speclal Alloys . When specified by the (22)
owner/user, alloys listed in Table MM-5.2.5-1 may be
used for process contact surfaces in unique applications,
such as original equipment ma nu facturer (OEM) process
instrumentation, pump internals, etc.
MM- 5.2.6 Unlisted Alloys. Alloys not listed in Part MM (22)
and having corrosion resistance less than that typical of
304L-type stainless steel may be used for process contact
surfaces in unique applicarions such as OEM instrumentation when the owner/use r has determined that t he
proposed material is suitable for the intended service.
MM-5.2.1.3 Duplex Stainless Steels. The corrosion
resistance and mechanical properties of duplex stainless
steels listed in Tables MM-2.1-1 a nd MM-2.1-3 are based
on having roughly equal amounts of ferrite and austenite
in the microstructure at room temperatu re while also
avoiding undesirable secondary phases.
The UNS S32101 grade listed in Table MM-2.1-1 may be
prone to the precipita tion of undesirable ni trides and
ca rbides when exposed to temperatures in the ra nge
of 1,200°F to 1,570°F (650°C to 850°C). Similarly, the
d uplex stainless steel, UNS S32205, may be prone to
the precipitation of undesirable secondary intermetallic
phases such as sigma and chi. This precipitation occurs
continually in the ra nge of 1,200°P to 1,830ºF (650ºC
to 1 OOOºC). Exposure time to undesirable temperatures
reached during high-temperature service, heat treatment,
or joining should be minimized. The material manufactu re r s hou ld be co nsu lted fo r speci fic instructions
regarding heat treatment.
(22)
MM-5.3 Filler Materials
Filler material shall conform to a published specification. Tables MM -5.3 -1 through MM -5.3-4 list the recommended filler metals for welding the listed austenitic,
superaustenitic, and duplex stainless steels and nickel
alloys.
Table MM-5.3 -5 lists the recommended materials from
which consumable inserts may be made for use in welding
the listed superaustenitic and duplex stainless steels.
Table MM-5.2.5·1
Materlals for OEM Equlpment
MM-5.2.2 Nickel Alloys. The nickel alloys li sted in
Tables MM-2.1-2 and MM-2.1-3 may be prone to precipita tio n o f secondary p hases suc h as mu and P. Such
secondary precipitation typically occurs when the material is subjected to temperatures in the range ofl,SOOºF to
1,800ºF (820ºC to 980ºC) and can creare a detrimental
effect on the material's corrosion resista nce. Expos ure
time to undesirable temperatures reached during highte mperan,re service, heat trea tment, or joining should
be minimized.
(22)
UNS Number
EN Oesignation
Common Name
Platinum (coating)
Gol d (coating)
Silver (coating)
RS0250
TI -
Grade 1
Ti -
Grade 2
Ti -
Grade S
TI -
Grade 7
3.7025
R50400
3.7026
RS6400
MM-5.2.3 Castings. When castalloys discussed in this
3.7164
sectio n solidify, microsegregation of ch ro mium a nd
molybdenum occurs.Segregation reduces corrosion resistance and is corrected in castings by a full solution anneal
as specified by the material specification oras recommended by the material manufacture r. Ali casi materials
shall be supplied in the solution-a nnealed condition, a nd
the solution-anneal procedure shall meet the time a nd
te mperature requirements of the product specification.
Any weld repa ir by the casting ma nufacturer shall
meet the requirements of the specifica tion or sha ll be
as speci fied by the owner/user.
(22)
(22)
RS2400
RS6320
TI -
Grade 9
RS3400
Ti -
Grade 12
N06200
Hastelloy C-2000 [Note (!)]
N06600
lnconel 600 [Note (2)]
N07718
1nconel 7 18 [Note (2)1
2.4668
17-4 PH [Note (3))
S17400
1.4542
GENERAL NOTE: Alloys listed between horizontal lines are not
MM-5.2.4 Copper Alloys. In applications allowed in
equivalent, bttt comparable.
Part SO or a pproved by the owner /user, coppe r
tubing, as li sted in Table MM -2.1 -4, may be used for
process gas distribution systems.
NOTES:
(l) Hastelloy C•2000 is a registe-red trademark of Hayne.s lnternational, Jnc.
(2) lnconcl is a rcgistcred tradcmark of Spccial Mctals Corp.
(3) 17•4 PH is a registered trademark of AK Steel.
30
(22)
Table MM-5.3-1
Filler Metals for Austenitic Stainless Steels
(22)
FIiier Metal
Base Metal Alloy (Note (1))
SMAW
GTAW/GMAW/ SAW/ PAW
ISO
UNS
Designa·
tion
EN
JIS
AWS
SFA
UNS
3581-A
EN
Designation
Designation
Classification
Spe-cifica-
Designation
Designa-
tion
Designation
E308·15
5.4
W308 10
S30400
tion
ER308
5.9
530880
ER308L
ER308Si
53088 1
ER308LSi
S30888
14343-A
JIS
Designation
EN
Designation
5.4
19 9 L
1.43 16
19 9 L SI
1.4316
19 9 Nb
1.4551
19 9 Nb SI
1.4551
W30813
f.R3081.
W30813
ER308LSi
E308L-17
W308 13
5.9
5.4
530883
~
"'"".,,
"'o
;.,
;;:
19 9 L
1.43 16
19 9 L SI
1.4316
19 9 Nb
1.4551
199 Nb Si
1.455 1
19 9 L
1.4316
19 9 L Si
1.4316
19 9 Nb
1.4551
19 9 NbSi
1.4551
N
N
YS308L
YS308LSi
W3 16 10
ER316L
f.3 16-16
W3 16 l 0
ER3 l6LSi
E316-17
W31610
5.9
S3 1683
S31688
19 12 3 L
1.4430
19 12 3 L Si
1.4430
19123Nb
1.4576
19123NbSI
1.4576
20 25 5 Cu N I,
1.45 19
20 2S 5 Cu L
1.4519
ES316-16
ES316-17
tion
S30888
ES308L·16
ES308L•17
E316•15
Designa-
Y5308
YS308L
YS3085i
YS308LSI
E308L-16
SUS304L
Z 3321
S30883
f.5308-16
ES308-17
1.4306
SUS316
Specification
W308 10
1.4307
1.4401
Classification
UNS
Designation
W308 10
f.3081.-15
S31600
tion
SFA
f.308-17
50S304
w
,...
Designa-
ISO
AWS
E308•16
1.4301
S30403
JIS
Z 3221
YS316L
YS316LSi
Table MM·5.3·1
Filler Metals for Austenit ic Stainless Steels (Cont'd)
Filler Metal
Base Metal Alloy [Note (1)1
UNS
Designa-
EN
Designa-
)IS
Designa-
tion
tion
tion
S3 I 603
SMAW
AWS
Classln•
cation
E316L-15
E3 16L-16
E316L-17
E3J7L-15
E317L-16
E3 17L-17
1.4404
1.4435
w
N
SFA
Speclflcation
UNS
Deslg:na•
tjon
5.4
W3 16 13
W3 16 13
W3!613
W3 17 I 3
W3 1713
W3 !713
GTAW/GMAW/SAW/PAW
ISO
3581·A
Designa-
tion
EN
Destg:nation
JIS
Z 3221
Designa•
tion
AWS
Classln•
catjon
SFA
Speclnca-
UNS
Designa•
tion
tion
ER316L
f.R316LSi
ER317L
5.9
S31683
S3 1688
S3 1783
ISO
14343·A
Designation
EN
Designa-
)IS
Z 3321
Designa-
tion
tfon
19 12 3 L
1.4430
19 1 2 3 L Si
1.4430
19123Nb
1.4576
19 12 3 Nb Si
1.4576
20 2S 5 Cu L
1.45 19
19 12 3 L
1.4430
19 123 1, Si
1.4430
19123Nb
1.4576
19 12 3 Nb Si
1.4576
18 16 5 N L
1.4440
18 16 5 N L
1.4440
2016 3 Mn N L
1.445S
20 16 3 Mn L
1.4455
20 25 5 Cu N L
l.45I9
20 25 5 Cu 1,
1.4519
SUS316L
ES316L·16
ES316L-17
ES317L-16
ES317L-17
..
>
3:
.,"'..,
~
N
YS3 16L
YS316LSi
YS317L
GENERAL NOTE: Thc use of AWS/UNS fillcrmctal is rccommendcd forweldl ngofUNS base metal; thc use orEN filler metal is r ccommcnded íorweldlng ofEN base metal; the use ofJIS fillcrmct.al is
recommcndcd for w cldi ng of JIS base metal.
NOTE: (1) Alloys listed between horizontal lines are not equivalent but comparable.
Q
N
N
Table MM-5.3-2
Filler Metals for Superaustenitic Stainless Steels
FIiier Metal
Base Metal Alloy
(Note (1))
UNS
Designa•
EN
tion
Oesignation
N08904
SM AW
AWS
Classification
Spe-cification
SFA
UNS
Oesignation
ENiCrMo-3
5.11
W86112
GT AW/ GMAW/SAW/ PAW
ISO 14172
Designation
EN
Designation
AWS
SFA
UNS
Classification
Spedfication
Oesignation
ERNiCrMo-3
5.14
N06625
ENiCrMo·4
W80276
ERNiCrMo·4
N10276
ENICrMo•lO
W86022
ERNICrMo•IO
N06022
1.4539
531254
(22)
ENiCrMo•3
5.11
ISO 18274
EN
Designation Designation
20 25 5 Cu N L
[Noto ( 2))
1.4519
20255Cu NL
(Note (3)]
1.4519
Ni 6625
2.4621
Ni 6625
2.4831
W86112
ERNiCrMo•3
ENiCrMo·4
W80276
ERNiCrMo·4
NI0276
ENiCr Mo-10
W86022
ERNiCrMo-1 O
N06022
1.4547
5.14
N06625
Ni 6059
2.4609
Ni 6082
2.4806
~
Ni 6625
2.4621
Ni 6625
2.4831
"'"".,,
"'o
;.,
;;:
w
w
N08367
ENiCrMo•3
N08926
W86112
ERNiCrMo•3
ENiCrMo·4
W80276
ERNiCrMo-4
1'110276
ENiCr Mo-10
W86022
ERNiCrMo-1 O
N06022
W86112
ERNiCrMo-3
EN ICrMo•4
W80276
ERNiCrMo•4
N10276
ENiCrMo-10
W86022
ERNiCrMo-10
N06022
ENiCrMo-3
5.11
5.11
1.4529
5.14
5.14
N06625
N
N
N06625
Ni 6059
2.4609
Ni 6059
2.4607
Ni 6625
2.462 1
NI 6625
2.4831
GENERAL NOTE: The use of AWS/UNS filler metal is recommende11 for welding of UNS base metal; the use of EN filler metal is recommended for welding of EN base metal.
NOTES:
(1) Alloys listed between horizontal lines are not equivalent, but comparable.
(2) Filler metal designation as per ISO 3581 ·A.
(3) Filler metal designation as per ISO .14343-A.
Table MM-5.3·3
Filler Metals for Duplex Stainless Steels
(22)
Filler Metal [Note (2)1
Base Metal Alloy
[Note (l)f
UNS
EN
Designation
Designation
S321.01
SMAW
AWS
SFA
UNS
Classification Specification Deslgnation
E2209
EN
Designation
Designation
AWS
SFA
Classification Specification
W39209
ER2209
W39553
ER2307
[Note (3) 1
S82371
5.4
5.9
UNS
Desiguation
E2553
E2593
W39593
ER2553
S39553
W39594
ER2594
S32750
E2595
W39595
E2209
5.4
ISO 18274
EN
Designation Designation
S39209
E2594
l.4I62
S32205
GTAW/GMAW/SAW/ PAW
ISO 3581-A
22 9 3 N t
1.4462
22 9 3 N 1,
1.4462
23 7 N L
1.4362
23 7 N L
1.4362
25 9 4 N L
1.4501
25 9 4 N L
1.4501
W39209
ER2209
5.9
S39209
E2553
W39553
ER2553
S39553
E2593
W39593
ER2594
S32750
[2594
W39594
E2595
W39595
[Not.• (3)1
w
~
1.4462
.
>
3:
.,"'..,
~
22 9 3 N L
1.4462
22 9 3 N L
[Note (3)]
1.4462
22 9 4 N L
1.4501
22 9 4 N L
1.4501
GENERAL NOTf.: The use oí AWS/UNS filler metal Is recornmended for welding of UNS base metal; 1:he use of f.N filler metal is recommended for weldi ng of EN base metal.
NOTES:
(1) Alloys Usted bet\Yecn horizontal Unes are not cqulvalcnt. but comparable.
(2) Any super duplex st;iinless steel filler metal c.an be used to weld any duplex st;iinl ess steel.
(3) Addition of up to 5% of nitrogen to the shielding gas is r ecommended to aid i n obtaining ferrite/austenite balance.
N
Q
N
N
Table MM-5.3-4
Filler Metals for Nickel Alloys
(22)
Filler Metal
Base Metal Alloy ¡Note (1)]
GTAW/GMAW/SAW/PAW
SMAW
ISO
UNS
EN
JIS
AWS
SfA
UNS
Designa-
Designa•
Designa•
Classif'ica-
tion
tion
tion
tion
Specification
AWS
SFA
UNS
Designa•
Cla~if'ica-
Specifica-
tion
tion
tion
tion
Designation
ERNiCrMo•J
ERNiCrMo-4
5.14
N0662S
ENICrMo-4
W86112
W80276
ENiC'rMo--10
W8602Z
ERNIC,Mo• 10
5.11
Designa-
14172
Designa•
tion
tion
Ni 6059
2.48 19
EN
5.11
ENiCrMo--10
W86112
W80276
tion
Ni 6059
2.4607
5.14
N06625
NI0276
N06022
2.4609
N16059
2.4607
YNiCrMo-3
YNiCrMo-4
ENi6022
ENi6276
ENi6625
ENiCrMo-3
ENIC'rM()-4
ENiCrMo--10
5.11
W861 12
W80276
W86022
ERNICcMo-10
NCF625
2.4621
5.14
"'"".,,
"'o
;.,
N06625
N10276
N06022
Ni 662S
EN16022
ENi6276
ENi 6625
N
N
2.4831
YNICr Mo-3
YNiCrM0·'1
GENERAL NOTE: The use of AWS/UNS íillermetal is recommended forweldingofUNS base metal; the use ofEN filler metal is recommended forwelding ofEN base metal; the use ofJJS filler metal is
recommended for welding of JIS base metal.
N"OTE: (t} Alloys listed between horizontal lines are n()t equivalent, but comparable.
~
;;:
ERNiCrMo•3
ERNiCrMo-4
Ni 6625
2.4856
tion
N06022
E:RNiCrMo• LO
NI 6059
NW6022
w
tion
YNICrMo·3
YNiCrMo-4
ERNiCrMo·3
ERNiCn\1o,4
W86022
2.-1602
V,
Designa•
Z 3334
Designa•
ENi6022
ENi6276
ENi6625
ENICrMo-3
ENiCrMo-4
N06625
)IS
EN
18274
Designa•
N10276
2.4609
NIY0276
N06022
ISO
Z 3224
Designa•
ENiCrMo-3
N I 0276
)IS
ASME BPE-2022
Table MM-5.3-5
Consumable lnserts for Superaustenitic and Duplex Stainless Steels
(22)
Baso Metal Alloy (Noto ('! ))
UNS Deslgnatlon
ACI Deslgnatlon
lnsert Alloy ( Note (2))
EN Deslgnatlon
UNS Doslgnatlon
EN Doslgnatlon
Su iu~raustenltlc Stalnless Steels
N06022
Nl0276
1.4539
2.4856
2.4602
2.4819
N06022
Nl0276
08 '6
N10276
1.4529
2.4856
2.4602
2.4819
531254
N06625
N06022
N10276
1.4547
2.4856
2.4602
2.4819
)'J4651
CN3MN
N066is
N06022
Nl0276
)93254
CK3MCuN
N06625
N06022
N10276
1.4557
2.4856
2.4602
2.48 19
Duplex Stainless Steels
532101
S32205
S32750
N06625
N06022
N10276
1.4162
S32205
2.4602
2.48 19
N06022
N10276
l.4462
¡nios
W3MN
2.4602
2.4819
No6oii
Nl0276
1.4470
2.4602
2.4819
GENERAL NOTE: 1'he use of UNS consumable i nserts is recommended for welding of UNS base metal; the use of EN consumable inserts is
recommended for welding of EN base metal.
NOTES:
(l ) Alloys listed between horizontal lines are not equivalent, but comparable.
(2J Sec MM·4 for listed rod. bar, or plate spcdftcations from w hich these consumablc i nserts may be manufacturcd.
36
ASME BPE-2022
Filler ma t er ials ot her t han t hose li s t ed i n
Tables MM -5.3 -1 through MM -5.3-5 may be used with
the prior approval of the owner/user provided that
(a) they produce weld metal having corrosion resistance equal to or greater than that of the base metal
(b) the welding procedure is qualified in accordance
with Part MJ
Proprietary filler materials may be used with the prior
agreement of the owner/user, provided ali requirements
of Part MJ a re met.
When filler metal is used, the manufacturer shall identify the filler metal in the docume ntation provided with the
componen t.
(22)
MM-5.3.l Austenitk Stainless Steels. Only the iowcarbon grades of s tainiess steel filler metais may be
used to weld these alloys. lf a fil ler meta l is used, it
should be in accordance with the filler metals listed in
Table MM-5.3-1.
( 221
MM-5.3.2 Superaustenitic and Duplex Stainless
Steels. lf a filler metal is used during the ma nufacture
of process components, it sho uld be in accordance
with Table MM -5.3-2 or Table MM-5.3-3, as app ropriate.
lf a consumable insert is used, it shoul d be in accordance
with Table MM -5 .3 -5. Other nicke l-chro mium-molybden um fille r meta ls o r co nsu mab le inserts may be
used as long as the cor rosion resista nce of the final
weld metal meets or exceeds that of the base meta l.
The manufacture r shall also identify the filler me tal or
consumable insert as part of the documentation.
( 22)
(22)
MM-6 MECHANICAL PROPERTIES AND LEAK
TESTING
(22)
MM-6.l Tubing/Piping
Ali tube or pipe used for process contact surfaces and
non-process contact surfaces shall meet the mechanical
p roperty requi rements of the specificatio n to which
they a re manufactured.
MM-6.2 Fittings and Valves
Refer to DT-2 for pressure a nd strength requirements
for fittings and valves.
When material is cold worked, its mecha nical properties can be expected to change from those of the original
heat of the raw material. MTRs for fittings are therefore
not required to list mecha nical properties; however, if
t hey do, they shall conform to the specifications for
the raw materials from which the fittings were fabricated.
MM-6.3 Toughness
Sorne ofthe materia Is listed in Tables MM-2.1-l through
MM-2.l -3, as well as Table MM -5.2.5-1 , u ndergo a
decrease in toughness when used at low temperatures,
to the extent that other appl icable corles may require
impact tests fo r applicatio ns even a t temperatures
higher tha n 20º F (- 7ºC) . lt is the responsibility of the
owner /user to e nsu re tha t such testing is performed
and tha t the requirements of ali applicable codes are rnet.
MM-6.4 Testing
MM-5.3.3 Nickel Alloys. lf a fil ler metal is used, it
should be in accordance with the filler metals listed in
Table MM -5.3-4.
Refer to DT-6 for the testing requireme nts for fittings
and MC-4.3.1.1 for the testing requirements for valves.
MM-5.3.4 Copper Alloys. Table MM-5.3.4-1 lists the
filler metals to be used for brazing copper tubing.
MM-7 POSITIVE MATERIAL IDENTIFICATION
Whe n pos it ive mate r ial ide n t ification (P M1) is
perfo rm ed, it is limited to all oy verification. Refer to
Nonmandatory Appendix W for guidance regarding procedures and data inte rpretation.
(22) MM-5.4 Heat Treatment
Heat treatment of process compone nts made from the
a uste nitic sta inless steels in Tab le MM -2.1-1 is not
addressed by th is Standard.
For the listed superausten itic and duplex sta inless
steels, if t he filler meta ls o r co nsu mab le inserts in
Table MM-5.3-2, Table MM- 5.3 -3, or Table MM -5.3-5
are used, a postweld heat treatment is not required. lf
those alloys a re welded autogenous ly, postweld heat
treatment is required in accordance with Table MM-5.4 -1.
MM-8 CORROSION-RESISTANCE REQUIREMENTS
MM-8.l General
The specific service environment for which the alloys in
Tables MM-2.1-1 through MM -2.1-4 may be used is not
within the scope of this Part. The possibility of mate rial
deterioration in service should be considered by the
owner/user. Carbi de p hase degradation of corrosion
resistance, suscepti bility to intergra nula r corrosion of
austeni tic rnate rials, and grain boundary attack of
n ickel-based alloys are among those it ems req uiring
attention.
37
(22)
ASME BPE-2022
Table MM-5.3.4-1
Brazing Filler Metals for Copper
(22)
Base Metal (Note (1))
UNS Number
EN Des-lgnatlon
c 10200
Filler Metal
AWS Classtflcatlon
SFA Spectflcatlon
UNS Deslgnatlon
BCuP-3
S.8
C5528l
CSS283
CS5284
C55280
CSS282
CSS281
CS5283
CS5284
CSS280
CS5282
CSS281
CS5283
CSS284
CS5280
C55282
BCuP-4
BCuP-5
BCuP-6
BCuP-7
C12000
S.8
BCuP-3
BCuP•4
8CuP-S
BCuP-6
BCuP•7
C12200
5.8
BCuP-3
8Cuf>-4
BCuP-5
BCuP-6
BCuP-7
EN Deslgnatlon
CW024A
GENERAL NOTE: The use oí AWS/UNS filler metal is recommended for bra7,ingofUNS base metal; the use ofEN filler metal is recommended for
braiing of EN base metal.
NOTE: (1) Copper grades llstcd betwcen horizontal llnes are not equivalcnt. but comparable.
38
ASME BPE-2022
( 22)
Table MM-5.4-1
Solution Anneal Heat Treatment
Requirements for Superaustenitic and Duplex
Stainless Steels
Base Metal Alloy [Note (l)J
priate to use electrochemical test methods or a standard
immersion test method to evaluate the effect of the various
parameters. Sta ndard ASTM corrosion tests commonly
used are discussed in Nonmandatory Appendix F.
Solution Anneal
UNS
EN
Temperature, ºF (ºC)
De.slgnatlon
Deslgnatlon
[Notes (2), (3). and (4)]
MM-9 MINIMUM REQUIREMENTS FOR ALLOYS IN
PART MM
Sur,eraustenltlc Stalnless Steels
N08904
1.4539
S3 1254
1.4547
section as a minimum.
2.100 (1150)
For materia ls to beadded to PartMM. the information in
MM-9.1.1 or MM-9.1.2. as applicable, shall be provided to
the ASME BPE Staff Secretary.
2.025 (! 105)
N08926
2,010 (! 100)
2,010 (1 100)
1.4529
Duplex Stainless Steels
1.4162
MM -9.Ll Wrought, Cast, and Welded Fabricated (22)
Applications
1,870 (1020)
1,870 (1020)
(a) Listing of the alloy in an industry-recognized specification or standard including !ensile strength properties.
{b) Evidence that the proposed material, in both the
wrought and welded conditions, will have corrosion resistan ce equal to or greater than 304L stainless steel (UNS
S30403) in a service environment within the scope ofthis
Standard. Materials that will not be welded (e.g., some
cas ti ngs) do no t req uire co rrosion testing in the
welded condition.
(e) Weld ed austenitic stainless stee l tube shal l be
capable of passing the weld decay test in ASTM A249/
A249M, Supplement S7 a nd the intergranular corrosion
test in e ither ASTM A270/A270M. Supple ment S1 or
ISO 3651 -2 Method B. See Nonmanda tory Append ix F
for additional in formation.
{d) Evidence that the material s urface can be mecha nically polished, electropolished, or passivated to meet the
applic.able req uirements of Part SF.
( e) Recomme nd ed we lding proces s(es}, fi ll er
meta l(s}, and evide nce showi ng that th e combi nation
o f base meta l, fil ler me tal(s}, and reco m me nded
welding process(es} meets the applicable require ments
of Parts MJ and SF. Special restrictions, exceptions, or
guidance s hall be noted.
1,870-2.010 (1020-1100)
S32205
1.4462
(22)
Metallic materia Is shall meet the requirementS of this
2,100 (1150)
N08367
S3210 1
MM-9.1 General
2,000 (1 095)
2,000 (1095)
1,870-2.010 ( 1020-11 00)
NOTES:
(1) AJloys Usted between horizontal lines are not equivalent. but
comparable.
(2) Minimum solution anne.al temperature un.less range is specified.
(3) No minimum anneal time isspecified, however, very short anneal
times can result in inadequate time at temperature to resto re the
corrosion resistance of autogen(>us welds.
(4) Post•solution anncal cooling shall be achicvcd by a water quench
or rapfd cooling by other mcans.
Resistance to corrosion is an essential characteristic of
the materials used to fabricate the systems governed by
this Standard. Corrosion testing is recommended whenever specific p roduction performance characteristics
must be determine d. The owner/use r s hall have the
final responsibility for proper material selection.
MM-8.2 Corrosion Testing
Corrosion testing may be performed for the following
reasons:
(a) to compare a numberof alloys in a specific standard
MM-9.1.2 Specialty OEM Material Applicat ions
(a) Listing of the a lloy in an industry-recognized specification or standard. Tensile strength properties shall a lso
be included unless the material is used only as a coating.
(b) Evidence that the proposed material, in both the
wrought and welded conditions, will have corrosion resistance equal to or greater than 304L stainless steel (UNS
S30403} in a service environment within the scope of this
Standard. Mate rials tha t will not be welded (e.g., some
castings and coatings) do not require corrosion testing
in the welded condition. Sprayed or vapor deposited coatings s hall be tested over the base mate ria l used in the
environment
(b) to de termine the compatibility of an a lloy in an
owner/user-defined environment
Once a particular alloy has been selected for an application, more extensive testing may be appropriat e. This
tes ting may involve t he eval uat io n of any o ne o f a
number of process variables on material performance.
These va riables include, but may not be limited t o,
upset temperature conditions, varyi ng concentrations
of the corrosive age nt or condition, cleaning chemical
type and concen tration, va rious surface finishes,
welding process, and filler meta l alloy. lt may be appro-
39
(22)
ASME BPE-2022
(e) For we lded coatings, recommended we lding
prncess(es), filler metal(s), and evidence showing that
the combination ofbase metal, filler metal(s), and recommended welding process(es) meets the applicable requ irements of Parts MJ and SI'. Specia l restrictions,
exceptions, or guidance shall be noted.
commercially s upp lied parts. See Non mandatory
Appendix F for additional information.
(e) Evidence that the material surface can be mechanically polished, electropolished, or passivated to meet the
applicable requirements of Part SF.
(d) For sprayed or vapor deposited coatings, a recommended spraying process(es) or vapor deposit ion
process(es). Special restrictions, exceptions, or guidance
shall be noted.
40
ASME BPE-2022
PART PM
POLYMERIC AND OTHER NONMETALLIC MATERIALS
PM-1 PURPOSE AND SCOPE
Sorne thermoplastics, s uch as thermoplastic elastomers,
combine an elastomer such as ethylene propylene diene
monomer (EPDM) with a plastic such as polypropylene,
giving the resulting thermoplastic compound properties
of flex endurance and sealability so it can be used for
tubing. seals, diaphragms, etc. Thermoplastic elastomers
(TPE) combine the features of melt processability a nd tlexibility.
Many polymeric materials are described in ASTM standards that detail the ir composition a nd mechanical prope rties. lt is the owner/user's respo nsibility to select
materials that are appropriate for their a pplications.
Filler materials may be used to enhance the properties
of thermoplastíc polymers. Fillers may be carbon based,
inorga nic, me tallic, organometallic, etc., as needed for
performance.
Additives for thermoplastic polymers may be used to
aid in thermal stability, flexibility, gam ma stability, extru·
date performance, crystallization control, oxidative stabil ity, mold release, plasticization, and adhesion. Additives
may be used in the bulk of the polymer as well as the
surface, as required.
The purpose of this Part is to provide the basis for
selecting and using polymeric and other nonmetallic
materials.
This Part describes the types of polymeric and other
nonmeta llic materials and identifies different ways to
characterize materials.
PM-2 MATERIALS
Polymeric and nonmetallic materials have found widespread use in bioprocessing equipment because of their
broad ra nge of physícal and chemical properties, their
ability to be formed into co mplex shapes, an d their
biocompatibility. Polymeric mate rials may be used in a
range o f applications incl uding st a tic and dynamic
seals, hoses, pumps, tubing. barrier coatings, diaphragms,
valves, and filters. The choice ofmaterial class depends on
the design requirements and material performance, both
as installed and during use.
For in-depth discussion and guidance on polymeric and
nonmetall ic materials, see Nonmandatory Appendix O.
PM-2.1.2 Thermoset Poly mers . Thermosets a re polymers that, in their final state a fter processing, are rende red
substantially insolubleand infusible. Fully processed thermosets cannot be resoftened or re-formed by exposure to
heat. Exposure to excessive heat will cause degradation.
Thermoset polymers are processed from a liquid or
malleable state and are converted to the solid state by
irreversible curing with heat, catalysis, or other means.
Chem ical cross-lin ks a re fo rmed between polymer
cha ins during the curing process. This results in an interconnected polymer network with the cross-link junctions
restricting flow of the polymer when exposed to thermal
or mechanical stresses.
Thermoset polymers can be classified into either the rmoset e lastomers or thermoset resins, with the elasto·
mers being more common. Thermoset e lastomers are
often elastic and soft materials a nd are used for seals,
gaskets, tubing, diaphragms, hoses, etc. Examples ofthermoset polymers are shown in Table PM-2.1.2-1 .
Most thermoset polymeric materials conta in reinforcing fillers and other additives to meet required use conditions. Fillers may be carbon based, inorganic, metallic,
o rga nometall ic, etc., as needed for pe r formance .
PM-2.1 Materials of Construction
Materials of construction s hall be selected to ma intain
the purity a nd integrity of the product/process tluid. lt is
th e owner/user's responsibility to select the a ppropriate
mate rials of construction for the conditions of use. Materials should be compatible with the stated processing cond itions. cleaning solutions (where app ropriate), and
sterilizing conditions (where appropriate), etc., as specified by the owner/user. The following sections outline the
major classes of polymeric and nonmetallic materials and
their requirements for use in bioprocessing equipment.
PM-2.1.l Thermoplastlc Polymers. Thermoplastic
polymers will melt and flow to form desired shapes
when s ufficiently heated. They can be melt-processed
into a wide variety of shapes by molding, extruding, thermoforming, etc., and can be re-formed and shaped with
heat and/or pressure.
Thermoplastic materia ls are often used for fittings,
t ubing. piping, diaphragms, seals., li ners for vessels,
column tubes, filter media a nd capsules, etc. Examples
ofthermoplastic polymers are s hown in Table PM-2.1.1-1.
41
ASM.E BPE-2022
Table PM-2.1.1-1
Common Thermoplastic Polymers and Applications
(22)
Ty¡,e of Polymer
General thermoplastícs
The1moplastic polyolefins
Thermoplastic nuoropolymers
Thcnnoplastic elastomers (TPEJ
Example Polymers
Exam1,1e Appllcations
Polyester ( PET)
Polyamide (nylon)
Polycarbonate (PC)
Polysulfones ( PSU, PES)
Polyethcr ethCl' ketonc (PEEKJ
Fittings, connectors, filter housings.
Polypropylene ( PP)
Ultra-low-density polyethylene (U LDPE)
Low-dcnsity polycthylenc ( LDPEJ
Hlgh-density polycthylenc (H OPE)
Ultra-high-molecular -weight polyethylene (UHMWPE)
fitti ngs, connectors, piping a nd rigid
Fluorinated ethylene propylene (FEP)
Períluoroalkoxy ( PFA)
Polytctranuorocthylcne { PTFE)
Ethylene tetranuor oethylene {ETFE)
Polyvinyl idiene Ruoride ( PVOF)
Fittings, piping and tubing. flexible
Blcnds of EPDM with polypropylenc
Styrene-isobutylene-styr ene block polymers
Copolymer s of ethylene and octane
Ethylene-viny l acetate copolyrner ( EVA)
T ublng, bags
piping a nd rigid tubing. column
tubes, fil ter media
tubing, filter media and capsules,
bags, vcsscls, vcsscl linlngs, and
coatlngs
hose, tilter media and capsules,
d iaphr agms, pumps, vcssels, vcsscl
li ni ngs, and coatings
Table PM-2.1.2-1
Common Thermoset Polymers and Applications
Type of Polymer
Example Polymers
Example Ap¡,llcatlons
Thermoset elastomers
Ethylene propylene diene (EPDM)
Ethylene propylene rubber ( EPR)
Silicone (VMQ)
Fluoroelastomers ( FKM)
Pcríluoroelastomcr ( FFKMJ
Tubing, seals, gaskets, diaphragms,
and hoses
Rigid therrnosets
Fiber-reinforced polymer (FRP/GRP) composites
Tanks and pipes
42
ASME BPE-2022
Table PM-2.1.3-1
Examples of Nonmetallics
Examples or Nonrnetamcs
Glass
Types of Nonmetallic
Amorphous tno1•ganlc 1lonmeta1llc material
Borosi1icate
Soda-lime
Example Applications
Slght glasse-s. vessel lights,
optical sensors. glass
electrodes
Sintcred mate rials
Aluminum oxide
smcon carbide
Slllcon nitñde
iung.sten carbide
7,irconium dio:idde
Crystalline inorganic nonmetallic material
Mechankal seals. bearing_<;,
process sensors
kcaction-bonded matcria)s
smcon carbide
Sillcon nltrlde
Multiphase mixture of <."rysta1line si1icon
carbide or nitride .-ind silicon
Mechanka) scals
Siliconized carbon-graphite
Multiphase mixture of Cl)'StaJline silicon
MechanicaJ seals
c:Hbldc, rarbon, and graphltc
Re-sln•linpregnated carbon-graphite
Multlphase inlxture of cal'bon, graphlte,
organic resin, and potcnt:ial inorganic
nonmet.allic additives
Me-chanlcaJ seals
Cemented materials
Crystalline inorganic nonmetallic in a
metallic matrix
Mechankal seals. bearing_<;
Tungst.en carbide with alloyed binder
Tungsten carbide with nickel binder
Tungsten carblde wlth cobalt blnder
Elastomer formula tions typically contain 5% to 50% filler
to achieve optimum properties.
Polymeric materials exposed to process fluids and/or
that have a high probability of exposure shall comply to the
USP directive with regar·d to USP <87> (or ISO 10993-5)
and USP <88> Class VI (or ISO 10993-6, -10, a nd -11) on
biological reactivity (see PM-3.1). Examples of mate rials
tha t may come into direct contact with prncess fluids
include tub ing, pipe, fi ttings, fil te rs, b ags, gaskets, Orings, diaphragms, pinch tubes, and valve stem seals.
PM-2.1.3 Other Nonmetallic Materials. Solid singlephase nonmetallic materials can be divided into amorp hous nonmetallic materials (e.g., glass, amorphous
ca rbon) and crystall ine nonmeta ll ic materials (e.g.,
sintered silicon carbide, graphite).
lf manufactured by heating and s ubsequent cooling,
these materia Is are often referred toas cera mies. Materials
may consist ofa mixture ofan amorphous anda crystalline
phase (e.g., glass-ceramics). To improve performance,
nonmetallic materials may be combined with other mater ials such as metals or polymers to form multiphase
mixtures. Examples of such materials are meta l- matrix
composites such as cemented tungsten carbide with an
alloyed n icke l b inder matrix a nd resi n-impregnated
carbo n-g raphites. Sorne of the more commo nly used
nonmetallic materials are listed in Table PM-2.1.3-1.
PM-2.2.1 Certificate of Conformance. A Certificate of (22)
Confo rmance sha ll be issued by the manufacturer to
certify conformance to this Standard whe n required by
t he e nd-user. Add itio nal ce rtification documenta tion
may be req uired. The Certificate of Conformance shall
contain the information summa rized in Table PM-2.2.1-1.
PM-2.2.2 Labeling and Marking. Manufacturers s hall
mark t he package contai ning polymer components or
assemblies with the manufact urer' s name, part
nu mbe r, and lo t number or uniq ue identifier (see
Table PM -2.2.1-1) to e nable the manufacturer to trace
back to the raw mate rial(s) and processing conditions
used to fabricare the component/assembly. Manufact urers s hou ld mark the component/assembly itself to
avoid potential loss of traceability and to aid in positive
identificarion of components/assemblies after use.
(22) PM-2.2 General Requirements
Materials shall be selected to not affect the purity or
integrity ofthe drug product. The owner/user is responsible forthe qualification of materials forthe intended use.
The req uire me nts for conformance are summarized in
PM-2.2.1. The requirements relate to identification, traceabili ty, biocompatibility, and marking.
43
ASME BPE-2022
Table PM-2.2.1-1
Content Required on the Certificate of Conformance
(22)
A¡,pllcatlons
Polyme rlc
Sea ls
(lncludes
Requlrements
to Conform
to ASME 8PE
Diaphragms
and
Hyg1enlc
Unlon Seals)
[ Note (1))
Hoses Tubing
Connec-
Polymeric
Other
tors
Polymeric
Process
Fllters
Chroma-
(l ncludes
Contai ners
( Rlg1d
[Note
(2))
tography Steam to/
Columns Through)
X
X
and
Flexible}
X
Nonme-
tallic
Compon ents
Process
Components
Si ngle-Use
Assemblies
X
X
X
Manufacturer's
name
X
X
X
X
Manufacturer's
contact
info rmatiOn
X
X
X
X
X
X
X
X
X
X
l'art number
X
X
X
X
X
X
X
X
X
X
Lot number or
unique
ldcntifier or
serial number
X
X
X
X
X
X
X
X
X
X
Material(s) of
construction
(process
contact)
X
X
X
X
X
X
X
X
Compound
number or
unique
identifier
X
X
X
X
Cure date or date
X
X
X
X
X
X
X
of
manu facture
USP <87> or
ISO 10993-5
X
X
X
X
X
X
X
X
USP <88>
Clas; VI o r
ISO 10993-6,
X
X
X
X
X
X
X
X
X
X
X
-10. -11
GENERAL NOTE: For tOmponents subjected to operatl ons such as gamma ir r adiatíon or steam, spécifk certification shall be provided. See
Part SU.
NOTES:
(1) For hygienic union seals, the intrusion category shaU be provided (see MC~4.2) .
(2) Specific lot release criteria may be re-quired for different tyµesoí filtration elements depending on their type and application, These additional
requirements should be decided by the owner/ user and the supplier.
PM-2.2.3 Change Management
(22)
(a) impact on bioprocessing product safety, efficacy,
purity, identity, or strength
(b) impact to form, fit, or function of the product, which
may include
(1) formulation changes
(2) manufacturing means, met hods, o r materials
changes
(3) changes to published or agreed specifications
(4) d iscontinuance of a ma terial, component, or
assembly
(5) changes in regulatory or compliance status (e.g.,
USP)
PM-2.2.3.l General. This secrion provides standa rd
proceduresand guidel ines for manufacturersof polyme ric
o r other nonmetall ic process contact materials, compone nts, a nd assemblies to ma nage a nd co mmu ni ca te
changes.
PM-2.2.3.2 Change Classifications. The magnitude
of qualificatio n and regulatory fi ling requi re ments fo r
an owne r/user to implementa change related to a mate·
ri al, com po ne nt, o r assem bly is de pe nde nt on t he
following attributes:
44
ASME BPE-202 2
Table PM-2.2.3.2-1
Change Levels and Minimum Change Notification Requirements
Notification Requir ement
Typital Examples,
Cha nge
Level
Oescription
Not Representative of AII
Changes
Preliminary Cha nge
Notification Prior to Change
Notification
Change Notification
Prior to Cha nge
lmplementation
Level 3
A change that requires a
minimum of 6 months
for thc end uscr to
plan and a mlnlmum of
12 months fo r t he owner/user
to implement
Change impacting leaclwbles 6 months minimum
and extractables profiles
required
12 months minimum
required
Leve! 2
A changc that requlres a
minimum of 3 m()nths t()
plan and á míni mum of
Rcvislon to a product
spedficati()n_, change In
part number
3 months mlnimum
recommended
6 months minlmum
requi red
Chánge in labeling, change
Neme required
3 m()nths mínimum
requi red
Noti fication not required
Notification not required
The change notHicatíon
The change notifkatíon
6 months for the owner/ user
to implement
L...evel 1
A change that requires a
minimum of 3 months
fo r the owner/user
to implement
L...evel O
Emergency
in document fonna t
(e.g., C of C), editorial
update oí analytic.al method
A change that Is not expected
to impact the attributes
in PM-2.2.3.2
Cer tain non-process contact
An emergency change occur s
when the manufacturer does
Force majeur e, act of God
changes (e.g., change in
carton supplier)
s hould be expedited to
the greatest extent
possible approp1iate
for the leve! of change
not have prior knowledge
that they will be impacted
by a change
Ta b le PM -2.2.3.2 -1 de fines fou r levels of c ha nge
comme nsurate with the complexity of change a nd the
amount of time needed for own er/ users to a ddress requireme nts associated with the change. Manufacturers,
whe n selecting t he leve) of change for no tifi cation,
shoul d co nsid e r ty pi ca l ow ne r /u se r r eg u la t o ry
co nstra ints as we ll as tech nica l, business, and supp ly
chain practices to anticípate notification time needed
by the owner/user to qualify and implement the change.
should be expedited to
the greatest extent
possible appropriate
forthelevel ofchange
(e) documentation and qualifica tion da ta to characterize the change
(fl change leve) per Table PM-2.2.3.2-1
In the event of a Leve) 3 change, the manufacturer
should provide preliminary change notification documen tation to the owner/ user as defined in Table PM-2.2.3.2-1.
Prelim inary cha nge notifi cation provides advan ced
warning to the owner/user prior to release of required
change notification documentation (e.g., documentation
and qualification data) that may not be available at the
time of preliminary change notification. A plan for implementation with a nticipated timelines s hould be included
in the preliminary notitication. Change notificatlon s hall
include the documentation a nd qualification data to characterize the plan.
PM-2.2.3.3 Owner/User Notification. The manufacture r s hould provide change notification documentation
to th e ow ne r/ user per the t imelin es de fin e d in
Table PM-2.2.3.2-1. The change notifica tio n shou ld
include
(a) ide nt ifica ti on of the ma nu fa ctu rer's prod ucts
affected by the change
(b) explanation of why the cha nge is being made
(e) description of the change (curre nt sta te a nd modified sta te)
(d) known potential impact to form, fit, or function and
impact through the s upply chain
PM -2.2.3.4 Manufacturer's Responsibilities. The
manufacture r sha ll have procedures and documentation
t hat effective ly ma nage cha nges b oth internally and
throughout the supply chain and defines requirements
for owner/user notification. The manufacture r s hall ma intain a record of notification and change implementation.
45
ASME BPE-202 2
PM-3.2 Extractables and Leachables
Manufacture rs should establish a single point of contact
for change communication.
PM-3.2 .1 Extractab les . Extractab les a re chemica l
substances that can be removed from polymeric materials
using approp ri ate solvents (e.g.. pola r and nonpolar).
Extraction studies a re conducted under conditions that
exceed typical bioprocess manufacturing or storage conditions (e.g., higher temperature, p H, or concentration or
longer exposure time) and are used to genera te an extraeta bles profile for a given polymeric ma te rial. Manufacturers sho uld provide extractab les profile data for
polymeric materials used in equipment/components on
request by t he owne r/use r. The extractables profile
generated may vary depending on both the extraction condit ions a nd t he extract ion fluids used in t he st udy.
Depending on the pu rpose of the study, one or more
of the extractio n studies d escribed in PM -3.2.1.1 o r
PM -3.2.1.2 should be done to generare an extractables
profile.
PM -2.2 .3.5 Owner/User Responsibilities. The
owner/use r should provide a single point of contact
for change comm unication. The method of receiving
co mmun ication sho uld be electro nic (e.g., an e-ma il
address such as change@companyx.com). The ow ner/
user should acknowledge receipt of the communication
to the manufacturer's single point of contact a nd evaluate
the change notification for impact to their processes.
PM-3 PROPERTIES ANO PERFORMANCE
Materials should be selected to retain their functional
properties a nd to minimize their impact on the process
fluid. Mate ria Is should be selected to not affect the purity
and integrity of the drug product. This section outlines the
requirements for biocompatibility, extractables/leachables, physical properties, and che mica l compatibility.
Each of the following sections should be considered for
the application.
PM-3.2.1.l Polymeric Material Speciflc Extraction
Study. This study is done to generate a n extractables
profile that cha racterizes the total content of solub le
chemical substances contained in the polymeric material.
The extraction solvent(s) and conditions shall be appro·
pria te for the particular polymeric material being tested.
Nonmandatory Appendix P-2 identifies recommended
conditions for a polymeric ma te rial specific extraction
study.
PM-3.1 Biocompatibility
"Biocompatibility" is defined here as the ability of a
substa nce or material to be in co ntac t wit h living
matter such as bact eria or mammalian cells without interfering in any way with its me tabolism or ability to live a nd
procreare. Polymer materia Is shall be biocompatible with
the system fluid to ensure that the system fluid is not
adversely affected by the polymer material. The biocompatibility and the proper material selection shall be the
responsibility of the system user.
Biocompatibility testing of candida te cornponents for
qualification requires both in vivo (animal testing) and
in vitro (testing in glass) tests. In vivo testing is described
in the United States Pharmacopeia (USP) in Chapter <88>
(or ISO 10993-6, -10, and -11) and involves intramuscular
implantation, intracutaneous injection, a nd systemic toxicity testing. In vitro testing is described in the United
States Phannacopeia in Chapter <87> (or ISO 10993-5)
and is used to place extraer from candidate polymers
in direct con tact with living cells (typically mouse
cells) for a prescri bed period of t ime. The a mount of
cell lysing (death) shall be recorded and reported for
the particular polyme r material.
Material ma nufacturers shall provide, on customer
request, docume ntation (test report) of the in vivo USP
<88> Class VI and in vitro USP <87> testing on final manufactured parts. Failure of either test indicares unacceptable biocompatibility of candidate material. Such failu res
are often attributed to leachables from cured elastomeric
seals extractab les a nd may in cl ude cata lyst resid ues.
cross-linking agents, process aids, plasricizers, etc.
PM-3.2.1.2 Extraction Study in Bioprocess Model
Solutions. This study is done to generate an extractables
profile under conditions that exceed those typically found
in bioprocessing applications. The model solutions a nd
extraction conditions should be selected based on the
intended use of the equipment/component This study
generares a n extractables profile that may be used to
pred ict potentia l leachables. Nonmandatory Append ix
P-3 identifies recommended conditions for an extraction
study in bioprocess model solutions.
PM-3.2.2 Leachables. Leachables, typically a subset of
extractables, are chemical substances that migra te into the
drug product from p rocess equipment or its containe r
under normal conditions of use and/or storage. Leachables may also be created as a result of chemical reactions
with other leachables a nd/or ingredients in the process
íluid or drug product Leacha bles stud ies cond uct ed in
process and of the final product shall be the responsibility
of the owner/user.
PM-3.2.3 Sample Preparatlon . Extractio n stud ies
shall include careful sample preparation appropriate to
the test article and a nalytical techniques to be used.
The size ofthe sample should be determined in consideration of the material, test equipment, analytical test
sensitivity, and the sample available for testing.
Any tool used for sample preparation shall not adulte•
rate the sample.
46
ASME BPE-2022
Prior to extraction, test samples should be exposed to
the same pretreatment process (under worst-case conditions) that the material would see when used as intended.
PM-3.5 Physical and Mechanical Propertles of
Thermoset Polymers
PM-3.2.5 Risk Assessm ent. The owner/user should
consider supplier data, relevan! standards, regula tory
guidance, and industry recom me ndations as listed in
Nonman dat ory Appe ndix P, whe n performing a risk
assessment.
The results of the risk assessment should determine the
suitability of the equipment/component for its in tended
use.
Physical and mechanical properties can be characte rized using many differe nt standards (e.g .. ASTM, ISO, DIN.,
and )IS). Typical properties incl ude hardness, t ens ile
strength, elongation to break, modulus, and tear strength.
In some cases, abrasion resistance, compression set, specific gravity, transparency,etc., may be important. Properties may be affected by manufacturing and use conditions
(e.g., temperature, pressure, physical stress). Common
tests for evaluating physical and mechanical properties
are listed in Nonmandatory Appendix l.,. Property requirements should be discussed between the owner/user and
the supplier, and the owner/user shall be responsible for
determining the suitability ofthe material for the application.
PM-3.3 Physical and Mechanical Properties of
Thermoplastic Polymers
PM-3.6 Chemical Compatibility of Thermoset
Elastomers
The physical and mechanical properties of thermoplas·
tics a re importan! to better understand how fluid expo·
sure could affect t he polymer's strength, stiffness,
inertness, durability, barrier properties, etc. Physical
and mechanical properties can be characterized using
many different standards (e.g., ASTM, ISO, DIN, and
)IS). Typical properties include tensile strength, elonga·
tion to break, modulus, a nd, in sorne cases, seam strength,
weld strength, coefficient of friction, compress ion set,
tensile set, hardness, specific gravity, and transparency.
Co mmon usefu l tests for eval uati ng thermop lastic
performance are listed in Nonmandatory Append ix L.
The interpretation of immersion test results is dependent on the specific application. In such cases, a different
material may be more su itable for the application. The
overall li fe of the equipment may be shortened signi ficantly if the correct polymer is not selected. The enduser must ultimately interpret the relevance of the test
results for the applicable process.
Chemical concentration, te mpera ture, and duration of
exposure can ali affectthe propertyretention ofthermoset
elastomers. When selecting a the rmoset elastomer for
chemical contact, the user should consult the supplier
for case his tories and test data, where availab le. lf
fu rther tes ting is req uired, specific íl uids sho uld be
used to expose test samples for the necessary time and
tem perature. Chem ica l compatibility is particularly
important for materia Is thatare reused. Chemical compatibility testing should be done to screen candidate materials fo r applications involving clean ing, storage, or
exposure to potentially harsh chemicals.
PM-3.2.4 Documentation. Documentation of results
shall include the extraction method(s), analytical technique(s) protocol, sample surface area (or weight) to
volume ratio, a nd extraction time and temperature. Relative li mits of detection should be reported.
PM-3. 7 Physical and Mechanical Properties of
Other Nonmetallic Materials
Physica l and rnecha nical properties of other nonmetall ic mater ial s, s uch as those li sted in Tab le
PM-2.1.3-1, may be characterized using many different
standards (e.g., ASTM, ISO, DIN, and )IS). Typical properties may include, but are not limited to, hardness, strength,
self-lubrication, and transparency. In some cases, low friction between sliding surfaces may be important. Properties may be affected by use conditions. Material selection
shou ld be d iscussed between the owner/ user and
supplier, and the owner/user sha ll be responsible for
determining the suitability of the material for the application.
PM-3.4 Chemical Compatibility of Thermoplastic
Polymers
Chemical concentration, temperature, and duration of
exposure can ali affect the property retention of thermoplastic polymers. When selecting a thermoplastic polymer
for chemical contact, the user should consult the supplier
for case histories and test data, where available.
lf further testing is required, specific fluids should be
used to expose test samples for the necessa1y time and
temperan1re.
PM-3.8 Chemlcal Compatibility of Nonmetallic
Materials
Chem ical composition, temperature, and dura tion of
exposure may ali affect the properties of other nonmetallic
materials. When selectíng nonmetallic materials, such as
those listed in Table PM-2.1.3-1, the user should consult
t he supplier for test data, where available. lf further
47
ASME BPE-2022
testingis required, specific tluids should be used to expose
test samples for the necessary time and temperature.
t.L = change in length, in.
tJ.T = temperan,re change, ºF
PM-3.9 Polymeric Surface Finish
(SI Units)
LIL = LX a XLIT
Polymeric material contact s urface classifications are
found in Part SF.
where
L = length of the pipe nm, mm
a = coefficient of thermal expa nsion, mm/m/°C
material and temperanire dependent
t.L = change in length, mm
lJ.T = temperanire change, ºC
PM-4 APPLICATIONS
(22)
PM-4.l Single-Use Components and Assemblies
See Part se, Part SJ, or Part SU.
PM-4.2 Piping
Typical coefficients of thermal expansion at room
temperature by material type are found below. Consult
the manufacturer for exact coefficient values.
The following s hall be considered in the design of polymeric rigid piping and tubing.
(22)
PM-4.2.1 Sizing Comparisons. Thermoplastic piping
systems are avaílable in a variety of sizing standards.
Tu be/pipe (e.g., Schedule 40, Schedule 80), Standard
Dimensiona l Ratio (SOR) 11, and SOR 21 are some of
the most common sta ndards used. Ta ble PM -4.2.1-1 is
a reference that compares the outside and inside dimensions of these standards. lt is important to consider these
standards when performing system sizing calculations to
en hance dimensional align ment of pipe/tube inner
diameters to enable sterility, cleanability, and drainability.
Tube inside dimensions are critica! for a lignment to stainless steel systems.
{U.S. Customa,y Units)
PVDF 6.6 x 10-s, in./in.f°F
PFA 7.0 x 10-s. in.fin./°F
PP 8.33 x 10-s, in./in.f°F
(SI Units)
PVDF 1.2 x 10-s. mm/m/°C
PFA 1.2 x 10-s, mm/m/°C
PP 1.5 x 10-s, mm/mf°C
t.T is the maximum (or mínimum) temperature minus
the installation temperature. lf the installation te mperature or time of year is unknown, it is practica! to increase
aT by 15% for safety. lt is not necessary or practica! to use
the maximum temperature minus the mínimum temperature un less it will truly be installed in one of those con·
ditions.
PM-4.2.2 Pressure Ratlngs. Polymer piping systems
have varying pressure ratings depending on ma te rial
and sizing standards. Valves and mechanical connections
such as sanitary adapters, flanges, or threads may carry
pressure ratings independent of pipe a nd fittings. Elevated
operating temperatures wi ll decrease overall system
rating. Consult mate rial manufacturers for specific detaíls.
PM- 4.2.4 System Support Crlteria
PM-4 .2.4 .1 Support Distances. Supports s hall be
placed based on the spacing requirements provided by
system manufacturers. Hanging distances are based on
system material as well as the specific gravity and
temperature of the process media. Operating conditions
of ali applicable processes, including CIP and SI P, s hall also
be considered. Hanging criteria generally increase with
system operat.ing te mp eratures. The p lacement of
ha ngers, gu ides, and a nchors is crit ica! in systems
exposed to thermal cycling. Hanger locations should be
identified by the system e ngineer and laid out to allow
for expa nsion and contraction of the pipe over its life
of operation.
PM-4.2.3 Thermal Expansion. Polymeric materials
will expand and contract with changing temperature conditions. The effect of thermal expansion shall be considered and designed for in every thermoplastic system.
To compensate for thermal expansion, it is recommended to use loops, offsets, and changes in direction. By using
the pipe itself to relieve the stress, the integrity of the pipe
system is maintained. The use ofbellows or pistons is not
recommended due to the formation of pockets and gaps
where liquids may be held up. The amount of thermal
expansion growth in a pipe system is generally calculated
by the following formula:
PM- 4.2.4 .2 Hanger and Clamp Types. Avoid using
hangers that place a pinpoint load on the pipe when tight·
ened. A U· bolt hanger is not recommended for thermoplastic p iping. Hangers that secure the pipe 360 deg
around th e pipe are preferred. Thermoplastic clamps
are also recommended over metal clamps, as they a re
less likely to scratch the pipe in the event of movement.
Clamps should be evaluated to avoid rough edges that
{U.S. Customary Units)
LIL = 12 x L x ax LIT
(3)
(2)
where
l = length of the pipe run. ~
a = coefficientofthermal expansion, in./in.f°F mate·
ria! and temperature dependen!
48
Table PM-4.2.1-1
Size Comparison of Common Thermoplastic Sizing Standards
SS Tube
Nomlnal
Slze
Sys-te m
1
/z
3/.1
o.o.
Sch 40
1.0.
1
1 In.
mm
In.
mm
0.5
0.75
12.7
0.37
19.1
25.4
0.62
0.87
o.o.
1.0.
1
1 In.
mm
15.4
0.84
21.3
0.53
20.6
26.2
34.6
1.05
l.32
26.7
33.4
42.2
0.74
0.94
1.26
1.48
9.4
0.84
21.3
0.61
15.7
22. 1
1.05
l .32
26.7
33.4
42.2
0.8 1
1.03
1.36
48.3
1.59
40.4
52
62.1
77.3
76.1
2.88
3.5
4.5
153
6.63
1.5
38.1
1.37
34.8
1.66
1.9
2
50.8
1.87
2.37
47.5
2.38
4
6
6
102
152
88.9
114
3.04
4
2.88
3.5
4.5
2.05
2.45
2.87
3.84
60.2
72.9
97.5
60.3
73
3
2
2.5
3
5.78
147
6.63
168
3
6.03
1.66
1.9
2.38
48.3
60.3
73
SOR 11
1.0.
1
1 In.
mm
mm
mm
l 'l2
63.5
76.2
o.o.
In.
In.
1¼
Z'l2
Sch 80
o.o.
In.
mm
13.4
0.79
18.8
23.7
0.98
l .26
1.57
20
25
32
31.9
37.S
SOR 21
1.0.
1
1 In.
mm
0.59
16.2
20.4
o.o.
In.
mm
0.79
20
25
32
0.64
16.2
40
0.77
1.02
1.28
40
0.83
1.07
1.38
1.97
50
1.61
40.8
1.97
50
1.73
21.2
27.2
35.2
44
63
75
90
2.02
2.41
51.4
61.4
2.48
2.24
57
73.6
63
75
90
67.8
81.4
99.4
145
1.91
48.6
2.48
88.9
114
2.29
2.86
3.79
2.95
3.54
4.33
no
2.9
3.54
168
5.71
58.1
72.7
96.2
145
6.3
160
5.14
24.2
32.6
0.98
l .26
1.57
1.0.
1
1 In.
mm
90
131
2.95
3.54
4.33
no
2.67
3.07
3.8
6.3
160
5.69
1;;
:,:
t
"''".,,
'"
;.,
o
N
N
ASME BPE-2022
could damage the pipe. ldeally, if a metal clamp is being
used, an elastomer material should be used in between the
pipe and the clamp. Refer to Part SD for exterior cleanability.
(22)
PM-4.3.2.5 Hose Materials. Hose assembly mate- (22)
rials shall conform to applicable sections of SD-2.4.1.2
a nd PM-2.1.
(a) Biocompatibility. The biocompatibility and proper
material selection shall be the responsibility of the enduser. Biocompatibility testing of candidate hose assemblies for qua lification requ ires USP <87> (or ISO
10993-5) and USP <88> Class VI (or ISO 10993-6, -10,
a nd -11) tests on ali polymeric process contact materials.
End-users may request similar testing on noncontact
layers that may come in contact with the process fluid
if the inner liner fails. Hose assembly suppliers shal l
provide, on customer request, documentation of the
biocompatibility testing on final man ufactured hose
assembly materials. Failure of either test indicates unac·
ceptable biocompatibility of the candidate hose assembly.
(b) Surface Finish. Surface finish ofmetallic end fittings
shall conform to the requirements of Part SF.
(e) Particle Generation. Hose assembly designs should
min imize wear that generates particles that could enter
the process.
{d} Extracta/1/es. Hose assembly materials shall
conform to the requirements of PM-3.2.
PM-4.2.5 Connections and Fittings. Design of equipment should minimize the number of mechanical connectio ns. Fus ion welded connection s shou ld be used
whereve r practica!. Hygien ic des ign of connections
shall conform to SD-3.1.
PM-4.3 Hose Assemblies
PM- 4.3.l General. This section defines the requi rements for flexible hose assemblies intended for repeated
use. Hose assemblies are defined here as a length of a flex·
ible, polymeric element with at least one end connection
securely affixed and capable of containing fluids unde r
specified conditions (e.g., pressure and temperature).
PM-4.3.2 Hose Construction
PM-4.3.2. l Flexible Elements. Elements may be
constructed from a single, homogeneous material or
multiple layers. Multilayer elements may consist of an
inner contact !ayer surrounded by one or more add itional
reinforcement layers and an outer cover. Reinforcement
layers may include fabric braiding, metal wire braiding,
and various elasto meric materíals. Th e li ner design
shall allow for drainability and cleanability as required
by the end-user.
PM-4.3.3 Hose Assembly Performance. The equipment supplier should be informed of ali the conditions
under which the hose assembly may be expected to
operate. This should include t he methods, frequency,
and length of cleaning a nd sterilization procedures. In
addition to the service temperature and pressure, any parameters that may affect the hose assembly performance
should be provided. The eq uipm en t supplier should
inform the end- user of the life cycle expectancy and
the methods that will ensure that the hose assem bly oper·
ates within its design specification (e.g., routine mainte·
nance).
PM-4.3.2.2 Mechanically Affixed and Reusable End
Connections. Metallic and nonmetallic end conn ections
are attached to t he flexible elemen t by mechanical
compression. The design shall ensure a sea! is maintained
at the end of the barb [see Figure SD-3.2.1-1, illustration
(d)]. Band-style hose clamps are not recommended [see
Figure SD-3.2.1-1, ill ustration (c)). The fitting should be
designed to minimize entrapment of liqu id in the hose
assembly. Dimensions a nd tolerances of the process
connection shall be consistent with Table DT-7.1-1.
PM-4.3.3.l Service Temperatures and Pressures.
Hose assemblies s hall be capable of withsta nd ing
the rmal and pressure cycling between the rated upper
and lower te mperature and pressure limits.
PM-4.3.2.3 Flare-Through End Connections. Flarethrough end connections are connections in which the
inner contact !ayer of the flexi ble element extends
through the fitting and is formed into the end connector.
Flare-through end connections may have integral gaskets
or provisions for standard gaskets.
PM-4.3.3.2 Nonroutine Events. The complete procedure for nonroutine events such as passivation, derouging,
and postconstruction cleaning should be supplied by the
end -user. The sup plier s hou ld inform t he end -user
whether the hose assembly will perform as specified
during these events. The end-user shou ld perform a
risk assessment to dete rmine if a new hose assembly
is required after nonroutine events.
PM-4. 3.2.4 Molded -in- Place End Connections .
Molded-in-place e nd connections are secured to the flex·
ible element by a thermal or chemical bond. Molded-inplace end co nnections using nonrigid mate rials may
require add itional stiffening reinforcement to achieve
an adequate process connection sea!. Molded-in- place
e nd connections may include an integral gasket.
PM-4.3.3.3 Cleaning Systems
(a) Clean -in -Place {CIP). Hose assemblies shall be
designed in accordance with SO-3.1. The hose assembly
shall be installed to enable drainability (see SO-3.2).
(b) Clean-out-of-Place (COP}. Externa) surfaces ofhose
assemblies subject to COP shall be compatible with
cleaning agents and be nonabsorbent. Hose assemblies
50
(22)
ASME BPE-2022
PM-4.3.5.3 Test Requirements. Conformance testing
is do ne on initial qualification of the hose assembly.
Testing is intended to show design conformance and is
not required on every hose assembly. Testing shall be
repeated for significan! changes in raw mat erials or
processes used to fabricate hose assemblies.
shall be designed to allow effective removal of cleaning
agents from externa! surfaces.
PM-4.3.3.4 Sterilizing Systems. Hose assembly requirements shall be based on the steri lization method
used. Ali process contact surfaces should be designed
t o mi nimize crev ices. When crevices canno t be
avoided, sterilization testing shall be performed to validate sterility withi n the system bounda ries. Ali hose
assemblies and hose assembly process contact surfaces
shall be designed to accommodate expans ion a nd contraction during sterilization and cooldown stages.
PM-4.4 Polymeric Hygienic Unions
When using polymeric hygien ic unions, severa] application variables should be considered to ensure optimu m
performance. Some variables include fluid type, process
temperature, system pressure, vibration, ma terials of
construction, sterilization method (where appropriate ),
cleaning methods (where appropriate), and duration of
use. Pressure a nd t em peratu re ratings of polymeric
hygienic unions should be provided by the manufacturer.
Polymeric ferrules and clamps should be designed and
manufactur·ed to ensure proper fit-up a nd avoid leakage.
Mate rial of construction and the molding process impact
the tolerances of polymeric ferrnles; consequently, tolerances a re not the same as they are for metallic ferrules.
Polyme ric ferrules shall meet the nominal dimensions and
tolerances o f Table DT-7.1 -2 except for di mension A,
which shall achieve clearance as per DT-9.4(e).
PM-4.3.4 Hose Assembly lnstallation . Hose assem·
blies shall be installed per SD-3.2 and used in accordance
with the supplier's guidelines (e.g., bend radius). Change
in hose assembly length due to pressure and temperature
cycling and the potential effect on drainability should be
considered by the e nd -user.
( 22)
PM-4.3.5 Conformance Requirements
( 22)
PM-4 .3.5.1 General Requirements. A Certificate of
Confo rmance shall be iss ued by the hose assembly
supplier to certify conformance to this Sta ndard when
required by the end-user.
( 22)
PM-4.3.5.2 Certlflcate of Conformance. The Certifi•
cate of Conformance shall contain the following information:
(a) manufacture r's name
(b) part number
(c) unique identifier of the hose assembly
( d) material of construction of process contact items
(e) compliance to USP <87> (or ISO 10993-5) a nd USP
<88> Class VI (or ISO 10993-6, ·10, and -11)
{fJ packaging and storage recommendations (this may
be in another document)
The supp lier's name and u nique ide ntifier shall be
ma r ked on either the hose assemb ly itself or the
package containing the hose assembly. The unique identifier shall enable the supplier to identify the raw material
and processing conditions used to fabricate the a rticle.
Supp lie rs shall mark the hose assembly itself to avoid
potential loss of traceability and to aid in positive identification of hose assemblies.
PM-4.4.l Multiuse
PM-4.4.1.1 lnstallation. The manufactu rer shall
provide installarion procedu res.
PM-4.4.1.2 Performance. Poly meric hygienic unions
shall meet the seal intrusion requirements oí MC-4.2.
PM-4.4.1.3 Cleaning. Ferrules and clamps should be
cleanable as per SD-2.4.2 and SD-3.1.2.2.
PM-4.4.1.4 Bioburden Control. (Reserved for future
content)
PM-4.4.1.5 Seals. [Reserved for future content)
PM-4.4.2 Single-Use. For general single-use requirements, see Part SU.
PM-4.4.2.1 lnstallation. See PM-4.4.1.l.
PM-4.4.2.2 Seals. See PM -4.4.1.5.
51
(22)
ASME BPE-202 2
(22)
CHAPTER 4
DESIGN FOR MULTIUSE
(22)
PART SD
SYSTEMS DESIGN FOR MULTIUSE
(22)
The pipe design a nd the flushing sequence, including
associated var iables (e.g., velocityJ. s hall meet s pecifica•
tions provided by the owner/user.
SD-1 PURPOSE ANO SCOPE
The purpose of Part SO is to establish design guidelines
applicable to bioprocessing equipment. Wherever "equipment" is stated in this Part, it shall mean ali bioprocessing
equipment, components, assemblies, a nd systems.
The purpose of this Part is to provide requirements for
the specification, design, fabrication, and verification of
process equipment and syste ms that are fit for intended
use, and to minimize risk to the product. Part SO a lso
provides design guidelines that s hould b e a pplied at
the discretion of the owner/ user on the basis of assessed
risk to the product Figures in this Part are intended to
illustrate accepted applications of general design princi pies and are not intended to limit alternate designs.
The scope of Part SO encompasses requirements for
equipment, process systems, and utilities that could
potentially impact product quality. Specific guidance is
prov ided for b iob u rde n control in man u facturing
processes. including design requirements for cleaning,
sanitization. and sterilization of bioprocess systems.
(22)
SD-2.1 Containment
The contaimnent level ofthesystem or individual pieces
of equipment should be speci fied a nd communicated by
the owner/user.
The owne r/user shall determine the conta inment leve!
for the particular typ e of equipment or system, in accordance with the Centers for Oisease Control and Prevention
(COC) a nd guidelines of the National lnstitutes of Health
(NIH) or directives of the European Union a nd other ap•
plicable local codes or environmenta l regu lations.
SD-2.2 Bioburden Control
(22)
Part SD provides recom mended des ign features of
components and equipme nt tha t should be incorporated
into hygienic systems. These design elements, properly
implemented a nd in conjunction with proper bioburd en
red uctio n measures such as CIP/S IP, ena ble hygienic
systems to control bioburden.
Jt is the owner/user's responsibility to p rovide the
fo llowing in formation for the d es igner t o det ermine
the des ign fea tures required to maintain bioburde n
control:
(a) the acceptable leve! of bioburden before, during,
a nd at completion of a process ste p or sanitization interval
(b) the duration tha t bioburden control needs to be
main tained whether in a closed -p rocess o r o pen •
process system
This Part does not address self-sanitizing processes but
does address features of continuously operated systems
such as hot water-for-injectio n and p ure steam that
control bioburden by continuous heat and are considered
self-sanitizing process utility systems.
SD-2 GENERAL GUIDELINES
Ali equi pment a nd systems s hall be designed accord ing
to the bioprocessing application, requirements, a nd specifications ofthe owner/user. ltshall be the responsibilityof
the owner/user to specify a ny requirements for cleaning
or sanitization of the equipment 0 1· system.
Following installation, to remove construction debris or
foreign bodies, process contact liquid-service systems
s hou ld be fl ushe d wi th deion ized or be tter-q uality
water or chemically cleaned., per specifications provided
by the owner/user, before being placed into service. This
does not apply to single-use or precleaned components.
The design shall provide for the removal of components
(e.g .. pumps, control valves, spray devices, instrumenta•
tion) that may be damaged by construction debris during
flushing. lf removal is not practica), the design s hall allow
for a temporary strainer installed upstream of the compo•
nent, sized to catch the debris.
SD-2.3 Bioburden Reduction
Bioburden reduction is an activity performed with the
purpose of achieving a measured reduction in bioburden
levels. in the equipment or product, to allowable levels.
52
(22)
ASME BPE-2022
Depending on the ch osen methodology or goal, the activity
may be performed prio r to equipme nt use, be tween
process steps, or during a process step.
(a) For process o pe rations in multi us e sys te ms,
bioburden reduction is typically accomplis hed by, but
not limited to
{1) cleaning (with or without chemicals)
(-a) clean-in-place (CIP)
(·b) clean-out-of-place (COP)
(2) steaming
(•a) steam-in-place (SI P)
(·b) autoclaving
(3) dry heat
(4) process heating
(•a) batch heating
(·b) pasteurization
(·e) high-temperature short-time (HTST)
(-d) ultra-high-temperature (UHT)
(5) process filtration
(6) chemical sanitization
(·a) ozone
(·b) vaporous hydrogen peroxide (VHP)
(·e) chlorine dioxide
(·d) other acids, bases, or solvents
(7) ultra violet light
(b) For single-use systems, where sanitization/sterilization occurs prior to product contact, bioburden reduction is typically accomplished by, but not limited to
{1} gamma-irradiation
{2} autoclaving
(3) electron beam (E-beam)
(4) ozone
(5) ethylene oxide (ETO)
( 22)
( 22)
that could thermaliy degradeduringSIPshall be evalua ted
by the owner/user.
5D-2.3. 1.1.1 Requirements. Pro cess syste ms (22)
subject to Sil' shall be designed to
(a) provide for air removal within the SIP boundary
(b) provide for removal of condensare within the SIP
boundary
(e) be d rainable in conformance with $0-2.4.3
{d) have provisions in place for verification of SIP
performance
(e) have no dead legs within the SIP boundary
50·2.3.l.l.2 Recommendations. Process systems (22)
subjett to SI P should be designed to
(a) avoid concurre nt steam supplies from alternate
locations to prevent stagnant zones/entrained air
(b) monitor temperature and pressure at appropriate
locations (e.g., vessels) that confirm saturated steam conditions within the SIP boundary
(e) monitor temperatu re at every SIP boundary point
during performance verification
{d) e nable cont inuous verification or period ic confirmation of the validated state
(e) maintain the integrity of the system post-S IP
W mainta in monitored temperature pointS within 2ºC
(assum ing ±0.SºC accuracy of the RTD) of each other
during dwell within the SIP boundary
(g) maintain monitored tempera ture points within 2ºC
(assum ing ±0.SºC accuracy of the RTD) of t he corresponding saturated steam temperature for the system
pressure during dwell
(11) maintain monitored temperature points a bove the
mínimum specified SIP temperature and in accordance
with S0-2.3.1.1 within the SIP boundary during dwell
5D-2.3.1 Thermal 5anitization. This section specifies
the design requirements for equipment that is sterilized or
sanitized by the application of heat. Thermal sanitization
includes dry heat treatment, SIP for sanitization, SIP for
sterilization, steam out of place (autoclaving), hot liquid
sterili1,ation, and hot liquid sa nitization.
5D-2.3.1.2 Depyrogenation. (Reserved for future
content]
50-2.3.2 Chemical 5anitization. (Reserved for future
content]
SD-2.4 Fabrication
5D-2.3.1.1 5team-in-Place. Equipment parts and
components subjected to SIP should be des igned and
constructed to withstand continuous exposure to satu•
ra ted s team at a mí nim u m te mperature o f 266º f
(130ºC; representing 24 psig/1.65 bar under saturated
steam conditions) for a d u ratio n o f at least 100 hr
under conti nuous steady-state condi tions. Ali process
contactsurfaces subjected to SIP shali reach the required
temperatures, under the required satu rated steam pres·
sure conditions, during the SIP cycle. Executing SIP opera·
tions at temperatures exceeding 266ºF (130ºC) may cause
degradation of elastomers or damage to other compo·
nents, resulting in reduction of overall equipment life.
SIP conditions that are more stringent may be imposed
by the owner/user. The use of elastome rs (withi n a
piece of equipment or certain process instrumentation)
Fabrication shall be performed in facilities where the
process contact surfaces are protected from contamination. During field welding and assembly, surface contamination shall be prevented.
Systems, equipment, and components shall be cleaned
with a suitable cleaning agent and covered for protection
before shipment. The use ofpreservative fluids is not recommended.
Any process contact surfaces that require shipment
with preservatives or coatings shall be
(a) mutually agreed to, in advance, by the owner/user
and manufacturer
(b) clearly identified to ali parties
(e) in conformance to FDA or other applicable regula tions, as appropriate for the process
53
ASME BPE-2022
50-2.4.l Materlals of Constructlon
(22)
(1) Ali surfaces shall be cleanable. Surface imperfections (e.g., crevices, gouges, obvious pits) should be eliminated whenever feasible.
(2) Ali surfaces shall be accessible to the ciean ing
solutions a nd shall be accessible to establish and determine efficacy of the cieaning protocol.
(3) Fasteners or threads shall not be exposed to the
process, stea m. or cieaning fluids. The use of threads
withi n t he process req uires owner/user agreement.
Bolted attach ments shou id be elimina ted whenever
possible.
(4) No engraving o r embossing of materials (for
ide11tification or traceability reaso11s) shouid be made
011 the process contact side. Whe n markings are required
011 process contact surfaces. other methods of identification shall be used.
(b) The following provisions are applicable to tubing.
equipment, or systems intended to be cleaned in place:
(1) Interna) ho rizontal surfaces shou ld be minimized.
(2) The equipment should be drainable or capable of
having e nergy applied ( e.g., pressu rized gas, vacuum,
heat) to remove liquid. The equipment shali be free of
areas where soil or contaminants could collett The equip·
ment should be free of areas of low tlow a nd velocity or
impact where soil or contaminants could collect.
(3) Design of corners and radi i sho uld meet the
following requirements: Ali interna! angles of 135 deg
orless on surfaces shall have the maximum radius possible
for ease of cleanability. Where possible, these surfaces
shall have radii of not less tha n 'Is in. (3.2 mm) except
w he re requ ired for fun ctiona l reasons, such as the
bonnet/ body connection. For special cases, the radi i
may be reduced to 1/ 16 in. (1.6 mm) when agreed to by
t he owner/user. When t he 1/ 16 in. (1.6 mm) ra d ii
cannot be achieved for essent ial fun ctional reasons
such as tlat sealing surfaces and flow control apertures,
the surfaces of these interna! a ngles shall be readily accessible for cieaning a nd examination.
50-2 .4 .l .l General. Gene raliy, materials such as
stainless steels (e.g., 316-type and 316L·type alloys),
duplex stai nless steels, and higher alloys have proven
to be acceptable. The owner/user shall be responsible
for the selection ofthe appropriate materials of construction fo r the specific p rocess. Metallic materials of
construction a re listed in Part MM.
When nonmetallic materials are used (e.g., polymeric
materials or adhesives), the owner/user shall specify
which one of these materials shall carry a Certificate of
Conformance.. The conformance of material shall be explicitly stated (e.g., conform ing to FDA 21 CfR 177 and USP
Section <88> Ciass VI). Polymeric materials and other
nonmetallic materia Is of construction a re listed in Part PM.
50-2.4 .1.2 Process Co mpatibility
(a) Materials of construction shall be capable ofwithstanding the temperature. pressure, and chemical corrosiveness of the process.
(b) Materials shall be co mpatible with the sta ted
bioprocessing conditions, cleaning solutions, and SI P conditions. etc., as specified by the owner/user.
(e) Surfaces exposed to bioprocessing fluids, cleaning,
and SI P conditions must be
(1) homogeneous in nature
(2) impervious
(3) inert
(4) nonabsorbent
(5) nontoxic
(6) insoluble by process or cleaning tluids
(7) resistant to corrosion, scratchi ng, scoring, and
distortion
(d) Materials that are in contact with biop rocessing
fluids shali be identified by a n industry-recognized standard (see MM-4).
50-2.4.1.3 5urface Coatings. Ciad or electroplated
surface coatings. plating. and surface preparatory chemicals may be used provided approval from the owner/ user
has been obtained. Ali surface coatings shali rema in intact
and be tolerant to the process, SIP and CIP fluids, and
temperatures, without peeling or cracking.
50-2.4.3 0rainability
50-2.4.3.l General. For the purpose of bioburde n (22)
control a nd cleaning, gravi ty is a n effecti ve way to
e nable drain ing. Fo r dra ina bility, li nes shou id be
pitched to d esignated points a t a specific slop e. Refe r
to Nonma11datory Appendix C for suggested method of
slope measure ment. Fo r dra inab le piping/tub ing
systems, the owner/use r may define the syste m slope
in acco rdance with one of t he des ignations listed in
Table SD -2.4.3.1-1. Orainab le piping/tub ing systems
shall have a co nt inuous pitch tha t is equa i to or
greater tha n the slope designation. Li11e sectio11s up to
10 in. (25 cm) in length (or longerwith advance a pproval
ofthe owner/user) that are level or have a positive slope
lessthan theslopedesignation areacceptable ifthe section
is fitting-bound.
50-2.4.1.4 Transparent Materials
(a) Transparentmaterials (e.g.,glass, polymer) thatare
used in viewing ports shall be rated for the applicable
pressure, temperature range, a nd thermal shock.
(b) lntern ally coated giass shall o nly be used if the
coating complies with FDA regulations or a nother reg·ulatory a uthority's regulations and is approved by the
owner/ user.
(22)
50-2.4.2 Cleanablllty
(a) The foliowing provisions are applicabie to tubing,
eq uipment, or systems intended to be cleaned:
54
ASME BPE-2022
Table SD-2.4.3.1-1
Slope Designations for Drainable Unes
{ 22)
Slope
Oesignation
GSDl
GSD2
GSD3
GSOO
Minlmum
Slope,
in./ft
Mlnlmum
Slope,
mm/m
Mlnlmum
Slope,
%
1
/ 16
s
0.5
¼
¼
10
1.0
20
2.0
Mlnhnum
Slope,
deg
0.29
0.57
1.1 5
Line slope not required
(22)
5D-2.4.3.2 DrainabiUty Design Considerations. The
system's process requirements should be considered in
the selectíon of slope designation.
(a) Process contact lines exposed to liquíd should be
sloped to mínímíze pooling in the system.
(b) Lines that are steam sterílízed in place should be
sloped to enable condensate removal.
(e) Lines that are cleaned in place should be sloped to
enable removal of cleaning fluíds.
The physícal characterístícs of the system (e.g., line síze,
materíals, fluid viscosíty, fluid surface tensíon) will influence draínabilíty at a gíven slope and should also be
considered. The owner/user may apply addítíonal critería
ín the selection of slope designatíon to address issues such
as product recovery or maintenance. Fluid retention due
to surface tensíon and surface adherence should be
co nsidered whe n us in g tub ing less tha n 3/ 4 in.
(19 mm) . Syste m level ing sho uld be conside red for
mobile equipment that is designed to be drainable.
{ 22)
SD-2.4.3.3 SlopeConsiderations. Therecommended
mínimum slope designatíon for drainable process contact
línes is GS02.
(22)
(b) The equipment manufacturer shall specify the type
of lubricants that are to be used for maintenance. lf the
specified lubricant is not accepted by the owner/user, the
choice of an alternative shall be agreed to by the owner/
user a nd the equipment manufacturer.
(e) The owner/user shall give his approval for the
lubricants that could come in contact wíth the process.
These lubricants shall be ídentífied by name, manufacturer, and grade a nd shall conform to FDA or other applícable regulatory codes.
SD-2.4.4.2 Exterior Design. Equipment located in (22)
clean areas ís periodica lly cleaned by wash-down or
manually cleaned by wipe-down with harsh cleaníng solutíons. Such equipment shall conform to the followíng:
(a) Materials of constn,ction should be corrosíon resistan t, easily maintained, cleaned, a nd sanítized without
flaking or shedding.
(b) Finishes shall be compatible with the area/room
classification as agreed to by the owner/user and manufacturer.
(e) Components shall be capa ble of beíng chemically
cleaned, steam cleaned, or pressure washed.
(d) Ali burrs or weld marks shall be removed.
(e) Hinges should be easily removable or cleanable.
(jJ Equipment mounted on cabinets that are exposed to
the e nvironment should be mounted flush.
(g) Skids shou ld have no openi ngs in t he frame
allowíng water retention. Supporting skíd frame struct ures and modules shou ld be constructed from fully
sealed tubes or pipes, which are easily cleaned. Frames
should have rounded rather than sharp edges.
(h} Motors, gearboxes, and similar equípment should
not retaín fluids or cleaning solutions on theír externa!
surfaces.
(i) Namep lates for taggíng equípment should be
constructed from corrosíon-resístant material. such as
stainless steel or polymeric material, a nd should have
mínima! crevíces. The nameplates should be attached
and sealed or attached with a corros ion-resístant wíre
loop.
O) There should be adequate clearance below or under
the equipment for cleaning. anda clearance for discharge
should be províded. Elevated eq uipment u nder open
frames should have a mínimum cleara nce of 6 ín. (150
mm) for wash-down a nd clean ing. In other cases a
mínimum of 4 ín. (100 mm) would be adequate.
(k) Joints a nd ínsula tion materials shall be sealed and
impervious to moisnire and cleaning agents.
(/) Electrical enclosures a nd conduít should be cleanable and use materials of constructíon that are compatible
with cleaning agents.
(m) Painted surfaces shall be identífied by the fabri ca tor and have the adva nce approva l of t he owner/
user. Ali paínt systems shall be FDA compliant.
SD-2.4.3.4 Drain Points
(a) Piping and equipment sho uld be insta lled with
designated low-point d rains and hi gh-poi nt vents for
d rainab ili ty. The n umber of d rain points and vents
shou ld be mi nimized. The equ ipment man ufacturer
shall indicate the proper oríentation to optimíze draínability. The owner/user shall ensure that proper orientation is achieved.
(b) Systems or eq uípme nt that cannot be drained
should be capable ofhaving e nergy applied (e.g., pressurízed gas, vacuum, heat) to remove the liqu id, where
required.
SD-2.4.4 Míscellaneous Design Details
SD-2.4.4.1 Lubricants
(a) Grease a nd other lubrica ting fluids that are used in
gearboxes, drive assemblies, e tc., shall be contai ned to
prevent leakage of t he lubrícants or process, either
dírectly or indírectly (e.g., through seepage, sea! leaks).
55
ASME BPE-2022
SD-2.4.4.3 Surface Finishes. The finishes of process
contact surfaces shall be specified by the owner/user in
accordance with the definitions of Part SF in this Standard.
in SD -3.5.1 and SD-3.4.3. Equipment nozzles closed during
CIP/SIP operations shall be designed to meetthe minimal
dimensional and orientation crite ria detailed in SD-3.4.2
and are not dead legs if they are cleaned or sanitized under
specified conditions (e.g., flow/impingement, steam penetration, temperan,re, time).
SD-2.5 Hygienic System Design
The hygie nic design ofthe system shall incorporate the
applicable functionality for passivation, cleaning, sanitizatio n, stea m-in-place, process fl uid distribut ion, and
process para meter measu re ment a nd co nt ro l. The
syste m's hygienic phys ical (gene ral ar ra ngeme nt)
design shall be integral with its operations incl uding,
but not limited to, valve sequencing, parameter measurement, and controls. The owner/ user a nd designer should
evaluare the design across ali operations to confirm tha t
the design mitigares contamination riskto the productand
to identify installation, operational, and performance verification testing requirements.
SD-2.6 Animal-Derived lngredients
(22)
Process contact surfaces of components, eq ui pment,
and systems shall be constructed from and processed
with materia Is that are free from animal-derived ingredients/prod ucts (ADI/ ADP), or shall be manufactured with
materials tha t meet the conditions of the Committee for·
Medicinal Products for Human Use (CHMP, formerly
known as CPMP) No te for Gu ida nce (EMEA/410/01
rev 3).
S0-3 PROCESS COMPONENTS AND EQUIPMENT
SD-2.5.1 Tube/Pipe Branches. Tube/pipe branches
that are closed (e.g., closed valve, cap ped b ranch tee)
during a n operation should be designed and installed
to mitigate contam inatio n r isk. Tube/pipe b ra nches
closed duri ng CIP/SIP operations, designed to meet the
minimal d ime nsional a nd orientation criteria detailed
in SD -3.1 .2.2, a re not dead legs if they are opera ted,
cleaned, or sanitized underspecified conditions (e.g., velocity, temperature, time). Tube/pipe branches that are
open during CIP/S IP shall be designed to enable flow
of cleaning/sanitizing fluids under specified conditions.
Tube/pipe branches with valves that a re cycled during
processing operations should be designed to mitigate
cross -contamination risk a nd are not dead legs if they
a re toggled, cleaned, or sanitized under specified conditions (e.g., flow/ impinge men t, s tea m penetratio n,
temperature, time).
(22)
S0-3.l Connections, Fittings, and Piping
SD-3.1.1 General
(a) Design of equipment should minimize the number
of connections. Butt-welded connections should be used
wherever practica!.
(b) Connections to eq uipment shall use acceptable
hygienic design connections, mutually agreeable to the
owner/user and manufacturer.
{e) Ali connections shall be capable of CIP and SIP.
Fittings shall be so designed that there will not be any
crevices or hard-to-clean areas aro und the gasketed
joint. ASME raised-face o r flat-face fla nged join ts
should be avoided where possible (see Figure SD-3.1.1-1).
{d) Fe rrules and ferrule connections should not consti·
tute a dead leg. The use of short welding ferrules should be
incorporated into the design to promote enhanced clean·
ability or bioburden reduction of the system.
(e) Process contact fittings exposed to liquid should be
dra inable when properly installed.
(/) Threaded fittings, exposed to process fluid, are not
recommended (see Figure MC-2.2.2-5).
(9) The use of flat gaskets may be acceptable, whe n
agreed to by the owner/user a nd manufacturer, for applications where it is considered self-sa nitizing (i.e., in pure
stea m distribution systems).
(h) The centerline radius of factory-bent tubes shall be
in accordance with Table DT-3-1, CLR, (R).
(i) Piping systems described in Part SD referto hygienic
tubing systems. Caution should be exercised if using pipe
(instead of tube) to ensure that the requirements of this
Standard are met. The requirements of hygienic tubing
(e.g., su rface fin ish, d imensions, and to lerances) are
not typically met by pipe.
SD-2.5.2 Tube/Pipe lns truments. Process tubi ng/
pip ing instr umentatio n and associated co nn ection
points should be designed to mitigate the risk of contamination d ue to extended ferrule connections and a ny
a nnu lar space aro un d the se nsor. lnstru ment tees o r
short-outlet tees confo rmi ng to DT-4.1.2 shou ld be
used where feasible, maintain ing l/A < 2 [see Figure
SD-3.4.3-1, ill ustration (a)]. When an instrument tee or
short-outlet tee is not used, the tee should be orie nted
such that cleaning and sanitization fluids circulate into
the branch and annu lar space around t he instn,men t
sensor, and air is not trapped, to avoid the forma tion
of a dead leg. The syste m designe r shall identify instn,ment locations where l/A or l/d < 2 is not met.
SD-2.5.3 Equipment Nozzles. Equipment nozzles used
to accommodate agitators, controls, instrumentation, or
process fluid transfer should be designed to mitigate
contamination risk dueto extended connections or the
ann ula r space aro und the inserted appu rte nance by
meeting the dime nsional and orientation criteria detailed
56
(22)
ASME BPE-2022
Figure SD-3.1.1-1
Flat Gasket Applications
la) Aange With Flat Gasket
le} Stub-End / Lap Joint
lb) Aange With O-Ring
Id) Weld Neck
le) Slip On
lg) Threaded
111 Socket Weld
57
ASME BPE-2022
Table SD-3.1.2.2-1
Lid Dimensions for Flow-Through lee:
Full-Size Standard Straight lee With Blind Cap
SD-3.1.2 System Deslgn
5D-3.1.2.1 General
(a) Product holdup volume in the system should be
minimized.
(b) Bioprocessing piping and tubing design shou ld
have routing and loca tion priority over process and
mechanical support systems.
(c) Pipingand connections to in-linevalves should be of
all-welded construction where feasible, practica!, and
agreed to by the owner / user and man ufacturer. To
ensure t he highest degree of hygien ic des ign, the
piping systems should use welded connections except
where make-break connections are necessary.
L
L~ _ _,
Nominal
__ _ _
_
Wall
Thickness
1.D. (d)
Brancb, L
(Branch)
1/,
0.035
0.035
0.065
0.180
0.305
0.370
12.00
6.88
5.58
>¡,
0.065
0.620
2.16
2.10
2.07
2.07
t 'li
0.065
0.065
0.870
1.370
2.52
1.56
0.065
0.065
1.870
2.370
2.19
2.14
2.44
2.44
0.065
0.083
0.109
2.870
3.834
5.782
2.44
2.83
4.24
0.85
0.74
0.73
Size, in.
•1,
o/u
2
2 1/ 2
3
4
6
5D-3.1.2.2 Closed Tube/Pipe Branches. Closed tube/
pipebrancheswill be measured by the term l/d, where l is
the leg extens ion from the I.D. wall normal to the ílow
pattern or direction, and d is the I. D. of the extension
or leg of a tub ing fitting or the nominal dimension of a
valve or instrument For valves, l s hall be measured to
the sea! point of t he valve. Tables S0 -3.1.2.2-1 and
S0 -3.1.2.2-2 indicare l/d values based on the BPE definition for various nibing geometries and configurations.
There is evidence that an l/d of 2 or less may prevent
the branch from being a dead leg; however, the size and
shape of the brancl1 are also important in determining if
the branch could lead to contamination. With sufficient
tlow through a primary pipeline, a brancl1 may not constitute a dead leg.
The orientation of a brancl1 is critica! to the cleanability
ofthesystem. The branch shall be oriented to avoid a dead
leg (e.g .. a vertical branch with an l/d of2 or less may still
result in a dead leg with trapped gas or residual materials ).
For high-purity water systems, an l/d of 2 or less is
attainable with today's manufacturing and design technology. For other bioprocessing syste ms, s uch as puriflcation, filtration, and fermentation having cluster, block,a nd
mu ltiport va lves, an l/d of 2 or less is achievable.
However, it may not be achievablewith certain equipment
and process configurations as they are currently manufactured. An l/d of 2 or less is recommended but s hall
not be construed to be an absolute requirement. The
system designer and manufacturer sha ll make every
attempt to eliminate system branches wit h an l/d
greater th an 2. lt will be the respons ibility of the
system manu facturer or designer to identify where exceptions exist or where the l/ d of 2 or less cannot be met
An l/d of 2 or less may not be achievable for weir-type
valves clamped to tees a nd certain sizes of close welded
point-of-use valves, as shown in Figure SD-3.1.2.2-1, illustrations (a), (d), (e), (f). a nd (g). For the header a nd valve
size combinations where the l/d of 2 cannot be met using
these configurations, a specific isolation valve design, as
shown in Figure S0-3.1.2.2-1, illustrations (b)and (e), may
be required to achieve the desired ratio.
L/cl
3.33
1.30
1.03
58
ASME BPE-2022
Table SD-3.1.2.2-2
Lid Dimensions for Aow-Through lee:
Short-Outlet Reducing Tee With Blind Cap
L
r
Nominal
Branch Slze, In.
Tee Wall
Thlckness
Branch Wall
Thlckness
Branch 1.0.,
Tee Slze, In.
d
Branch, J,
(Branch)
%
'1,
0.035
0.035
0.180
0.85
'I,
'1,
0.035
0.035
0.035
0.035
0.180
0.305
0.180
0.305
0.82
0.82
0.69
0.69
4.71
4.53
2.67
3.83
2.26
Nomlnal
L/d
½
%
¾
'1,
'1,
%
0.065
0.065
0.065
0.065
3;,
½
0.065
0.065
0.370
0.69
1.86
1
'1,
0.065
0.035
0.180
0.69
3.83
1
%
0.065
0.065
0.065
0.035
0.065
0.065
0.305
0.370
0.620
0.69
0.69
0.69
2.26
t.86
1.11
0.065
0.065
0.035
0.035
0.180
0.305
0.69
0.69
3.83
2.26
0.065
0.065
0.065
0.065
0.065
0.065
0.370
0.69
0.69
0.69
1.88
0.620
0.870
0.79
0.065
0.065
0.065
0.035
0.035
0.065
0.180
0.305
0.370
0.69
0.69
0.69
3.83
2.26
1.86
0.065
0.065
0.065
0.065
0.065
0.065
0.620
0.870
1.370
0.69
0.69
0.69
0.79
o.so
0.065
0.065
0.065
0.035
0.035
0.065
0.180
0.305
0.370
0.69
0.69
0.69
3.83
2.26
1.86
0.065
0.065
0.065
0.065
0.69
0.69
0.79
0.065
0.065
0.065
0.065
0.065
0.035
0.620
0.870
1.370
%
0.065
'1,
'1,
'1,
1
1'1,
'1,
t½
%
'I,
1'1,
'1,
t½
1½
2
2
'1,
2
1
'1,
'1.
'1,
2
2
'1,
2
11/i
'1,
2½
21/2
%
2½
'1,
21/2
'1,
2½
2'1,
1
11/2
2
'1,
2½
3
3
3
3
3
1
1.11
1.11
1.11
0.69
0.69
0.69
o.so
1.870
0.180
0.035
0.305
0.69
2.26
0.065
0.065
0.370
0.69
0.065
0.065
0.065
0.065
0.620
0.870
0.69
0.69
1.86
1.11
0.79
59
0.37
3.83
ASM.E BPE-2022
Table SD-3.1.2.2- 2
Lid Dimensions for Flow-Through Tee:
Short-Outlet Reducing Tee With Blind Cap (Cont'd)
Branch 1.0 .,
d
Dranch, /.
(Branch)
0.065
1.370
0.69
o.so
0.065
0.065
0.035
0.035
1.870
2.370
0.180
0.305
0.69
0.69
0.7 1
0.71
0.37
0.29
3.93
0.065
0.065
0.065
0.370
0.620
0.870
0.71
0.7 1
0.71
1.91
Nominal
Tee Slze, In.
Noniinal
Branch Slze, In.
Tee Wall
Thkkne.ss
Oranc-h Wall
3
3
3
t½
2
0.065
0.065
0.065
0.083
0.083
2½
Thickness
L/ d
4
¼
4
'la
4
'I,
4
¾
4
1
0.083
0.083
0.083
4
11/z
0.083
0.065
1.370
0.71
0.52
4
2
0.083
0.065
1.870
0.71
0.38
4
2 1/2
4
3
6
6
0.083
0.083
0.109
0.065
0.065
0.035
2.370
2.870
0.180
0.71
0.7 1
0.86
0.30
0.25
4.77
'la
6
½
0.109
0.109
0.035
0.065
0.305
0.370
0.86
0.86
2.82
2.32
6
6
¾
6
6
6
t½
0.109
0.109
0.109
0.109
0.065
0.065
0.065
0.065
0.620
0.870
1.370
1.870
0.86
0.86
0.86
0.86
1.39
0.99
0.63
0.46
0.109
0.109
0.065
0.065
2.370
2.870
0.86
0.86
0.36
0.30
0.109
0.083
3.834
0.86
0.22
6
6
¼
1
2
2½
3
4
60
2.32
1.14
0.81
ASME BPE-2022
Figure SD-3.1.2.2-1
Accepted Point-of-Use Designs
(bl
(al
Typic8l short-outlet tee
-· ----·-,-·---·--· -
··rMinimsl span
..l
T
+-:=:!=::-}__:r
(room for
clamp 01ll y)
(1)
Branch
Uull or
reduood sizo)
(dl
(el
Note (1)
Short outlet
to minimize ,--"'--t-....L.-,
brsnch
le,,gth
Tsngential side outlet
(to provide full drainage)
(f)
(g)
NOTES:
(1) l/d of Z or less.
(Z) l/d = O (preferred).
61
ASME BPE·2022
Figure 50-3.1.2.3-1
0ouble Block-and-Bleed Valve Assembly
Process 1
Prooess 2
Bleed valve
50-3.1.2.3 System Piping
(g) Field bending of rubing is permitted for diameters
up toand including ½in. (15 mm). Thecenterline radius of
ficld-bent tubcs shoul d be not lcss than 2.5 times thc
nomin al tubc dta metcr to mitigate the risk of i nterior
surface damage (e.g.. wrinkles, strtations, and cracks).
Field bending of tubing in larger dlameters or smaller
be nd r adii may be used w ith t he approva l of t h e
owncr/ user w hen appropriate examlnation techniqucs
and procedures ( e.g., visual, borescope, and sectioning)
are used.
. ('.•) Ball valves ar e not recommended in íl uid hygienic
p1prng systems. See SD-4.2.3(b) for further commenrs.
(/) See SF- 2.4 regarding cleaning and passivation.
Passivation of elecrropol ished surfaces is not required
unl ess the surface has been al tered (e.g., welded or
mechanically polished) orexposed to externa! contamination alter electropolishing.
(a) Rouring ofpiping should be as direct and short as
possible to cnsure a mlnimal quantity ofCIP solution to flll
a circuir and eliminare cxcessive piping and fittings.
(b} Cross•contamination of process streams shall be
physically prevented . Methods of separation uscd i n
industry are
{1) rcmovabie spool piece
{2) U•bend transfer panel
(3) double bloc k-an d-bleed valve syste m (see
Figure SD-3.1.2.3-1)
(4) mix-proof valving
(e) The useoffluid bypass piping (around traps, control
valves, etc.) is not recommendcd.
(d) The use of redundant in -líne equipment is not recommended due to the potential creation of dead legs.
(e) Eccentric reducers shall be used in horizontal
plping to eli minate pockets in the system.
(D T he system shall be designed to elim inate air
pockets and prevent or minimize air entrainrnenL
62
ASME BPE-2022
that will permit the piping to deflect under operating conditions.
ú) The use of blind welds in piping systems should be
avoided. Proper installa tion sequencing of the pipi ng
syst e m ca n reduce the number of blind welds. See
MJ-7.3.3(b) and GR-5.3.4 for further details.
( 22)
SD·3.l.2.4.2 Pipe Ha ngers and Sup ports for (22)
Nonmetallic Piping
SD·3.l.2.4 Hygienic Support Systems
(a) Nonmetallic piping system ha ngers and supports
shall be e ng ineered based on the specific materials
selected. When properly installed, stress concentration
po ints will be mi nim ized. The su pports and ha ngers
shall be installed to e nsure drainabili ty a nd overcome
any deflection. Refer to manufacturer's recommendations
for spacing, which is based on calcularions that take into
consideration the piping material, densiry, modulus of
elasticity, d iameter a nd wall thickness ofthe pipe, specific
gravity ofthe tl uids being transported, operating tempera ture, and thermal expansion properties.
(b) The requirement of a continuous support shall be
determined based on the operating temperatures a nd the
specific gravity of the process fluid being transported.
Support cha nnels may be available in a "V" or "U"
section and shall be manufactured with no sharp edges
that may embed or ca use damage to the pipe exte rior.
These are commonly available in stainless steel or fiberglass reinforced plastic (FRP) materials. These supports
cannot restrict axial moveme nt of the piping and shall be
approved by the owner/ user.
(a) Hygienic supports should be used within classified
spaces. Hygienic support design should incorporare drainable geometry to facilitare cleanability, have no exposed
threads, and have minimal potential for collecting a nd
t rapping debris or liquids on the hanger. Materials of
construction shall be corrosion resistant and compatible
with the chemical, thermal, and physical performance re·
quirements of the instaHed location. The ma terials shall
have adequate strength and durability to withstand the
application of any continuous or cyclic thermal exposure
that may be encountered in the designed service.
(b) The piping sho uld ma inta in proper contin uous
slope for drainabi lity. Hygienic support systems shall
assist in maintaining the required slope and alignment
u nder ali ope rati ng conditio ns, ta king into accou nt
t hermal cycl ing, distortio n, settling, mo me nt loads,
fluid specific gravity, etc. The support system should
be designed to distribute loads a nd stresses from a ny
potential movement. The supports sha ll be installed
witho u t add in g st ress to the t u be or pipe in an
attempt to achieve a desired slope.
(e) The support systems shall provide for, and control,
the inte nded movement of the system. The des igner
should take into account system and equipment movement when plann ing t he design. Anchoring sys tems
should be designed to avoid piping motion in any of
the th ree Cartes ian axes. Guiding systems should be
designed to allow piping axial motion due to thermal
or mechanical loads. An a nchor serves to secure the
piping in place, a nd a guide will allow axial motion of
the piping and is used to allow for thermal expansion.
(d) Supports/hangers should be installed elose to each
change in direction of piping. The only exception is on
short subassemblies using small-diameter tube [<1.000
in. outside diameter (O.D.)] that is installed in a drainable
position and does not bear any additional weights or loads
fro m othe r process equ ipment. Hangers shall be o f
adequate stre ngth and d u rabili ty to withstand the
imposed loads per MSS SP-58, Ta ble l. Per ma nufacturer's
recommendations, supports/hangers should be installed
as close as possible to (and on both sides of, if possible)
concentrated loads including valves, instrumentation, and
filler housings.
( 22)
SD·3.2 Hose Assemblies
SD-3.2.1 General
(22)
(a) Permanently installed hose assembl ies shall be
installed a nd supp orted for drai nab ility [see Figure
SD-3.2.1-1, illustrat ions (a) a nd (b)) . In tem porary
ru ns, hose assemblies may be ma nually drai ned after
disconnecting.
(b) Hoseassemblies shall be installed to avoid strain on
end connections. Hose assemblies shall not be used as a
substitute for rigid tube fittings oras tension or compression elements.
(e) Hose assembly length should be mi nimized and
fitted for purpose.
(d) Hose assemblies shall be easy to remove for examination or cleaning.
(e) Hose assembly shall be clearly marked or tagged
with t he design-allowable working press ure/vacuum
and design temperature range.
(j) Hose assemblies shall be inspected and maintained
on a scheduled basis.
SD-3.2.2 Flexible Element
SD -3.1.2.4.l Pipe Hangers a nd Supports for
Metallic Piping. Metallic piping system hangers a nd
supports shall be installed in conforma nce to MSS SP·
58, MSS SP-69, MSS SP-89, and ASME 831.3 standards.
To e nable drainabil ity, the metallic pipe or tube to be
installed shall meet the straightness criteria of ASTM
A1016. The support spacing shall not exceed a distance
(a) The fl exible element of the hose assembly shall be
cons tructed of materials that permit t he appropriate
degree of movement or drainable offset at installation.
(b) The interior surface of the flexible element shall be
cleanable and drainable.
63
(22)
ASME BPE-2022
Figure 50-3.2.1-1
Flexible Hygienic Hose 0esign
Equipment
Equipment
Drninabte
Flex hose i n horizontal
ta) Accepted
(bl Not Acoepted
Flex:ible element
Flexible element
Gap
Substantlally
flush
Uniform sealing force
(el Accepted
Hygienic fitting
with hose ba rbs
Hygienic fitti ng
w ith hose barbs
(di Not Accepted
(e) The materials used s hall be compa tible w it h
cleaning and SIP conditions.
(b) The owner/user s ha ll evaluate whether holdup
volume and drainability characteristics of a diaphragm
pump are acceptable for the application. Some process
applications require the process syste m, including the
diaphragm pump, to remain continuously flooded with
sanitizing solution ínstead of being drained.
(e) Process contact diaphragms, O-rings, gaskets, and
seals shall conform to Part MC. Process contact metallic
materials of construction shall conform to Part MM.
Nonmeta lllc proc ess co ntact s u rfaces including
diaphragms s hall conform to Part PM.
(d) Where applicable, check valves shall conform to
SD-3.13
(e) Where used, diaphragm fasteners s hall be attached
within the pump head such that crevices or threads a re not
exposed to the process fluids.
(f) The owner/user should consider leak detection and
leak path design of the pump to identify a failure that can
lead to process contamination or biohazards.
50-3.2.3 End Connections
(a) End conn ections shall be of a material a nd design
sufficiently rigid to withstand the combined forces of the
burs t pressure ra ting of the flexible element and the
compression forces required to affect the secureassembly
with the flexible element. [Refer to Figure SD-3.2.1-1, illustrations (c) and (d).]
(b) End connections shall be of a material compatible
with the process fl uid, cleani ng solutions, and steam
where applicable. Materials s hall meet the requirements
of SD-2.4.1 or Part PM.
(e) End connections shall meet a li surface fínísh re quírements of Part SF.
(d) End connections shall be a hygienic connection
design per MC-3.3.2.
SD-3.3 Pumps
(ZZ)
1
Nonuniform sealing force
50-3.3.2 Hygienic Pumps
50-3.3.1 0iaphragm Pumps
50-3.3.2.l General
(a) Diaphragm pumpsmaybe used in positive displacement pump applications. Diaphragm pumps are available
that provide feantres such as low shear, constan! flow or
press ure, low pulsation, high turndown ratio (e.g.,
1,000:1), and low particle generation.
(a) Pumps shall be cleanable. Pumps shall be selected
accord ing to the operating conditions determined by the
owner/user (e.g., process. CIP, SIP, passivation).
64
ASME BPE-2022
Figure SD-3.3.2.2-1
Pump lmpeller Configurations
(al Open
(b) Semi-Open
(i) Ali pump sea Is should be designed to minimize seal
material degradation.
O) Shaft seals shall conform to Part MC.
(b) Ali process contactconnections to the pumpshall be
of a hygien ic des ign (see Figures MC-2.2.2-1 th rough
MC-2.2.2-4).
(22)
(e) Shrouded/Closed
SD-3.3.2.2 Centrifuga! Pumps
SD-3.3.2.3 Positive Displacement Pumps
(a) Hygienic centrifuga) pumps shall be capable of CIP.
(b) Ali process contact surfaces shall be dra inable
without pump disassembly or removal.
(e) Shroude d/closed impellers should not be used.
Figure SD -3.3.2.2-1 illustrates open, se mi -op en, a nd
closed impelle r configurations.
( d) The impeller shall be attached to the shaft in such a
way that ali crevices a nd threads are not exposed to the
process. Threads, such as in a n impeller nut/bolt, shall be
sealed by an 0 -ring or hygienic gas ket. Refer to
Fi gure SD -3 .3 .2.2 -2. The use of 0 -rings or hygie nic
gaskets shall be consistent with Part MC.
(e) Suction, discharge, and casing drain connections
shall be a n integral part of the pump casing.
(JJ Casing drains sha ll be at the lowest point of the
casing, to ens ure drainability (see Figure SD-3.3.2.2-3).
(9) The use of an elbow-type casing drain is not recommended without the use of an a utomatically controlled
drain. The casing drain connection shall be designed to
minimize the l /d as s hown in Figure SD-3.3.2.2-4.
{h) The pump discharge connection s hould be tilted to
a ll ow for full venting of the cas in g (see
Figure SD -3.3.2.2-3).
(a) When poss ible, posit ive d isp lacement p um ps
shoul d be configured with vertically mounted inlets
and outlets to promote drainability and venting.
(b) When using interna! bypass pressure relief devices,
they shall be of a hygienic design. lt is preferred that an
externa], piping-mounted relief device (hygienic rupture
disk) rather than a pump-mounted bypass be used.
SD-3.3.2.4 Rotary Lobe Pumps
(a) The owner / user shall specify the chemical, thermal,
a nd hydraulic operati ng cond itions of the pump (e.g,.
process, CIP, SIP) to ensure proper component selection.
Hygienic rotary lobe pumps are temperature sensitive
(e.g., rotor to casing contact dueto thermal expansion).
(b) The pump s hould be designed and installed to minimize holdup volume.
(e) Rotor fasteners shall be attached to the shaft in a
way that crevices a nd threads are not exposed to the
p rocess. Threads and crevices sh all be isolated from
the process flu id by an appropriate hygie nic sea!, such
asan 0-ring or hygienic gasket (see Figure SD-3.3.2.4-1).
(d) The pump cover s hall sea!aga instthe pump body by
meaos of an 0 -ring or hygienic gasket.
65
(22)
ASM.E BPE-2022
Figure SD-3.3.2.2-2
Acceptable lmpeller Attachments
(a) lmpeller Nut With 0-Ring
(b) lmpeller Nut With Hygienic Gasket
66
(e) No lmpeller Nut
ASM E BPE-2022
Figure SD-3.3.2.2-3
Casing Drain Configurations
(b) Vertical
(a) Horizontal
67
ASM.E BPE-2022
Figure SD-3.3.2.2-4
Casing Drain Lid Ratios
~
~
p::s:::;
'
.
1'
\
·~·,
11
.,-
-
L-
'
d
L-
(al Weir-Style
(bl Radial-Style
Diaphragm Valva
Oiaphragm Valve
68
~
-L
(el Capped
ASM E BPE-2022
Figure SD-3.3.2.4-1
Rotary Lobe Pump Rotor Attachment
(1) Ali interna! surfaces should be sloped or pitched for
drainability.
(g) Test protocols for drainability shall be agreed on in
advance by ali the parties (see SD-7.4). Ali vessels should
be checked for drainability during fabr ication.
Rotor
Pump cover
SD-3.4.2 Vessel Openings
Rotor fastener
Shaft
(a) Nozzles that a re designed to be cleaned by a spray
device should have the smallest l /d ratio possible. For
non-flow-through nozzles, an l /d of 2 or less is recommended (see Figure SD -3.4.2 -1}.
(b) Nozzles less than 1 in. (25 mm) in diamete r are not
recommended unless the system design provides for SIP
and CIP through the nozzle.
(e) Bottom-mounted agitators, valves, pads, etc., shall
not interfere with the d rainability of the vessel.
(d) Sidewall instrument pro bes and nozzles should be
sloped for drainabi lity, un less the instrume nts used
require horizon tal mo unti ng (see Figures SD -3.4.2-2
and SD-3.4.2-3).
(e) Bla nk covers or hygienic plugs used in process
contact applications shall have the same finis h as the
vessel internals.
(1) Drain valves should be drainable. designed with a
mínimum branch L/d, sized, a nd installed to enable vessel
drainability for ali operations.
(g) The number and location of spray devices should be
selected to elim inate shadowing of compone nts (e.g.,
manways, mixe r shafts, dip t ubes, baffles, sidewall
nozzles).
(h} Manways should be located on the vessel top head.
lf sidewall manways are required, they shall be sloped for
drainability.
(i) Sample valves shall be designed a nd installed in
accordance with SD-3.l l.
O) As requi red by the process. inlet nozzles tangential
to the vessel surface may be used (see Figure SD -3.4.2-4).
{k) Manway covers should be dished rather than a ílat
design.
(/) Fla nges that have me tal-to-metal contact on the
process contact side shall not be used.
(m) Ali nozzles should be flush and radiused with the
interior of the vessel exce pt where projec tio ns a re
req uired to ensure ad d itives are directed into t he
process fl uid (e.g., c he mical addi tio n} (see Figure
SD-3.4.2-5).
(n) Flanges for bottom, centerline-mounted agita tors
should be designed in accorda nce with Nonmandatory
Append ix EE (see EE-3.3).
(e) Ali process contact 0 -rings, gaskets, and shaft seals
shall conform to Part MC.
(1) lf a pressure relief device is used, it shall be of
hygienic design in conforma nce with SD-3.15.
{22)
SD-3.4 Vessels
SD-3.4.1 General. This section defines the req uire·
ments that are to be met in the design, fabrication, and
supply of pressurized a nd nonpressurized biopharmaceutical vessels.
(a) Des ign and fabricatio n of vessels a nd interna!
compo nents shall ens ure that surfaces are free of
ledges, crevices, pocketS, and other surface irregularities.
lf more restrictive tolerances are required, they shall be
included as part of the fabrication specifications for the
project.
(b) Ali heat transfer surfaces should be drainable and
ventable.
(e) Reinforcing pads, doubler plates, poison pads, etc.,
should be constructed of the same mate rial as the vessel.
These components should be installed on non -process
contac t surfaces. No tell tale holes a re allowed o n
process contact surfaces.
(d) Vessels tha t a re to be exposed to te mperatures
a bove 176º F (BOºC) [e.g.. SIP, hot wa ter-for-injection
(WFI), hot U.S. Pha rmacopeia (USP} wat ers, and hot
CI P solut ions] s hou ld be designed for full vacuum
service [maximum allowable working pressure- external
of 15 psig (1 barg}].
(e) Top and bottom heads on vessels that are cleaned in
place shall be draina ble. Dished heads such as torisphe•
rica! [e.g., ASME flanged and dished (F&D}, 80:10 F&D],
elliptical, and hemisphe rical a re the most common types.
Flat or conical heads should slope at not less than 1/s in./~
(10 mm/m) to a common drain.
69
ASM.E BPE-2022
Figure SD-3.4.2-1
Nozzle Design
(22)
Minimum 1 in. between nozzles
l.
Vertical Nozzles
Radial Nozzles
(al Allow for Clamp Access (Notes 111 and (211
Same distance
~ - ~J
(b l (Notes (31 and (41)
(e) (Note (511
NOTES:
(1) Less dead space.
(Z) Better CIP/SIP capabilities.
(3) Potential problems with CIP and SIP with capped connections.
(4) Dead space: stagnant areas.
(5) AII l/d ratios to be calculated on long•side di mensions for vessel heads.
70
ASME BPE-2022
Figure SD-3.4.2-2
Side and Bottom Connections
Oished head or shell
Radius
Note (11
(al Accepted
/
~~ ~....,.,....,.,
'~ " ' ~
lb) Accepted
(el Not Accepted
NOTES:
(1) rr a nat gasket is used, mismatch or diamcters can result in crcviccs.
(2) Telltole hole required.
71
Nondraining edge
, , ,$3
ASM.E BPE-2022
Figure 5D-3.4.2-3
SidewaU Nozzles
(22)
Slope
~
M inimize - 1 -,11.11-
land ing
(a) Accepted
(bl Accepted
(el Accepted
[Notes 111 and (211
[Note (31)
[Notes 111 and (411
NOTES:
(1) May also be pitched per application.
(2) lnstalled plug. instrument, or device may require manual cleaning out of place.
(3) Oirect CIP impingement requíred.
(4) Mounting hardware removed for darity.
72
ASM E BPE-202 2
Figure SD-3.4.2-4
Vessel Design Tangential Nozzles
L
Oefinition of L/dfor Tangential lnlet:
Top Section View
GENERAL NOTE: CIP through nozzle is re-commended.
Figure SD-3.4.2·5
Typical Nozzle Detall
Outside groove design
lnside g roove design
Radius
(a) Swage/Butt Weld Design
(Accepted: lf Vessel Wall Is
Thin Enough to Fiare)
lbl Full Penetration Groove Weld
With Fillet Design
(Acceptedl
73
ASME BPE-2022
Table S0-3.4.3-1
Annular Spacing Recommendations for
Hygienic Oip Tubes
Dip Tube Size
Tube O.O.
½
mm
12.7
'!.i
19.1
1
25.4
t½
2
38.l
In.
S0-3.4.4 Fabrlcatlon
Mount Nominal
Slze
In.
mm
50
3
50.8
63.5
76.2
2
2
3
3
4
4
6
4
101.6
6
2½
(a) Weld joint designs sha ll conform to MJ -3.2. For
process contact surfaces, b utt joints shou ld be used
and the use oflap joints should be minimized. lntermittent
welds shall not be used on process contact surfaces.
(b) Flanges are not recommended for process contact
applications, and their use should be minimized. The bore
of weld neck flanges shall be the same as the f.D. of the
connected componentS to preven! ledges and nondrainable areas.
(e) Where slip-on ílanges are used, the process contact
fillet weld shall be designed for drainability a nd CIP.
50
75
75
100
100
ISO
150
S0-3.4.5 Flnlshes
(a) Surface finishes shall be specified in Ra values (see
Table SF-2.4.1-1).
(b) Process contact surface fi nish specifications shall
perta in to ali the wetted or potentially wetted surfaces
(e.g., vapor space, nozzle necks, agitators, thermowells,
dip tubes, baffies).
(e) The polishing of a connection face, body flange, etc.,
shall extend up to the first seal point.
S0-3.4.3 lnternal Components
(a) Sparger a nd dip tubes shall be designed in accordance with SD-3.4.l (a), SD-3.4.l(d), SD-3.4.l(f), and
SD-3.4.l(g) . Sparger and dip tubes shall incorporate
low-point drains [where applicable, i.e., horizontal lines
should slope at not less tha n 1/8 in./ft (10 mm/m)] a nd
be properly supported to ensure drainability. Refer to
Table SD-2.4.3.1-1 to determine the appropriate slope
designation.
(b) Dip tubes a nd spargers mounted in the nozzle neck
should have a n a nnular space between the O.O. of the dip
tube or sparger a nd the 1.0. of the nozzle neck in accordance with Table SD-3.4.3 -1. An l/A of 2 or less is recommended (see Figure SD -3.4.3 -1, illustration (a)]. lf a larger
L/A exists, a method for cleaning this space shall be specified. In ali cases, sufficient annular space to allow access
for CI P coverage shall be provided.
(e) Dip tubes shall be designed for CIP or cleaning out of
place (COP). Spargers should be designed for CIP. Where
the sparging device cannot be CIP'd, the device shall be
removable for COP or replaceable.
(d) Removab le dip t ubes and spargers shall be
designed to e nsure that t he installation ori en tation
conforms with the design intent.
(e) Sp ray devices shall meet the requirements of
SD-3.9.
(J) Interna! supportmembers shall besolid, ratherthan
hollow, because hollow support members have a higher
risk of fatigue and contamination problems (see Figure
SD-3.4.3-2).
(g) Mitered fittings for interna] pipe work should be
avoided. When mitered joints are used, they shall be
designed and fabrícated in accorda nce with the appropriate codes.
SD-3.4.6 Sight Glasses
(a) Sight glasses on vessels should be designed with
refe rence to SD -3.4.2(a) . Sig h t glasses on vesse ls
should be designed with the smallest L/d possible a nd
incorporate cleanable O-ring designs when applicable
(see Figure SD-3.4.6-1).
(b) Refer to Pl-9.1.2.3 for additional sightglass requireme nts.
(e) Surface finish for the metal frame shall meet the
requirements of Part SF in this Standard.
(d) Sight glasses shall be marked with the glass type,
maximum pressure, and temperature rating per DT-11.1
and DT-11.1.1.
(e) Part MC requirements shall be met when mounting
a sight glass.
(J) Preferred sight glass mo unt ings are shown in
Figure SD-3.4.6-1.
S0-3.4.7 Portable Vessels
(a) Casters shall be cleanable and compatible wi th
cleaning solutions used for externa! cleaning.
(b) Casters should be designed for the environment in
which the vessel will be used.
(e) Portable vessels should be designed to resist over•
turning during normal operating conditions.
(d) Flexible hoses used to connect portable vessels
shall meet the requirements of SD-3.2.
(e) Provisions for staticgrounding should be evaluated
a nd incorporated into the vessel design, if required. The
connections for static grounding should be designed to be
cleanable.
74
ASME BPE-2022
Figure 50-3.4.3-1
Accepted Nozzle Penetrations
Mechanical seal area
L
L
f---lP+ A
(a) Oip Tubo or Sparge
(Notes (1) - (311
(b) Agitators
(Notes (2) and (4))
NOTES:
(!) Nozzle and dlp tubc slze per Table SD-3.4.3•1.
(2) l/A less tl,an 2:1.
(3) Requirements also apply to nozz.les with instrument penetrations,
(4) A= 1 in. (25 mm) mínimum.
75
ASM.E BPE-2022
Figure 5D-3.4.3-2
lnternal Components
(22)
Sdeg
Round
bar stock
Support brece can
be deleted if design
allows
(a) Hygienic Oesign
(b) Nonhygienic Oesign
(Not Accepted: Flat Surfaces,
Ledges, and CIP Shadows)
(Accepted: Sloped, Mínimum Shadow,
and Curved Surface)
lnterm ittent weld:
Continuous weld
/
not drainable
crevice
Orainable
Welded pad or
doubler plata
Ooubler plate
~ NotCIPcapable
of
(shadow)
Capable o f CIP
(no shadows)
(e) Good Deslgn
(Accepted)
(d) Poor Design
(Not Accepted)
Pooli ng
potential
CIP
i
Thermowell
Thermowell
~ - - 1 ~1
Oroplet formation
(e) Positive Slope in AII Directions
(Acceptedl
(f) Positive Slope in Only One Direction
(Accepted)
76
ASME BPE-2022
Figure SD-3.4.6-1
Sight Glass Design (Accepted)
la) Full Flange Sight Glass
on Hygienic Pad Connection
lb) Hygienic Clamp on Hygienic Pad Connection
(Note 11))
le) Hygienic Clamp Sight Glass
(d) Hygienic Cross Sight Flow lndicator
le) Typical VesS<II Sight Glass Mounting Tangent to Tank Head
NOTF,:: ( 1) Mounting hardware removed for darity.
77
(22)
ASME BPE-2022
50-3.4.8 Media Bulk Contalners. [Reserved for future
content]
(k) Agita tor mechanical sea! performance and the
seal's ability to maintain a closed system for bioburden
control, process containment, etc., is a function of agitator
shaft and drive assembly mechanical integrity. Agitator
des ign should address the dyna mic forces that act on
the s haft and impe lle r asse mbly (e.g., maximum
applied torque and impelle r hydraulic forces) and the
resonant frequency of the assembly to ensure that component alignme nt and deflection are within the manufactu re r' s to lera nce . The agi t a t or torque, be nding
mome nt, a nd vertical downward mounting loads shall
be provided by the manufacture r to support design of
the associated vessel mounting flange/nozzle.
50-3.4 .9 Cryogenic Containers. [Reserved for future
content]
SD-3.5 Agitators and Mixers
(22)
50-3.5.1 General
(a) Ali process contact surfaces ofagitators a nd mixers
with their associated components shall be accessible to
the cleaning fluids for clean-in-place service (CIP; e.g.,
via spray, directed flow, immersion).
(b) Process contact surfaces should be draina ble a nd
shall not interfere with vessel drainability.
(e) Machined tra nsitions (shaft ste ps, coup lin g
surfaces, wrench flats, etc.) should be smooth, with 15deg to 45-deg sloped surfaces.
(d} The annular space between the agitator shaft a nd
the agitator nozzle shall, for cleaning purposes, have an
L/A of2 or less,or a mínimum ofl in. (25 mm) gap, whichever is larger, to faci lita te CIP sp ray coverage [see
Figure SD-3.4.3-1, illustration (b)).
(e) The manufacture rs of agitators a nd mixers shall
provide a design that meets the cleaning a nd sterilization
specifications provided by the owner/user. The ma nufacturer shall veri fy that their equipment is capable ofbeing
cleaned.
(fJ Top-entering mixers with shaft seals are typ ically
mounted to a vessel using a flanged or hygienic cla mp
conn ection [see Figure SD-3.5.1-1, illustrat ions (a), (b).
a nd (e)). The designer shall e nsure that
(1) the use of 0 -rings or hygienic gaskets to sea!
between mating surfaces shall be consisten t with the
curren t g uida nce provided in Part MC (see Figur·e
MC-3.3.2.2-1).
(2) the selected mounting arrangement will support
the agita tor mounting design loads while achieving an
a ppropriate sea!.
(3) the fla nge and nozzle construction is consistent
with requ ire me nts of other applica ble codes and standards (e.g., ASME BPVC, Section VIII; ASME 831.3)
(g) Bottom, centerline-mounted agitators should be
designed in accordance with Nonmandatory Appendix
EE (see EE-3.1).
(h) Socket head cap screws shall not be used in process
contact a pplications.
(i) The d esign of agitator process contact parts should
mi nimize the occurrence of void spaces. Ali voids should
be closed by either fabrication (welding) or approved
sealing techniques (0-ring seals, etc.).
OJ The use of in-ta nk nonwelded connections (shaft
couplings, impeller hub-to-shaft, impelle r blade-to-hub,
etc.) should be avoided to minimize potential cleanability
50-3.5.2 ln-Tank 5 haft Couplings
(a) Welded in-tank shaft connections are preferred.
(b) The use of in-tankshaft couplings shall be agreed to
by the owner / user.
(e) ln•tank couplings shall be of an accepted hygie nic
design. See examples in Figure SD-3.5.2-1.
(d) ln-ta nk coupling location sho uld be drive n by
process and mechanical considerations.
(e) Threaded shaft con nections are accepted for intank couplings [see Figure SD-3.5.2-1, illustration (a)).
(1) Shaft rotation is limited to a single direction for
threaded shaft connections to ensure that shaft sections
do not separate.
(2) The designer will ensure t hat the us e of a
threaded shaft connection is appropriate for the selected
shaft diameter and design loads.
(3) Hygienic bolted coupling construction may be
used whe re appropriate for the particular application
[see Figu re SD-3.5.2-1, illustra tion (b)).
(fJ Threads shall not be exposed in a ny type of shaft or
coupling hardware connection.
(9) The preferred location for fastener hardware is on
the unde rside of co upl ings. Accepted fastener types
include
(1) hex-head cap screws
(2) acorn-head cap screws
(3) threaded studs with acorn nuts
(h) Fastener heads shall be free of raised or engraved
markings that might inhibit cleanability.
(i) 0 -rings rather than tlat gaskets are preferred to sea!
coupling mating surfaces. Figure SD-3.5.2-2 presents the
following acce ptable approaches for sea! a pplications:
(1) 0 -ring located in a single groove inboard of the
coupling O.D. (see Figure SD -3.5.2-2, illustration (a)]; 0 rin g compressi on, interna! space t o accom moda te
compression, and outboard clearance space ali designed
to minimize the intrusion of process fluid between the
coupling faces a nd to faci litate flow of CI P fluid.
issues.
78
ASME BPE-2022
Figure SD-3.5.1-1
Agitator Mounting Flanges
(b) Hygienic Union With Gasket
(al Bollad Flange With 0 -Ring
(el Pad Flange
79
ASME BPE-2 022
Figure SD-3.5.2-1
Shaft Coupling Construction
W rench ílats
Note (1)
(b) Bolted Coupling
(Accepted)
(a) Threaded Coupling
(Accepted)
NOTE: (!) Scc Figure SD-3.5.2•3 for altcrnatlvc bolt scals.
80
ASM E BPE-202 2
Figure SD-3.5.2-2
Shaft Coupling Seal Arrangements
(a)
(bl
O•ring groove detail
(e)
(di
Threaded Coupling Examp le
Detail. Accepted Alternatives
81
ASME BPE-2022
(2) Alternate construction for 0 -ring located in a
groove j ust in b oar d of th e coupling O.D. (see
Figure SD-3.5.2-2, illustration (b )]; 0-ring restrained by
lip at coup ling circu mfere nce wi th clea ra nce space
provided as a bove to ensure cleanability of the coupling
a rea.
(3) Alternate construction for 0 -ring loca ted in
grooves in both coupling halves inboard of the coupling
O.D. (see Figure SD-3.5.2-2, illustration (e)]; outboard
clearance space provided as above to ensure cleanability
of the coupling area.
(4) 0 -ring wi th attached inboard flat segment
located between coupling faces (see Figure SD-3.5.2-2.
illustra tion (d)]; outboard clearance space provided as
above to e nsure cleanability of the coupling area.
{j) Bolted flanges shall be sealed. Examples of accepted
fastener seals are shown in Figure SD-3.5.2-3 as follows:
(1) 0 -ring sea! (illustration (a)]
{2) 0 -ring sea! alternate (illustration (b))
(3) sea] washer with metal core (illustration (e))
(22)
(2) Hub-to-shaft clearance for removable impellers
shall be sufficient to preclude shaft surface finish damage
during installation a nd removal.
(3) Removable hardware (e.g., impeller hub and
shaft, impeller set-screws and hub) should be sealed in
a manner consistent with the guidance provided for inta nk couplings (see SD-3.5.2).
(d) Removable impellers and impellers with ílat, horizontal surfaces (e.g., flat-blade disk turbines, concaveblade disk turbines) may require additional design or
cleaning practice to facilitate liq uid removal and cleanability ( e.g..drain holes, spray ba ll or wand additions.
increased CIP flow, adjusted spray coverage. impeller
rotation).
S0-3.5.5 lmpeller and Shaft Support Bearings
(22)
(a) Normal operation of a shaft-steady bearing ora
magnetically driven mixe r with in-ta nk impeller o r
shaft su pport bearings (see Fig ures SD-3.5.5-1 and
SD-3.5.5-2) generates particulate debris. lt is the responsibility of the owner/user to establish compliance with
applicable standards (e.g., USP limits for particulate material in injectables) as appropriate.
(b) Tank plates tha t support bottom-mounted magnetically dr iven mixers shall not interfere with vessel drainability.
(e) Whe n a n application mandates the use of shaftsteady/foot bearings, design features and procedures
are requ ired to e nsure cleanabi lity (e.g., d rain holes,
spray ball or wand additions, increased CIP flow, operating the steady bearing immersed in CIP fluid).
(d) Shaft-steady bearings, where used, shall not interfere with vessel draina bility.
(e) Shaft -steady bearing pedestal support members
may be of solid or hollow construction. Hollow pedestal
supports, if used, shall be of sealed (welded) construction,
inspected for integrity, and accepted pe r criteria given in
Part M) after installation.
W Magnetically driven mixers require design features
and procedures to ensure cleanability (e.g., drain holes,
spray ball or wand additions, increased CIP flow, operating the agitator with the magnetically driven impeller
immersed in CI P fluid).
{g) The arrangement of wear surfaces (bushing. shaft,
or shaft sleeve) shall enable drainability.
S0-3.5.3 Shafts and Keyways
(a) One-piece shaft construction, without mecha nical
couplings, is preferred.
(b) Solid shafts are preferred over hollow shafts.
(e) Hollow shafts, if used, shall be of sealed (welded)
construction, inspected for integrity, and accepted per
criteria given in Part M) prior to installat ion.
(d) Keyways exposed to the process are not recom·
mended.
(e) Keyways, whe re employed d ue to mechan ical
design considerations, shall have edge rad ii as specified
by SD-2.4.2 (b)(3) .
(f) Keyways may require additional design or cleaning
practice to ensure drainage a nd cleanability (e.g., spray
ball or wand additions, increased ClP ílow, a nd adjusted
spray coverage).
(9) Permanent shaft hardware, installed on the process
contact side, that may be required for routi ne mai ntenance (e.g., support collar·s for mechanical sea! installation
a nd removal, lifting eyes for shaft or impeller installation
a nd removal) shall be drainable and cleanable.
(22)
SD-3.5.4 Hubs and lmpellers
(a) All -welded im peller assemblies (e.g., hubs, blades)
a re preferred.
(b) lmpeller hubs welded to the shaft a r·e preferred
over removable hubs.
(e) Removable, hygienic impellers may be used where
impeller adjustment or substit ut ion is req ui red for
process reasons or where impelle r removal is required
due to mechanical design and/or installation considerations.
(1) Removable impellers may be one-piece or split
hygie nic construction.
SD-3.5.6 Mechanlcal Seals
(a) Mechanical shaft seals shall inco rporate design
featu res for d rainab ility, surface finish, material of
construction, etc., as outlined in Part SD, and shall be
suitable for the application (e.g., process, CIP, SIP, passi·
vation).
(b) Normal operation of a mechanical sea! generates
particulate debris. It is the responsibility of the owner/
user to establish compliance with applicable standards
82
(22)
ASME BPE-2022
Figure SD-3.5.2-3
Fastener Seal Arrangements: Alternative Bolting Designs
(al Accepted
(bl Accepted
83
(el Accepted
ASM.E BPE-2022
Figure SD-3.5.5-1
Shaft-Steady Bearing
Bushing (press flt
lnto houslng)
Chamfer radius
Steady bearlng legs
(aolld round preferred;
grlnd/cut to flt tank bonom)
Tankbottom
(al Hygl•I• Tripod Study BNring
(Altamltive DNign - Fllt Bar l.8gS Wrth Rounded Edgee)
Hygienic set screw
with O-ring
Detall A
Detall A
0-Ring Wrth G,_,,. Expoeed for Flu9hing
(b) Altamltive Bu9hing S.Curing Method
84
ASME BPE-2022
Figure SD-3.5.5-2
Magnetically Coupled Mixer (Typical Bottom-Mount)
lmpeller
lmpeller (driven) magnet
l mpeller hub
Bearing svrrace
Magnetic coupling
comprised of these parts
Wel d plato
lmpeller blades
Orive magnet
Motor
Gear reducer
Tank head
(e.g., USP limits for particulate material in injectables) as
appropriate.
(e) Sea! debris wells or traps (see Figure MC-2.3.2.3-2)
may be used to prevent ingress of sea! face wear particles
that could contaminate the process fluid.
(d) Refer to Part MC for specific sea! design details.
(e) Mechanical seals for bottom, centerline-mounted
agi t at o rs sho uld be designe d in accorda nce with
Nonmandatory Appendix EE (see EE-3.2).
( 22)
(e) Process contact surface fin ishes shall be fully
inspectab)e to confirm surface finish quality. Wh en inspection is not practical, prior to fabrication or procureme nt,
the manufacturer s hould provide inspectable samples
representative of the fabrication process.
SD-3.6.1 Application Design Considerations
(a) The heat exchanger should be designed and fabricated to provide smooth, crevice-free process contact
surfaces.
(b) For hygien ic heat excha nger applications where
crevices can not be avoided (e.g., prod uct on the s hell
side), the system s hall be designed to mitigare contamination risk through operational controls (e.g., self-sanitizing
conditions).
SD-3.6 Heat Exchange Equipment
(a) Required opera ting cond itions s hould be established prior to t he design o r selectio n of the heat
exchanger. The manufactu re r's design shall take into
account the most demanding of these operating conditions.
{b) To reduce process contamination risk, systems
using heat excha ngers shou ld be designed s uch that
the operating pressure for the process contact side is
greater than the operating pressure of the non-process
side.
SD-3.6.2 Shell and Tube
(a) Shell-and -tube heat excha ngers shall be of a double
tubesheet design to prevent product contamination in the
case of a t ube-to-tubesheet joint failure (see Figut"e
SD-3.6.2-1 ).
(b) After the tubes are expanded into the inner and
o uter tubesheets, the process contact s urface shall
meet the specified surface finish requirement.
85
ASM.E BPE-2022
Figure SD-3.6.2-1
Double Tubesheet Heat Exchanger Bonnet Design
(22)
Outer tubesheet
Accepted
Full radius on
bonnet pockets
Tube deformation from forming
(typical on both tubesheets)
_jj_ Leak detection slot s
Seal wel
Tube bund le must slope t oward bonnet
U-tu be bu ndle
Tube hole key cut groove
(typical on both tubesheets)
NOTE: (1) Owner/user to spcdfy lnlet tubing slopc. Hcat exchangcr manufacturcr to slopc i nlet on bonnet to match lnlct tubing slopc.
86
ASME BPE-2022
For tu bes not included in the ta ble, a mínimum bend radius
of 1.5 times the tube diameter is recommended, however
SD-3.6(c) should be consulted.
(e) Tubes shall be welded to the outer tubesheet to
eliminate a ny crevices.
(d) The distance between inner a nd outer nibesheets
shall be sufficient to allow leak detection.
(e) The process con tact side of the heat exchanger
system sha ll be dra inable or capable of having liq uid
removed by other means (e.g., pressur•ized gas,
vacuum, heat) . The manufacturer should specify t he
required drainable orientation for the heat exchanger.
(f) When tra nsverse baffles are required, they should
be notched to allow for drainage.
(g) The heat excha nger bonnet, nibe bundle, and shell
shall have a positioning device or mark to ensure proper
orientation a nd installation.
(h) The manufacturer's performa nce calculations shall
take into account any bonnet bypass imple mented to aid
drainage.
SD-3.6.3 Plate and Frame. Plate-a nd-fra me-type heat
exchangers should be used only by agreement between
t he owner/user a nd des igner dueto the difficulty of
CIP a nd SIP.
SD-3.7 Transfer Panels
SD-3.7.1 General
(a) The tra nsfer panel shall be constructed so that the
process contact surfaces can be cleaned by a CIP Huidor
other method specified by the owner/ user. The process
contact surfaces shall be free of crevices., pockets, and
other surface irregularities.
(b) The transfer panel nozzle elevation shall be prop·
erly designed with respect to the connecting equipment
such as tank and pump to ensure draina bility, cleanability,
and bioburden control during process transfer, CIP, and
SIP.
(e) Design and fabrication of the transfer panel and
associated co mponents must e nsure that the pipi ng
system can be drained when properly installed. This is
not to imply that panel nozzles or subheaders should
be sloped (see Figure SD-3.7.1-1).
(d) Taggi ng/label ing of the t ransfer pa nel and its
componentS shall be per SD-2.4.4.2 (i). Tagging nozzles
on the back side of panels will help reduce the number
of incorrect piping connections during field installation.
SD-3.6.2.1 Straig ht Tube Design. Expansion or
contraction for ali specified diffe rential thermal conditions sha ll be eva luat ed whe n designing t he heat
exchanger.
SD-3.6.2.2 U-Tube Design
(a) The technique used to form U-bend tubes shall
ensure the bendi ng process does not create structural
imperfections (e.g., cracks, voids, gouges ). The technique
should minimize surface imperfections (e.g., orange peel,
rippling).
{b} lf requested by the owner/user, the ma nufacturer
shall supply a sectioned sample of the bend area.
(e) The sectioned sample should be from the same tube
batch or heat that wi ll be used to fabricate the heat
exchanger.
(d) The sectioned sample shall be the smallest bend
radius in the exchanger.
(e) The sample shall be sectioned so that the bend
centerli ne is visible.
(f) The interna! surface of the U-bends shall be free of
relevant liquid penetra nt indications, as defined by ASME
BPVC, Secrion VIII.
(g) The I.D. ofthe U-bends should be large enough for a
borescopic examination.
(h) Mín imum recom men ded be nd radii for hea t
exchangers should be as follows:
Nominal Tube O.O.
SD-3.7.2 Nozzles or Ports
(a) Nozzle construction shall accommodate a design
feature that will ass ist in the eli mination of interna!
surface anomalies caused in part by joining the nozzle
to the panel structure.
(b) The method of joining a nozzle into a panel structure shall be of hygienic design. Acceptance criteria for
these weldsshall meetthe requirementS ofTable MJ -8.5-1.
(e) Each front nozzle connection shall be of a hygienic
des ign and the horizontal projection minimized to enable
liquid removal.
(d) To e nsure proper panel functionality and joint
connection integrity, panel nozzles shall not be sloped
(see Figure SD-3.7.2-1).
(e) Nozzle-to -nozzle clearance shall be such that
jumper dra in valve inte rference, if applicable, will not
occur when jumpers are connected in ali possible operating a nd cleaning configurations.
(f) Nozzles shall be capable of being capped. Caps may
include bleed valves or pressure indicators for safety or
operating purposes.
(g) Nozzle position a nd parallelism tolerances are extremely critica! to proper panel functionality and should
meet the recommended tolerances perTable DT-7.3-1 and
f-igure SD-3.7.2 -1.
Minimum Bend Radius
in.
mm
in.
mm
0.375
0.500
9.5
12.7
0.625
0.750
15.2
19.)
0.625
0.750
1.000
15.8
19.1
25.4
0.938
1.125
1.500
23.8
28.6
38.l
(22)
87
(22)
ASM.E BPE-2022
Figure SD-3.7.1-1
Transfer Panel Looped Headers
Level
r "l
f(
,_ s,';;;;; -
Level
(al Accepted
(bl Not Accepted
88
)
Level
ASME BPE-2022
Figure SD-3.7.2-1
Transfer Panel Tolerances
(22)
♦ Tol.2 C
[Notes ( 1) ond (2))
-
~
/
/
-
-
/
1
/
/
/
/
1
/
/
/
/
1
/
- - - - - 1 1 - - j / /lTol. 11A 1
[Notes (2), (3), ond (4))
-
-
I//IT01.11s :
[Notes (2), (3), ond (4))
1
e
/
-
NOTES:
( !) For posidon tolcrancc Tol.2. sce Table DT-7.3-1.
(2) For testlng parallcllsm and posltion, thc use of speclfically made test pancls is rccommcndcd.
(3) For ílatness tolerance of singular sealing faces of ferrules, see Table DT-3-1.
(4) For parallelism tolerance Tol.1, see Table DT-7.3-1.
89
ASME BPE-2022
(22)
SD-3.7.3 Headers or Pre-Plped Manlfolds
(a) When a looped header design is employed, the
branch length at cappcd or unuscd nozzles, or to the
weir of the unused polnt•of-use valve, shoul d be min imlzed. Th e dimension of the subheader leg to the
nozzle face should not exceed an L/d of 2 (see
Figure SD-3.7. t • 1). A dead-ended or unlooped subheader
is not recommended.
(b) For nozzle drainabillty, regardless of use, subheaders and pre•píped manifolds shall not be sloped. Allencompassing lines including long r uns with theexception
of subheaders, manifolds, and noiztes rnay be sloped as
defined in SD-2.4.3.
(22)
S0· 3.7.4 Jumpers or U•Bends
(a) Jumpers shall be constructed wíth hygienic conn ections on both ends designed to mate w ith the panel
nozzles.
(b) Jumpers may have a low-point draín to provide for
both drain ing and vacuurn break a~er the liquid transfer
has been cornpleted (see FigureS0-3.7.4-1). The brancl1 L/
d of a low-point drain connection should be minimized.
Zero-static diaphragm valves are recomrnended for lowpoint drains if available from the manufacturer (see t-igure
S0-3.7.4-1, illustrations (a) and (d)]. Low-point drain
designs that incorporate a spool piece allow for full rotarion of the drain valve (see Figure S0-3.7.4-1, illustrations
(a), (b), and (c)]. This design ensures that the drain valve is
always at the true low poln t of the assembled Jumper
connection in any specified orientation.
(c) Jumper position and parallelism tolerances are ex•
trcmcly critica! to proper panel functional ity. Rccom•
mcnded tolerances are pcr Table DT-7.3• 1 and eigu re
S0-3.7.2-1.
{d) Reducing jumpers shall not be used unless rhe re•
ducing jumper is drainable in ali orientations. Any rcduc•
tíon in line sizc should be madc behind the primary nozzle
connection (behind panel structure), thus allowing ali
connections to be the same size on t.he front of the panel.
(e) The overall panel deslgn should be such that the
quantity of uniq ue jumper centerline dirnensions is mini·
mized.
(fl The samc Jumper should be uscd for process
transfer, CIP, and SIP.
(g) lf a pressure indicator is installed on a jumper, it
shall be a hygienic design and mountcd in a manncr that
maintains draín ability in ali jumper posilions. The L/d
should be 2 or less.
(22)
S0· 3.7.5 Draln or Drlp Pans
(a) Drain pans, ifused, shall be built asan integral part
of the transfer panel. The intended function is to collect
spilled Ruids thatcan occurduringjumperorcap removaJ.
(b) Drain pans shall slope (preferred mínimum of ¼
in./ft (21 mm/m)] to a low point and be piped to the
process drain. The depth of the drain pan is determined
by calculating the largest spill volume and accommodating
ir with a sufficient pan holding volu me. Consideration
should be given to increasing the drain pon connection
size in lieu of lncreasing pan depth. The preferrcd drain
port location Is central bottom draining or centra l back
draining.
(e) The elcvation of the pan should take into accounr
rhe clearance rcquired forthe jumper drain val ve position
whcn a conncctíon is made to the bottom row of nozzles.
Thc pan should extend horizontally to accommodate the
furthest connection or drain point from the face of the
panel.
SD-3.7.6 Proxlmity Swltches
{a) Proximity switches are used to detect the presence
or absence of a jumper with a stem positioned between
sclccted nozzlcs.
{b) The use of magncric proximity switches that are
mounted behind the panel structure to avoid penetration
ofthe panel face is preferred. This eliminatioa ofstructuraJ
penetration removes any unnecessary cracks, crcvices, or
threads at thc point of attachment, cffecti vely mitigating
risk of process Auid entrapment or contamination.
(e) Jumpers will con ta in a magnetic stem to activa te the
corr espondi ng proximity switch. The use of a fcrrous
magnetic material is requi r ed; however, it shall be
fu lly encapsulated to ensure that the ferrous material
does not contaminate the classlíled manufacturing
area. The acceptance criteria for welds joining the
sensor stern to the j urnper shall meet the requírements
of Table MJ -8.5-1.
{d) The rnagnet should be of sufficient gauss raling to
properly actívate the corresponding proximity switch. In
addition, the temper an,re rating of the magnet should
wíthstand the specified temperatu re ranges for process
and SIP wíthout compromising the magnet performance.
{e) The proximity switch mounting shall be fabricated
ro maintain the specified design location. The proximity
swi,tch shall not interfere wíth the functíon, cleaning, or
ma111tenan ce ofthe transfer panel to which it is mounted.
SD-3.8 Filtratlon Elements and Components
SD -3.8.l General. Th ís section defines and recommends design elements related to hygíenic filtratlon
processes. This section includes aseptic and nonaseptic
processes and includes the following filtration components: houslngs, holders, and elements. More information
0 11 ílltration elements and cornponenlS may be fou nd in
Nonmandatory Appendix T.
SD-3.8 .2 Filtration Formats. There are two basic
modcs of filtratlon: direct ílow and tangcntial ílow. For
mul tluse filters, cleaning and/or sanitiiation should be
90
(22)
(22)
ASM E BPE-2022
Figure 5D-3.7.4-1
Transfer Panel Jumpers
(al Accepted
(b) Accepted
(el Accepted
Id) Accepted
(el Not Accepted
(1) Not Accepted
(g) Not Accepted
91
ASME BPE-2022
considered. For single-use filters, sanitization req uirements shall be determined by the owner/user.
tabs by the locking t ab reta iners is not requ ired to
secure cartridges for operation.
(d) ali surfaces of the cartridge socket shall meet the
required finish for the wetted surfaces as specified by the
owner/ user.
(e) t he cartridge 0-ring(s) sha ll be complete ly
contained within the socket bore.
50-3.8.3 Housing and Encapsulation. Filter housings
and encapsulated components a re wetted and are vessels
operating under pressure. Requirements for vessels oper·
ating under pressure are found in ASME BPVC, Section
VIII, as referred to in GR-1. The owner/user shall be
responsible for informing the manufacturerof ali expected
operating cond itions to which the filter housings may be
exposed. The ma nufacturer shall be responsib le fo r
ensuring the filter housing and encapsulated components
will operate safely under said conditions.
SD-3.8.3.3.2 Testing. The cartridge manufacturer
shall validate that its ca rtridge design fits, seals, a nd
rema ins in place with one of the hous in g designs
shown in Tables DT-4.5.1-1 and DT-4.5.2-1.
S0-3.8.4 0esign for Cleaning and Sanitization
50-3.8.3.1 Housings. Housings shall be designed in
accordance with S0 -5.4.4. Materials used in the construc·
tion of filtration housings shall conform to Part MM for
metallic materia ls or Part PM for polymeric materials.
Ali dimensions of hygienic clamp ferrules on polymeric
filter housings shall conform to Table DT-7.1-2.
50-3.8.4 .l Filler Elements. Filtration elements shall
bedesigned in accordance with SD-3.1 and shall be compatible with the cleaning agents (to be agreed by the manufacturer and owner/ user).
S0-3.8.3.2 Encapsulatlon. Encapsulated filtra tion
elemen ts are designed for hand ling p urposes or in
place of metallic housings. Materiais used in the encapsulation of fiitration elements shall conform to Part MM for
metallic materials or Part PM for poiymeric materials.
S0-3.8 .4.1.2 Exterior Surfaces. Ali exterior
surfaces shall conform to S0-2.4.4.2.
SD-3.8 .4 .l.l Seals. Ali seals shall confo rm to
Part MC.
S0-3.8.5 Sanitization
S0-3.8.5.l Filter Elements
S0-3.8.3.2.1 Holders. Ma terials used in t he
construction of holders sha ll conform to Part MM for
metallic materials or Part PM for poiymeric materials.
S0-3.8 .5.l.1 Chemical San itization . Chemica l
sanitizat ion processes are used to reduce bio bu rden.
Ali prod uct contact surfaces sha ll be compatible with
the sanitization agents selected (to be agreed by the man u·
facturer and owner /user).
S0-3.8.3.3 Code 7 Cartridge Lock 0esign. The ASME
BPE Code 7 lock is designed to be used with filler
cartridges using an SAE AS 568-226 double-0 -ring sea)
a nd a two-locking-tab design.
SD-3.8.5.1.2 Thermal Sanitization. Thermal sanitization requirements should be considered during the
design process. The components shall be designed to
accommodate the elevated temperatures and the expansion and contraction during exposure and cooldown
stages. Special consideration should be give n when
designing for potential vacuum si tuat ions. Filtration
elements shou ld be t es ted and verífied for mu ltiple
steam cycles per vendor qualificatíon methods. Filtration
elements shall conform to SD-2.3.1.
S0-3.8.3.3.l 0eslgn Features. This design consists
of the following features:
(a) a socket bore t hat is machined into a base or
cartridge plate into which the filt er cartridge 0-ring
adapter is inserted.
(b) a locking tab retainer mechanism that captures the
cartridge locking tabs when the cartridge is inserted into
the socket bore.
{1) Table DT-4.5.1· 1 shows a recessed tapered lock
retainer design in which the locking tab retainers are
machined into a plate and the machined recesses
capture the cartridge locking tabs as the cartridge is
rotated into position.
{2) Table DT-4.5.2-1 shows an externa! tapered lock
retainer design in which a set of metal cages captures the
cartridge locking tabs as the cartridge is rotated into position.
(e) the locking retainers shall be designed with a taper
to provide a secure lock for the cartridge. The cartridge
tabs shall travel through the narrowing tab retainers until
a tight fit is achieved. The taper shall be on the upper
portion of the tab retainer. Full capture of ca rtridge
S0-3.8.6 Flltratlon Performa nce. The owner/user
shall be responsible for informing the manufacturer of
ali the conditions under which the filter ele me nts may
be expected to operate. This shall indude the methods,
frequency, and duration of clean ing and sanitization
procedures. In addition to the service temperature and
pr·essure, any parameters that may affect the filtration
performance shall be provided.
S0 -3.8 .6.l Service Temperature and Pressure.
Filtra tion elemen ts shall be capable of wi thstanding
thermal and pressure cycling between the rated upper
and lower temperature and pressure limits.
92
ASM E BPE-2022
S0-3.8.6.2 Routine Mai nte nance. To e nsu re
contin ued fil tration performa nce, consideratio n shali
be given to the accessibility of ali filtration components
for routine maintenance.
based cleaning soiutions. The flow rate recommendations
in this section are for metallic vessels.
(a) Spray devices distribute rinse and cieaning soiutions to interior surfaces of bioprocessi ng equi pment
by direct spray and use sheeting action for rema ining
targeted areas. Spray devices are aiso used in other applications [e,g., water systems to maintain coverage of the
storage tank head space and in clean-out-of-place (COP)
cabinet washers].
(b) The d ifferentiai pressure across the spray device
ge ne rat es liquid veioc ity ex it ing t h rough the sp ray
device orífices, nozzles, or slots. Differential pressure
a nd its r esu lt ing flow are key para mete rs of sp ray
devices, Piow is the recommended control parameter
because it is independent of temperature and location
of the measurement device,
(e) The spray pattern, as it exits the device, is deter·
mined by t he spray device design. Spray patterns are typically streams/jets or fans.
(d) The impact pattern is determined by the interaction
over time of the spray pattern and the geometry of the
equipment
(e) During design, consideration should be given to the
following in the selection of spray device(s):
(1) residue characteristics
{2) equipment geometry and appurtenances
(3) phys ical location and orie ntatio n of spray
device(s)
(4) p rocess requirements includ ing air-purge and
steaming, if applicable
(5) cl eani ng system capacity
(6) installation of screen/s trai ner to protect the
functionality of the spray device
(7) cleaning cycie time
(8) cieaning chemistry compatibility with mate rials
of construction
(9) potential orífice erosion (e.g., from CIP and SJP)
(fl Spray devices are either static or dynamic.
{1) Static spray d evices co nti nuously prod uce a
de fined im pact pattern by s ta t iona ry d irect s pray.
Static spray devices have no moving parts. Exampies of
static spray devices include static spray balls, stationary
nozzies, and spray wands.
(2) Dynamic spray devices are either single axis or
m uitia xis. Both prod uce a defined impact pattern by
mov in g mul tidirec tio nal sp ray(s). Dy namic s pray
device rotation is rinse wate r/cleaning solution driven
or motor driven. Dynamic spray devices have moving
parts, which may include bearings, gears, a nd n u-bines.
(-a) In single-axis dy na mic spray devices (see
Figure SD-3.9.1·1), when the orifices/nozzles/slots are
manufactured at an a ngie, the resuiting force spins the
spray head. Rotation can also be turbine or motor driven.
S0-3.8.6.2.1 lntegrity Testing and Permeability
(a) lntegrity Testing. Tests may be required to ensure
that the fiitration eiements a nd components are integral
and meet specific process requirements. Sterilizing-grade
membranes should be tested to t he speci fic bacteria!
retention protocoi (refer to 2004 cGMP Filtration Guideline a nd ASTM F838). The following are typical integrity
test procedures that may be performed:
(1) pressure decay test
(2) bubble point test
(3) d iffusional flow test
(4) water intrusion test
Other integrity testi ng methods should be agreed on
between t he manufacturer and owne r/user. lntegrity
testing may be performed either pre· or postprocess.
(b) Normalized Water Permeabi/ity. During tangential
flow applications, a normalized water permeability test
(NWP; see Nonmandatory Appendix T, T-2.5) or clean
water flux test may be performed.
S0-3.8.7 lnstallation. lnstallation shall be in accordance with the manufacturer's guidelines.
SD-3.8.8 Conformance Requirements
S0-3.8.8.1 General Requirements. A unique ide ntifie r shall be indelibly marked on the filtration element
or support structure. The unique identifie r shall enable
the owner/ user to identify the supplier a nd the supplier
to identify the raw material a nd processing conditions
used to fabricate the articie. A Certificate of Conformance
shali be issued by the filt ration eiement manufacturer to
certify conformance to this Standard when required by the
owner/user.
S0-3.8.8.2 Certificate of Conformance. The Certificate of Conforma nce shall contain the following information:
(a) manufacn,re r's name
(b) date of manufacture of the element
(e) unique identifier of the element
(d) material of construction of process contact items
(e) compliance to USP <87> (or ISO 10993-5) a nd USP
<88> Ciass VI (or ISO 10993-6, -1 0, and -11)
Other certifications of conformance should be agreed on
by the manufacturer a nd owner/user.
SD-3.9 Spray Devices
(22)
S0-3.9.1 General. This section covers spray devices
in tended fo r use in biop rocessi ng equ ipment t hat
either remains in place or is removed duri ng production.
Recommendations in th is section a re val id for water-
93
ASME BPE-2022
Figure S0-3.9.1-1
Oynamic Spray Device: Single Axis
(e) Effective coverage shall not be affected by flow rate
variations of 10% oras otherwise agreed on by the owner/
user.
W Spray devices shall be accessible for functionality
verification, inspection, and maintenance.
(9) Removable spray device(s) shall be capable ofbeing
re-installed in a repeatable manner by unique identifiers
to ensure proper installation location.
(h) Spray device selection, orientation, and Jocation
shall be designed to ens ure t he eq uipment and the
targeted surfaces of its appurtenances (e.g., manways,
dip-tubes, baffies, nozzles, agitator shaft, and impellers)
are exposed to rinse water/cleaning solution.
(i) Spray device(s) shall be provided with a leve) of
docu mentation that is consistent wíth the equipment
for which it is to be instal led and in accordance with
GR-5 documentation requirements.
ü) Process contact surface finish of a spray device
should be consistent with the equipment for which it
is installed oras otherwise specified by the owner/
user and in accordance with the definitions of Part SF.
(k) Spray de vices shall not use lubricants other than the
process liquid. Dynamicdevices are typically lubricated by
the rinse/cleaning solution(s).
GENERAL NOTE: Spray pattern is for illustration purposes.
S0-3.9.2.l Static Spray Oevice Requirements
(a) Static spray devices shall have a positioning device
(preferred) or mark to allow for proper orientation during
re-installation, as static devices are orientation sensitive
(see Figure SD-3.9.2.1-1).
(b) Weld-on or self-cleaning sli p-joint/clip-on connections are acceptable. Provision shall be made to ensure
proper o rientation and location if one or more slipjoint/clip-on-style static spray devices are used.
(e) A portion ofthe flow is directed toward the specific
appurtenances.
(d) The flow rate gu ideline fo r vert ical cyli ndrica l
vessels with d ished heads is 2.5 gal/min/ft to 3 gal/
min/ft (31 L/m in/m to 37 L/m in/m) of inner vessel
circumference. Reference Fig ure SD -3.9.2.1 -2. The
majority of the flow is directed toward the upper head
to ensure coverage of appurtenances and provide the
sheeting action.
(e) The tlow rate guideline for horizontal cylindrical
vessels wit h d ished heads is 2 gal/m in/ft to 3 gal/
min/ft (25 L/min/m to 37 L/min/m} of perimeter (2l
+ 2d). Reference Figure SD-3.9.2.1 -3. The majority of
the flow is directed toward the upper one-third of the
vessel to ensure coverage of appurtenances a nd
provide the sheeting action.
W Flow requi rements for the specific application
should be confirmed with the spray device manufacturer,
equipment manufacturer, or other subject matter experts.
{·b} Multiaxis dynami c spray devices rotate in
more than a single plane (see Figure SD-3.9.1·2). When
r in se water/cleaning sol ution driven, the flow
through the spray device turns a turbine wheel, which
typically turns the body around one axis as well as the
nozzle(s) around a second ax is, creating a repeatable
indexed pattern. When motor d riven, the body and
nozzles are turned mechanically by the motor.
(9) Sp ray devices can be designed as removable,
retractable, or to remain in place.
{h) Spray device(s) are specific to the application and
equipment. Spray devices are generally not interchangeable without considering the specific tlow, pressure,
equipme nt design, sp ray pattern, and drainability of
the spray device(s).
(22)
SD-3.9.2 Spray Device Requirements
(a) Materia ls of construction s hall confo rm to
SD-2.4.1.2 orasotherwise agreed on with theowner/user.
(b) When installed, spray devices shall be drainable
a nd cleanable ins ide and outside or as otherw ise
agreed on with the owner/user.
(e) Spray device(s) shal l be installed per manufacturer's instructions.
(d) When operated within speci fication, the spray
device(s) shall produce repeatable effective coverage
over a defined area of the equipment.
94
(22)
ASM E BPE-2022
(22)
SD-3.9.2.2 Single-Axis Dynamlc Spray Device
Requirements
(e) Flow requ irements for the specific applica tion
should be confirmed with the spray device manufacturer,
equipment manufacn,rer, or other subject matter experts.
(f) High-velocity gas flow from air-blows or steam
passing through liquid -driven spray devices can result
in wear to bearing surfaces. Consideration sho uld be
take n to res tr ict gas flow t hrough t he spray device
according to the manufacturer's recommendation.
(a) The installation or the design should allow for rotation verification or frequency verification or both.
(b) Weld-on or self-cleaning slip-joint/clip-on connections are accepta ble. Other hygienic alternatives shall be
agreed on with the owner/ user.
(e) The flow rate guideline for vertical cylindrical
vessels with dished heads is 1.9 gal/min/ft to 2.3 gal/
mi n/ft (23.6 L/mi n/m to 28.6 L/min/m) of inner
vessel circumference. The majority ofthe flow is directed
toward the upper head to ensure coverage of appurte·
nances and provide the sheeting action.
{d} The flow rate guideli ne for horizontal cylindrical
vesseis with dished heads is 1.4 gal/min/ft to 2.1 gal/
min/ft (17.4 L/min/ m to 26.1 L/mi n/ m) of perimeter
(Zl + 2d). The majority oí the flow is d irected toward
the upper one-third oí the vessel to ensure coverage of
appurtenances and provide the sheeting action.
Figure SD-3.9.1-2
Two-Axis Dynamic Spray Device
GENERAL NOTE: Nurnber of jets is for illustration purposes.
95
ASM.E BPE-2022
Figure SD-3.9.2.1-1
Static Spray Device
Locating pin
Alig nment bracket
Vessel l ref.l
Spray holes for noule annulus
Orain hale at lowest point
Figure SD-3.9.2.1-2
Flow Rate GuideUne for Vertical Cyl.indrical Vessels
■ Multiple-axis dynamic jel devices
300
1300
800
O Single-axis dynamic spray devices
Oi.ameter, mm
1800
2300
oStatic spray devices
2800
100
360
90
330
80
300
70
270
"'•"' 60
240
e
·e
:i• 50
J
•
¡¡:
e
~
210 ,;
40
a:
150
¡¡:
120
30
90
20
60
10
30
o
2
3
4
Diameter, tt
96
•
180
~
ASM E BPE-2022
Figure SD-3.9.2.1-3
Aow Rate Guideline for Horizontal Cylindrical Vessels
■ Multiple•axis dynamic jet devices
O Single-ax is dynamic spray devices
OStatic spray devices
Perimete, (2d + 2L), mm
4500
6000
7500
9 000
10500
12000
13500
1S000
16500
18000
200
¡------1r----;---.....,.---""'T---..,..---......- - ~.....- - ~.......--~-,. 750
100
t------ir----i----+----+----+---+ - - - + - - - + - -=-1 100
650
800
e
140
550
t----t----f------l----+----+----+~ -
E
• 500
""~ 120 t----t----t------l------l----::_.J--t
tic 'ºº t----t----t------l--::::---
450
· 400
1 so 1----1----~h-
e
E
:J
i&
350
a:
3
300
l
250
200
40
150
=---+----+----+----! 100
20
50
20
( 22)
25
30
40
35
Perimeter (2d + 2L), ft
45
50
55
SD-3.9.2.3 Multiaxis Dynamic Spray Device
Requirements
take n to restrict gas flow through the spray device
according to the manufacturer's recomme ndation.
(a) The installation or the design should allow for rotation verification or frequency verification or both.
(b) The time to complete a full im pact pattern (see
Figu re SD-3.9.2.3 -1) ata specified press ure or flow
rate shall be provided by the manufacturer.
(e) Weld-on or self-cleaning slip-j oint/clip-on connections are accepta ble. Other hygienic alternatives shall be
agreed on with the owner/ user.
{d) The fl ow rate guideline for vertica l cylind rical
vessels with dished heads is 1.3 gal/min/ft to 1.5 gal/
min/ft (16.1 L/m in/m to 18.6 L/mi n/m) of inner
vessel ci rcu mfe rence to ensure coverage o f a ppurtenances a nd provide the sheeting action.
(e) The flow rate guideline for horizontal cylindrical
vessels with dished heads is 0.8 gal/min/ft to 1.2 gal/
mi n/ft (9.9 L/min/m to 14.9 L/m in/ m} of perimeter
(2l + 2d} t o e nsure coverage of a ppurtena nces a nd
provide the sheeting action.
(J) Flow requ irements for the specific application
should be confirmed with the spray device ma nufacturer,
equipment manufacturer, or other subject matter experts.
(9) High-velocity gas flow from air-blows or steam
passing through liquid-driven spray devices can result
in wear t o beari ng surfaces. Co nsideration should be
SD-3.10 Disposables That Require Presterilization
or Poststerilization
[Reserved for future content)
SD-3.11 Sampling Systems
SD-3.11.1 General
(a) Sa mpling equ ipment in the biop harmaceu tical
industry is used for the collection of samples that then
undergo chemical or microbiological evaluation. Sampling
may be either aseptic or nonaseptic.
(b) Sampling syste ms shall not adulterate the process
fluid being sampled nor affect the sample cha racterístics
being tested.
(e) Asep tic sampling systems shall be steamable or
presterilized single-use.
(d) Hygíenicsampling syste ms shall either be cleana ble
or single-use.
(e) Aseptic samplíng systems shall be closed to isolate
the process; protect the sample, sample container, and
sam ple t ransfer process from the env íron men t; and
obtain representative samples.
97
ASME BPE-2022
Figure SD-3.9.2.3-1
lmpact Pattern Buildup
Half
SD-3.11.2 Aseptic Sampling Systems
Full
stream of the trap is used in the process or sampled for
quality assurance.
(b) Where used in process systems, the traps shall be
capable of effectively venting air.
(e) Whe re installed on process systems, traps shall be
maintainable to allow easy examination a nd clea ning.
We lded traps are acceptab le if agreed to by the
owner/user.
( d) The tra p design and mode ofoperation shall be such
that the risk of soil attachment to the wetted surfaces is
mini mized, especially around the bellows and seat (see
Figure SD-3.12-1).
(e) The trap shall be sized and installed to opera te such
that there is no backup of condensate into the process
equipment a nd clean steam system under operating conditions. Operating conditions include heat-up, hold, a nd
cooldown.
(f) The trap shall be designed such that the normal
mode of mechanical failure is in the open position.
(g) Therrnostatic stearn traps, installed in vertical trap
legs, are preferred for use in clean steam systems (see
Figure SD-3.12-1).
(h) Trap operation/reactivity should be improved by
the installat io n o f an u ninsulated section of t ubing
upstream ofthe trap [suggested 12 in. (30 cm) as recommended by supplie r] (see Figure 50-4.2.2-2).
SD-3.11.2.1 Basic Requirements
(a) Steamable sample systems shall meet the relevant
requirements of SD-2.3.1.1.
(b) Sampling systems intended for multiple-use shall
be cleanable.
(e) Sa mple valves shall meet t he requireme nt of
MC-3.3.2.3.
(d) In septum sample devices, the needles shall be ster·
ilized prior to insertion into the vessel or process line.
(e) Collecting devices shall be designed, connected,and
disconnected in ways that maintain the in tegrity of the
sample.
SD-3.11.2.2 lnstallation. The sampling device shall
be installed to maintai n the aseptic barrier between
the process fluid being sampled a nd the environment.
Consideration should be given to ease of assembly and
subsequent handling of the sample.
SD-3.11.2.3 Sample CoUecting
(a) When using single-use collecting devices, considera tion shall be given to maxi mum pressure ratings of
valves, adaptors, and bags.
(b) Consideration should be given to the impact of
absorption a nd off-gassing that could lead to nonrepresentative samples. Polymeric material requirementS for
leachables and extractables are listed in Part PM.
S0-3.13 Check Valves
(a) Check valves tha t a re used in product contact applications shall be ofhygienic design. They shall be designed
for CIP. Crevices and holdup volumes should be minimized.
(b) Check valves in process contact a pplications should
be installed in a manner that e nables draining. Nondrainable valves may be used for liq uid strea ms that flow
continuously (e.g., a compendia! water loop) or whe re
valves are wetted with a sanitizing medium when not
SD-3.11.3 Nonaseptic Sampling. [Reserved for future
content]
S0-3.12 Steam Traps
( a) Steam traps are not conside red hygienic. Steam trap
bodies shall have a n interna! surface finish (excluding the
bellows assembly) as agreed to by all parties. Surface
finish specification shall match the clean steam condensate tube finish specification unless the condensate down98
(22)
ASME BPE-202 2
Figure SD-3.12-1
Steam Traps for Clean Steam Systems
Radius interna! corners
(where practica!}
Sealed bellows
Sloped for drainability
(b l Weld &d Trap
(a) Serviceable Trap
(e) Relief devices, including discha rge piping, shall be
installed in conformance to a pplicable codes (e.g., fla mmable liq uid s a nd co mbustibles in acco rda nce with
NFPA 30).
(f) Pressu re relief va lves t hat a re used in product
con tact app licatio ns shall meet the require men ts of
MC-3.3.2.3(a) on both sides of the valve seat. Crevices
and holdup volumes should be minimized.
(9) Safety p ress ure relief valves that are used in
product contact a pplications shall meet the requirements
of MC-3.3.2.3(a) up to the valve seat.
(h) Pressure a nd safety pressure relief valves shall be
installed in a ma nner that permits draining on both the
process and discharge sides of the valve seat.
(i) Pressure relief valves that a re used in produce
contact a pplicatio ns shall be CIP capable. lf required
for CIP o r SI P, a n override that allows flow thro ugh
the valve shall be included.
(j) Pressure relief valves that a re used in product
contact applications shall conform to MC-3.3.2.3.
in use (e.g., chromatography system that is fi lled with
sodium hydroxide solution between uses).
(e) The flow d irection a nd requ ired orienta tion for
dra inabili ty shoul d be clea rly ide ntified on the device.
Where the val ve is integral to equipment (e.g., diaphragm
pumps, homogenizers), indication ofthe flow direction is
not requ ired.
(d) The use of check valves with springs in produce
contact should be a voided. The owner/user should dete rmine whether check valves that use a spring are acceptable for other process contact applications. Applications
where spring check valves are typically acceptable include
condensate re moval lines a nd dry process gases.
(e) Check valve design shall conform to MC-3.3.2.3.
SD-3.14 Oriflce Plates
Orífice pla tes, when req uired and used in hygien ic
piping systems, shall be installed in a drainable position.
( 22)
SD-3.15 Relief Devices
(a) Rupture disks (or othe r hygienic pressure relief
devices approved by the owner/ user) shall be installed
in a hygienic manner without compromising the safety
or efficiency of the system.
(b) The cleaning system design shall e nsure that the
rupture disk (or other hygien ic pressure reli ef devices
app roved by the owne r/ user) will not be da maged by
the clea ning process (e.g., mechan ical forces, chem ical
compatibili ty).
(e) Ruptu re d isk (or other hygie nic pressure relief
devices approved by the owner/ user) installatio n shall
conforrn to the l/d ratios mentioned in SD -3.1.2.2.
(d) Ru pture disks shall be installed in the manufacturer's recommended holder to e nsure proper functionality and cleanability.
SD-3.16 Liquid Pressure Regulators
(a) Regulato rs should be ins talled to be dra ina ble
through the outle t or inlet ports.
(b) There shall be no voids or crevices within the area
wetted by the fluid. Regulator designs, where a portian of
the valve stem penetrates the sensing diaphragm, shall be
avoided unless provisions are made to avoid entrapment
of foreign matter and any leakage through the interface
between stem and diaphragm. especially after SI P.
(e) Due to the inhere nt design characteristics of selfcontained regulators, manual meaos of override may
be requíred to allow for cleaníng a nd draining.
99
(22)
ASME BPE-2022
Fi gure SD-3.17.1- 1
Example Strainer Types
(22)
Hygienic clamped connection for strainer element removal.
lnstallation of strainer should consider this pull-out length.
Strainer body
Strainer element
lperforated type)
>
Slope of installation
Flow indicator marking
l external to process)
(a) Straight-Line Strainer
Hygienic gasket
Strainer element
(perforat ed type)
(bl Gasket Strainer
GENERAL NOTE: Gasket $Lráiners do n<)t have a stand-alone strainer body. When installed, the gasket SLrainer is int.egr.d to the hygíenic piping,
whkh act.s as the straíner body.
(e) Surface finish achievement or measurement may
not be possible for ali a reas of straining surfaces (e.g ..
strainer element holes, openings, or mesh) .
(d} For strainers in-line withi n process piping, t he
ma nufacturer should state the operating flow coefficient,
Cv, when free of solid particulate loading and maximum
allowable pressure drop.
(e) Strainer body design features (e.g., sight glasses)
shall not create a dead leg.
(22¡ SD-3.17 Strainers
SD-3.17.1 General. Strainers as described in th is
section are intended for process component a nd equipment protection (see Figure 50-3.17.1-1) a nd are not
designed for bioburden control. Strainers are permitted
in locations where they reduce the risk ofcontamination of
a process (e.g,. CI P return line).
SD-3.17.2 Design and Manufacture
SD-3.17.3 Selection, lnstallation, and Operation
(a) Strainers intended for single-direction flow shall
have the flow direction indicated on the strainer body.
(b) The straine r body should have the same surface
finish as specified for the process piping or equipme nt
in which it is being installed.
(a) Perfo rated stra iner elements t ha t are free of
cre vices are preferred for use in perma nent hygienic
installa tions. Where perforated strainers ca nnot be
100
ASME BPE-2022
50-3.18.3.1.3 Hyg ienic Connections. Hygieni c
connections shall conform to other Parts of this Standard.
used, the use of other types of strainers (e.g., wire mesh,
wedgewire) is permitted ifthe risk of contamination to the
process is mitigated.
(b) When specifying strainer e lements, the owner/user
s hould provide strainer element hole/mesh size and
allowable pressure drop ata given flow across the strainer
element and body w hen free of solid particula te loading.
(e) Straine rs shall have field tagging (e.g., ID tag,
engraving} to e ns ure externa! visual identification postinstallation.
(d) The installed strainer s hall allow for removal of the
element for inspection or cleaning.
( e) Strainers s hall be drainable when free of so lid parti·
culate loading a nd installed in the recommended orientation.
{fJ The design or installation of the strainer within the
system s hould enable detection and removaJ of captured
so lid particulates (e.g., visual inspection or press ure
differential monitoring}.
( 22)
50-3.18.3.2 5anitization
50-3.18.3.2.l Chemlcal 5anitization. All product
contact surfaces within the syste m s hall be compatible
with the sanitization agents selected.
50-3.18.3.2.2 Thermal 5anitization . When
therma l sa n itizatio n is used, ali co lumn product
con ta et surfaces shall be designed to accommodate expan sion and cont raction during exposure and cooldown
s tages.
50-3.18.4 Column Materials. Colum n materials for ali
p roduct cont.act surface wetted parts shall conform to
application sections of Parts SD, PM, and SF.
50-3.18.5 Column Performance. The owner/user
s hall be responsible for informing the manufacturer of
the conditions under w hich the column may be expected
to operate. This shaJI include the methods, freque ncy, and
duration of cleaning and sanitization procedures. In addition to the service temperature and pressure, any parameters that may affect the column performance shall be
provided.
SD-3.18 Chromatography Columns
50-3.18.1 General. This section defines typical design
elements related to large-scale chromatography columns
and includes columns that are intended for repeated use in
processing. Although chromatography processes are not
typically aseptic, design features for cleaning and/or sanitization s hould be considered. More information on chromatography columns can b e found in Nonmandato ry
Appendix T.
50-3.18.5.1 5ervice Temperature and Pressure.
Columns shall be capable of withstanding thermal and
p ressure cycling between the rated upper and lower
temperature and pressure limits.
50-3.18.5.2 Routlne Maintenance. To e ns ure
continued column performance, che accessibility of ali
column components for routine ma intenance s hall be
considered.
50-3.18.2 Pressure-Retalnlng Parts. The column tube
is both a product contact surface anda pressure-re taining
component. Chromatography columns are vessels operating under pressure and should meet the requirements
of ASME PBVC, Section VIII, as referred to in GR-1, as applicable. If the column tube is acrylic, it shall comply with
ASME PVHO-1, Case 14, Low UV. The owner/user is
respo nsible for informing t he manufacturer o f the
norm al and abnormal operating conditions to w hich
th e column may be exposed. The manufacturer is responsible for ensuring the column will operate safely under
said conditions.
50-3.18.6 Conformance Requirements
50-3.18.6.1 General Requirements. A unique identifíer shall be indelib ly marked on t he column or the
column's support s tructure. The unique identifier shall
enable the owner/ user to ide ntify the supplier a nd the
s upplier to identífy the raw material and processing conditions used to fabricate the a rticle.
50-3.18.6.2 Certificate of Conformance. A Certificate ofConformance shall be issued by the colu mn manufacturer to certify conformance to this Standard when
required by the owner/user.
The Certificate of Conformance s hall conta in t he
following information:
(a) manufacturer's name
(b) unique identifier of the column
(e) mate rial of process contact items
(d) compliance to USP <87> Class VI (or ISO 10993-5}
and USP <88> (or ISO 10993-6, -1 0, and -11}
Also see Table PM-2.2.1-1.
50-3.18.3 0esign for Cleaning and 5anitization
50-3.18.3.l Cleaning. Columns should be designed
in accordance with SD-2.4.2 with the exception of the
bed supports and flow dis tributor. Cleaning of chromatography columns is achieved by control of contact time and
concentration of the appropriate cleaning agents.
50-3.18.3.1.1 5eals. Ali sea ls s hall conform to
Part MC.
50-3.18.3.1.2 Exterior 5urfaces. Exterior s urfaces
of columns shall be nonabsorbent and compatible with
cleaning agents. Columns s hall be designed to allow effec·
tive removal of cleaning agents from s urfaces.
101
ASME BPE-2022
(ZZ)
SD-4 PROCESS UTILITY SYSTEMS
( e) Sample valves s hould be installed only as needed on
the main loop.
(f) Sample valves should be installed where water is
u sed for the process to demonstrate water qua lity complia nce to compendia! monographs.
(g) Any valve used to provide clean utility services to
the POU assembly (e.g.. steam or clean gas) should b e
fabricated in such a manner as to achieve an l/d of 2
or less downstream from the primary POU valve (see
Figure SD-4.1.2.1-1, illustrations (a} and (c)J.
(h) The length of tubing from POU valves to process
eq ui pment s hou ld be mi n i miz e d (see
Figure SD-4.1.2.1-1, illustrations (a} and (b)].
(i) lf evacua ting the system is not possible, appropriate
porting of the primary POU valve s hould be accomplished
to facilitate sanitization.
{j) When heat excha ngers are used as POU coolers [see
Figure SD-4.1.2.1· 1, ill ustration (c)], the design sha ll
conform to SD-3.6.
(k) Physical breaks shall be employed between hoses,
drain valves, or any other component leading to drains or
sinks to avoid back·siphoning into the POU assembly [see
Figure SD-4.1.2.1· 1. illustrations (d) and (e)). The distance
H of the physical break s hould be at least twice th e inner
diameter of th e hoses, drain valves, or any other compo·
nent leading to draíns or sinks to avoid back-siphoning
into the POU assembly. The break sha ll be at least 1
in. (25 mm} for hoses. dra ín valves, or other components
with interna! diameters less than or equal to 1/ 2 in. (13 mm}
(see Figure SD-4.1.2.2-1 ).
(/) Tubing an d other p ipi ng materia ls should be a
mínimum of¾ in. (19 mm} in diameter to e nable draining
of water after use.
(m) POU assemblies shall be drainable as indicated in
SD -2.4.3.
(n) A POU may include a venturi or orífice plate, if the
restriction of water ílow is required. Where used, the additions of these components will require a blowdown to
enable drainability.
( oJ When compendia! wate r systems are constructed of
metallic materials, the surface finish s hould be less than or
equal to 25 µin. R. or 0.6 ¡1111 (see Part SF} a nd may be
internally electropolished. Ali 316L-type inte rna! s urfaces
shall be passivated.
(pJ When compendia! water syste ms are constructed of
polymer materia Is, the s urface finish s hould be less than or
equal to 25 µin. R0 or 0.6 µm.
SD-4.1 Compendia! Water Systems
(a) Compendia! wa ter systems, s uch as USP Grade
Water-for -lnjection (WFI}, USP Grade Pu rified Water
(PW),and Highly Purified Wate r (HPW), s hall be designed
as looped circulatory systems, rather than noncirculating.
dead-ended, branched systems.
(bJ Loops s hall be designed to provide fully developed
turbulent flow in the circulating sections a nd to prevent
stagnation up to the weir of each point-of-use valve.
(ZZ)
SD-4.1.l Compendial Water Generation
(a) Ali surfaces that shall come into direct contact with
the compendia! water, feed water, or condensate/blowdown produced bythe units shall be constructed of316- or
316L-type stainless steel or other mate rial as specified by
the owner/ u ser.
(b) Connections to the compendia! water, feed wate r,
or condensate/blowdown compendia! water by the units
sha ll be made by the use of hygienic design fittings. Ali
fittings s hould be constructed in s uch a ma nner as to
avoid dead legs and crevices.
(e) Units should be drainable and should not contain
a reas where agents u sed to clean, descale, or passivate the
units are tra pped or not easily flushed d uring rinsing
opera tions.
SD-4.l.2 Compendial Water Distribution Systems
(ZZ)
SD-4.1.2.l Point-of-Use Piping Deslgn for Compendial WaterSystems. Point-of-use (POU) can be definedas a
location in a compend ia! water loop where water is
accessed for processing or samp ling. Typically, the
point•of-use assemblies are composed of the following
e lements:
{a) piping associated with a compendia] water loop at
the physical POU
{b) POU valves, equipment, and instruments
Additional process components a nd equipment may be
added to satisfy any application or system requirements
a nd will be d iscussed furth er in this Part (see Figu re
SD-4.1 .2.1·1}.
(22)
SD-4.1.2.2 Critical Design Criteria for Point-of-Use
Assemblies
(a) Ali point-of-use assemblies s hould be designed to
enable draining through the POU valve.
{b) Assemblies shall be designed for sanitization (e.g.,
hot flush, SIP).
(e) Valves used in POU applications should be welded
into the water distribution loop where possible. Current
industry designs a re available to achieve an l/d of2 or less
(see SD-3.1.2.2).
(d) Sample val ves should be integral to the design ofthe
primary valve and should not constitute dead legs.
SD-4.2 Clean/Pure Steam Systems
This section is applicable to both clean and pure steam
systems.
SD-4.2.l Clean/Pure Steam Generation
(a) Ali s urfaces that come into direct contatt with the
clean/pure steam, feed water, or condensate/blowdown
produced by t he units sha ll be constructed of 316· or
102
(2Z)
ASM E BPE-2022
Figure 50-4.1.2.1-1
Point-of-Use Piping
Compendia! water
Compendi a! water
distribution loop
distri bution loop
Min.
~---
~=-, Clean gas or
[
clean steam
Min.
Process
Equipment
Min.
1
(b) Direct Connect to Equipment
Drain/steam trap/
(
)
y sample point
Process
Equipment
(a) Hard Piped t o Equipment
Compendia! water
distribution loop
Compendia! wate
distribution loop
Physical break
-7-F
1
Clean gas or ,I---Vo''l----1
clean steam
Iv
1-Min.-
M in.
------r
Sink
Orain
1
(d) Sink
e,,,.
Heat exchanger
(double tubesheet)
Compendia! water
distribution loop
Orain/steam trap/
sample point
Process
Hose
Equipment
assembly
(e) Integral Heat Exchanger
Physical break
T
Sink ¡ floor
-----. r=:=-'='Orain
(el Hose
103
ASME BPE-2022
Figure SD-4.1.2.2-1
Physical Break in Point-of-Use Piping
(f) Trap legs should be installed at least every 100 ft
(approximately 30 m), upstream of control a nd isolation
valves, at the bottom of vertical risers, and a t any other low
points.
(g) Condensate systems shall be designed to drain to
a nd from steam traps. The use ofoverhead, direct-coupled,
pressurized condensate return systems should be avoided
(see Figure SD-4.2.2-2).
(h) Where possible, ali components within the distribution system should be drainable.
(i) Dead legs should be avoided by design of runs a nd
the use o f steam t raps to remove co ndensate (see
Figures SD-4.2.2-1 and SD-4.2.2-2).
(j) Branches a nd points-of-use should be routed from
the top ofthe steam header to avoid excessive condensate
loads at the branch (see Figure SD-4.2.2 -2).
(k) Sampling points for clean/pure steam should be
locat ed to collect representative sa mp le(s) o f the
system (e.g., generator outlet, distribution header ends,
critica] points-of-use, a utoclaves, or SIP stations).
H
t
GENERAL NOTE: H = 2d or H = 1 in. (25 mm) if d < 1!, in. (13 mm).
SD-4.2.3 Clean/ Pure Steam Valves. This paragraph (22)
covers isolation, regulation, and control valves that a re
part of the steam system a nd are subject to continuous
steam service.
(a) Valves for steam service shall be drainable.
(b) Ball valves are an acceptable indust1y standard for
isolation purposes on continuous steam service. Threepiece-b ody ball valves s ho uld be use d instead of
single-body designs for both cleanability a nd maintaina bility. The bore of the ball valve assembly shall match
the inside diameter ofthe tube (see Figure MC-2.3.1.3·1).
(cJ Al i component.s shall be suita ble for conti nuous
steam serviceat the temperatures and pressures specified
by the owner / user.
(d) Requ irements for operation under CIP and SI P con·
ditions [see MC-3.3.2.3(a)(10) and MC-3.3.2.3(a)(12)) can
be relaxed when agreed to by the owner/user.
(e) Secondaiy stem seals with telltale connections are
not required for steam service.
(f) Valves shall be accessible for maintenance.
316L-type stainless steel or other material as specified by
the owner/ user.
(b) Connections to the clean/pure steam, feed water, or
condensat e/blowdown produced by the units sha ll be
made by the use of hygienic design fittings. Ali fittings
should be co nstntcted to be free of dead legs and crevices.
(e) Units should be drainable and should not contain
a reas where agents used to clean, de·scale, or passivate
the units a re trapped or not easily ílushed during rinsing
operations.
(22)
SD-4.2.2 Clean/ Pure Steam Distribution System
(a) The distribution system shall have adequate provision to remove air during start·up and normal operations.
The use of air vents installed at locations where air is likely
to be trapped, such as at the e nds of steam headers, can
assist in this requirement.
(b) The horizontal distribution lines should be sloped
in the direction of ílow as indicated in SD-2.4.3. Whe re
necessary, increases in height should be achieved by
vertical risers (see Figure SD-4.2.2-1).
(e) Adequate provision should be made toallow for li ne
expansion and to prevent sagging of the distribution li nes.
so that li nes are drainable.
{d} Distribut ion systems s ha ll not be directly
connected to any nonhygienic steam systems (e.g ..
plant steam systems).
(e) Trap legs for the collection of condensate from the
steam distribution syste m should be of equal size to the
distribution line for sizes up to 4 in. (100 mm), and one or
two line sizes smaller for lines of 6 in. (150 mm) or larger.
These shall be trapped at the bottom. The line size reduction can be made after the branch to the trap leg (see
Figure SD-4.2.2-2).
SD-4.3 Process Gases
SD-4.3.1 Process Gas Distribution Systems. For this (22)
section. a process gas distribution system is one that
extends from the bulk supply source (including cylinders)
to the points of use as defined by the owner/user.
(a) The installation ofprocess gas delivery and distri·
bution systems for use within the scope of this Standard
requires appropriate selectio n of piping materials. Ali
components shall be supplied or rendered both hydro·
carbon free (e.g., oil free) and particulate free prior to
installation and use.
(b) For materials of construction, the owner/ user shall
specify ali materials. When copper is used, it should be
ha rd drawn and installed in acco rd ance w it h t he
104
ASME BPE-2022
Figure SD-4.2.2-1
Typical Clean Steam System lsometric
Point -of -use
Slope in direction
of steam ftow
(typ.)
Thermal
expansion
Min. (typ.)
loop
Clean steam
generator
Sam ple
cooler
Provide steam traps
(a) whtrc lint translttons fro m horizontal to vertical (at U, 4_) bottom of thc vertical riscr)
(b) at least every 100 rt (30 m)
(e) at end of each header or branch
(d) at thermal expansion loops or transitions
(e) where stearn is sampled
105
ASME BPE-202 2
Figure 50- 4.2.2-2
Clean 5team Point-of-Use 0esign
-=
Clean steam
header
Trapped condensate
(with valve closed)
Accepted
Clean steam
user
Clean steam
specification
¡
1
12 in. (30 cm)
uninsulated
section
L
Accepted
Not Accepted
specification
Steam trap
Clean steam
Airgap
condensate header
at drain
a:
1
Clean steam
condensa te
-;,,
curre nt edition of NFPA 99, Chapter S. When copper is
specified in a clean room or area, the owner/user shall
confirm that ali planned cleaning and sanitizing agents
a re compatible with copper and ali materia Is of construction. Whenstainless steel tubing is specified, the materials
o f choice are 304 L-type or 316L-type alloys. Orb ital
we lding is the recommended joini ng method. lnside
clean rooms. the mate rials of choice are 304L-type or
316L·type stainless stee l t ubing a nd fi tti ngs. The
owner/ user and ma nufacturer s hall agree on a li
joining methods, levels of inspection, and accepta nce
criteria for ali joints prior to installation.
(e) Compression fittings may be used for valves, regulators, mass tlow controllers, and other instrumentation
systems at the source a nd within system boundaries.
(d) Gas systems are not designed or configured with the
intent or provisions to be cleaned, passivated, or chemically treated after installation. Features such as slope,
high-point vents, a nd Iow-point drains need not be incorporated into these systems.
(e) There shall be no nonvolatile residue. The system
design shall ensure that gas will rema in pure throughout
its delivery.
W lt is important to select a ppropriate prefilte rs a nd
final system filters. The final point-of-use gas purity shall
conform to the process requirements.
(g) Gas systems testing and sampling shall conform to
21 CFR 211 and ICH Q7 (lnternational Conference on
Harmonization, Good Manufacturing Practice Guidance
for Active Pharmaceutical lngredients).
SD-4.4 Process Waste Systems
This section addresses process waste syste ms because
the reliable function of the waste system can reduce the
riskof conta mination to the process. By designing systems
that can be cleaned a nd rendered safe for access a nd
preventive maintenance., relia ble operation may be
achieved.
50-4.4.1 General. The manufactu ring of biologics
generates liquid waste in various quantities that may
or may not contain viable microorganisms. The liqu id
waste comes d irectly from the process tluids and may
include cleaning solutions mixed with product components, buffers, or media.
The performance of process waste treatment systems
may benefit from the sanitary d esign requirements of
Part SO . The desig n of the p rocess waste transfe r
line(s) shall prevent p rncess was te backflow to the
process system(s), reducing the risk of contamination.
The effectiveness a nd safety of process waste treatment
systems have been shown to benefit from incorporating
the design p rincipies o f Part SO. This is true of bio-
106
ASME BPE-2022
inactivation systems where heat or chemical dosing is
used, or where biosafety containment is requir•ed.
SD-5.1.4.3 lnlet Fllter Assembly
(22)
(a) l'or this section, an inlet filter shall be defined as a
filter element installed in a housing of suitable material.
The inlet filter assembly shall be defined as the filter(s)
local to the bioreactor.
(b) lnlet filter assemblies shall be designed for SIP with
provisions to remove entrapped air and condensate.
(e) lf multiple inlet filters are used in series, then the
filler assembly closest to the bioreactor shall be a sterilizing filter.
(d) Provisions shall be made for integrity testing of the
inlet filler assembly in situ or out of place.
(e) lf one or more inlet ho usings are included in a
cleaning circuit, the filler element or elements shall be
removed prior to introduction of cleaning solutions.
(!) Gas filters should be installed a bove the bioreactor
liquid level.
SD-4.4.2 Bio-lnactivation Systems. Depending on the
type of waste, the treatment method is chosen based on
effectiveness, efficiency, and jurisdictional requirements.
The owner/user shall define the inactivation conditions
and verify the effectiveness of the system with respect to
these requirements. Bio-inactivation may be designed to
be continuous or batch type and is achieved using one or
more of the following methods:
(a) thermal
(b) chemical
(e) radiation
The system design should min imize fouling and buildup
of solids and fílms. Bio-inactivation systems should be
cleanable to allow safe d isassembly and maintenance.
Where biosafety co ntai nment is a req uire ment, t he
system shall be sanitizable.
In bio-inactivation systems, piping design features
spec ifi ed in SD -2 a nd SD-3 may he lp in achieving
proper an d repeatable ope ra t io n of these process
waste systems.
5D-5.1.4.4 Gas Sparging Assemblies
(22)
(a) Spargers shall be defi ned as mechanical devices
no rm ally located below an impeller used to dispe rse
gases within a charged bioreactor. This section applies
to sparge lances, wands, rings, and other devices (see
Figures SD-5.1.4.4-1 th rough SD -5.1.4.4-4) that may be
mounted in the bioreactor vessel to introduce various
gas streams for process operario ns. Sparge device assemblies shall meet the requirements of SD-3.4.2.
(b) Spargers shall be designed for SIP with the vessel.
(e) Spargers should be designed for CIP. lf the sparge
element cannot be CIP'd, provisions shall be made to
remove the sparge assembly from the bioreactor for replacement or cleaning out of place.
(d) The remova ble sparger shall be supplied with the
means to ensure that the installation orien tation is in
conformance to design intent.
(e) lf a check valve is installed in the sparge line within
the sterile envelope, it shall be designed for CIP and SIP.
SD-5 PROCESS SYSTEMS
SD-5.1 Bioreactors and Fermentors
SD-5.1.l General. For this section, the terms "fermentors" and "bioreactors" are interchangeable. A bioreactor
or fermentor shall be defined as a vessel-based system
used in the growth of microorganisms or plant, mammalian, or insect cells.
SD-5.1.4 System Design
SD-5.1.4. l lnlet Gas Assembly. The inle t gas
assembly shall be defined as a pipi ng assembly that
has the ability to deliver controlled amounts of filtered
gases into a bio reactor vessel. The assembly shall
include but is not limited to the items in SD -5.1.4.2
through SD-5.1.4.5.
SD-5.1.4.5 lnlet Gas Piping
(a) Overlay piping is defined as piping that directs
filtered gases to the vessel headspace.
(b) lnlet gas assembly piping (sparge and overlay)
within the sterile envelope shall meet the requirements
as defined in SD -3.1.2.
5D-5.1.. 4.2 Flow Control Devlces
(a) Flow control devices (e.g., rotameters, mass tlow
controllers, and modu lating control va lves) shall be
installed ou tside of the sterile boundary; t herefore,
piping req uirements within this section may not apply.
However, provis ions sha ll be included within the
design to prevent instrumentation damage due to SIP
procedures and backflow.
(b) Flow control devices should be sized to preven! a
vacuum cond ition, or a provision to bypas s the flow
control device shall be provided to maintain positive pressure in the vessel.
5D-5.1.4.6 Exhaust Gas Assembly. The exhaust gas
assembly is defined as a piping assembly that maintains
the integrity of the sterile boundary with respect to sterility and pressure. The assembly shall include but is not
limited to the items in SD-5.1.4.7 through SD-5.1.4.9.
SD-5.1.4.7 Exhaust Filter
(a) Fo r t his section. an exha ust filler sha ll be
defined as a fil ter element (as described in Nonmandatory
Appendix T) installed in a housing of suitable material.
107
(22)
ASME BPE-2022
Figure SD- 5.1.4.4-1
Gas Sparging Assembly - Lance
1
'
1
'
¡-·
(lt o➔ o ·ooo
1=::
'
¡¡
1
ií
'
ií
1
J¿_
Plan
71:
l.'i
l.'i
:¡
l.
l.·1
l.·1
Elevation
108
1
ASM E BPE-2022
Figure SD-5.1.4.4-2
Gas Sparging Assembly - Sintered
/
r
Sintered element
removed for CIP
/
1
- - - - - - - - - - ------ - - - - - -
'
i!
1
ii
íi
Ji
Plan
CIP spray hole
(for mounting ferrule CIP)
11
11
11
11
11
11
¡¡
¡¡
- - - - - - -------
CIP drain hole at /
lowest point of cap
i ::
•
Elevation
109
ASM.E BPE-2022
Figure SD-5.1.4.4-3
Gas Sparging Assembly - Ring
1
--- -- - -
'
- - - --.---
- - - --
~=-
1
¡¡
íj
Plan
Ji
Jj
CIP spray hole
Uor mounti ng ferrule CIP)
-- - - -
- - -- CIP drain hole at _ /
lowest point of cap
i'
1'
Elevation
110
ASM E BPE-2022
Figure SD-5.1.4.4-4
Gas Sparging Assembly - Single Orifice
1
------------
'
1
---
~=:
ii
1
¡¡
i/
¡¡
Plan
CIP spray hole
(for mounting ferrule CIP)
5:::..-::-::..::::::.:::-::.,_.-::::.::f"
Elevation
111
ASME BPE-2022
(b) Exhaust filters s hall be designed for SIP. The housings shall be insta lled in s uch a way as to prevent the
collection of condensate in the elements due to SIP.
(e) lf redundant sterilizing-grade exhaust filters are
used in series, then the filter farthest from the bioreactor
shall have a maximum rating of 0.2 µm absolute. In addition, provisions shall be included for draining condensate
from the piping between the filters.
(d) Consideration should be made for CIP or removal in
the case of cleaning out of place.
(e) Provisions s hall be made for integrity testing of the
exhaust filter assembly.
{jJ lf one or more exhaust fil ter housings a re included in
a cleaning circuit, the filter ele ment or eleme nts shall be
re moved prior to introduction of a cleaning solution
(9) To prevent the ex haust filters from becom ing
bli nded by condensate saturation during operation, the
exha ust gas assembly may include exhaust condensers
( Figure SD -5 . 1.4. 7 - 1), exhaust heaters ( Figure
SD-5.1.4.7-2), or steam jacketed or e lectrically heat
traced filter hous ings (Fig ure SD -5.1.4.7 -3). These
items shall be designed for SIP and CIP.
(b) Re movable dip tubes (see Figure SD-3.4.3-1) shall
be inserted through a hygienic fitting. The removable dip
tube shall be s upplied with the means to e ns ure that the
insta llation orientation is in conformance to design intent.
(e) Bioreactor dip tt1bes s hall be designed for CIP or
cleaning out of place (COP).
SD-5.1.4.12 Harvest Valves/Bottom Outlet Valves.
This section applies to a li valves installed in the vessel
bottom head.
(a) Harvest valves s hall meet the requirements of
MC-3.3.2.3.
(b) Bioreactor harvest valves s hall be designed for SIP
a nd CI P or COP.
SD-5.1.4.13 Agitation Assemblies. This sectio n (22)
appl ies to mechan ical agitator assemblies mounted in
the bioreac to r for achiev ing o ne or more mixingrelat ed un it operations (e.g., b le nding, mass trans fer,
heat transfer, and solids s uspension).
(a) Agitators shall meet the requirements of SD-3.5.
(b) Ag ita tors with dual mechanica i sea is (see
Figure MC-2.3.2.3-2) or magneti c coup lings (Figure
SD-3.5.5 -2) are recommended to iso late b io reacto r
contents from the environment.
(e) Agita tor seal or magnetic coupling components
shall be designed for CIP and SIP.
5D-5.1.4.8 Exhaust Gas Plplng
(a) The exhaust gas assembly with in t he ste ríle
envelope s hal l meet the requ ireme nts as defi ned in
SD-3.1.2.
(b) The design of exha ust gas piping from the bioreactor s hould ensur·e that there is no condensa te accumula tion in the line downstream of the system.
SD-5.1.4.14 Mechanical Foam Breaker Assemblies. (22)
This section applies to mechanical foam breaker assemblies that may be mounted in the bioreactor for reducing
oreliminating foam accumulation in thevaporspace ofthe
bioreactor.
(a) Foam breaker assemblies s hall meet the requireme nts of SD-3.5.
(b) Foam breake rs with e ither dua l mechanical seais
(Figure MC-2.3.2.3 · 2) or magnetic cou pli ngs (Figure
SD -3.5.5-2) are recommended to isolate bio reacto r
contents from the environment.
{e) Foam breaker seal or magne tic coupling compo·
nents s hall be designed for either CI P or for both CIP
and SI P as appropriate.
SD-5.1.4.9 Sack Pressure Control Devices
(a) lf requ ired, back pressure control devices (e.g.,
mod ulating control valves or regu lators) sho uld be
installed outside of the sterile boundary.
(b) Back pressure control devices s hall not hinder the
bioreactor's capability of being SIP'd a nd CI P'd.
(e) lf a vapor-liquid separator is used in the exha ust
within the sterile envelope, it s hall be designed for CIP
and SI P.
SD-5.1.4.10 Feed Unes. This section applies to bioreactor piping systems used to feed liquid ingredients (e.g.,
pH control reagents, antifoam reagents. media, nutrient,
and inoculum). Feed lines sha ll be designed with the
appropriate piping system to allow CIP and SI P of the bioreactorvessel and the feed line itself. CIP and SIP of the feed
line may be done independe ntly or simultaneously with
the bioreactor.
(22)
SD-5.1.4.15 Interna! Coils
{a) Interna! coils s hould be avoided where possible.
(b) Product contat"t s urfaces of interna! coils require
provisions for CIP and SIP.
SD-5.1.4.16 Baffles. Baffle assemblies shall meet the
requireme nts of SD-3.4.
SD-5.1.4.17 Spray Devices. This section applies to
sprayballs, wa nds, and othe r dev ices (see Figure
SO-3.9.2.1-1) tha t may be mou nted in the bioreactor
vessel fordistributing cleaning solution during CI P operations.
(a) Spray device assemblies s ha ll meet the req uirements of SD-3.4.2 a nd SD-3.9.
SD-5.1.4.11 Dip Tubes. This section appli es to ali
bioreactor port tube-extensions within the vessel.
(a) Bioreactor dip tubesshall meet the requirements of
SD-3.4.2.
112
ASM E BPE-2022
Figure SD-5.1.4.7-1
Exhaust Gas Condenser
..+ Vent
lnsulation w ith
sheathing
Cooling
inlet
Figure SD-5.1.4.7-2
Exhaust Gas Heater
Steam
..+ Vent
lnsulation with
sheathing
Condensate
outlet
113
ASME BPE-2022
Figure 50-5.1.4.7-3
Electrically Heat Traced Filter Housing
S0-5.1.5 0eslgn for Bloburden Control
(a) The area within t he bioreactor sterile envelope or
boundary shall be designed forcleanability and bioburden
control. As a mínimum, the bioreactor sterile envelope or
bo u ndary sha ll include the follow in g (see Fig ures
SD -5.1.5-1 and SD-5.1.5-2):
(1) vessel internals
{2} inlet gas piping from the filter element(s) to the
vessel and a ny installed isolation valving (lf redundant
steriliz ing-grade fi lters are used in series, t he inlet
filler element farthest from t he reactor vessel shall
define the sterile boundary.)
(3) exha ust gas piping from the vessel side of the
exhaust fil ter(s) to the vessel and a ny installed isolation
valving (lf redundan! sterilizing-grade filters a re used in
series, the exha ust filter farthest from the reactor vessel
shall define the sterile boundary.)
(4) agitation assembly includingall internal surfaces
of the impellers a nd the shaft up to the mechanical shaft
seal in contact with the product
(5) feed systems from the vessel to the seat of the
isolation valve nearest to the bioreactor vessel or if
the feed stream is being filter sterilized, the sterilizinggrade filter element
(6) sampling system
(7) product harvesting system from the vessel to the
seat of the isolation valve nearest to the bioreactor vessel
(b) A bioreactor is made up of a number of subassemblies. Process·contacting subassemblies require special
design consideration for cleaning and bioburde n control.
(e) The bioreactor design for cleanability and sterility
shall take into consideration the biosafety leve! require·
ment for the syste m. A bioreactor shall be designed in
accordance with a biosafety level requ irement as
defined by the National lnstitutes of Health or equivalent
organization (e.g., BSL·l, BSL-2, BSL-3, or BSL-4). The
biosafety leve! req uiremen t s hould be dete r mined
based on the organism, the process, the product being
produced, a nd the owner /user's preferences. To meet
a specific biosafety leve! requirement, special operational
cons ide ra t ions (e.g., steam blocks) may have to be
addressed with in the bioreactors' subassembly designs.
lf the bioreactor has been used to grow an organism
that requires biohazard conta inment, provision shall be
made to deco ntam inate ali su rfaces t hat may have
co me in co ntact with the product prio r to CIP, orto
contain a nd decontaminate the fluids used for CIP.
Outle t
lnsulation w ith
sheathing
Electric heat trace
e
e
lQ]
e
e
Temperature
c,ontroller
(22)
t
lnlet from vessel
(b) lf not removed during processing, spray device
assemblies shall be designed for SIP.
S0-5.1.4.18 lnstrumentation
(a) lnstniments installed within the sterile envelope or
boundary shall be designed for SIP. Consideration should
be made in the design for instrument removal for calibration.
(b) lnstnunents installed within the sterile envelope or
boundary shall be designed for CIP or removed for COP.
(e) Temperature-sensing elements should be installed
in the rmowells. Piping associated wíth in-line thermowells shall be sized to allow sufficient steam and condensate flow.
50-5.1.5.1 0rainabillty
(a) lnlet gas piping with in the sterile envelope shall
meet slope req ui reme nts as defined for GSD3 in
Table SD-2.4.3.1-1.
(b) Exha ustgas piping within the sterile envelope shall
meet slope re qui reme nt s as defined for GSD3 in
Table SD-2.4.3.1- 1.
114
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ASM E BPE-2022
Figure SD-5.1.5-1
Fermentor Sterile Envelope
Optional
..
lnd icates sterile boundary
¡'
E.xhaust
Optional
r .. 7
,------------'
'-------,
,__!C_IP_ ~>-------- --------+--~--L.=;_~ . _J
c!i
Optional
ó< Air
Nutrient
'-----'
...
[D
GENERA~ NOTE: Design may vary.
115
ASM.E BPE-2022
Figure SD-5.1.5-2
Bioreactor Sterile Envelope
Opóonal
lndicates sterile boundary
Opóonal
r-:.7
'---------,
,----- -----'1
1
>---------------,---~--L~- ~
I~C_IP_ _
Opóonal
Nutrient
ILI
GENERAL NOTE: Oesign may vary.
116
ExhaUSl
ASME BPE-2022
(d) For dip tube(s), the SIP operation shall director
balance steam distribution to establish and maintain sterilization temperature within the tube(s) during the sterilization hold period.
(e) Specia l considerations for spray devices are as
follows:
(1) The SIP operation shall direct or balance steam
distribu tion t o es tablish an d mainta in sterilization
temperature within the spray device during the sterilization hold period.
(2) With the exception of a combination sparger/
spray device, interna! spray devices should be located
above the bioreactor operating liquid leve!.
(3) lí the bioreactor is sterilized with media in the
vessel, and the spray device assembly extends or is located
beneath the work.ing leve! ofthe media, the SIP operation
shall direct steam flow through the device into the vessel.
(f) Forsystems with a dual mechanical agitator seal, the
following requirements apply:
(JJ The mechanical sea! and the barrier fluid system,
bounded by the nearest upstream valve(s) or filter(s) and
the downstream outlet port(s) on the seal, shall be SIP'd.
(2) The design shall preventthe differential pressure
between the vessel and the barrier fluid system from
exceedi ng the ma nu facturer's recommendations. The
barrier fluid system should indicate if operating conditions fall outside the design range.
(3) During post-SIP cooldown, t he design shall
prevent vacuum in the barrier íluid system.
(e) Ali wetted surfaces ofsparge devices shall besloped
into the vessel for drainability.
(d) Feed line valves and piping orientation shall be
designed for drainability during CIP and SI P.
(e) Ali wetted surfaces of dip tube(s) shall be sloped
into the vessel for drainability.
(f) Bottom outlet valves shall be designed, sized, and
installed to be drainable and to enable drainingofthe bioreactor contents for ali operations.
(9) Bottom-mounted agitators shall not interfere with
the draining of bioreactor contents.
(22)
S0-5.1.5.2 Cleaning
(a) The area within t he sterile envelope should be
designed for CIP. For components that cannot be CIP'd,
the design shall allow removal for replacement or
manual cleaning out of place.
{b} lf instruments will be cleaned out of place, blind
caps or plugs should be provided to maintain the integrity
of the bioreactor system.
(e) lf CIP of the ingredient feed system is performed
d ur ing active cu lture operations, then t he design
should include provisions to preventcross-contamination
between CIP solutions and product.
{d) lf one or more dip tubes are clea ned in place with
thevessel, both the inside and outsideofthedip tubesshall
be cleaned.
(e) Provisions shall be included in the design to clean
the productcontactsurfaces ofimpellers. Additional spray
elements may be required to achieve coverage.
(f) CI P for sparge devices that use pornus material for
gas distri bution requires particular attention. These
devices should be eva luated for CIP cleanability and
should be removed from t he bioreactor for externa!
cleaning or replacement when CIP is not feasible.
(221
SD-5.1.7 Testing. The bioreactor vessel should be
press ure/vacuu m and te mperature rat ed per t he
ow ner / use r's des ign criteria. The vessel s hall be
constructed, tested, inspected, and stamped in accorclance
with local ordinances, regulations, and codes.
SD-5.2 Cell Disruptors
SD-5.1.5.4 Thermal Sanitization/Sterilization
SD-5.2.1 General. Homogenizers and high-shear fluid
processors disrupt cells by sudden cavitation, high shear,
or impingement of a highly pressurized process fluid.
Homogenizer systems consist oí a variable-speed posi •
tive displacement pump and an adjustable orífice. The
system may also include a feed pump and a cooling
heat exchanger.
High-shear fluid processors are a variation ofthe homo•
genizer operating at higher pressure ranges. High·shear
íluid processors include a fixed ·speed positive displace·
ment pump and a fixed orífice.
Refer to Figure SD·S.2.1· 1 for a typical cell disruptor
process ílow schematic diagram.
(a) The area within t he sterile envelope should be
designed for SIP. For those components or assemblies
that cannot be SIP'd, the design shall allow removal for
steam sterilization using an autoclave as long as additional
provisions are provided for sterilizing the interface (e.g.,
steam block) once the components or assemblies are
reconnected to the remainder of the bioreattor system.
Autoclaved components or assemblies shall be capable
of being steam sterilized without degradation to any of
the elastomers or polymers that make up the components
or assemblies.
(b) lf t he bioreactor is sterilized with media in the
vessel, the SIP operatio n sha ll direct steam flow
through the sparge device.
(e) lf the bioreactor is steril ized with media in the
vessel, and one or mo re d ip tubes exten d below the
working level oí t he media, the SIP operation s hall
direct steam flow th rough the dip tube into the vessel.
SD-5.2 .2 Syste m Performance Requlrements. The
following system performance requirements and operating parameters shall be defined:
(a) process fluid properties (e.g., cell mass concentra •
tion, shear sensitivity, density, viscosity)
(b) operating pressure range
117
(22)
Figure SD-5.2.l· l
Cell Disruptor Process Fl ow Schematic Diagram
s:~:~···'C)~---------------------------1
1
CIP bypass
~ - - - - - - - - 1 Coolant return
7
r --,
1
1
P(OdUCt
t--t
1
1
7
1
1
1
1
Optional
cooting
Prod vct
1
1
excNnget
L
_ _ _J
Coolam suppty
Pump
(piston ptunger/
intens.ifi e, pump>
~
3:
.,"'..,
,_.
,_.
(X)
~
L
High--pressure b ou ndary
GENERAL NOTES:
(a) Only major piping and i nstruments are shown.
(b) Additional or altemative piping, valves, instruments, and equipment may be required for the following purposes:
(.1) p ressure safety
(2) CIP re-quirements
(3) SIP requirements
(4) multiple•stage/pass unlt
_J
N
0
N
N
ASM E BPE-2022
(e) process íluid ílow rate
(3) CIP bypasses should be provided parallel to flow
restrictions for hydraulic balancing. Means of flow veri fication should be provided for cleaning circuits that
employ parallel cleaning paths.
(4) The cell disruptor should be operated d uring
cleaning, typically a t the highest ílow rate availa ble.
(5) lf present, seal lubrication syste ms should be
designed to be cleaned or ílushed.
(b) Portions of cell disruptors tha t are not designed for
CIP shall be identified. Those identified portlons shall be
designed for disassembly and reassembly for COP and examination.
( d) process temperature range
(e) required cell disruption efficiency
S0·5.2 .3 System Oesign. The ma nufactu rer shall
d ise lose whe n AS ME BPE no nconforming materia Is,
connections, or seals a re requ ired for product contact
areas in high-pressure applications.
S0-5.2.3.1 lnlet
(a) Continuous flow and pressure shall be present to
prevent damage to the cell disruptor. Pulsations or íluctuations of the process tlow should be minimized.
{b) The system should be capable of priming/pu rging
air from the system during start-up.
(e) The system should be capa ble of maintainingan environment free of air entrainment during operation.
S0-5.2.4.3 Chemical Sanitization
(a) Where chemica l san it ization is specified, t he
components within the sa nitization bounda ry shall be
designed fo r exposu re to an d removal of san it izi ng
agent while maintaining the sa nitized sta te.
(b) The manufacturershould recommend the chemical
sanitization ílow rate and pressure.
SD-5.2.3.2 Pump and Orífice
(a) The manufacturer shall disclose if seal materials in
contact with process íluids do not meet the requirements
of SD-2.4.1.1 (e.g., USP Section <88> Class VI).
(b) When h igh co ntain me nt is specifi ed, the cell
disruptor shall be designed as a closed system (e.g., homogenizer with double packed cylinder sea! design, containment of seal quench íluid, containment of components
with the isolator).
SD-5.2.4 .4 Thermal Sanltization. Where t he rmal
sanitization is specified, the surfaces within the sanitization boundary shall be designed for SI P or hot liquid sanitization.
S0-5.2.5 Oeslgn for Servlceablllty, Examlnatlon, and
Operatlon. The high-pressure zone shall be capable of
disassembly for periodic cleaning a nd inspection.
S0-5.2.3.3 Outlet. lf requi red by the process, the
system shall be des igned to re move heat generated by
the cell disruptor.
SD-5.3 Centrifuges
SD-5.2.3.4 lnstrumentation. The system should be
designed to e na ble high-pressure sea l integrity monitoring (e.g., viewing through a sight glass, conductivity
monitoring, or turbidity monitoring).
S0-5.3.1 General. Centrifugation is a process used to
separate suspended mate rials of different densities using
centrifugal force. Centrifuges may be used for collection of
solids such as harvest of cells or inclusion bodies of precipitated protein, or for clarification ofbioprocesssolutions.
Different types of centrifuges include d isk stack centrifuges. tubular bowl centrifuges, si ngle-use centrifuges,
and ultracentrifuges.
In bioprocessing, the centrifuge is typically used to
separate cells from cell broth or cell debris or precipitates
from liquid, or to recover incl usion bodies alter homogenization of microbial cells.
S0 - 5.2.4 Oe slgn for Bloburd e n Contro l. T he
bio burden control stra tegies (e.g., CJP, COP, wa te r
rinses, SIP, hot or superheated water sanitization, chemical sanitization) for product contact surfaces shall be
defined by the owner/user. The preferred mode of equipment storage (e.g., flooded or dry) shall be defined.
SD-5.2.4.1 Orainability. The design shall accommodate forced expulsion for the re moval of liquid when the
system is specified to be stored dry.
SD-5.3.1.1 Disk Stack Centrifuge. Ad isk stack centJ·ifuge consists of a cylindrical bowl containing a stack of
conical disks separated by spacers, which reduce the
d istance and increase t he surface a rea for particulate
settling when under centr ifuga) force.
S0-5.2.4 .2 Cleaning
(a) The followingare recomme ndations for cell disruptors designed for CJP:
{1} The manufacturer should recommend CIP ílow
rate and pressure.
(2) The equi pment shou ld be des igned to ena ble
cleaning verification/validat ion of ali process contact
surfaces.
SD-5 .3.2 System Performance Requirements. The
following system per formance capabilities should be
defined at the beginning of design:
( a) whether the centrifuge is intended for open, closed,
or briefly exposed operations
(b) product to be separated
(1) sali d co ncent ration [e.g., packed cell vo lume
(PCV))
119
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ASME BPE-2022
(2) solids cell type or particle size and distribution
(3) recovered product pilase: supernatant, solids, or
(b) Disk Spacing
{1) Spacers between disks should be drainable.
(2) Spacers should not interfere with system cleana bility.
(e) The diskstack shall be designed with a material that
can withstand the mechanical stresses that the centrifuge
will undergo during operation.
both
(4) de nsity differ ence be twee n so lvent and
suspended solids, if available
(5) viscosity and surface tension ofliquid, if available
(6) product shear sensitivity
(e) multipurpose or dedicated to a single product
(d) batch or continuous operation
(e) batch size
W process liquid feed flow rate
(g) process temperature
(h) descriptionofowner/user's processes immediately
upstream and downstream of the centrifuge
(i) req uirements for processing volatile flammable
materials
SD-5.3.4.4 lnstrumentation
(a) lnstrumentation should be installed to detect a
failure in t he bo wl disc ha rge or flo o d ing of the
tyclone, if present.
(b) Centrifuge instr umentation s ha ll mo nitor
a bnor mal mach ine vibrat ions t hat may resu lt in a
safety hazard and unit failure.
(e) The system should be capable of regulating bowl
speed to co ntrol the ce ntrifuga! forces that separate
the product.
(d) The qualityofthe supernatantshould be monitored
through a sight glass or instrument such as a turbid ity
meter.
SD-5.3.2.l Process Parameters. The following additional process parameters required to confirm sys tem
capabilities should be defined:
(a) cleani ng requireme nts (e.g., CIP or man ua l
cleaning)
(b) sanitization requirements (e.g.. SIP)
(e) maximum allowable processing and cleaning/sanitization times
(d) requirements associated with the biosafety leve!
and room classification of the process and system
(e) required feed and discharge pressure
W purity criteria (e.g.. solids in supernatant, turbidity,
yield, based on prior produt"t tests or experience)
SD-5.3.4.4.1 Supernatant Outlet Pressure Control
Valve. The supernatant outlet on centrifuges that are not
hermetically sealed should have a pressure control valve
to keep the bowl flooded.
SD -5 .3 .4 .5 Compendial Water Separation. The
compendia! water system shall be isolated from potential
process contamination (e.g., by use of a break tan k or
double block and bleed val ve).
SD- 5.3.3 Operatlng Capabllltles and System Funct.lon. The system should be designed with an alternative
liquid feed source (e.g., purified water, buffer) for priming
SD-5.3.4.6 Interfaces. [Reserved for funire content]
SD-5 .3 . 5 Design for Bioburden Control. The
bioburden control strategies (e.g., CIP, SIP, chemica.l sani·
tization) and associated conditions (e.g., temperatu re,
pressure, chemistry) for product contact surfaces shall
be defined.
of the centrifuge.
SD-5.3.4 System Design
SD-5.3.4.1 Feed. Forintermittentdischargesystems,
the centrifuge system shall control and monitor the feed
flow rate and pressure.
SD-5.3.5. l Dralnabllity. Cent rifuges that are not
designed to be drainable may require additional means
for liquid removal (e.g., air blow). The centrifuge shall
be designed to facilitate liquid removal under dynamic
bowl conditions.
The solids catcher inside the centrifuge and the solids
discharge connection to the cyclone are typically horizontal. Provisions for liquid removal from these surfaces
shall be provided in accordance with SD -2.4.3.1.
SD-5.3.4.2 Bowl
(a) lf a cyclo ne is present in intermit tent so lids discharging centrifuges, it shall be capa ble of containing
and decelerating t he d ischarged bowl cont ent s. The
cyclone should be cleana ble.
(b) Nozzles at the periphe1y, top, or bottom of the bowl
in continuous solids-discharging centrifuges should allow
for continuous discharge of settled contents.
(e) Process compatibility, cleaning. and sanitization requirements shall be considered when selecting materials.
Components in the centrifuge that are subj ect to high
dynamic stresses (e.g., peripheral rotating components)
may require high strength materials.
SD-5.3.5.2 Cleanlng
SD·S.3.5.2.l Disk Stack Centrifuges. Disk stack
centrifuges should be designed for CIP. Additional requ irem ents for disk stack centrifuges subject to CIP
include the following:
(a) Product contact surfaces (e.g., bowl, hood, solids
catcher, cyclone) shall be compatible with the cleaning
solutions.
SD-5.3.4.3 Disk Stack
(a) Dísks shall be removable for visual inspection.
120
ASME BPE-2022
(b) Sampling points for representative cleaning verification/validation of product contact surfaces shall be
defined.
(e) The manufacturer shou ld reco mmend the CIP
supply flow rates, pressures, and cleaning step times
required to clean the centrifuge.
(d) The recovery, sampling, or monitoring of t he
various cleaning streams shall be defined.
(5) recirculation streams for tangential How filtration (TFF} systems
(e) operation
{1} in-line dilution or formulation
(2) diafiltration
(3) measurement of Huid characteristics
(4) control strategy [e.g., for TFF - transmembrane
pressure (TMP} control, permeate flux control, permeate
pressure control, retentate How control)
(5) percent volume reduction a nd final volume
(d) filtration element
(1) preparation for operation
(2) expected pressure drop at the indicated How
rates
(e) system
(1) the fluids to which the system may be exposed
(2) acceptable holdup volu mes
(3) temperature of operating area and process fluids
(4) room classification
(f) automation
(1) control system requirements
(2) sensors and monitors for detection of system
performance
(g) cleaning and sanitization requirements, including
the following:
{1) methods
{Z) freq uency
(3) durarion
SD-5.3.5.2.2 Other Centrifuges
(a) Centrifuges that are not designed for CIP shall be
capable of disasse mbly and reassembly for cleaning and
examination.
{b} Areas of primary and incidental product contact
that require manual cleani ng or cleaning out of place
(COP) in addition to CIP shall be defined.
SD-5.3.5.3 Chemical Sanitization/Sterilization.
(Reserved for future content]
SD-5.3.5.4 Thermal Sanitlzation/Sterilization.
Centrifuges subject to SIP shall be designed in accordance
with SD-2.3.1.1 and, in certain ju risdictions, may be
conside red pressure vessels (see GR· l ). Sa tu ra ted
steam penetration across components that define the
SI P boundary of the system shall be demonstrated.
SD-5.3.5.5 Post-Use Storage. The design shall meet
the sterilization/sanitization and storage requirements
(e.g., temperature, pressure, chemistry} and storage
condition (e.g., Hooded or dry} specified for bioburden
control.
SD-5.4.3 Operating Capabilities and System Function. Piltration systems shall be designed to control
and monitor filtrate ( or tangential and permeate How}
according to process require ments. Multi use systems
shall be designed to allow for process cleaning and sani·
tization.
SD-5.3.6 Design for Serviceability, Examination, and
Operation. [Reserved for future content]
SD-5.3.7 Testing. [Reserved for future content)
SD · S.4.4 System Deslgn. The sys tem s hou ld be
designed to promote recovery of product (e.g., drainable
branches and path-by-path air blows to recover product
retained in lines and filter elements} and meet cleaning
and sanitization requirements. The system should be
designed to mitiga te the risk of crossover of feed solutions,
which could contaminate the process.
Filtration system designs should conform to SD-3.1.
Whe re multiuse systems are not drainable, refer to
SD-2.4.3.
Whe n required by system function, components
present in direct flow and ta ngentia l flow filtration
systems shall include the following:
(a) feed and filtrate for direct tlow; permeate and
retentate for tangential flow
{b) valves
(e) pumps
(d) vessels (feed and filtrate collection)
(e) instruments (process monitoring and control}
(fJ one or more filtration elements and element holders
{22) SD-5.4 Filtration
SD-5.4.l General. Filtration systems are used for the
purposes of product purification, product concentration,
and reduction ofbioburden. Filtration systems include the
filter elements (see Part PM} and filter housings/holders,
and may include pumps, vessels, piping, tubing, fittings,
valves, and instrumentation.
The following sections describe the general design requirements for the operation, cleaning, and sanitization of
a multiuse filtration system.
SD- 5.4.2 System Performance Requirements. The
cond itions and performa nce parameters under which
the system will operate shall be defined. Typical items
to consider include the following:
(a) type a nd mode of filtration
(b) inlet/outlet streams
{1) inlet and outlet physical and chemical properties
(2) How rates required
(3) pressure conditions
(4) number of feed and outlet streams
121
ASME BPE-2022
The syste m design s hould mitigate the r isk ofleakage a nd
carryover of residua l solutions to subsequent steps.
be provided. Drain points s hall not create d ead legs. A
common drain port on the s kid is preferred.
Direct flow filtration housings shall include a low port
dra in to facilitate cleaning and removal of liquid from the
system as well as filtration e lement changeouts. Liquid
tee -style fil ter housings s hould be insta lled vertically
for dra inabili ty. ln-li ne vent filler housings subject to
SIP s hould be installed vertically with the conde nsate/
drain port directed downward (see Figure SD-5.4.5.1-1).
Tangentia l flow cartridge housings s ubject to CIP or SIP
s hall be designed with connections and covers that will
a llow the unit to drain.
5D-5.4.4.1 Materials. The process contact materials
shall be compatible with process fluids, includ ing those
used for cleaning a nd sanitization.
5D-5.4.4.2 Pumps. Pumps designed for both process
a nd CIP s hall meet the required duty points (i.e., flow rate
a nd pressure) for each operation.
5D-5 .4.4.3 ln struments for Feedback Control of
Process Liquids. When multiple liquids are combined,
the flow ra te of the feed solutions (and ret entate fo r
tangential flow systems) to the filter element should
be monitored.
50-5.4.5.2 Cleaning. Where direct flow filtration
housings are CIJ>'d, provision for draining orforced expulsion ofliquid shall be included to facilitate cleaning ofthe
system. Cleaning of filtration systems is achieved using the
CIP TACT principies (see SD-6.3.1).
Direct flow filtration elements a re typically not reused
a nd are not installed during the cleaning process.
Tangential flow filtration e lements may be designed for
mu lt iuse an d cleaned alo ng wit h t he system. When
multiuse e lements a re CIP'd. the system shall be designed
to be hydraulically bala nced to ensure suitable conditions
(e.g., ílow rates) to properly clean the filtration elements.
5D-5.4.4.4 Multiple Connections. Where required,
the system shall be design ed to enable isolation of the
fil ter a t its connection points (e.g., for removal of the
filter, to s hut off permeate, or to bypass t he fi lter
elemen t) or to control the di rectio n of flow th rough
the fil te r (e.g., top to bottom vers us bottom to top).
5D-5.4 .4.5 Air Entrapment. Th e system should be
designed to minimize the introduction into and accumulation of air in the filter housings. The system s ha ll be
designed to relieve trapped gases from the filter housings.
Sight glasses or instrumentation s hould be installed when
required to facilitate air detection.
5D-5.4. 5.3 Chemical 5anltizatlon/5teri llzatlon.
Process contact components within the system s hall be
exposed to the chemical solution for a specified duration.
The components shall be compatible with the sanitization
agents and conditions seiected.
lfa system s ubjecr to chemical sanitization/ste rilization
includes eie ments not compatible with the chemical conditions req uired, ! hose elements s hall be isolated or
removed during the cleaning process without compromising the system integrity.
5D-5.4.4.6 Filter Element Housing Design
(a) Parts forming interna! crevices s hould b e easily
disassembled to enable access for cleaning.
(b) Ali wet ted su rfaces s ho uld be accessible fo r
cleaning and examination.
(e) Ali nozzle connections s hall be of a hygienic design.
(d) Baffle piates, when used, s hould be cleanable a nd
designed for SI P.
(e) The housing assembly. end plates. a nd connections
should be designed to preven! bypassing of process fluid
around the element.
{f) Vent filters for hot liquid processes should be heat
traced or steam jacketed. Other methods for preventing
excessive moisture accumulation in ven! filters, s uch as
oversizing filte rs, vent heaters, or condensers, may be
considered.
5D-5.4.5.4 Thermal 5anitizatlon/5terlllzatlon .
Systems shall be compatible with th e thermal conditions
to which the system will be exposed.
lf a syste m subject to SIP includes elements not compatible with the therma l conditions required, those elements
s hall be isolated or removed during SI P without compro·
mising the system integrity.
5D-5.4.6 0eslgn for 5ervlceablllty and lnspectlon.
Multiuse systems shall be designed to facilitate service
and inspection includi ng removal and replacement of
the filter elements.
5D-5.4 .5 Deslgn for Bloburd e n Reduction . Th is
section covers drainability, cleaning, a nd chemical and
thermal sa nitization/sterilization for the purpose of
bioburden reducrion.
50-5.4.7 Testing. Selecrion of filt ration integrity and
performance test methods should be based on evaluation
of process risks.
When the filter is used as a sterilizing or viral removal
filter, provisions for integrity testing should be provided.
Acceptab le test methods include the following:
(a) pressure hold test to identify system leaks fordirect
and tangential ílow systems
5D-5.4.5.1 Drainability. Filtration systems should be
designed to minim ize holdup volum e. Piping systems a nd
componenrs of filtration systems that a re designed to be
drainable shall be sloped to e na ble draini ng. Drain valves
shall be installed at low points. Wh ere liquid removal is
required but drainability is not possible or practica!, a
method of forced expuls ion of liquids (e.g., by air) shall
122
ASME BPE-2022
Figure SD-5.4.5.1-1
Tank/Vessel Vent Fillers
(al ln-Line Design
(Accepted)
(bl T-Type Design
(Acceptedl
Por the purposes of this section, "column" shall refer to
any co mpone nt (e.g., col umn, cartridge, caps ule,
membrane adsorber) housing the stationary medium.
A chromatography system may also include provisions
for
(a) assisting with the packing of a column with the
stationary phase
(b) evaluating the performance of a packed column
(e) performing in-líne dílution and in-líne formulation
operations
For the purposes of this section, "gradient operation"
refers to flow rates of two or more liquids to be adjusted
such that the physical and chemical characteristics of the
resulting chromatography feed solution change over time.
(b) tra ns membra ne test t o con firm a bsen ce o f
membrane fouling in tangential flow filtration systems
(c) salt rejection testing to confirm system integrity in
reverse osmosis applícations
(d) bubble point or forward flow diffusion tests in sterílízing-grade direct flow filtration systems used to verify
bioburden control
(e) particle tests in viral fílter systems e mp loyed to
confirm specific viral removal
{ 22)
SD-5.5 Chromatography Systems
(22)
SD-5.5.1 General. Ch romatograp hy systems a re
used for produce purification, concentration, and viral
load reduction . Chroma tography sys tems include
pumps, piping. valves, instrumentation, and a stationary
medium t hat is contained in a colum n, ca rt ridge, or
capsule. The statio na ry me dium/p hase may be a
membrane adsorber or resin.
The chromatography system shall not contribute to the
contamination of the product. This section describes
opera tiona l. cleaning, and sanitizatíon requirements of
multiuse chromatography systems. This section does
not address the requirements of systems intended for
single-use. Chromatography systems used for analytical
testing are not included in the scope of this section.
(22)
SD-5.5.3 Operating Capabilities and System Func- (22)
tion. The chromatography system shall be capable of delivering a consistent flow of liquids through the stationary
phase and mitigating the risk of introducíng gas onto the
column. Multiuse systems shall be designed to be cleaned
and san iti zed . lf colu m ns a re stored packed with
stationary phase, the systems shall be capable of main taining a tlooded bacteriostatic condition.
When grad ie nt chromatograp hy operations are
required, gradie nt accuracy capability sha ll be defined.
The chromatograp hy system sh ould be designed to
provide an e lutio n b uffer flow path that minimizes
axial dispersion.
123
ASME BPE-2022
(e) shelf hea ting and cooling rate (clean, dry, and
empty)
(f) shelf temperature uniformity requirements
(g) evacuation rate
(h) mínimum vacuum level
SD-5.5.5 Deslgn for Bloburden Control
(22)
5D-5.5.5.2 Cleaning. Chromatography systems shall
be designed for CIP. Systems should be designed in accor·
dance with SD-3.1.
5D- 5.5.5.3 Chemical Sanitization/Sterilization.
SD-5.6.3 Operating Capabilities and System Function. The lyophilizer should be capable of the following
Chemical sanitization p rocesses a re used to reduce
bioburden. AII process contact surfaces of system compo·
nents shall either be compatible with the selected sanitizarion agents orbe capable of being removed or isolated
prior 10 the sanitization process.
funcrions:
(a) shelf a nd condenser temperature control
{b) vacuum pressure control
(e) condenser defrost
{d) loading a nd unloading (when specified)
(e) stoppering (when specified)
(fJ vacuum integrity testing
(g) filter integrity testing
(h) cleaning
(i) sterilization/sanitization
5D- 5.5.5.4 Thermal Sanitization/Sterilization.
Chromatography systems may be designed for thermal
sanitization. lf a system is designed for thermal sanitization, components shall be designed for the specified conditions, or sha ll be removed or iso lated p rior to the
sanitization process. Note that if items are removed for
sanitization, they should be sanitized sepa rately a nd reinstalled in a controlled e nvironment to avoid contami nating the system.
SD-5.6.4 System Design. A lyophilizer is comprised of
functional components/systems, as shown in Figu re
SD·S.6.4-1, which are designed for isolation, cleanability,
and bioburden control.
AJI components shall be specified for the applicable
pressure, vacuum, temperature range, therm al shock,
a nd expos u re ro san itizing agents [e.g., vaporized
hydrogen peroxide (VHP)] when applicable.
Process contact surfaces made from nonmetallic material should conform to SD-2.4.1.l , SD -2.4.1.2, SD-2.4.1.4,
and Part PM.
5D-5 .5.5.5 Post-Use Storage. Chromatography
systems are typically stored tlooded with a sanitizing solution to maintain bioburden control.
(22)
S0-5.6 lyophilizers/Freeze Dryers
SD-5.6.1 General. For the purpose of this section, the
terms "lyophilizer'' and "freeze dryer" may be used synonymously. This section describes the requirements for
cleanability and bioburden control of lyophilizers that
a re used for biopharmaceutica l pro cessi ng. This
section appl ies to lyophilizers in which product is
loaded onto shelves. Other designs that use methods
and components not described in thís section should
be evaluated and agreed on by the owner/user. A lyophilizer comprises a nu mber of interconnected components.
Components with process contact surfaces shall be
designed for cleanability a nd bioburden control.
Lyophilizer surfaces of components, piping, eq uipment,
or systems that are isolated by design from both product
and process fluidsare not process contactsurfaces anda re
not required to be designed for cleanability or bioburden
control. Examples of surfaces that are not process contact
surfaces include the exterior surfaces of equipment, drain
lines. vacuum li nes, a nd systems containing hydronic or
hydraulic fluids.
5D-5.6.4.1 LyophiUzer Chamber
(a) The interior surfaces of the lyophilizer chamber
(chambervessel) are considered process contactsurfaces.
(b) The lyophilize r cha mber includes ali necessary
fitti ngs and closures (e.g., doors, bellows, isolatio n
valves). The chamber floor shall be drainable.
(e) The su rface finishes of t he chamber interna!
surfaces (i.e., door, walls, ceiling, floor) shall be specified
by t he ow ner/ user us ing the designations in Table
SF-2.4.1-1.
(d) Where the chamber interfaces with the clean room
orisola tor, the surfaces shall meet the owner/user's specified requirements.
5D-5.6.4.2 Condenser Vessel
(a) T he condenser vessel, used to contain the
conde ns e r heat excha nger. is co n nec ted to t he
chamber vessel a nd may be separated by a main isolation
valve.
(b) Ali surfaces shall be drainable.
(e) In syste ms designed with backstreaming prevention (i.e., prevention of reverse flow from the vacuum
pumps), t he condenser vessel is downstream of the
cham be r. T he condenser vesse l s urfac es are not
process contact surfaces and do not have surface finish
requirements.
SD- 5.6.2 System Performance Requirements. The
following system performance require me nts shall be
defined:
(a) vacuum integrity requírements
(b) product capacity (vial quantity or required product
shelf area)
(e) condensing capacity (liters)
(d} mínimum shelf temperature
124
ASME BPE-2022
Figure SD-5.6.4-1
Typical Lyophilizer Component Assembly
Condenser vacuum
isolation valve
(22)
Condenser relief valve
Condenser SIP/CIP
inlet valve
Hydraulic cylinder for
moving shelves
system
Condense, vessel
vacuum
pump
CIP inlet
Steam inlet
Chamber relief valve
Gas filter assembly
lsolation bellows
Chamber shelves
Chamber door
CIP spray nozzles
inside chamber
125
ASME BPE-2022
{d) In systems no t designed wi th backstreaming
prevention, the condenser vessel s urfaces a re process
contact s urfaces. The surface finishes of the condenser
vessel s hall be speci fied by the own er/user using the designa tions in Table SF-2.4.1-1.
(e) The bellows shall be sealed a t each end to isolate the
inside ofthe lyophilizer from externa! conditions. Bellows
may be bolted or welded into place. A bellows sealed by a
bolted íla nge connection with an 0-ring seal within the
chamber vessel facilitates replacement a nd maintenance.
The inside of the bellows may be evacuated, vented, or
pressurized to facilitate retra ction or extension of the
bellows. The lyophilizer may be provided with a leaktest system to ensure the bellows is intact.
(d) When specified, the bellows s hall be suitable for
ste rilization a nd shall allow for full penetration of the sterilizing agent a t ali surfaces inside the ste rile bounda1y.
SD-5.6.4.3 Lyophilizer Shelves
(a) The flat s urfacesofshelves supporting containers of
product (e.g., via ls containing product) are considered
process contact s urfaces.
(b) The flat s urfaces of s helves a re considered product
contact s urfaces if product without conta iners is placed
directly on the shelves.
(e) Surfaces ofthestructural components ofth eshelves
are considered process contact s urfaces.
{d) The s he lf heat t ransfer performance depends on
shelfflatness. The loading/unload ingand ini tial containe r
closure perfo rma nce require the shelves to be level.
Therefore, shelves are not req uired to be slop ed and
may not be drai nable. Meth ods ma y be req uired to
remove res id ual CIP liq uid (e.g., collaps ible s he lves
may be contracted to remove residual ClP liqu id from
shelf su rfaces followed by a process t hat fac ilitares
drying, such as SIP followed by a vacuum hold}.
(e) The s urface finishes of s helves shall be s pecified by
the owner/user using the designations in Table SF-2.4.1-1.
A rougher surface may be specified for the bottom side of
the s helves by the owner/user to meet process requirements (e.g., stopper adhesion prevention).
SD-5. 6.4.6 Inte rna! Moving Parts. The following
s hould be co nsidered in t he d esign o f movi ng parts
(e.g., t he raising and lowering of the she lves) within
the chamber or condenser vessel:
(a) Nonmetallic ma terial may be used for moving parts
to reduce friction (e.g., PTFE, PEE K, UHMWPE). The selection of the material s hould consider minimizing particle
generation.
(b) Contact surfaces between moving parts s ha ll be
exposed to solutions used for cleaning and bioburden
control.
(e) A bellows may be used to isolate the chamber or
condenser from moving pa rts that are not of hygienic
design.
SD-5.6.4.7 Spray Devices
(a) Spray devices are used in lyophilizers to facilitate
thecleaning of surfaces inside the chamber and condenser
vessels. Spray devices in the condenser vessel may also be
used for directing s pray at the condenser coole r to facilita te defrosting of the condenser cooler.
(b) Spray devices designed for cleaning should provide
s uffi cie nt flow and force to clean ílat s urfaces (e.g.,
shelves) by direct spray. Cleaning the interna! surfaces
of a lyophílizer by direct spray may require a supply pressure and ílow rate that a re s ubstantially higher than a re
typical for cleaning an empty vessel. The s upply pressure
a nd ílow rate should meet the manufacturer's recommendation for these spray devices.
(c) Both static and dynamic spray devices are accepta ble for use in lyophilizers. The use a nd application of a
particular spray device design s hould be agreed on among
the owner/u ser, lyophilizer manufacn,rer, and CJP system
integrator. The number of spray devices may be reduced if
the shelves are allowed to move during cleaning. Spraying
of s helves should be designed to avoid the interference of
spray streams of opposing directions.
(d) The use ofthreaded connections for spray devices
should be avoided.
(e) Spray devices s hall meet the provisions of SD-3.9.2.
(f) Spray device design, location, and orientation shall
e ns ure a pp ur tena nces (e.g., nozzles, bellows, s he lf
supports, hoses) are exposed to complete spray coverage.
SD-5.6.4.4 Vacuum Systems
(a) The lyophilizer vacuu m pumps and condense r
cooler establis h a pressure gradient during lyophilization
from the chamber vessel through the condenser vessel
resulting in single-direction ílow toward the lyophilizer
vacuum pumps. To maintain an e nvironment appropriate
for aseptic processing in the chamber vessel, the vacuum
system shall preven! reverse ílow (backstreaming).
(b) The lyophilizer vacuum pumps are not hygienic
components and should be designed to be outside the
sterile bounda1y.
(e) Where vacuum pumps for wet service (e.g., Jiquid
ring vacuum pumps) are used to evacuate air /vapor from
the cham ber and conde nser vessels, they should be
located outside the sterile boundary.
5D-5.6.4.5 lsolat.lon Bellows
(a) Jsolation bellows are employed to isolate nonhygienic moving components from the lyophil izer sterile
boundary.
(b) The s urfaces of t he bellows and its mou nt ing
con nections exposed to the inside of t he lyop hil izer
a re considered process contact s urfaces and should be
assessed for cleanability. The bellows shall be extended
during the cleaning cycle to provide access to ali exposed
process contact surfaces.
126
ASM E BPE-2022
(k) Door sea) lubricants s ha ll not be used in aseptic
processing applications.
(/) Refer to Part MC for specifications of seals used in
bioprocessing.
5D- 5.6.4.8 Gas Filter Assemblles
(a) For the purpose of this paragraph, the gas filter
assembly is d efine d as t hose filters installed for t he
purpose of filtering process gases supplied by the lyophilizer. The filter assembly includes the filter media, seals,
housing, a nd connected n,bing.
(b) The last filterin the path of the gas to the Jyophilizer
(proximal fil ter) shall be part of the sterile boundary and
be designed for the ch osen mea ns of bioburden reduction
(e.g., SIP or VHP). This filter s hall be a ste rilizing-grade
filter. lf a red und a nt ste rilizi ng filter is used, bot h
filters s hall be included within the sterile boundary.
(c) Fil ter assemblies that are steamed in place shall be
designed to
(1) limit the pressure drop across the filter to within
the manufacturer's specifications in the specified flow
direction
(2) permit t empera ture monitori ng in a location
representative of the coldest location
(3) accommodate the integrity testing of the proximal filter, either in situ or out of place
(d) lf CIP of the gas fil ter assembly is specífied, provisions shall be made in the design for removal ofthe filter
element or elements prior to the CIP. Filter e lements shall
be reinstalled prior to sterilízation of the filter assembly.
SD-5.6.4.10 Valves
(a) Valve design a nd selection for service shall follow
MC-3.3.2.3(a) and Part 5D as a ppropriate. The application
of a s pecific valve type for a given service s hould be agreed
on by the manufacntrer and owner/user.
(b) Hygienic valves shall be used inside t he sterile
boundary.
(e) Diaphragm valves a re acceptable for hygieníc fl uid
service.
(d) Buttertly va lves may be used as part of the sterile
bo unda ry when pipi ng/tubi ng is larger tha n 2 in. in
diameter.
(e) Ball va lves may be used outs ide the ster ile
boundary to establish positive isolation.
(jJ Pressure relief devices or ru pture disks of hygienic
design may be used as part of the sterile boundary.
(g) lf the lyophilizer is designed for isolation between
the chamber and condenser, the isolation valve may take
the form of a rn ushroom valve, butterfly valve, or other
proprietary va lve design.
SD-5.6.4 .11 lnstruments
5D- 5.6.4.9 Doors and Door Seals
(a) Ali instruments within the sterile boundary should
conform to a li applicable sections of Part PI, including
Pl-2.1, Pl-2.1.2(c), Pl-2.1.2(f), and Pl-2.2.2.
(b) lnstr umen ts in p rocess contact sho uld be o f
hygienic design.
(e) lnstrument probe s urfaces and side port penetrations shall be oriented for drainability.
(d) lnstruments installed within the sterile boundary
should be designed for CIP and sterilization. lnstruments
not designed for CJP should be re moved for cleaning and
reinstalled for sterilization.
(e) Locations with product-sensing instruments (e.g.,
t hermoco uples and RTDs) and wire lead-throughs
should be considered whe n designing for cleaning and
sterilization.
(J) lnstrumentation with integral seals or diaphragm
seals is preferred within the sterile boundary. The risk
of using instrume ntatio n without integral seals or
diaphragm seals (e.g., Pirani gauges) should be assessed
based on the risk to product quality as determined by the
owner/user.
(a) Lyophilizer doors and door seals shall be des igned
to withstand vacuum, cleaning, a nd sterilization conditions.
(b) Lyophilizer doorsshall be accessible, cleanable, and
replaceable a nd should be capa ble of undergoing inspection without dismantling.
(e) For multiple-door systems, the doors shall be interlocked to allow the opening of only one door a t a time
during normal operation.
(d) Doors and locking hardware that interface with the
clean room should not be retracted to uncontrolled space.
(e) Both sliding and swing door designs are acceptable.
(j) Door seals can be made with either static or inflatable sea Is. Static seal groo ves that hold the sea! may be on
either the door or the chamber.
(g) The sea) groove may be set back from the cha mber
flange edge to keep the sea) in position during vacuum
conditions.
(h) Compression of a single static sea l to achieve a
metal -to -meta l co ntact is p refe rred to avoid a ga p
between the door and chamber vessel.
(i) The door static-seal design s hall provide access for
manua l sanitization as the seal face under compression
does not permit penetration of sterilizing agents.
0) A combination (static a nd inflatable) seal design
with the statíc seal círcumscrib ing the inflatable seal
p rov ides for penetration of sterilizing age nts across
th e sealing face of the intlatable seal.
SD-5.6.5 Design for Bloburden Control. Lyophilizers
des igned for b iobu rden control sho uld co nsider the
following:
(a) pressure or vacuum hold testing in preparation for
the bioburden reduction process. See SD-5.6.7 for vacuum
integrity testing.
127
ASME BPE-2022
(b) evacuation of air from the chamber and condenser
vessels to reduce the potential forairto be trapped during
the bioburden reduction process. Effective air evacuation
may be achieved through the use of a liquid ring vacuum
pump or similar.
(e) for the purpose of identifying a reas that should be
exposed to sterilizing agents, the following areas within
the chamber and condenser vessels define the sterile
boundary as indicated in Figure SD-5.6.5-1:
(1) the inside surfaces of the cha mber vessel to the
chamber door isolation seal.
(2) the inside surface of the condenser vessel to the
condenser door isolation seal.
(3) the chamber a nd condense r drains to the first
isolation drain valve.
{4} the vacu um pump inle t co nne ction in t he
condenser vessel to the first isolatio n vacuum valve
closest to the condenser vessel.
{5) the vacuum break/gas inlet line to the sterile gas
fil ter. lfredundant st erilizing filters in series are used, the
sterile boundary ends at the membrane of the fil te r farthest from the chamber vessel.
{6) the CIP/SIP inlet lines to the first CIP/SIP isola·
tion valve that is closed during the lyophilization process.
(7) the sealing surface on ali instruments connected
to the chamber a nd condenser vessels.
(8) thermocouple/RTD seals connected directly to
the chamber a nd condenser vessels.
{9} theexposed surfaceofthe pressure reliefvalve or
ru pture disk.
(3) Nozz les a nd o ther appurtenances that are
clea ned by li quid spray in g shou ld allow co mp lete
coverage.
(4) Lyophilizer inte rna Is should be designed to avo id
low points where fluid can be trapped.
SD-5.6.5.l Dralnabillty
(a) Interna! liquid distribution pipingshall be sloped to
meet the requirements of GSD2 for drainability.
(b) Exte rna! liquid distribution pipingshall be designed
with val ve actions that facilitate draining. The pipe slope
shall meet the requirements of GSD2.
(e) The liq uid leve! in t he chamber and condense r
vessels should be minimized during once-through CI P
by correct sizing of the drain and by providing slope
to the respective drain. A CIP drain pump may be used
to assist draining of the chamber and condenser vessels.
(d) When recirculated CIP is used, recirculated systems
shall be draina ble, including pump casings.
(e) The chamber and condenser ves seis shall be draina ble.
(1) Process contact surfaces shall be sloped to meet
the requirements of GSD3 fordrainability ofCIP fluids and
to prevent t he collection of conde ns ate during the
steaming processes.
(2) Interio r surfaces of nozzles penetrating the
vertical walls of the vessel shall be sloped to meet the
requirements of GSD3.
(3) The íloor ofthe vessel shall be sloped toward the
drain connection to meet the requirements of GSD3,
unless otherwise agreed to by the manufactu re r and
owner/user.
{d} Interna/ Connections and Fasteners
(1) Threads sealed by an 0 -ring or hygienic gasket
are accepta ble. The use of exposed threads wi thi n the
lyophilizer ste rile boundary should be avoided. lf other
mea ns of fastening are no t practica!, the use of
exposed threads may be permitted with the agreement
of the owner/user. The su rfaces of ex posed t hreads
should be among those assessed for cleaning a nd penetration of sterilizing agents.
(2) For process contact surfaces, the use of pins,
clevis rods, snap rings, a nd cli ps may be requ ired to
mo u nt ha rdware ins ide the ste rile bou nda ry b ut
should be minimized and agreed on by the owner/
user. The surfaces of these fasteners should be a mong
those assessed for cleaning and penetration of ste rilizing
agents.
(3) Socket head cap screws a nd counterbored holes
inside the sterile boundary shall only be used with the
agreement of the owner/user.
SD-5.6.5.2 Cleanlng. The following requirements
a re for CIP of lyophilize rs:
(a) Systems used to clean lyophilizers shall conform to
SD -6.3.3. Cleanability requirements of SD-2.4.2 are appli·
cable to lyophilizers except for SD-2.4.2 (b)(1 ), which does
not apply to lyophilizer shelves.
(b) lt is accepted practice to use water as the CIP fluid
for cleaning water-soluble compounds. Water for injection
shall be used forthe final rinse in aseptic processingappli·
cations.
(e) The c ha mber vessel, which includes interna!
shelves, should be cleaned via interna! spray devices
designed to provide coverage of targeted surfaces. Risk
to product qua li ty should be considered when determini ng the requi red coverage. The acceptance criteria
fo r coverage shall be agreed to by the man ufacturer
and owner/user. Nonmandatory Appendix L provides
a n acceptable procedure forspray device coverage testing.
{d) The process contactsurfaces within the condenser
vessel may be clea ned via interna! spray devices to
provide the coverage agreed on between the manufacturer a nd owner/user.
(e) 8ranch Connections
(1) The provisions of SD-3.1.2.2 are applicable to
liq uid-service process contact piping, leading to the
lyophilizer.
(2) Nozzles within the sterile boundary should be
designed to allow for full exposure to the sterilizing agent.
128
ASME BPE-2022
Figure SD-5.6.5-1
Lyophilizer Sterile Boundary
(22)
lnstrument sealing surfaces - - - - on chamber and condenser
Sealing surface o f pressure relief
va lve on chamber
Sealing surface of
Thermooouple/RTD seals
pressure relief
vatve on condensar
connected to chamber
and condenser
Vacuum pump inlet
connection to the
first isolation valve
lnside
Condensing plates
or coils
Shelves
lnside condenser
Vacuum break/gas
inlet line to sterile
gas filler
Condenser
Chamber
Chamber and condenser drains up to
first isolatio n valve
(e) When recirculated CIP is used, recirculated systems
shall be capable of removing residual chemicals and debris
during the final rinse.
(d) if cooling and drying are accomplished with the
introduction of a process gas with open drains, a positive
pressure differential shall be maintain ed to preserve the
sterile boundary during this operation.
(e) temperature mon itored throughout the SIP cycle
should include coldest (worst-case) locations. lf routine
monitoring of worst-case locations is not practica!, the
temperature of locations that have been correlated to
the actual worst-case locations may be monitored instead.
{f) to minimize cold locations d uring SIP, horizontal
penetrations should be sloped to allow condensare to
drain.
SD - 5.6 .5.3 Thermal Sanitization/Sterilization.
When designing lyophilizers for SIP
(a) steam should enter the lyophilizer at only one point
ata time to minimize the potential to trap air or condensate. lf steam needs to enter through multiple locations
simul taneously, the design should create flow paths that
avoid air entrap ment. The design should ensure that
condensate will freely flow toward low-point drains.
(b) a dual control design may be used to deliver high
steam flow rates thatareoften required during the heating
phase and to maintain tight control of temperanire and
pressure during the exposure phase. For example, one
regulator or control valve may be used for the heating
phase and a separa re regula tor or control valve may
be used for tight control during the exposure phase.
(e) a vacuum drying phase should be used to eliminare
any condensare remaining within the sterile boundary
following SIP.
SD-5.6.5.4 Chemical Sanitization/Sterilization.
When des ign in g lyoph ilizers for sterilization with
hydrogen peroxide gas under vacuum
(a) the system should be designed to be dried and have
a surface te mperature that meets the supplier specifica tion for the hydrogen peroxide supply system (typically
between 59°F (lSºC) and 176°F (80°C) ] prior to the start
of the sterilization process.
(b) the system should be designed to verify that the
residual hydrogen peroxide levels are below the establis hed thresho lds, after t he sterilization process has
been completed. Threshold levels should be agreed on
129
ASM.E BPE-2022
transfer lines, vent lines) and which cleaning methods
(e.g., CIP, COP, water rinses) and sanitization methods
(e.g., chemical sanitization, SIP, hot-water flush) are to
be used. When a sol ut ion steril izing-grade filler is
SIP'd wi th t he sys tem, the s terile en velo pe sha ll
include the filter membrane. In practice, this requires a
design that achieves sterilization conditions across the
filler membrane.
For systems that require closure, controls to achieve
and maintain a functionally closed system after mixing
may include
(a) equipment to achieve required bioburden reduction in prepared solutions (e.g.. sterilizing-grade filters.
HTST, sterilization vessels)
(b) technologies that pre pare equipment for use (e.g.,
CIP, SIP, use of gamma-irradiated single-use components)
(e) procedures and designs to maintain control during
processing and holds after bioburden reduction (e.g.,
system closure after sanitization, drying equipment for
holds, and hold and processing time limits)
by the owner/user for both opera tor's safety and the
potential impact on the product quality.
SD-5.6.7 Testing. The following requirements are for
leak-rate (vacuum integrity) testing:
(a) Lyophilizers designed for aseptic lyophilization
processes shall be designed to meet lea k-rate testing
criteria as agreed to by the owne r/use r. The sterile
boundary should be leak tested before aseptic operations
begin. The leak rate is calculated as follows:
Q = '1PV
Lit
where
Q
V
= leak rate, mbar-L/s
= the lyoph ilizer syste m volume subject to the
vacuum, adjusted to exclude the volu me occupied
by interna! hardware, L
liP = the absolute pressure rise during the test, mbar
lit = the test duration, sec
(b) Leak-rate testing should be performed on a clean,
dry. and fully assembled and insulated system with the
condenser coo ler in operati on to cap ture resid ua l
vapor. Typically, leak rates less than 0.02 mbar-L/s are
acceptable for new installations. Leak-rate tes ting is
intended to confirm vacuum integrity of the system.
(e) Leak-rate tests are performed at high vacuum con·
ditions with an absolute pressure typically on the order of
0.01 mbar.
{d) Sufficientstabilization time will avoid misinterpre·
tation of the vacuum leak rate due to virtual leaks. Virtual
leaks are identified by a leak rate thatstabilizes over time.
(e) Individual component assemb li es t hat are
subj ected to vacuum conditions should be helium leak
tested prior to final installation.
SD-5.7.2 System Design
5D-5.7.2.1 Contamination Control. Measures should
be taken to contain powders that are added to mixi ng
tan ks and to conta in aerosols that may be generated
during so lution preparation to mitigate the risk of
cross-contami nation between operations. The owner/
use r s hall assess the risk of cross -con tam ina t io n
between operations. Controls to mitigate the risk of
cross-contam ination may incl ude
(a) physical separation (e.g., separate rooms. isolators)
(b) airflow controls (e.g., dust collection systems, filtration of circulated air, flow direction)
(e) use of closed-process systems
( d) temporal separation
(e) procedural separation
The owner/ user shall specify requirementS for mitigatio n of risks from environmenta l conta mination and
growth of adventitious agents such as bacteria, fungí,
and vinises in solutions during processingand hold times.
SD-5. 7 Solution Preparation Systems
Solution preparation systems are used for the preparation, storage, and distribution of buffer solutions. media
solutions, and other reagent5 used in bioprocessing,
formula tion, and filling opera tions. Syst ems may
include components for t ransfer and mixing of solids
and liquids (e.g., agitators, in-line mixers, vacuum trans fer
equipment, intermediate bulk containers). The systems
may also include tanks/vessels for solution preparation
and for solution storage. Systems may also include compo·
nents designed specifically for bioburden reduttion or
solution conditioning. Examples ofthese include filtration
systems and thermal cond itioning systems such as ultrahigh-temperature/h igh-temperature short-time (UHT/
HTST) systems.
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SD-5.7.3 Design for Bioburden Reduction
SD·S.7.3.1 Filters. Systems used for buffer distribution may require a fil ter to reduce bioburden during transfers to downstream systems, particularly when the buffer
is growth-promoting or is transferred to a holding system
before use.
5D-5.7.3.2 Preparation Tanks. Preparation ta nks
may be des ign ed for ope rations t hat a re briefly
exposed to the room environment (e.g., add it ion of
reagen ts t hrough an ope n po rt) when app ropriate
meas ures are exercised for biobu rden co nt rol and
other pa rt ic ula te co nta minat ion (e.g., flltration to
reduce bioburden after reagentS are dissolved).
SD-5.7.1 Operating Capabilities and System Function. The owne r/ user s hall define wh ich process
contact surfaces require cleaning and sanitization (e.g.,
vessel int ernals, solids t ransfer equipm ent, solu tion
130
ASME BPE-2022
SD-5.7.3.3 Tanks for Long-Term Storage. Tanks
u sed for long-term storage of solutions should be designed
to be sterilized unless the intended solution is bactericida!
or bacteriostatic.
(b) The ways of providing a single -pass rinse include
{1) d irect connection supp ly from a utility water
system with hygie nic safegu ards to prevent backflow.
lf a direct utility connection is used, the design s hould
mitigare the effect of variat ion in supply pressure (e.g.,
dueto draw by other users) and its impactan the flow rate.
(2) use of a water break-tank. The break-tank s hall
be drainable and vented. Rinse water from the break-tank
shall not contribute to the soiling or bioburden load in the
cabinet.
(e) The hydraulic conditions (i.e., pressure and flow
rate) for the rinsi ng phases s hall be consistent with
those established for washing phases to ensure consisten!
rinsing of the washable items, the chamber interior, and
the complete hydraulíc círcuit.
SD -5 .7.3.4 Thermal Sanitization/Sterilization.
Systems used for aseptic processing s hall have a li s urfaces
that contact ste rile process streams downstream of the
biob urden control device capable of being sterilized.
This incl udes interfaces between compone nts that are
sterilized separate ly.
SD-6 PROCESS SUPPORT SYSTEMS
SD-6.l Cabinet Washers
SD-6.1.1 General. This section describes the requirements for washers that are designed to clean various
materials and components s uch as glassware, drums,
contai ners, hoses, pa ll ets, and accessories (washable
items) that are not cleaned in place. Requirements in
t his section are intended to be applied to cabinet
washers, but may be applied to other types of washers
as appropriate.
(a) Cabinetwashers shall be fully automatic and should
be capable of mul tiple cycle types for various load conditions. Cabinet washers may be designed with an integ rated che mi cal add ition system o r receive cleaning
solutions from a CIP system.
(b) Cabinet washers shall include racks or holdi ng
systems designed to enable repeatable exposure of washable items to cleaning solutions.
(e) The documentation require ments of GR-5 are applicable to process contact components/instruments of
cabinet washers.
SD-6.1.4 System Design
(a) Materíals of Construction
(1) Process contact s urfaces shall conform to the re quirements of SD-2.4.1.
(2) Ali welded metallic process contact surfaces s hall
be passivated in accordance with SF-2.6.
(3) Externa! s urfaces of the washer cabinet shall be
fabricated with material that is resistant to cleaning and
sanitizing agents as specified by the owner/user.
(4) Process contact po lymeric materials shall
conform to Parts MC and PM.
(5) Process contact metallic materials s hall conform
to Part MM .
(b) Surface Finish. The surface finishes for the interior
s urfaces of the chamber, wetted process contact tubing.
and exterior surfaces exposed to cleaning solutions s hall
be spec ified by t he owner/user usi ng designations
p rovided in Table SF-2.4.1-1 . Electropol is hing is not
required.
SD-6.1.3 Operating Capabilities and System Function
SD-6.1.4.l Wash Chamber
(a) Cabinet washers shall be capable of deliveri ng
cleaning sol utio ns and of the s ubsequent rinsing of
cleaning solutions from washed surfaces.
(b) Cabinet washers s hould have the ability to perform
the following general phases during the cycle:
{1) prewashing
(2) washing
(3) rinsing
(4) final rinsing
(5) drying with heated filte red a ir
(6) cooling with filtered air
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(22)
(a) The interior s urfaces of the cham ber are considered
process contact s urfaces. These surfaces, which have the
potential to drip onto washed items, s hall have complete
spray coverage (see SD-6.1).
(b) The interior of t he chamber shall co nform to
SD-2.4.2. In te rna! s u rfaces t hat may be difficu lt to
c lea n (e.g., w hee ls, cabling, ex te rna ! s ur faces of
exposed hygienic-cla mp connections) s hould be minimized and assessed for the risk to product quality.
(e) Ali interna( s urfaces s hall be sloped for drainability
with a slope agreed on between the owner/u ser and fabricator. Where possible, a slope of not less than 'la in./ft (10
mm/m) is recommended.
(d) Externa( surfaces should be insulated to minimize
heat transmission and promote cleaning and drying.
(e) Breastp lates, re inforci ng pads, dou bler plates,
poison pads, etc., which are required for welding dissimilar mate rial to the chamber, s hould be of the same material as the chamber.
SD-6.1.3.l Rinse Requirements
(a) The final rinse step may be performed using recirculated water integrated with drain steps oras a singlepass rinse (or series of single-pass rinses) to remove residual cleaning solutions. The final rinse water at the outlet
of the washe r s ha ll meet the owner/user's acceptance
criteria (e.g., conductivity, total organic carbon, cycle
time).
131
(22)
ASME BPE-2022
(/) Lubricants shall not be used where they may come in
contact with cleaning solutions 0 1· washable items.
(3) Loading racks may be d es igned to distribute
rinse and clean ing sol utions to interior a nd exterior
surfaces of the washable items.
(4) Loading racks should have a surface finish that
meets the surface finish requirements of the cha mber.
Surface finish veri fication may not be possible for ali
components of the loading rack.
(5) The loa ding rack ma nifol d fabrication shall
conform to SD-3.1.2.3.
(6) Loading rac k des ign co nside ra tions sho uld
include the disassembly required forinspection a nd mainte nance.
SD-6.1.4.2 Chamber Openi ngs
(a) Nozzles that are designed to be cleaned by a spray
device should have the smallest l/d ratio practical. For
non-flow through nozzles. an l/d of less than 2 is recommended (see figure SD-3.4.2-1).
(b) Sidewalls and chamber-ceilíng nozzles should be
fl ush wi th th e in te ri o r of t he c ha m b er (see
Figure SD-3.4.2-5).
(e) Blank covers shall have the same surface finish as
the chamber internals.
(d) Process valves sha ll meet the requireme nts of
MC-3.3.2.3.
(e) Sample valves shall meet the requ ireme nts of
SD-3.11.2.1.
(/) Sight glasses on the chamber shall meet the requirements of Figure SD -3.4.6· 1. Sight glasses sho uld be
designed with the smallest L/d practica!a nd should incorpora te cleanable seal des igns.
SD-6.1.4.5 Alr Drying, lntake, and Exhaust Systems.
Where specified by the owne r/user to dry washed items,
the following provisions a re applicable:
(a) The air intake system shall be filtered. A prefilter
a nd HEPA filter system a re recommended to protect the
washed ite ms.
(b) The drying system shall provide heated, filtered air
to the chamber, the hydraulic circuit, and in-line compo·
nents.
(e) The filtered air used for drying may be supplied
from a controlled or uncontrolled environment.
(d) Temperature and humidity variability of intake air
should be considered in system design.
(e) The exhaust ducting should be designed to direct
condensate to a drain.
SD-6 .1.4.3 Washer Door and Door Seal s
(a) Washer doors and door seals shall be designed to
prevent wash fluid leakage during the entire wash cycle.
(b) l'or multiple-doorsystems, the doors shall be interlocked to allow the opening of only one door ata time for
loading and unloading.
(e) Both sliding a nd swing door designs are acceptable.
(d) Doors that interface with classified clean ro01ns
should not be retracted to an uncontrolled space.
(e) Construction of the door shall meet SD-2.4.1.
(/) The interna! surface finish of the door shall be the
same as specified for the chamber interna! surfaces.
(9) Solid or inflatable door seals shall meet the requirements of SD-2.4.1.1 (e.g.. conforming to FDA 21 CFR 177
and USP Section <88> Class VI).
(h) Refer to Pa1t MC for specifications of seals.
(22)
SD-6.1.4.6 Spray Systems. Design of spray systems (22)
in cabinet washers requires the integration of ma nifolded
spray d evices in the cha mber with those installed in
loadi ng racks. Spray systems in cabinet washers may
use both s t a ti c and dy na mic spray d e v ices tha t
conform to SD-3.9.
(a) Loading-rack spray systems may have interchange·
a ble spray devices to accommodate a va riety of washable
ite ms in a single rack.
(b) Translational/reciprocating spray devices in the
cabinet using mechanica l devices (e.g., pulleys and
PTFE sheathed cables) should be designed for ease of
disassembly for inspection and maintenance.
(e) Mechanical devices used in the chamber shall be
compatible with the process fluids a nd shall be cleanable.
SD-6.1.4.4 lnternal Components
(a) Washer cabinet interna! compo nents include
loading racks and supports, thermowells, spray manifolds,
etc.
(b) Weld-in thermowells (see Figure SD-3.4.3 ·2, illus·
trations (e) and (t)] shall have the same finish as the
chamber internals.
(e) l,oading racks/accessories
(1) The racks are designed to supportthe cleaning of
specific washable items. The rack des ign should be verified to provide complete spray coverage for washable
items defined by the owner/user in an a rra ngement
for which the loading rack is designed.
(2) Load ing racks shall secure the washable items
during the wash cycle.
SD - 6. l.4.7 Chem lcal Additlon System s. When (22)
cleaning solutions are not provided by a CIP system,
the following provisions are applicable:
(a) A number of chemicals that function as pH adjusters. emulsifying agents, or soil re movers may be added
during the cabinet washer cycles. The design considera·
tions should include positive identification of each chemical delivery and connection.
(b) Concentrated chemicals may be delivered to the
washer from bulk distribution systems or from loca l
holding containers. The design of concentrated chemical
delivery and storage systems should consider minimizing
human contact.
132
ASME BPE-2022
(e) Design of concentrated chemical storage and distribution components should consider safety provisions.
(d) The design should include monitoring of adequate
bulk chemical supply (e.g., leve!) forthe entire wash cycle.
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SD-6.1.5.2 Dralnability
(a) The chamber drainability should be verified during
fabrication. Verification methods a nd acceptance criteria
for drainability shall be agreed on in advance by ali the
parties.
(b) lnstrument probes and sidewall penetrations (see
Figure SD -3.4.2 -2) shall be sloped for drainability, unless
the instruments used require horizontal mounting (see
Figure SD-3.4.2 -3).
(e) Loading racks shall be drainable.
SD-6.1.4.8 Recirculation Pumps
(a) The pump shall have sufficient capacity (flow rate
and pressure) for ali spray confígura tions used in the
washer.
(b) Pumps shall conform to SD-3.3.2.
(e) Pump seals shall conform to Part MC.
SD-6.1.5.3 Cleaning
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SD-6.1.4.9 Heat Exchangers
(a) The design should enable multiple chemical additions during the prewashing and washing processes.
{b) Cleaning solution temperature shall be controlled
and monitored during washing a nd rinsing phases.
(e) The pressure and flow rates of cleaning solutions
supplied to dynamic and static spray devices within the
cha mber or loading racks should be monitored.
(d) lf cleaning solutions are recircula ted during the
cycle, the recirculation pump shall meet the requirements
of SD-3.3.2.
(e) The design should provide final rinse water atan
elevated temperature fe.g.,> 149º F (65ºC)] for sanitization
and improved dryíng efficiency.
(f) The system shall be designed to provide a nalytical
verification of final rinse water quali ty (e.g., conductivity,
total organic carbon).
(a) Heat exchangers included in cabinet washers to
heat cleaning solutions, rinse water, etc., shall conform
to SD-3.6.
(b) Heat exchangers using stea m ora thermal liquid
may include shell-a nd-tube, coil, or tube types.
(e) Electric heat exchangers may be director indirect
immersion type heaters.
( 22)
SD-6.1.4.10 lnstrumentation
(a) Ali process contact instruments should conform to
the applicable sections of Part PI.
(b) The design shou ld e nable operators to monitor
process paramet ers wit hout having t o pass t hrough
changes in room classifications.
SD- 6.1.4.11 Interfaces. Where the chamber interfaces with the clean room, the extern a! surfaces shall
meet the owner/user's specified requirements.
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(22)
SD-6.1.6 Deslgn for Servlceabllity, Examlnatlon, and
Operatlon
SD-6.1.5 Deslgn for Bloburden Cont.rol
(a) Cab inet washers should be designed to enable
access for inspection a nd serv ice of co mponents that
are subject to wear and to allow periodic calib ration of
instruments.
(b) Mechanícal co mpon ents and instrum e nts t hat
require maintenance may be located in an unclassified
space where the mainte nance can be performed.
(e) The washer design considerations should include
in tegra tion wi th the space where mai ntena nce is
performed (e.g., minimizing moisture dueto condensation) .
(d) Pumps should be designed a nd configured to ena ble
access for re moval, inspection, a nd maintenance.
(a) Cabinet washers shall conform to the fabrication
requ irements of SD-2.4.1.
(b) Tubing within the process contact boundary should
be orb ita l-we lded t ubing where poss ible and shall
conform to Part MJ.
(e) Ali wetted process co ntact surfaces sha ll be of
hygienic design per the applicable sections of this Standard.
SD-6.1.5.1 Branch Connections
(a) The provisions of SD -3.1.2.2 are applicable to
liqu id -service process contact piping lead ing to the
chamber and delivering cleaning solutions to the spray
manifolds.
(b) Liq ui d-service branch connections with an L/d
greater than 2 shall be provided with low-point drains
that a re opened between each phase of the washing
cycle to avoid cross-contamination.
SD-6.1.7 Testing. The test requirements shall be
defined by the owner/user and agreed to by the manufacturer, and may include tests beyond those described in
this section. These tests apply to newly installed systems
and to modificarions of existing systems (e.g., the addition
of a load ing rack to an existing system).
SD-6.1.7.1 Spray Devlce Coverage Test. Cabinet
was hers shou ld be t es ted to confirm complete spray
coverage ofthe specified washable items and the interior
process contact surfaces of the washer cha mber. The
133
(22)
ASME BPE-2022
spray device coverage tes ting described in SD-7.1 is
applicable to cabinet washers. The spray device coverage
test procedure described in Nonmandatory Appendix M
may be used for cabinet washers with the following additional considerations:
(a) Testing should include e mpty configurations (i.e.,
loading rack only).
(b) Testing should include racks loaded to capacity.
(e) lt is acceptable to bypass the drying phase of the
cycle to examine the wet condi tions. lf parts are dry
when inspected, they should be gently rewetted with
a mbient or cold water to observe any residual riboflavin
fluorescence.
(d) The sequence in which parts are examined should
be documented to prevent false positive results due to
tra nsfer of residual riboílavin from one washable ite m
to a clean washable item.
SD-6.2.3.1 Hard Goods Cycles. "Hard goods" refers
to goods such as me tallic instruments, containers, a nd
glassware. Effective remova l of noncondensable gases
is required fo r effective autoclaving of hard goods.
Hard goods may be wrapped or unwrapped. Unwrapped
goods can often be effectively autoclaved using either a
single vacuum pull or gravity air displacement. These
goods can sometimes be autoclaved a t higher temperatures. Multiple vacuum pulse preconditioning is required
for wr a pped goods to ensu re p rop er evacuation of
nonco nde nsable gases from both the autoclave
chamber and autoclaved goods. Steam sterilizers used
fo r the processing of wrapped or porous goods shall
be ab le to pull vacuum to leve ls below 1 psia [6 9
mbar) a nd maintain the vacuum with a maximum leak
ra te of 0.1 psi/5 min (6.9 mbar/ 5 min). Cooling. drying
(pulse, vacuum) is an optional cycle step used to dry
goods at the end of the autoclave cycle. Heated pulse
drying is also recommended for the drying of porous
goods suc h as rubber stoppers. Exhaust rates an d
heating rates should be adjustable for pressure-sensitive
materials.
SD-6.1.7.2 Drainability Test. The proposed drainabil ity t est procedure in SD -7.4 for vesse ls may be
applied to cabine t was he rs with the following exceptions/considerations:
(a) lt is not necessaryto fil! the chamberwith theoutle t
closed. The cha mbershould be wetted by liquid delívered
through the spray syste m.
(b) The cha mber drainability test should be performed
without drain pump assistance.
(22)
SD-6.2.3.2 liqu id Cycles . Fo rced air removal
preconditioning is a n optiona l cycle used to evacuate
the noncondensable gases from the autoclave chamber.
Liquid coolíng cycles should be provided to effidently
cool t he autoclave cha mber. Provi ding t he chamber
with overpressure helps prevent the liquid goods from
boiling over during the cooldown p hase. Liqu ids can
a lso be coo led by slow-rate ex ha ust. Hea ting rates
should be adjustable to help compensate for differences
in heating profiles of ite ms in mixed loads.
SD-6.1.7.3 Cycle Performance Test. The performa nce test shou ld de monstra te the ability to clean
loaded items based on an ide ntified list of washable
items. The test should verify re moval of residue from
su rfaces and tha t the fina l rinse meets the specified
wa ter qua lity (e.g., a n acceptable co mpe ndia! water
requirement) at the d rain within a specified pe riod of
time. The test should ve rify that the p rocess contact
su rfaces within the washer are also clea ned t o the
same specifications used for the washable items.
SD-6.2.3.3 Alr Fllter Sterillzatlon. An independent
air filter SIP sterílization cycle should be provided for
the in situ ste rilization of the chambervent filters ensuring
supply of sterile air for cooldown phases of autoclave
loads.
SD-6.2 Steam Sterilizers/Autoclaves
SD-6.2.4 System Design. Materials in contact with (22)
steam shall res ist corrosio n from steam and stea m
co nde ns ate. T he materia ls shall not affect stea m
quality and shall not release a ny substances known to
be toxic or tha t could adu lterate the product. Piping/
tubing and fittings shall be pressure and vacuum tight.
The piping/tubing layout should be designed to eliminare
dead legs within the sterile boundary. Tubing within the
sterile boundary should be orbital-welded stainless steel
tubing where possible and shall conform to Part MJ (Table
MJ-8.4-1) acceptance criteria. Ali process contact surfaces
within the sterile bounda ry including tubing. chamber,
a nd components shall be passivated.
The autoclave shall be e nclosed with paneling that is
resista nt to corrosion a nd is cleanable.
The surface finish within the sterile boundary need not
exceed 35 ¡tin. Ra (0.89 µm). Electropolis hing is not
required for steam sterílization systems.
SD-6.2.1 General. For th is section, "autoclaves" and
"stea m sterilizers" sha ll be used synonymously. This
section describes the requirementS of a utoclaves tha t
a re used in bioprocessing for the steam sterilization of
hard, dry-wrapped, a nd liquid materials.
This section does not pertain to pasteurizers, ETO (ethylene oxide), VHP (vaporized hydrogen peroxide), or CI02
(ch lori ne dioxide) type steri lization equ ipment. The
manufacture r shall define the steri le boundary of the
system.
SD-6.2.3 Operating Capabilities and System Function. Autoclaves should be capable of mul tiple cycle
types for various load conditions. Autoclaves shall only
be used to steril ize the types of goods for which they
a re designed. The most common load types are specified
in SD-6.2.3.1 th rough SD-6.2.3.3.
134
ASME BPE-2022
Elastomers shall conform to MC-3.1 through MC -3.3.
Elastomers shall be resistant to corrosion and to chemical
and the rmal degradation. Elastomers used in autoclave
applications shall be capable of withstanding pressures
of a mínimum of 25 psig a t 266• F (1.7 barg at 130•C).
Seals should meet the testing requirements specified in
MC-4.2.
{22)
S0-6.2.4.8 Jacket. The jacket shall be constructed
using materia Is that are resistant to corrosion and degra dation from steam or clean steam and clean steam condensate, as applicable.
S0 -6 .2.4 .9 lnstrumentation . Autocla ve pressure
and temperature shall be d isplayed atall doors. Ali instrumentS with in the sterile boundary should be of hygienic
design. lnstrumentS shall be capable of being calíbrated
and replaced. The instrumen tation sha ll include the
following:
(a) Temperawre. lndependent temperature elements
(one or two for monitoring and recording andan indepen dent one for controlling temperature) shall be provided.
The chamber temperature recording element should be
located in the chamber dra in. Eac h tempera ture
element shall be accura te to ±0.18º F (0.1 • e) wit h a
sensor response time <5 sec. The element installation
shall not affect the maximum leak rate. The tempera ture
elements shall be temperature and clean steam resistant.
(b) Pressure/Vacuum. Pressure/vacuum instruments
shall be provided . The press ure instruments shall
monitor the chamber and jacket pressures. Provisions
for recording chamber pressure during active autoclave
cycles shall be included.
(e) Date/Time. Provisions for recording the date and
time during an autoclave tycle shall be included.
(d) Recording. Recording may be achieved by paper or
21 CFR Part 11- compliant electronic means.
SD-6.2.4.l Chamber. Autoclave chambers are pressure vessels and shall be pressure and temperature rated
per the owner/user's design criteria with a mínimum
p res su re rating of 25 psig at 266 • F (1.7 barg at
130°C). The chambers shall also be vacuum rated.
For systems used in the processing of materia Is used in
the European market, autoclaves may also be required to
comply with relevant EUcodes [e.g., Pressure Equipment
Directive (PED) and EN-285).
SD-6.2.4.2 Doors. Autoclave door(s) shall be accessible, cleanable, and replaceable, and should be capable of
undergoing inspection withoutd ismantli ng. The door seal
shall be resistan! to clean steam a nd clean steam condensate. The door on the nonsterile side shall be capable of
reopening after closing without undergoing a cycle. The
door(s) shall not be capable of opening during a sterilization cycle. The doors shall be constructed ofmaterials that
are resistan! to clean steam and clean steam condensate.
For multiple-door systems, the doors shall be interlocked
to allow the opening of only one door at a time. The
un loading ("sterile-side") door shall remain sealed in
standby mode. Refer to Part MC for specifications of
seals used in bioprocessing.
S0-6.2.4.10 Interfaces
(a) Drain Temperature. Waste to drain temperature
s hall co nform to ow ne r/user specificat ions . The
owner/user shall specify discharge temperature requirements to the manufacturer.
(b) lnsulation. Externa) surfaces should be insulated to
minimize heat transmission.
(e) Biocontainment Special conditions such as bioseals
may be required for a utoclaves used in BSL-3 a nd BSL-4
applications. Please refer to the Biosafety in Microbiological and Medica! Labs (BMBL) and Centers for Disease
Control (CDC) guidelines for these special conditions.
SD-6.2.4.3 Sterile Air/Vent Filters. Where the sterilization cycle requires ad mission of air into the chamber,
the air should be filtered with a sterilizing filter (0.22 µm
or less). The filter element shall be replaceable. Provisions
for the steam in place of the vent fil ter elementS should be
provided.
SD-6.2.4.4 Steam Traps. Refer to SD-3.12 for requirements of steam traps.
S0-6.2.4.5 Loadlng Carts/Trays. Carts and trays
exposed to clean steam shall be constnicted of materials
resis tant to clean st eam and clean steam condensate.
Carts, trays, and chamber shall be accessible or removable
and cleanable.
{22)
(22)
SD-6.3 CIP Systems
SD-6.3.l General. This section addresses CIP systems
used to clean and reduce bioburden on process contact
surfaces. CIP systems include the CIP skid and the CIP
distribution system. The system shall be self-cleaning
and capable ofdistributing CIP fluids (e.g., cleani ng solutions, rinsewa ter, compressed air) to the targeted process
contact surfaces of a CIP cl ient.
The following terms are defined for this section:
(a) CIP path:thespecific route contacted with CI Píluids
during a CIP cycle (e.g., spray device path, inoculum line
path, addition line path). Multiple paths within a circuit
may be cleaned simultaneously or sequentially.
S0-6 .2 .4 .6 Valves. Valves and sealing materials
located within the sterile boundary sha ll confo rm to
MC-3.3.2.3. Valves within the sterile boundary are typically only exposed to clean steam service and chemical
(s) used during passivation. Exposure to these conditions
should be considered when selecting a valve type for this
application.
S0-6 .2.4.7 Check Valves. Provisions to prevent
back-siphoning into the service feed systems should be
considered.
135
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ASME BPE-2022
(b) CJP client: syste m or equipment (e.g., bioreactor,
buffer hold vessel) targeted for cleaning by a CIP system.
(e) CJP circuit: the sum of CIP paths within CIP clients
that are cleaned as part of a CIP cycle, as well as the CIP
skid, CIP supply, and return distribution system.
(d) CJP phase: a process-oriented action within a CIP
cycle, such as a rinse, wash, or air blow, that can be subdivided into steps and transitions.
(e) CJP cycle: the executed recipe of sequen tial CIP
phases estab lished to provide CIP fl uids to the CIP
circuit, e.g., rinses, washes, and air blows.
{j) TACT: an acronym for the cleaning process parame ters time. action, chemist1y, a nd temperature. The term
•action" refers to kinetic e nergy that drives breakdown
and suspension of residues from the process contact
surface.
circuit. Air blows should be sequenced through the individual CIP paths of a CIP circuit.
SD-6.3.3.5 Surface Treatment Cycles. lf the CIP
system is designed for surface treatment (e.g., derouging
or passivation cycles) of CIP clie nts, the CIP system should
have provisions to introduce and re move associated
chem icals.
SD-6 .3.3.6 Self-Cleaning Cycle. lf a self-cleaning
cycle of the CIP skid is required (e.g.. to clean the CIP
skid after maintenance), the skid design should have
piping that meets recirculation/cleaning requirements.
SD- 6.3.4 System Design
(a) Process contacting portions ofthe CIP system shall
be of hygienic design and fabricated as per SD-3.1.2 and
SD-2.4.3.
(b) Recirculating portions of the CIP system shall be
considered process contact and may be considered
product contact if used to clean product contact surfaces.
Risks (e.g., cross contamination and containment) associated with recirculating CIP systems should be evaluated
a nd addressed.
(e) CIP system materia ls of construction shall be
compatible with the process a nd CIP tluids.
SD-6.3.2 System Performance Requlrements. The
following techn ical requirements or parameters tha t
are essential for· design development shall be defined:
(a) rinse and wash duration range
(b) flow rate and pressure ranges
(e) clean ing agents and their was h concen tra tion
ranges
(d) rinse and wash temperature ranges
(e) final rinse water quality (e.g., TOC, conductivity)
{j) air blow requirements
(g) sampling locations
(h) drain limitations
Refer to SD-5 for CIP client cleaning requirements.
SD-6.3.4.l CIP Skld . A CIP skid is a system that
pre pares, delivers, controls, and monitors CIP solutions.
(a) The following parameters shall be monitored and
controlled:
(1) time: rinse, wash, air blow, or drain duration
(2) action: CIP supply tlow rate
(3) chemistry: CIP wash solution conce ntration of
deaning agents (e.g., by conductivity)
(4) temperature: CIP supply temperature
{b) The following parameters shall be monitored:
{1) CIP return temperature
(2) final rinse water quality (e.g., conduct.ivity. TOC)
(e) The following parameters should be monitored:
{1) CIP supply pressure
{2} CIP return tlow verification
CIP skids may be located in a fixed, centralized location
or may be portable and used adjacent to the CIP client.
When the CIP skid is installed in or moved into a clean
room, the clean room classification shall be addressed
in the selections of both skid surfaces a nd materia Is of
construction appropriate for the e nvironmental requirements.
The CIP skid shall be provided with a physical separation between the water supply and the CIP solutions.
SD-6.3.3 Operating Capabilities and System Function. The CIP system shall be capable of cont rolling the
following:
(a) TACT
(b) multiple water/solution feeds when required
5D-6.3.3.1 Rinse. The CIP system shall be designed
with the capability to provide rinse solu tions at the specified flow, pressure, and temperature to the CIP client.
SD-6.3.3 .2 Wash. When a formulated wash step is
required, t he CIP system shall be designed to dose and
mix cleaning agents to prepare wash solutions. The CIP
system shall be capable of supplying the wash solution
a t the specified cleaning agent co ncentration and
tempera ture.
SD-6.3.3.3 Drain. The CIP system shall be drainable.
The CIP system should support the use of multiple drain
paths ifrequired (e.g., biowaste inactivation system, waste
neutralization system). Where the CIP distribution or CIP
client cannot be drained, provisions for a motive force
such as a pump or pressurized gas (air blow) shall be
included for removal of residual liquid.
SD-6.3.4.l.l Wash/Rlnse Vessels
(a) A CIP system can include one or more vessels (e.g.,
separate wash and rinse vessels). Vessels can be used to
provide a physical separation between the water supply
and the CIP solutions.
SD-6.3 .3.4 Alr Blow. The CIP system should be
designed to provide pressurized air as a mot ive force.
if required, to ass ist in removing liquid from t he CIP
136
ASM E BPE-2022
( 22)
Figure S0- 6.3.4.1.1-1
Conical Vessel With Reduced Bottom Outlet,
or Tulip Ta.nk
(g) Vent filters on CIP skid vessels should be d esigned
to mitigate the risk of foam or moisture blinding the fil ter
eleme nt (e.g., heati ng the filter housing, bypassing the
filter during filling).
(h) The CIP skid vessel used for final rinsing should be
provided with a sterilizing-grade vent filte r ifthe vessel is
vented into unclassified space.
SD-6.3.4.1.2 Heat Exchanger. Heat exchangers
shall be designed to meet the full range of CI P cycle duties.
CIP return
SD-6.3.4.1.3 Supply Pump
(a) The CIP skid shall have flow control, either via
pump output or by means of ílow control valves.
(b) The pump a nd its associated piping (e.g., parcial
flow diversion) shall be designed to meet ali flow rate
and pressure requirements for ali CIP circuits.
Vonex breake
SD-6.3.4.1.4 CIP Return
(a) lf CI P íluids are returned to the CI P skid, motive
force is required (e.g .. pumps, eductors, gravity, or top
pressure).
(b) The CI P return sampling system should be designed
for two-phase ílow (i.e., liquid-gas mixtures) or vacuum
conditions where applicable.
~ CIP supply
S0-6.3.4.1.5 CIP Return Eductors. A CIP return
educator is a venturi device that provides motive force
(i.e., vacuum) to assist CIP íluid return.
(a) CIP return eductors shall be drainable.
(b) Design factors that should be cons idered when
us in g CI P r et u rn ed ucto rs include vapor p ressu re,
return line size, elevation. viscosity, and ílow rate.
(e) When CI P return eductors are used, the potential for
foaming should be considered.
(b) The rinse vessel should be sized to ensure uninter·
rupted delivery ofrinse solution during the rinsephases of
the CIP cycle.
(e) The wash vessel should be s ized to p rovide
adeq uate volume for the d uration of the was h step.
Sizing factors to considerare holdup volume for recirculation steps, total wash volume for once-through steps,
and wash solution losses.
(d) Where recirculation of wash solutions is requi red, a
no-foam inlet, tangential inlet, or dip tube should be used
for the return of wash solu tions to the wash vessel to
reduce the risk of foaming.
(e) The vesse ls s ho uld be p rov ided w it h vortex
breakers a nd adequate outlet sizes. Vessels should also
be located close to the CIP supply pump to ensure that
t he available ne t positive s uction hea d (NPSH) is
greate rthan required NPSH. lf removable vortex breakers
are installed, the design shall account for the effect of
vibrations a nd forces on the vortex breaker a nd vessel
wall.
(f) Air entrainment in the CIP return liquid can impact
CIP supply pump performance. CIP ret urn systems using
eductors or liquid ring pumps often have a high percentage of ai r in t he CIP li quid. Wash vessels sho uld be
designed to enha nce gas/liquid separation and provide
adeq ua te NP SH, as we ll as to r educe CIP cí r cuit
volu me. An example of a vessel having those features
is a conical tank with a tangential inlet and cylind rical
reduced diamete r bottom section (i.e., tu lip ta nk; see
Figure SD-6.3.4.1.1-1).
S0-6.3.4.1.6 Chemical Delivery. The CIP skid
chemical delivery does not require sanita ry design. Acceptable me teri ng me thod s for che mica l de livery
include one or more of the following:
(a) weight
(b) ílow totalization
(e) duration via mete ring pump or venruri
(d) conductivity
Typically one method is used for delivery, anda second
method is used for confirmation or final control.
SD-6.3.4.1.7 Compressed Air Supply. The CIP skid
may be provided with a clean compressed air supply to
assist the removal of the rinse o r wash so lution.
Compressed ai r shall meet t he q ual ity req uirements
for t he applications (e.g., by install ing a poin t-of-use
filter a t the CIP sk id). The supply press ure a nd flow
ra te shall meet the process requirements. Compressed
air may be supplied a t othe r loca tio ns in t he CIP
circuit to assist removal of rinse or wash solutions.
137
ASME BPE-2022
Figure SD-6.3.4 .2-1
CIP Looped Header (Supply or Retum)
(22)
To/from CIP
To/from CIP
circuit or path #1
circuit or path #2
Zero-static:-\
isolatio n valve ,
Minimum
Capped zero-static
Short-outlet tee (future)
valve (future)
To/from CIP skid
(5) The en tire looped header shall be cleaned during
a CJP cycle.
(e) Transfer Panels. Transfer panels shall be designed
a nd fabricated per SD-3.7.1.
{d) Multiport Va/ves. For this section, a CIP distribution
"multiport valve" is defined as a multiple-valve assembly
fabricated as a single body to minimize l/d values and
enable drainability (see MC·3.3.2.3(a) for details).
(e) Zero·Static Chains (see Fi9ure SD-6.3.4.2-2). For th is
secrion. a CIP distribution "zero-static cha in" is defined as
a manifold of circuit-specificzero-static valves. Provísions
shall be made to tl ush the manifold in a zero-static cha in.
(f) Swin9 Elbows and Pipin9 Spools (see Figure
SD-6.3.4.2-3). Swing elbows or piping spools shall be
connected to adequately supported piping to maintain
line slope and connection alignment.
(9) Mix-Proof Va/ves
(1) Mix-proof valves are double-seat valves with a
drain path between the seats that allows for simultaneous
pl'Ocesses in the two bodies ofthe valve. Mix-proofvalves
shall conform to the general design requ irements in
MC-3.3.2.3(a) and rising stem sea] valves requirements
in MC-3.3.2.3(c).
(2) Jf the process requires cleaning across a single
seat, the valve shall be provided with individual seat lifts.
(3) Mix-proof valve a rrays should be designed to
accommodate draining from the leak cha mber a nd sufficient access for maintenance of the valve internals.
(4) The mix-proof valve fitting-bound portion of
looped header configurations should be installed leve]
to a void low points where liquid may acc um ulate.
Pitch of the mix-proof va lve a rray may result in liquid
SD-6.3.4.1.8 lnstrumentation
(a) The CIP supply flowmeter shall be specified and
installed to measure the flow ra tes of CI P liquids.
(b) To address air in the CIP return, final rinse conduc·
tivity sensors should be located to ensure proper operation in both liquid and mixed-flow conditions ( e.g., by
providing a drainable instrumentation cup, compensated
through instrument settings).
SD-6.3.4.2 CIP Distri bution
(a) General
(1) The use and application of a particular distribu·
tion design or combination of designs should be decided
by the owner/user.
{2) The use of looped headers, transfer panels, a nd
valve types (e.g., divert, mix-proof, multiport, zero-static,
a nd diaphragm) should be considered in the design ofthe
CIP distribution system.
(b) Looped Headers (see Figure SD-6.3.4.2-1)
(1) The dimension from the looped header to the
isolation valve weir or seat s hou ld confo rm t o
SD-3.1.2.2 (see Figure SD-3.1.2.2-1 for d etails). The use
of short-o ut let tees or zero-static valves shou ld be
decided by the owner/user.
(2) Future connections (if applicable) on the looped
header should use capped short-outlet tees or capped
installed zero-static valves.
(3) Looped header connections should be oriented
horizontally when used in CIP return applications.
(4) CJP supply header design should provide fo r
adequate velocity in parallel cleani ng paths ( e.g.. line
size reduction in loop heade r) .
138
ASME BPE-2022
Figure SD-6.3.4.2- 2
Zero-Static Chain
(22)
Minimum
From CIP skid
ToCIP
skid or drain
CIP circuit or path
#1 supply
(22)
CIP circuit or path
#2 supply
(/) CIP return piping shall be designed to maintain
hydraulic balance (supply and return ílow} of the CIP
circuir.
(m) CIP return pumps
(1) CIP return pumps (if required} shall be designed
and fabricated per SD-3.3.2. Cent rifuga ( p umps are
preferred for CIP return ap plications . lf a gas/liq uid
mixture is anticipated, the n hygienic liquid ring pumps
are recommended.
(2) When a vessel is included in the circuit, CIP return
pumps should be placed as clase as possible to the vessel
bottom outlet and at the low point of the circuit.
(3) Provision shall be made to tlush through the
casing drain of CIP return pumps.
(4) CIP return pum ps shall be designed to main tain
hydraulic balance (supply and return tlow) of the CIP
Figure SD-6.3.4.2-3
Swing Elbow Arrangement
To/from
CIP circuit #2
Swing elbow
transition point
To/from CIP skid
To/from
CIP circuit #1
retention in valve bodies and should be risk assessed (see
Figure SD-6.3.4.2-4}.
(5) lf a mix-proof va lve with an exposed sliding stem
is used to divert process solut ion s, it shall allow for
cleaning of the stem s urfaces prior to contacting the
process tluids (e.g., by actuati ng the valve duri ng CIP}.
(h) The distribution piping and components in a recirculated CIP circuit shall be hygienic for design and fabrication as per SD-3.1.2 and SD-2.4.3.
(i) The distribution piping and components in a oncethrough CIP circuit or path (i.e., not recirculated} shall be
hygienic for design and fabrication as per SD-3.1.2 and
SD-2.4.3 upstream ofthe location of cleaning performance
verification.
O) CIP supply piping s hould be sized to ensure that the
fluid flow meets or exceeds the guidelines stated in
SD-6.3.5.2.1 and SD-6.3.5.2.2.
(k) The distribution circuitsshall bedesigned s uch that
fluid ílow will maintaín a positive pressure re lative to the
process drain, preventing backtlow.
circuit.
SD-6.3.5 Deslgn for Bloburden Control
SD-6.3.5.l Drai nability. (Reserved for future
content)
SD-6.3.5.2 Cleaning
SD-6.3.5.2.l CIP Flow Rates for Process Unes
(a) The CIP system shall meet the ílow rate requirements of the CIP client for each path and during each
phase of the CIP cycle.
(b) For effective cleaning, the CIP ílow rate and press ure shall be s ufficient to ensure that the cleaning agent
and rinsing solutions wet targeted s urfaces within the CJP
circuit.
(e) Turbu lent flow is required to clean targeted
s urfaces of the CIP client. Table SD-6.3.5.2.1· 1 details
tlow rate guidelines for solution contact in straight hori·
zontal and vertical lines far line sizes up to 2 in. (50 mm)
139
ASM.E BPE-2022
Figure SD-6.3.4.2-4
Mix-Proof Valve Array
(22)
2 • Top looped header
1 - Bottom looped header
(a} l$0metric Representation
I
I
Top looped header
I
(b) Schematic Representation
GENERAL NOTE: An·ows on top and bottom looped headers point toward fitting·bound section.
140
ASME BPE-2022
(d) l)ynamic flow conditions during routc transitions and
air b)ows may assist wetting.
Table SD-6.3.5.2.1-1
Flow Rates to Achieve
5 ft/sec (1.5 m/s)
(22)
I.D.
SD-6.3.5.2.2 CIP of Process Vessels
Flow Rate
Nominal Slze, In.
In.
mm
g¡un
Lpm
\!,
0.370
9.40
1.7
6.3
¾
0.620
15.75
4.7
18
1
0.870
22.10
9.3
35
11/ l
J.370
34.80
23
87
2
1.870
47.50
43
162
(a) Process vessels s hall be designed to consistently
e nable expos ure of t he interna) s urfaces to the CIP
liquids by spray device or ílooding.
(bJ Dis hed-head vertical vessels s hould have cleaning
solu tions delívered with the majority of flow directed
toward the upper head and sidewall area at the upper
knuckle radius. Cylindrica l horizontal vessels should
have cleaning solutions delivered with the majority of
tlow directed toward the upper one-third of the vessel.
(1) lf a static spray device is used, gravity provides a
sol ution sheeting over the side wall and bottom head
(vertical vessels) or lower s urfaces (horizontal vessels).
{2} lf a dynamic spray device is used, the device may
d irectly spray areas throughout the vessel or rely on
sheeting action.
(3) Figure SD-3.9.2.1 -2 details ranges ofílow recommendations for static spray devices on vertical process
vessels under typical cleaning loads. The recommendations in Figure SD-3.9.2.1-2 ensure sufficient coverage.
(4) The criteria toens ure sufficientcoverage on horizontal process vessels vary with geometry a nd size.
(e) Spray device design and location shall e ns ure
appurtenances such as ma nways, baffles, dip tubes,
agitator imp ellers, and nozzles are co ntacted with
cleaning solution. Some appurtena nces may require a dditional provisions for cleaning.
(d) Spray devices only ensure e overa ge of the exterior
of installed appurtenances a nd equip men t. Appu rtenances that have interior surfaces not reached by the
spray device coverage s hall be cleaned by other CIP
paths or removed and cleaned out of place.
(e) lf a vessel is cleaned with s pray devices, the Huid
leve) should be minimized in the process vessel during CIP.
Proper hydraulíc balance (supply and return ílow) of the
CIP círcuit and sizing of the bottom outlet valve s hould be
considered to minimize fluid leve).
(f) A vortex breaker shou ld be installed to prevent
vortex forma tion that may adversely affect the CIP operation.
(g) Vortex breaker s urfaces shall besloped to eliminate
pooling during CI P and positioned to not adversely affect
the hydraulic balance of the CIP circuir.
(h) For process vessels equipped with an agitator, the
impeller s hould be rotated atan appropriate speed during
the CIP cycle.
without branches, fittings, and oth er in-line components.
These flow rates correspond to a flow velocity of 5 ft/sec
(1.5 m/s), which is well in to t he turbulent range a nd
typical for CIP solutions.
(d) CIP flow rate requirements should be considered in
conjunction wi th other CIP process variables (e.g.,
temperature, chemical concentration, and time).
(e) Air trapped in branches may inhibit ful( contact of
cleaning agent and ri nsi ng solution to those process
contact surfaces. The tlow di rection, line orientation,
line size, and p resence and orientation of branches,
fittings, and other equipment can have a significant influence on the flow rate required to remove air. Adequate
solution contact may be achieved at a flow velocíty of
5 ft/sec (1.5 m/s) wit h 1.5 in. (38 mm) and larger
short-outlet tees (see Table DT-4.1.2 -5). Smaller-diameter
sh ort-outlet tees and tees with longer branches may
req uire velocities greater tha n 5 ft/sec (1.5 m/s) for
adequate solu tion contact. Solution contact in branches
can be enhanced in th e design by
(1) strategic use of zero-static valves
{2} tlow through branch or bleeding a ir from branch
(3) orienting blocked bra nches in the horizontal
position
(4) use of flush-mounted instrument fittings, shortoutlet tees, gauge tees, or mínimum l/d "instrument cups•
for s mall lines
(5) orienting branches so the fl ow of the liqu id
entering the tee is directed toward the blocked brancli
(f) Branches with r isk of incomplete solution contact
should be co nside red worst-case locatio ns that may
req uire local cleaning verification.
NOTE: Factors thatmay mitlgate the risk ofinsufficient cleaning
due to incompJete air remova) from branches include the
following:
(a) CIP flow rates higher than process ftow rates are likeiy
to wet ali surfaces that were soiled.
(b) lnstrumcnrs or other deviccs protruding into thc flow
SD-6.3.6 Design for Servlceability, Examinatlon, and
Operation. CIP return eductors shall be designed to be
removable for examination.
pat.h may create additional local turbulence.
(e) Condensate generated during hot washes or hot rinses
as part of a CIP cyde may provide some additiona1 rinsing of
surfaces.
141
ASME BPE-2022
SD-6.3.7 Testlng. During t he clean ing of pl'Ocess
vesse ls, suffic ien t expos ure shall be confirmed by
coverage testing per SO-7.1 at the site of equipme nt manufacture or after installation or both.
Thermal treatment system example configurations a re
shown in Figures SD-6.4.1.1-1 and SD-6.4.1.1-2.
5 D-6.4. 1.2 Scope an d Purp ose. This sectio n
addresses thermal treatment systems used in biop rocessing to reduce or elim inate viable microorga nisms a nd
viruses in a liqu id u nder continuous flow cond itions
whi le min im iz in g deg radatio n of t he prod uct o r a
product intermediate. Thermal systems may be designed
to ach ieve goals that do not require sterilization of the
process liquid, such as inactivation of viruses or a particula r bacteria! species. Bio-inactivation (waste treatment)
systems (SD -4.4.2) and food pasteurization systems are
not addressed in the scope of this section.
SD-6.4 Thermal Treatment Systems
SD-6.4.l General
(22)
5D-6.4 .1.1 Terminology. The following terms are
used in this section:
average residence time: the volume of the retention tube
divided by the volumetric flow rate. (Average residence
time should aiways be greate r than the required residence
time.)
SD-6.4 .2 System Pe rformance Requ irements. The
following system performance capa bilit ies shall be
defined:
(a) treatment temperature range
(b) required residence time at treatment temperature
(e) process liquid flow rate
{d) discharge temperature range
(e) maximu m heati ng surface te mperatu re, heat
tra nsfer fl uid temperat ure, o r process liquid heating
rate (ºF/sec, ºC/s)
Additional performa nce requirementS may be defined
by the owner/ user. Additional process parameters
required to confirm system capabil ities, including specifying the process tl uid's incoming temperature a nd other
properties, should be provided by the owner/user.
coi/ heat excha119er: a coiled tube for process liquid flow,
inside a shell or a second tube containing heating/cooling
medium.
cooling equipment: heat exchangers ora flash cooler used
to cool the process liquid after the retention tube.
e11er9y recovery heatexchan9e system: optional equipment
that takes heat from the discharge of the retention tube
a nd uses it to preheat the incoming process liquid. These
systems may have process fluid on both sirles of a heat
exchanger.
heating equipment: heat exchangers or directsteam injection equipment. Direct steam injection r·efers to use of a
steam injectorvalve (typical) ora steam infusion chamber.
hi9h · temperature short time (HTST): processing at a
com bination of temperature and required residence
t ime t ha t is designed to achieve a desired leve! of
bioburden reduction or viral inactivation. Treatment conditions (i.e., exposure temperatures and residence times)
for HTST systems range broadly, depending on the performance goal of the system.
SD-6.4.3 Operating capabilit.i es and System Function
50 -6.4.3. l Priming. The system shall be capable of a
priming operation to fill the piping with liquid, removeair,
and establish pressu re and flow con trol. The thermal
t rea tmen t system should be primed by the process
liquid to be treated ora priming liquid (e.g., WFI), or both.
required residence time: the mínim um exposure time
requ ired a t th e spec ified tempe ratu re to ac hieve
desired resuits.
5D-6.4 .3.2 Thermal Sanitization . The sanitization (22)
cond itions (e.g., time and temperature) of the system
sha ll be defined prior to the design or selection. UHT
systems shall be designed to enable sanitization. HTST
systems shall be designed to enable sanitization whe n
the treated process liquid has the potential to be compromised by the priming activities. The components (e.g.. the
receiv ing vessel, cool ing exchange r, fl ash cha mbe r)
requ iri ng t hermal sa ni t ization to meet fun ctlona l
closure criteria should be identified during design development.
retention tube: a section of tubi ng used in HTST/ UHT
systems to retain the p rocess liq uid (typically a n
aqueous solution) atan elevated temperature for a specified time.
ultra-high temperature{UHT}: processingat temperatures
above 275°F (135°C) with rapid heating and cooling and
s hort expos u re t imes to achieve what is ge nera lly
accepted as a sterile condition.
142
ASME BPE-2022
Figure SD-6.4.1.1-1
Example of HTST Process Flow Schematic Diagram
'
icomprQ$S,(l(I ¡¡¡~"::J<::l-o'<~_,,
/ ' PC'I
o
Water supply may
be either directly
connected {with
suitable safeguards
against backllowl or
via a break-tank
'--- - ~
Retention tube
Optional
water
,
break•tank :
'
....................... '
Optio na l
d irect energy
recovery heat
exchanger
Wetetpure ste,anJ>-------'----------··---
n ~
'-----~
c.:r) y- ~
Steam a,pplyl
Í\
r -'--'-- - --;
Medio
'-- _.JHeating
exchanger ~ - - -~
T
l tonckr'lsa1eretur9)
GENERAL NOTES:
(a) Only major plping and lnstrumcnts are shown.
(b) Additlonal or alternatlvc piplng, valves, lnstrumcnts, and equipmcnt may be required ror the following purposes, indudlng:
(1) pressure safety
(2) media prefillration with diffürc ntial prcssurc monitoring
(3) CIP requlrements
{4} SIP or hot water sanitization requirements
(5) altemative skid startup sanitizadon methods
(6) s ingle•pass media startup s.anitiiation methods
(7) low-pressure condensate ~turn
(8) maintenance and calibration requirernents
(9) rnergy recovrry
143
ASME BPE-2022
Figure SD- 6.4.1.1-2
Example of Direct Steam lnjection UHT Process Flow Schematic Diagram
V..cuum
( r-é' ,
Tte&1ed med ia
~ - - - - - - - --v"1-- - ~ '-/
rfl-{::1()-(<Cooh,nt supp~
se
y
~---,~~ :
LU--U...M COOl&r\Hetvt n
í~
'---
lndirect energy
reeovery/preheating
heat exchange loop \.
Water supply m ay
be e ither d irectly
connected {w it h
suitable safeguards
against backflow) or
) ._.__ _ _ __
./
Aetentioo tube
(r]; ••
'
'
Op1ion3I Wl'IICr 1
b reak--cank
:
via a break-tank
§w1p3
----'······"'···········•·•
Steam injector or
i nfusion chamber
Med ia
GENERAL NOTES:
(a) Only major piping and instruments a re shown.
(b) Additional or alternative piping. valves, instrurnents, and equipment may be required for the following purposes, including:
(1) pressure safety
(2) media pr eflltration with differential pressure monitoring
(3) CIP requ irements
•
(4) SIP or hot wat~r sanitization re,qulrcmcnLS
(S) altern;;ative skid startt1p sanitiz.ation methods
(6) single-pass media startup sanitiiation methods
(7) low·pressure condensate return
(8) maintenance and calibration requirements
(9) energy reoovery
SD- 6 .4.3.3 Temperature Stabílizatíon. Thermal
treatment syste ms shall be designed to sta bilize the
temp erature of t he liquid before initiating fo rward
flow to the destination. Heating, cooling, flow rate, and
back press ure con t ro l loops shall be enable d and
allowed to stabilize prior to heat treatment.
lf the system uses a prímíng liquid, such as WFI, the
system shall be designed to stabilize t he temperature
using t he príming liquid and then transition to and
meet the performance requirements using the process
liq uid. Stabilization using t he process liquid sho uld
contin ue until ali the priming liquid has been cleared
from the system, at which point the system shall initiate
forward flow of the heat-treated process liquid to the
destination.
SD- 6.4.3.4 Heat Treatment. The system shall be
des igned to deli ver heat-treated process liqu id to the
destination only if the performance requírements are
me t. lf they are not met, the system shall díve rt the
liquíd to another destination (typically to a draín or a
collection vessel). lf the heat treatment cond itions are
not maintaíned, the owner/ user shall specify whether
the system resanítízes itself, contin ues díverting un til
the temperanire and flow requírements are reestablished
without resanitization, or performs a shutdown sequence.
The system shall be desígned to continue heat treatment until the desired amount of liquid is treated. The
owner/user shall specify whether the system flushes residual treated process liquid forward using heat-treated
priming liquid to maxí mize recovery at the conclusion
of the process batch.
144
ASME BPE-2022
ene rgy recovery heat excha ngers (Figure SD-6.4.1.1-2)
shall be of hygienic design on the process fluid side.
The following types of heat exchangers may be used in
thermal treatment systems:
(a) She/1 and Tube. Shell-and-tube heat exchangers may
be straight n,be or U-tube. The effect ofbypass through the
bonnet drain slots and slippage between the bonnet and
tube sheet shall be considered in thermal design of the
heat exchanger.
(b) Coil-in-She/1. Coil-in-shell heat exchangers shall be
installed in a draina ble vertical orientation.
(e) Electric. Electric heat exchangers shall be designed
to provide uniform heating (e.g., where electric curren! is
applied directly to the process contact tube).
(d) Tube-in -Tube. Process liquid should flow through
the inner tube. Process fluid may also flow through the
outer tube in direct e ne rgy recovery heat exchangers.
(e) Plate-and-Frame. See cautions in SD-3.6 regarding
use of plate-and -frame heat exchangers before considering use in this application.
SD-6.4.3.5 Post-Use Sequence. The owner/user
shall specify whether the system shall be des igned to
perfo rm a cold fl ush o f the HTST or UHT equ ipment
prior to cleaning to minimize soil buildup a t the e nd of
p rocess ing. The post-use seq uence shou ld fin ish by
d rai ning t he syste m o r pro mp tly initiating the CIP
sequence.
SD-6.4.4 System Design
(a) The following parameters shall be monitored and
controlled by the system:
{1} heater outlet temperature
(2) cooler outlet temperature
(3) flow rate
(4) back pressure
(b) The following parameter shall be monitored by the
system: retention tube outlet temperature.
(c) The owner/ user shall specify whether the system
shall be primed using compendia! water (from a breaktank or from a backílow-protected direct water system
connection) or sanitized and primed using the process
liquid.
(d) The following should be considered in selection of
materials used in fabrication of HTST/U HT systems:
(1) Cyclic temperature and pressure conditions may
shorten the life of materials.
(ZJ Solutions athigh temperature mayaccelerate the
rate of metal corrosion or elastomer/polymer degradation.
(3) High-temperatu re operating conditions used in
UHT systems may exceed the temperatu re ratings of
typical bioprocessing eq uipment or components.
(e) Although UHT processing conditions a re above the
temperature limit specified in SD-2.3.1.1, process cont.act
materia Is used for these systems shall be selected to meet
the h igher temperature requirementS of the process.
{2 2 )
S0-6.4.4.2 Steam lnjectors
(a) Steam inj ectors shall introduce steam (typically
pure steam) directly into process liquids.
(b) Steam injectors shall be installed such that singlephase tlow isachieved at the desired outlettemperature. A
sight glass installed downstream of the steam injector is
recommended to confirm single-phase flow.
(e) Steam injectors shall be oriented to permit CIP, or
designed for disassembly and cleaning out of place (COP),
with agreement from the owner/user. Where the steam
injection system is designed for CI P, it shall be drainable
and exposed to CIP solution across the seat of the steam
injection valve.
(d) Media dilution a nd changes in retention time due to
condensa te addition shall be accounted for in the system
design.
SD-6.4.4.l Heat Exchangers. Heat exchangers shall
be designed to meet the performance require ments in
SD -6.4.2 and the app licable design criteria of SD-3.6.
Heat exchangers shall be designed to achieve fully developed turbule nt tlow conditions during process and CIP
operations, on the process liquid cont.acting side(s) of
t he exchanger. Heat exchangers sho uld be designed
a nd operated such that the press ure of the t reated
process liquid is higher than the pressure of the utility
or u ntreated process liq uid d uring heat t reatment to
reduce the risk of process liqu id conta mination, unless
the owner/user has assessed the risk of an alternate
design. The owner/ user should identify any requirementS
needed to minimize process fouling or e nhance cleaning
performance (e.g.. mínimum Reynolds number or velocity,
maximum process contact surface tempera ture).
Direct energy recovery heat exchangers with process
fluids on both hot a nd cold sides (Figure SD-6.4.1.1-1)
shall be o f hygie nic design o n bo th sides. lnd irect
SD-6.4.4.3 Flash Chambers. (Reserved fo r future
contentJ
S0-6.4.4.4 Pumps. Process contact pumps used in (22)
HTST / UHT syste ms sha ll be hyg ienic and s hall
conform to SD-3.3.
S0-6.4.4.5 Retention Tube
(a) To account for axial dispersion in the piping, the
average residence time necessary to achieve the required
residence time shall be defined by the owner/user.
NOTE: The average residence time should be specified so as to
mcct thc owner/user.. dcfincd probability thatcach proccss flu id
particle is retained for the requlred residence time. As an
example, the Taylor equation for axial dispersion in turbulent
flow was used to develop Figure SD-6.4.4•.5-1 which shows the
thcorctical additional rctcntion tubelcngth rcquired fora water•
like liquid treated at 216ºF (lOZºC) for 10 sec in a 1-in. (25-mm)
nominal retention tube to account for axial díspersion, assuming
145
(22)
ASME BPE-2022
Figure SD-6.4.4.5-1
Example of Addit ional Retention Tube Length Required to Account for Axial Mixing
Estimated fraction of not fully treated process fluid [Note (1)]
50
§
45
.,
-
o 40
.z
.z::o,
a'!
e •
:,
....
e
_,_ \
\
''
20
.,..
15
.!! o
" ....,~
a:
1
. ..
-~
-
~
-
-~
~
• • • • lE- 12
1
1
..
.... -
............
['..._
.......
10
e
-
-
Example Parameters:
Residence Time= 10 sec (10 s)
lnner Di ameter = 0.87 i n. (2.2 1 cm)
Temperatura = 216' F (102' CI
Density = 60.3 l b/ft3 (966.5 kg/m3)
Viscosity = 0.000185 l bm/ft-sec /0.000276 kg/m•s)
~
"' ... ... · •.... -.
... ...... ... ...
...
""
..
ti
- - lE-9
" ----. ----------------
25
E
...
\
eo ..
"'
·,;:CO
1E-6
-C
+' · ...
......0"" íi.,'"e 30
1- .,
=
1
\
,_
35
1e -3
... ...
--
0.•·1••••• • ••••;.
..... '""1"·• .... . .
r--.__
1
---
..._.....................
,-----r----1
.E
5
o
o
10
20
30
40
50
60
70
80
90
100
Aow Rate, L/min
NOTES:
(1) "Not fully treatcd" fluid is deflned as fluid whose rctention time is lcss than thc rcquired retentlon time.
(2) "Base lcngth" is the average Huid velocity in the rctcntion tubc multiplied by the rcqulrcd rctcntion ti me.
an insignificant numberofbends. In thefigure, toensurethatless
than 1 particle out of 10" has less tha n the 10-sec required
rcsidcncc time at 9.2 gal/ min (35 L/min), thc rctcntion tubo
length would have to increase by 24%. Actual retention tube
from the retention tube during operation. ltshall be drain·
able during cleaning and/or sterilization operations.
(9) No portion of the retention tube between the inlet
a nd the ouúet temperature sensors shall be heated.
geometry, such as the number and radii of elbows, toils, or
U·bends, may impact the results.
SD-6.4.4 .6 Flow Co ntrol. The flow rate shall be
controlled a nd monitored to ensure proper system operation.
(b) The retention tube diameter should be no larger
than the main system piping d iameter to minimize the
residence time ra nge dueto axial dispersion.
(e) The retention t ube shall be designed to e nable
vi sua l inspectio n at its inlet a nd outlet. The owner/
user shall specify whether inspection is required fo r
two-phase flowduring operation or for cleaning effectiveness.
(d) The retention tube shall be designed to maintain a
consistent temperature within the tube during heat treatment (e.g., the tube should be insulated and shall not have
branches or tees that could result in low local temperatures).
(e) No device shall be permitted for short-circuiting a
portion of the re tention tube (e.g.. bypass valves) to
compensate for changes in the process liquid flow rate.
(j) The retention tube shall have a continuous upward
s lope toward the discha rge conforming to Ta ble
SD-2.4.3.1-1 category GSD3 to e nsure that air is purged
SD-6.4.4.7 Back Pressure Control. The system shall
be designed to ensure that pressure downstream of the
heating exchanger or steam injector is above the process
flu id boiling pressure, until the treated fluid has bee n
cooled or until it reaches a flash chamber for cooling.
A p ress ure of a t least 10 psi (0.7 ba r) above t he
boiling pressure is recommended.
SD-6.4.4 .8 lnst rume ntation. [Reserved for future
content]
SD-6.4 .4 .9 Interfaces
(a) The owner/user shall specify the maximum allowable discharge temperature for connections to the system
outlet and drains.
146
ASME BPE-2022
(b) Average residence time should be determined. lt
may be determi ned by dividing the re te nt io n t ube
volume by the measured flow rate.
(e) lf a surface temperature limit has been speci fied by
the owner/user, the heating surface te mperature should
be verified. For electrically heated tubing, the exterior
surface temperature may be measured to provide an
indirect, b ut conservat ive, meas ure of t he in te ri or
surface temperature. For steam -liquid or liq uid-liquid
hea t exchange rs, t he utility-s ide (e.g .. steam or hot
wate r} inlet tempera ture may be measured to provide
an ind ire ct, b ut conservative, meas ure of t he t ube
surface temperature.
(d) lnitial testing of new equipment should document
the heat supplied to meet the process requirements. The
heat supplied can be documented as power input for elect rically heated tubes, steam pressure for steam heat
exchangers, and non-process liqu id in let a nd o utlet
temperatures for liquid-liquid heat exchangers.
(e) lnitial testing oí system performance should docu·
ment the steady-state pump speed, pump differential
pressure, flow rate, system back pressure, and back pres·
su re control valve position.
(b) The owner/user shall specify whether system sanitization/sterilization ends within the system boundary or
exte nds beyond the system boundary to ups tream or
downstream equipment.
(e) To design appropriate interfaces with source and
destination systems, the owner/user shall provide the
stated purpose of the system and the functional location
within the process (e.g., upstream or downstream of sterilizing filters}. The owner/ user shall specify whether the
thermal treatment system is inte nded to be implemented
as part of an open, functionally closed, or briefly exposed
process.
SD-6.4.5 Design for Bioburden Control
5D-6.4 .5.1 Drainabillty. The process con tact
portions of the system shall be drainable per S0-2.4.3.
5D- 6.4.5.2 Cleaning. Thermal t reatment sys te ms
shall be designed for CIP of process contact surfaces,
unless other me thods are speci fied where necessary.
Where fouling of hea ted surfaces may occur, cleaning
a nd operational procedures (e.g., v isual inspection)
should address pote ntial fou ling of those segments of
the system. When compendia) water from a break-tank
is used in no nrecircu lating mode to cond it io n a nd
flush the system, provision shall be made for the sanitiza•
tion of the water ta nk and its piping at a mínimum.
SD-6.5 lmmersion Washers
SD-6.5.l General. This section describes the require- (22)
ments for immersion washers used in bioprocessing that
are designed to clean parts out of place from their typical
insta llation. lmm ers ion washers are a subcategory of
clean-out-of-place (COP) washers, which incl udes
cabinet washers (see SD-6.1). When usi ng immersion
washers, parts are comp letely submerged within an
immersion tank throughout the cleaning cycle. Requirements in this section are intended to be applied to immer·
sion washers, but may be applied to other types of washers
where appropriate.
The following terms are defined for th is section:
5D- 6.4.5.3 Chemical Sanitization/Sterilization. lf
chemical sanitization or sterilization of t he system is
required, the area within the sterile envelope or boundary
shall be designed for exposure to and removal oíthe sanitizing agent while maintaining the sanitized state.
5D-6.4.5.4 Thermal Sanitization/Sterilization. lí
thermal sanitization or sterilization of the system is
required, the area within the sterile envelope or boundary
shall be designed for SIP or for sanitizing/sterilizing the
system with hot liquid.
designed load immersio11 basket/rack: a basket or rack to
5D-6.4.5.5 Post-Use Storage. [Reserved for future
ho ld parts tha t is designed for a specific, repeatable
loading configuration. A designed load basket or rack
is used for geometrically complex parts where there is
concern with cleanability of the part due to it requiring
specific orienta tion or placement, liquid hold up after
system draining. or entrapped air during a cleaning cycle.
end nozzle zo11e: a hydraulic circuitwith nozzles orjets that
encourages end-to-end flow within an immersion tank.
content]
SD-6.4.6 Oesign for Serviceability, Examination, and
Operation. [Reserved for future content)
SD-6.4.7 Testing. System performance requirements
(e.g., residence time at temperatu re) to be tested for
HTST or UHT shall be defined by the owner/user. The
system design should accommodate test instrumentation
required to verify the system performance and confirm
the control/monitoring process performance.
(a) Temperature performance should be verified using
temperature measurement devices independent oí the
system instruments at the inlet and outlet of the retention
tube. The independent sensors should be positioned in a
man ner that allows measu re me nt of the b ulk fl ui d
temperature.
general load immersion basket/rack: a basket or rack to
hold parts that is not designed for any specific loading
config uration o r orie ntation of the parts. A general
load basket or rack is used for geometrically simple
parts (e.g., gas kets} or non-process contact surface
components (e.g., clamps, tools) where repeatable orientation is not critica).
147
ASME BPE-2022
SD-6.5.4 System Design
immersion tank: the vessel designed to hold a nd allow
delivery o f cleani ng so lut ions in whic h pa rts a re
immersed.
parts: a ny compone nt to be cleaned in the immersion
washer, such as pipes, hoses, clamps, gaskets, fittings,
a nd accessories.
(a) lmmersion baskets/racks (general or designed
load) should incorporate thermoplastic or thermoset
material compone nts to prevent scratching of the parts
and the I.D. surface of the immersion tank.
(b) Mate rials of co nstructio n of immersion washer
process contactsurfaces shall adhere to the same requireme nts set forth in t he cabi net was hers section [see
SD-6.1.3(a)J.
(e) Materials of construction and general design ofthe
immers ion ta nk shall fol low req uirements for vessel
general design (see SD -3.4.1). The full vacuum servíce
design requirement is not appl icable to atmospheric
immersion tanks.
(d) The surface finishes for the interior surfaces of the
immersion tank, process contact tubing surfaces, and a ny
other process contact surfaces shall be specified by the
owner/ u ser using des ig na tions provided in
Table SF-2.4.1-1. Electropolishing is not required for
immersion washers.
(e) The surface finish ofbaskets/racks, supports, thermowells, guards, and other interna! ta nk components
s hould me et t he surface finish requíre me nts of the
tank. Surface finish verification may not be possible for
ali components of an immersion washer's baskets/racks.
(f) The inte rna! surface finish of the immersion tank
cover should be the same as specified for the immersion
ta nk interna! surfaces.
síde non/e tone: a hydraulic circuit with nozzles or jets
that encourages rotational flow within a n immersion tank.
SD-6.5.2 System Performance Requirements. lmmersion washers shall be capa ble of delivering a nd removing
cleaning solutions from surfaces of parts across multiple
phases of a cleaningcycle. lmmersion washers may beselfcontained, or receive cleaning solutions from a CI P system.
The following are typical general phases of an immersion
washer cleaning cycle:
(a) pre-rinse
(b) wash
(e) ri nse
(d) final rinse
The design should allow for multiple chemical additions
d uring washing phases. The hyd ra ulic conditions (i.e.,
pressure and flow rate) of ali rinsing phases should be
the sa me as fo r was h phases to e nsu re co nsistent
rinsing of parts, immers ion tank interior, and hydraulic
circuit. The fina l ri nse may be performed with recirculated
final rinse wate r integrated with drain steps to remove
resi dual cleani ng sol utions. The des ign should be
capable of providing a final rinse phase a t an elevated
temperatu re (e.g., >149 °F (65ºC)) to improve air d rying efficiency.
(22)
(22)
SD-6.5.4.1 Zone Design
(22)
(a) lmmersion washer des ig n can include m ultiple
zones to clean parts through various methods. Zone
piping design shall follow SD-3.1.2.2, wíth the considerati on that zone branch co nnections shall be ope ned
betwee n each p hase to avo id carryover. Ali zones
should be targeted during each phase to provide consis•
tent flushing.
(b) Turbulence is crítica! for cleaníng within an im mer·
sion washer, and zone desígn should provide adequate
turbulence to ali part surfaces. For example, tubing or
simila r parts that are not exposed to turbulence on the
I.D. from a side nozzle zone would require a n end
nozzle zone or d irect co nnection to a zone to provide
adequate I.D. flow.
(e) For zones with piping manifolds within the immer·
sion tank, baskets, or racks, the fabrication of the piping
man ifolds sha ll conform to t he applicable sections of
system piping (see SD-3.1.2.3).
SD-6.5.3 Operating Capabilities and System Function
(a) The immersion washer should control a nd monitor
time of exposure (contact time) during wash a nd r inse
pilases.
(b) The immersion washer shall control a nd monitor
cleaning solution temperature duri ng ali washing and
rinsing phases.
(e) The imme rsion washer should monitor the pressu re or flow of clea ning solu tions supplied to zo nes
within the immersion tank or immersion basket/rack.
(d) The immersion washer shall be designed to provide
analytical verification of final rinse wate r quality (e.g..
conductivity, TOC, number of final rinse steps).
(e) For immersion was he r capabilities for che mica l
addition, see SD-6.1.4.7.
{j) For immersion washer recirculation pump requirements, see SD·6.1.4.8(b) a nd SD-6.1.4.8(c).
(g) lmme rsion washer pumps should have sufficie nt
capacity (tlow a nd pressure) for ali zones used in the
washer.
(h) For imme rsion washer heat exchanger requirements, see SD-6.1.4.9.
SD-6.5.4.2 Tank and Cover Openings
(a) lmmersion tank and cover opening design sha ll
adhere to the same requ ire me nts used for cab in et
washers (see SD-6.1 .4.1).
(b) Side nozzles shall be of hygie ni c design (see
Figure SD-6.5.4.2-1).
148
(22)
ASME BPE-2022
Figure S0-6.5.4 .2-1
lmmersion Tank Side Nozzl e Oesign
Nonsmooth transition
tube to si de nozzle
(nondraini ng)
1.0. not fully welded
leading to crevices
Smooth transition
Note ti l from tube to side nozzle
(al Accepted
(bl Not Accepted
NOTE: (1) Supply tubing and ali side n():I.Zle.s should be drainable, either back through lne s upply tube header or int.o the lmmersion tank.
(e) lmmersion tank covers should be used and
designed to reduce operator ex posure to sp lashing
during operation as well as to minimize added humidity
to the area around the immersion washer. Both sealed and
nonsealed designs are permitted.
(d} Sealed (e.g., gasket or 0-ring) immersion tank
cove rs shall be designed to prevent wash fluid from
leakage during the wash cyde.
(e) Nonsealed imm ersio n tank covers shou ld be
designed to minimize wash fl uid leakage du ring t he
wash cycle.
(f) Both sealed and nonsealed types should be designed
to minimize wash droplet formation above the immersion
tank a nd loaded parts.
(9) Process contact static seals used in immersion
washers s hall conform to the requirements of Part MC.
{h) The external surfaces (e.g., frame, immersion tank
O.O.) shall meet the owner/ user's s pecified requirements
of the installed location of the equipment.
(i) External s urfaces should be insulated to minimize
heat transmission
(22)
(e) Ali immersion baskets/racksshould be designed for
disassembly required for inspection and maintenance.
S0-6.5.4 .4 Interfaces. hnmersion washers' partsare
loaded and unloaded in the sarne area/roorn classification.
lf process flow requires a separation of clean and dirty
parts, an irnrnersion washer s hould not be used.
S0-6.5.5 Oesign for Bioburden Reduction
S0-6.5.5.1 Orainability
(22)
(a) lmrnersion washer process contact surfaces shall
adhere to SD-2.4.3.
(b) For rectangular immersion tanks sloped both to
center a nd along the tank length, a mínimum lengthwise
slope designation of GSD3 (see Table SD-2.4.3.1 •1) should
be used for drainability. Other surfaces sloping to drain
within the tank are also recommended to have a minimum
slope of GSD3.
S0-6 .5. 5.2 Cleaning . Th e interior s urfaces and (22)
components of the tank as well as the baskets/racks
are co nside red process contact surfaces and should
conform to SD-2.4.2 excep t for SD-2.4.2(a)(4) . These
surfaces include the immersion tank wall I.D. a bove an
overflow port and the immersion tank cover I.D. surfaces
with the pote ntial to drip onto cleaned parts within the
immersion tank.
(a) Engraving or embossing of materia Is (for identification or traceability) is permitted on exte rior process
contac t surfaces, such as t he exterior of p rocess
contact tubing in the washer. Engraving or e mbossing
shouid be limited to only what is needed for unique iden·
tification or traceability.
S0- 6.5.4.3 Baskets and Racks
(a) General load immersion baskets/racks should be
designed to accommodate variable configurations a nd
load items. Parts used in these baskets/racks do not
req uire a specific orientation for drainability or to
prevent air entrapment.
(b) Designed load immersion baskets/racks s hould be
designed for repeatable loading and may be subject to
verification, if required by the owner/user, to assure
removal of entrapped ai r. Load items as well as t he
designed load immersion basket/rack shall be drainable.
149
ASME BPE-2022
(b) Adherence to SD-2.4.2(a)(2) for the immersion tank
wall 1.D. abovean overflow port and immersion tank cover
I.D. s urfaces s hould b e considered by the owner/user
depending on the criticality of the parts being cleaned.
(e) Final rinse tank leve) should be higher than wash
solution rinse leve) to promote quicker achievement of
final rinse conditions.
Parts with recessed holes or cavities should not be
cleaned in immersion washe rs. Risk of air entrapme nt
or inabili ty to drai n may impede exposure to a nd
re moval of cleaning solution.
parts from the baskets/racks or immersion tank to avoid
false results due to transíer oí residual riboflavin from
other· parts.
General load immersion washer baskets/racks are not
s ubject to the same testing due to the nonrepeatable a nd
nondesignated loading conditions and variations in parts
being cleaned.
SD-6.5.7.2 Drainability. Drainab ility testi ng fo r
im mers ion tanks should use methods described in
SD-7.4 for vessels, with the following additional considerations:
(a) At mínimum, the immersion tank s hould be íilled to
completely submerge the tank bottom.
(b) Drainability testing intended for ensuring immersion ta nk drainability should be performed without a ny
baskets/racks loaded.
(c) Any outlet straineror screen used in normal operation should be installed.
(d) Drainability testing can be performed on designed
load baskets/racks and loaded parts to veriíy dra ining oí
surfaces on these compone nts. The baskets/racks a nd
parts loading information a nd configuration should be
recorded, a nd the immersion tank should be filled to
a t m ínimu m above the highes t co mpo ne n! oí t he
basket/rack or loaded part.
SD-6.5.6 Design for Serviceability, Examination, and
Operation. lmmers ion washers s hould be designed to
e nable access for inspection and service of components
that are s ubject to wear, a nd to allow for periodic calibration of instruments.
SD-6.5.7 Testing
(22)
SD-6.5.7.l Flow Coverage. Designed load immersion
washer baskets/racks design ed for repeatable loading
shoul d have flow coverage (e.g., rib oflavin ) tes ting
performed for verification o f liquid coverage oí parts'
s urfaces. The spray coverage tes tin g desc ri bed in
SD-7.1 is applicable to t he flow coverage testi ng for
immersion washers. lí Nonmandatory Appendix M is
used, it is applica ble to immersion washers, with the
following additional considerations:
(a) The scope oí t he ribofla vi n ap plica tion a nd
expected removal should be documented and agreed to
by ali parties (e.g., parts and baskets/racks only; pa rts,
baske ts/racks, a nd immersio n tan k process co nta ct
s urfaces).
(b) Riboflavin may be applied while parts are loaded in
the baskets/racks inside oí the immersion tank, or may be
applied to parts prior to loading into the basket/ rack or
immersion tank. Application prior to loadi ng may be
required for parts with limited access areas such as
tubing lengths.
(e) lmmersion tank filling shou ld occur as in normal
opera tion and to the normal operating level. As once·
through rinsing is no t applicable to immers io n
washers, a comp lete fill, zone(s) r insing, and drain
s hou ld be performed not less t han two ti mes. The
maxim um number oí zone rinses (co mplete fil l and
dra in) d ur in g the riboflav in testing shall not exceed
the total n u mber of phases with co mp lete fill a nd
drain steps du ring an owner/user's norma l operating
wash cycle. Only the zones applicable to the components
being tested s hould be used. Pertinent information such as
iones used, time oí rinse, a nd zone seq uencing s hould be
recorded.
{d} Riboflavin ins pection mayoccurwhile parts are still
loaded in the immersion tank, outside oí the immersion
tank, or th rough a combination ofboth. lnspection outside
oí the immersion tank may be n eeded for parts with
limited access a reas. Care s hould be taken while unloading
SD-6 .6 lsolator Systems
SD-6 .6.1 General. lsolator systems, hereafter referred
to as isolators, a re u sed to crea te a controlled environment
for bioprocessing and quality control testi ng tha t is
isolated from operators and the background environment.
This section describes the design requirements for two
types of isolators, as follows:
(a) aseptic isolators, which a re designed to protect the
process from the environment, enable aseptic processing
(e.g., ce ll bank processing, liquid filling oí final product)
(b) co ntai nment isolators, which are des igned t o
protect the operator environ ment from t he process
a nd e nable saíe processi ng oí pote nt compounds (or
other hazards) in a n isolated environme nt
This section does not address equipment/components
u sed inside the isolator. Req uirements oí the process a nd
process e quipment enclosed by the isolator should be
provided by th e owner/ user. This section is not applicable
to restricted access barrier systems, which restrict access
but do not provide e nvironmental isolation.
SD-6.6.2 System Performance Requlreme nts. The
fo llowing system performance requirements s hall be
defined:
(a) environmental classification inside and outside the
isolator
(b) a irflow conditions as unidirectional or turbulent
(e) pressure differential target to background environment
(d) log reduction for decontamination
150
ASME BPE-2022
(e) overa ll cycle time li mit for decontamination a nd
aeration
(D temperature operating ranges
(g) humidity operating ranges
(h) recirculation air, make-up air, and total exha ust air
tlow limitations
(i) a llowable decontamination agent (e.g., vapor phase
hydrogen peroxide) concentration at the end of aeration
for product protection
SD-6 .6.4 System Design. lso iator systems contain (22)
b iop rocessing eq uipme nt and norma lly do not have
product contact surfaces. The owner/user shall specify
(a) surfaces req uired to be designed for product
contact
(b) isolator designation as aseptic or containment
(c) product sensitivity to decontamination agents
(d) s pecific environmenta i requirements (e.g.. inert gas
blanketing)
Process con tact s urfaces shou ld be impervio us,
nonreactive, nonadditive, and res istan! to cleaning/
decontaminating agents. Metailic process contattsurfaces
shall be fabricated with 316-type or 316L-typ e stainless
steel by weided construction, unless otherwise approved
by the owner/user. Exterior non·process contactsurfaces
may be fabricated with 304-type or 304L·type stainless
steel by welded construction.
Ali equipment should be compatible (chemically resis·
tant, nonpermeable) with cleaning a nd sanitization agents
specífied by the owner/user, e.g., sporicídal agents, pera·
cetic acíd, hydrogen peroxide gas, or 70% IPA.
Glove ports. comprising a glove and sleeve sealed into
the wall orwindow of a n isolator, shall be madewith materia Is resistant to decontamination agents a nd specified
sanitizing/cleaning agents (e.g., hard coated a lum inum,
stainless steel, UHMWPE).
Unless othen vise s pecified by the owner/user, process
contact s urfaces of meta l constructio n should have a
surface ro ugh ness of 35 µ in. R. (0.89 µm) or less.
Unless otherwise specified by the owner/user, the exterior (non-process contact s urfaces) of metal construction
should have a surface roughness compatible with the associated environmental classification. lf the exterior opera tional e nvironment is ISO class 8, a surface finish of 48 µin.
R,, (1.2 µm) orless is recommended for metal construction.
SD-6.6.3 Operating Capabilities and System Function
SD-6.6 .3.l Differential Pressure Control. Different ia i p ress ure set po ints s houl d be adj usta ble in t he
range of 0.06 in. to 0.18 in. (1 5 Pa to 45 Pa) of t he
water column. Phase tra nsitions in the isolator system
(e.g., re-dosi ng to ae ration, aer ation to production)
shall be controlled without ioss of pressure ba la nce in
the s urrounding room specífied by the owner/user.
it is permissibie for the set point to be positive or negative to the surrounding room as defíned by the owner/
user to meet the product manufacturing requirements.
The differe ntial pressure (b etween the isolator inte rior
and exterior) s hould be mainta ined within 0.02 in. (5
Pa) of water coiumn of the set point.
5D-6.6.3.2 Temperature and Humidity. The isolator
should be designed to monitor operational, decontamination, and aeration te mperatures within the rangespecífied
by the owner/user.
Humidifícatíon require me nts are application dependen! and s hould be agreed to by the owner/user. Consid·
eration should be give n to decontamination require ments,
prod uc t re quire men ts, pote nti a l sta tic e lec tricity
d ischarge, an d co ndensation withi n the isolator or
connected equipment (e.g., lyophiiízer).
SD-6.6.3.3 Decontamination. Unless othe rwise
specified by the owner/ user, the decontamination cycle
shall demonstrate a five log reduction of microorganisms.
The complete decontamination cycle includes leak testing,
conditioning, decontamination, and aera tion of residual
decontamination agents. The isoiator s ha ll be designed
to reduce the leve! o f the res idual decon tam ination
agent to a concentra tion to be specífied by the owner/
user. if vapor phase hydrogen peroxide is used, the aeration s hall reduce the res idua l vapor phase hydrogen
peroxide to <1.0 ppm at the specified operating temperature for operator safety. The isolator s hould be designed to
prevent opening during decontamination (e.g., incorporating door and window inte rlocks).
SD-6.6.4.l lsolator Shell. The isolator shell (the
ma in work chamber of th e iso lator). which may
include windows, líghts, and openings, s hould be designed
to integrate interna! equipment with ergonomic opera t ions. The isolator s hell constr uction should be designed
to accommodate the user-specified pressure d ifferential
with limited shell deformation. Isolator shell deformation
limits should accommodate openings where brittle material may be used such as glass windows and ligh ts.
To e nsure isolator s hell sea) integrity, tolerances for
isolator s hell and connection points should accommodate
the potential for weld heat distortion. The s hell s hall be
fabricated using welded construction unless otherwise
specified by the owner/ user.
The isolator shell construction radii of interna! corners
and seams should be 0.6 in. (15 mm) or greater to facilitate
cleanability.
The aseptic isola tor design should provide a barrier or
s ufficient space for the separation of particulate gene rating operations (e.g., stop pering a nd ca pping) from
the product fillíng operatíons.
SD-6.6.3.4 Venting During Aeration. The isolator
s hall be d esigned to safely exhaust decontami nation
gas through a dedicated exhaust system. For example,
if hydrogen peroxide gas is exhausted, a building stack
or catalytic fiiter may be required to safely convert the
hyd rogen peroxide into water vapor and oxygen as it
is reieased to the environment.
151
ASM.E BPE-2022
S0-6.6.4.2 lsolator Base Plate. The isolator base
plate (the lowest part of the isolator interior interfacing
with the isolator shell) shall be designed to separate the
isolator environment from the area below, which may
contain drives, motors, electrical installation, and other
components. The isolator base plate surfaces exposed
t o t he isolator envi ron ment are co nsidered process
contact surfaces. lsolator base plate penetrat ions shall
be designed with integral seals to establish a pressure
boundary to avoid contamination. Penetrations should
use rounded corners with mínimum radii of 0.6 in. (15
mm) to facilitate cleanability.
The isolator base plate thickness shall be designed to
support process equipment specified by the owner / user.
Where isolators are designed for CI P or liquid washing,
the isolator base plate shall be sloped to one or more
drains in the isolator base plate.
When the isolator manufacturer does not fabricate the
base plate, dimensions and tolerances for tight integration
with the isolator shell shall be provided to the isolator
manufacturer by the isolato r base plate fab ricator o r
owner/ user.
port shall be designed to provide an integral seal with
the isolator.
For containment iso lato rs, the glove po rt shall be
designed to allow a glove change without exposing the
used glove to operators.
SD-6.6.4.6 ULPA/HEPA Filters. For aseptic isolators. the total nonviable part iculate concentration shall
meet ISO cl ass 5 requirements using ULPA or HEPA
filte rs. Fo r asept ic isolators, the des ign sho uld be
capable of unid irectional (downward) airílow d uring
normal o peratio n with ai rfl ow ve locity of 90 ft/min
(0.46 m/s) ± 20% as measured 6 in. to 12 in. (15.2 cm
to 30.5 cm) below the d iffuser me mbrane. Turbulent
airflow condit ions are permitted dur ing decontamination
and aeration.
For containment isolators, ULPA filters are recommended. Airflow breacli velocity (e.g., as measured from an open
glove port) should be between 100 ft/min and 125 ft/min
(0.51 m/sand 0.64 m/s), unless otherwise specified by the
owner/user.
SD-6.6.4.7 Transfer Ports. The aseptic isolato r (22)
design shall provide for aseptic transfer of components
req uired fo r the ope ration (e.g., caps, stoppers fo r
fill ing). The design should accommodate com ponen t
t ra nsfer for in it ial setup and to rep lenish supp li es
during operation.
Connected nibing from a final filter into filling heads in
an isolator shall have an integral seal at the isolator shell.
The recommended location for the final fil ter is outside the
isolator.
A rapid transfer port (RTP, sometimes referred to asan
al pha-beta port) in which mating ports between the
isola tor and ano ther conta iner or sys tem, whose
exposed door surfaces become sealed when interlocked
to each other, shall be designed to maintain isolation integ•
rity while transferring materials into and out of an
isolator. The mating sur faces of RTPs shall create a
seal such that opened ports do not expose the isolator
environment to surfaces that have not been decontami•
nated.
RTPs should be located to accommodate the operator
access through glove ports and allow adequate clearance
from interna! equipment when open. Sizes should be
specified to incl ude the beta con taine r sea! clea rance
when docked. In containment applications, a mechanical
interlock should be provided to prevent the alpha door
fro m being o pened when the beta con ta iner is no t
docked. The use of RTPs for powder t ransfers t hat
come into direct contact with seals is not permitted.
Split valves that use the same interface technology as
RTPs, except that the interlock acts as a butterfly valve,
may be used for liquid or solids additions into an isolator.
Split valves are perm itted for use in both aseptic and
conta inment isolators.
SD-6.6.4.3 Doors/Windows. Doors/windows should
be designed, installed, and sealed to maintain the shell
integr ity and clea na bility. The design s hall provide
access to clean the inside of the windows.
Both fixed and opera ble window designs are permitted.
Door and operable window designs should consider interlocks to prevent opening during decontamination.
SD-6.6.4.4 Llghtlng. Lights sho uld be des ig ned,
installed, and sealed to allow illumination of the isolator
interior while maintaining the shell integrity and without
co mprom ising cleanability. The owner / use r sho uld
specify product sensitivities to certain wavelengths
(e.g., UV wavelengths) orto light intensity levels. The
type and intensity of light at the work location should
be specified by the owner/ user to meet ergonomic requirements (e.g., fluorescent lighting at 75 foot-candles
to 80 foot-candles (0.026 lumens/m2 to 0.028 lumens/
m2 ) o r LEO ligh t ing at 45 foo t-can dles to 5 0 foot·
candles (0.016 lumens/m 2 to 0.017 lumens/m 2 ). lf specified, the design should accommodate different levels of
lighting within the isolator (e.g., at least one for processing
and one for cleaning/sanitization). The placemen t and
o rientation of the lighti ng shou ld minimize reflection
and glare on the windows.
SD-6.6.4.5 Glove Ports. The design of an isolator
sho uld include a mock-up act ivity to determine the
final positio n of any glove port.. The mock-up should
include a life-size model ofthe isolator and the equipment
planned for use in the isolator for verifying ergonomics
and accessibil ity. Both oval and circular shapes are
permitted. Glove sea l construction inside the isolator
shall be free of crevices, t hreaded fast eners, o r any
areas difficu lt to clean and decontami nate. The glove
152
ASME BPE-2022
Pass -in/pass -o ut holes (openings that allow the
tra nsfer of material in to and out of iso lators while in
operation) shall be designed to be sealed by an externa!
door during a decontamination cycle. The design of aseptic
isolators should not permit opened doors of pass-in/passout holes to rest in a position above the aseptic operations.
The isolator shall be designed to maintain speci fied pressure differentials and airflow velocit ies with open pass-in/
pass-out holes during normal operation.
the ase ptic environment. Where seals are exposed to
cleaning or decontamination processes, they are considered process contact surfaces and shall be resistant to
cleaning and decontamination fluids. Process contactelastomers shall conform to the applicable requirements in
Part PM or Part MC. The potential for sea) degradation
and chemical absorption and subsequent desorption
should be considered in the selection of seal materials.
For exa mple, silicone and EPDM offer resistance to
many cleaning and decontamination agents.
lnflatable sea ls and static seals are perm itted. For
examp le, inflatable seals are acceptab le for doors/
wi ndows that are designed to be opened during setup
and cleani ng proced ures. The potential for occluded
areas should be considered in the design and use of inflatable seals. lnflatable seals shall have a continuous leak
check, using either constant pressure or constant flow.
Seals between the isolator shell and mating equipment
(e.g., depyroge nat io n t unnel, lyoph ilize r) shou ld be
designed to accommodate the effects ofthe thermal dila tion/contraction of the mating equipment. The tempera·
t ure at these interfaces should be co nsi dered in the
selection of sea) material.
When an isolator system comprises multiple connected
isolators, sea ls benveen isolators shall be designed to
expose sea) surfaces to decontamination agents during
a deco ntami natio n cycle. Single o r do uble seals are
permitted between isolator chambers.
SD-6.6.4.8 Airlock/Decontaminatlon Chamber.
Air loc k/decontamin atio n chambers, co mpartments
with an inner door and outer door used for moving material into and out of the isolator, shall be designed with
do uble-inter locked doo rs, wh ich prevent t he o uter
door (to room) fro m bei ng opened while t he in ner
door (to isolator) is open. Both doors should also be interlocked from opening during the decontamination cycle.
The in ner door shall be interlocked such that it can
only be opened after a successful deconta mination cycle.
{22)
SD-6.6.4.9 lnternalComponents. Forpiping/tubing,
ali wetted processcontact tubingshall conform to SD-2.4.2
and shall be either sloped or provided with an air purge, or
both, to enable liquid removal from lines per SD-2.4.3 and
Nonmandatory Appendix C. Welded joints are preferred. lf
disassembling of the pip e/tu be system is req uired,
hygienic process connections shall be used. Exposed
threads (e.g., the exterio r of hygienic clamps) should
be avoided within the isolator.
Brackets or other equipment shall not be located
directly above open containers in aseptic isolator interiors.
S0·6.6.4 .12 Externa! Surfaces. Exterior design req ui rements of S0-2.4.4.2 are a pplicable to isolators.
The externa)surfaces of an aseptic isolator shall be compa·
ti bie with the environmental classification to which it
interfaces. The following des ign practices should be
considered:
(a) Ali cables should be covered.
(b) Gaps between the isolator and other equ ipment,
such as depyrogenation tunnels or lyophilizers, should
be sealed.
SD-6.6.4.10 lnstruments
(a) Hydro9en Peroxide Detection. When hydrogen
pe roxide is used as a deconta minating agent, the
system should be designed to detect residual hydrogen
peroxide above specified critica! levels for product and
personnel safety. For personnel safety, residual hydrogen
peroxide shall be less than 1 pp m. The owner/user shall
specify the residual level lim it to protect the product. The
measurement pri ncipie and detection lim it of sensors
should be agreed on between t he man ufacturer and
owner/user. The sensor position shall provide for monitoring the worst-case location with in the isolator.
(b) Viable Particle lndicators. The isolators designed to
create ISO class 5 conditions shall include continuous
act ive air sampling for viable particle monitoring
during active processing.
(e) Nonviable Particle lndicators. The isola tors
designed to create ISO class 5 conditions shall include
continuous particle monitoring for nonviable particles.
(22)
S0-6.6.5 Oeslgn for Bloburden Control
S0-6.6.5.l Drainability. Horizontal process contact (2 2 )
surfaces of the isolator shall be drainable. lf CIP of the
isolator is specified, ali permanently ins ta lled interna)
liquid d istribution piping (e.g., spray wands) should be
sloped to meet the requirements of Table SD -2.4.3.1-1
category GS D2 where possible or suppli ed with an air
purge to facilitate liqu id removal per SD-2.4.3 and
Nonrnandatory Appendix C.
SD-6.6.5.2 Cleaning. Selection of cleaning agents
should be made with co nside ration of ali process
contac t materials including elastomer seals and
senso rs. lf CIP of the isolator is specified, ali process
contact surfaces shall be exposed to cleaning solutions
and accessible for visual verification.
SD-6.6.4.ll Seals. Ali elastomer seals shall meet 21
CFR 177.2600 orequivalent. Gaskets and 0-ringseals used
to seal the isolator are not considered product contact
su rfaces, but should be nonshedding where exposed to
153
ASME BPE-2022
SD-6.6.5.3 Chemical Sanitization/Sterilization. Ali
transpo rt syst ems shall be set in a position (or in
motio n) s uch t hat ali process con tact s urfaces are
exposed to the chemical agent used for the decontamination cycle.
me thods consistent with the certification standards for
an ISO dass S cleanroom should be applied.
SD-6.6.7.4 Mock-Up. Unless othenvise agreed to by
the owner /user, a mock-up at th e factory or user site
should be conducted prior to fabrication of aseptic isolators to assess aseptic operations through glove ports and
associated ergonom ics. When possible, the actual equipment or models of the actual equipment should be in place
for the mock-up.
SD-6.6.5.4 Thermal Sanitization/Sterilization.
[Reserved for future content]
SD-6.6.5.5 Post-Use Storage. Aseptic isolators
should be designed to maintain an ISO dass 5 environment
under dynamic and static conditions for a period of time
specified by the owner/ user. A post-use storage time
u nder static co nd itions s hou ld be specified by t he
owner/user and verified through e nvironmental moni toring.
SD-6.6.7.5 Airflow Verification and Visualization
Testing. The des ign of a irflow in aseptic iso lators
should be verified to maintain ISO class 5 conditions.
Airflow visualizatio n studies should be conducted
under specified conditions (e.g., ISO class 5) to demonstra te tha t che u nid irect ional airflow min imizes the
risk of contamination during operation. lt should demonstrate a sweeping action over and away from the sterilized/decontaminated equipment, product, containers,
and dosures.
Airflow visualization studies should document t he
airflow patterns under static conditions, dynamic (operating) conditions, and the airflow during ali interve ntions
(e.g., clearing a jammed vial).
SD-6.6.6 Design for Serviceability, Examination, and
Operation. The isolator systems should be designed to
enable safe access for inspection and service of compo·
nents that are subjett to wear, and to allow periodic calibration of instruments.
The isolator systems should be designed to provide
adeq uate space for maintenance accessibility of ali
mechanical compone nts.
SD-6.6.7 Testlng
SD-7 DESIGN CONFORMANCE TESTING
SD-6.6.7.1 lsolator Leak Testing. Both the pressure
decay and pressure hold methods of leak-rate testing a re
acceptable. When choosing a test method, consideration
should be given to the size of the isolator, time required for
testing. and externa) infl ue nces that may affect testing
(e.g., room temperature changes, room pressure changes).
The maximum leak rate shall be no greater than 1% of
the isolator volume per hour with ali pass-in/pass-out
holes and RTP fittings dosed and sealed (ISO 146447:2004, ISO 10648-2:1994 dass 3). Leak-rate test pressures sho uld be selected at 3 times to 5 t imes t he
working pressure as ag reed to by owner/user. The
temperature during t he leak test shall not cha nge
more than O. 9ºF (0.SºC).
Design conformance t es ting shall not r es ult in the
formation of any surface anomalies or contamination.
Ali design conformance tests and test results documentation shall have the date and time recorded. Each testdocument shall indude a record of personnel who performed
and confirmed the test results.
SD-7.l Spray Device Coverage Test
An acceptable spray device coverage test procedure is
provided in Nonma ndatory Appendix M. The purpose of
the spray device coverage test is to demonstrate and document liquid coverage of the process con ta et surfaces. The
test provides information a bout liquid coverage and the
conditions necessary to achieve this coverage as a prereq uisite for cleaning of the process equipment. Effective
coverage shall be visually determined using a fluorescent
solution and an ultraviolet lamp or by other verification
methods as agreed to by the owner/user and manufacturer. The mínimum acceptable water quality is noncompendial purified water ( e.g., reverse osmosis or
deionized). Acceptance criteria and coverage test pro toco)
should be agreed to by the owner/u ser and manufacturer.
Spray device coverage tests are not intended to demonstrate system cleanability. System cleanability is achieved
through the equipment design, the spray design, knowledge of the soils, deaning agent selection, and cleaning
process parameters. Clea nability is verified using a
complete CIP per protocol during cleani ng validation.
SD-6.6.7.2 Glove Leak Testing. System integri ty
should be confirmed by a glove leak test. A glove port
assembly tester is recommended to locate a potential
glove leak. lt is recommended to test both the installation
a nd the glove sleeve.
Leak testing methods found in ISO 14644-7 are acceptable. Unless otherwise specified by the owner/user, the
maximum permissible leak of0.5% of volu me per hour is
recommended. The use of a completely automated device
that uses pre-assigned test recipes is recommended.
SD-6.6.7.3 ULPA/HEPA Testing. The isolator design
shall include integral DOP (dispersed oíl particulate) or
PAO (polyalphao lefin) ports for HEPA filter integrity
testing with dioctyl p htha late or other approved
testing ae rosol challenge. For aseptic isolators, the
154
ASME BPE-2022
(a) The vessel shall be in its inte nded operating orie ntation within a tolerance agreed to by the owner/ user.
(b) The vessel shall be filled with water approximately
to the weld seam that joins the shell to the bottom head.
(e) The outlet valve shall be opened, the vessel shall be
vented to atmosphere, and the vessel shall be allowed to
drain.
( d) There shall be no puddles of water left on the ves sel
other than that retained due to surface tension.
Residual water may be present in the form of droplets
that typically do not exceed a diameter of 0.2 in. (5 mm).
Residual wate r droplets adhere to process surfaces due to
surface te nsion and a re not indicative of a vessel's drainability. Observed puddles that a re displaced with a 1.0-in.
(25 -mm) ru bber dowel ap plied perpendicular to the
puddle and re-form at the point of displacement indicate
a tlat or uni ntended low point, and t hat area shall be
repaired. Puddles that are displaced with a 1.0-in. (25 mm) diameter rubber dowel applied perpendicula r to
the puddle and do not return to the point of displacement
are considered to be large droplets and do not constitute a
test failu re.
SD-7.2 Cleaning, Steaming, and Bioburden Control
Testing
Cleaning. steaming. and bioburden control testing (in
addition to spray device testing) shall be as agreed to
by the owner/user and manufacturer, and in accordance
with acce pted industry standards.
SD-7.3 Fluid Requirements for Leak Testing
Where leak testing is required, the following tluids shall
be used:
(a) Hydrostatic testing shall use dean purified or deionized water filtered a t 25 µ or better, unless otherwise
agreed to by the owner/user.
(b) Pneumatic testing shall use oíl -free dean dry air,
nitrogen, or inert gas filte red a t 25 µ or better, un less
otherwise agreed to by the owner/u ser.
c22J SD-7.4
Vessel Drainability Test
Specific steps or operations in a bioprocess may require
vessels to be drainable. Adrainability test for such vessels
shall be conducted to confirm that the vessel has been
des igned and man ufactu red without any low poin t
other than its intended outlet or outlets. As a proposed
test proced ure, the following should be considered:
NOTE: Th is vessel drainability test is not in tended for fla t-bottom
caro·idgc--mount filter housings.
155
ASME BPE-2022
(22)
CHAPTER 5
PROCESS COMPONENTS FOR MULTIUSE
PART DT
DIMENSIONS AND TOLERANCES FOR PROCESS COMPONENTS
OT-1 PURPOSE ANO SCOPE
OT-4 DIMENSIONS
The purpose of this Part is to provide requirements that
ensure process component fit-up and compatibility.
This Part speci fies dimensions, tolerances, and ali
supplementary conditions far process components.
Fittings and process components a re designed far use
with nominal outside diameter (O.O.) tubing far the sizes
listed in Table DT-4-1. The dimensions are accompanied
with soft metric conve rsions from the U.S. Customary
units and are listed far refere nce only (see GR-6). For
nominal metric size tubingand fittings, refer to the a ppropriate international standards.
(22¡ DT-2 PRESSURE RATING
Table DT-2-1 shows the maximum allowable working
pressure and temperature ratings for metallic fittings
manufactured per DT-4.1 and manufactured from mate·
rials listed in Tables MM-2.1 •l through MM-2.1 -3, with the
exception of automatic tube weld caps listed in Table
DT-4.1.5 -1.
Meta llic fittings manufac tured to press ure a nd
temperature ratings that exceed those in Table DT-2-1
must be justified by methods accepted by ASME B31.3.
Metallic fittings listed in Table DT-4.1.5 -1 (automatic
tube weld cap) shall meet or exceed the p ressure and
temperature ratings shown in Table DT-2-l.
Special angle bra nch connections per DT-4.3 shall be
rated per the manufacturer's pressure a nd temperature
ratings.
Val ves manufactured to this Part shall be rated per the
manufacturer's marked pressure and temperature recommendations.
(22)
(22)
DT-4 .1 Fitting Dimensions
Dimensions far fittings that are governed by this Standard are grouped a nd categorized into tables.
Ali sizes shown in these tables are nominal O.D. tube
sizes.
Ali automa tic weld e nd fittings shall have mínimum
ta ngent lengths per Table DT-4.1-1. The tangent length,
Ti, is defined as the straight le ngth measured from the
welding end.
The categorized groups in DT-4.1.1 th rough DT-4.1.5
designate specific fitting dimensions.
0T-4 .l .l Elbows/ Bends. Refer to Tables DT-4.1.1 -1 (22)
through DT-4.1.1-10.
DT-4.l.2 Tees/ Crosses. Refer to Tables DT-4.1.2 -1 (22)
through DT-4.1.2· 13. The branch shall not intersect the
longitudinal weld of the run.
OT-3 WALL THICKNESS
0 T-4.1.3 Reducers . Referto Tables DT-4.1.3-1 through
DT-4.1.3-3.
The nominal wall thickness of the fittings and process
components at the point ofjoíníng shall be the same as the
tube to which they are welded. The thickness of the weld
e nds shall conform w ith the to le rances liste d in
Tables DT-3 -1 a nd DT-3 -2.
Afte r fabrication and surface treatment, the wall thickness in any farmed part of the fitting or process component, excl ud ing tu be, beyo nd the control port ian as
defined in DT-7, s hall be a mí nimu m of 65% of t he
nominal wall thickness. For guidelínes regardíng welds,
refer to Part MJ. Ali welds shall meet the provisions of
MJ-8 a nd Figure MJ-8.4·1.
0T-4 .1.4 Ferrules. Refer to Table DT-4.1.4· 1. Metallic (22)
hygienic clamp ferrule dime nsions are specified in Table
DT-7.1-1. Polymeric hygienic clamp ferrule dimensions
are specified in Table DT-7.1-2.
0T- 4.1. 5 Ca ps . Refer to Tables DT -4.1.5 -1 a nd
DT-4.1.5-2.
DT-4.2 Nonstandard Fitting Dimensions
Fittings not specifically described in Tables DT-4.1.1-1
through DT-4.1.5-2 may be constructed using combinations of centerline-to-end dimensions from the tables.
156
ASME BPE-2022
For tees a nd crosses, use Tables DT-4.1.2 -4 an d
DT-4.1.2 -8 for sta nda rd cla mp leg lengths ; Tables
DT-4.1.2 -2 a nd DT-4.1.2-7 for short- ou tle t branch
clamp lengths; Table DT-4.1.2-3 for short-outlet r un
cla mp le ngths; a nd Tab le DT-4.1.2-1 for weld end
lengths. Consideration shall be made for clamp clearances
when fabricatingfittings not depicted in Tables DT-4.1.1-1
through DT-4.1.5-2.
DT-7 TOLERANCES
DT-7.1 Fitting and Process ComponentTolerances
Tables DT-3 -1, DT-3 -2, DT-7.1-1 (me tallic) , a nd
DT-7.1-2 (polymeric) list the required tolerances for fabricated fíttings a nd process components, excluding tube,
dep icted by th is Standard. Table DT-7.1-1 li sts t he
req uired to lerances for metall ic mach ined hygienic
clamp ferrule profiles. Table DT-7.1-2 lists the required
tolerances for polymeric hygienic clamp ferrule profiles.
When metallic ferrules are welded to a process component
and polished, then the tolera nces in Tables DT-3-1 and
DT-3-2 shall apply.
These tolerances sha ll apply aft er heat a nd surface
t reatment. The control portion of the fitting or process
components (refer to C in the Table DT-3-1 illustration)
is the length from the welding end over which tolerances
for wall thickness a nd O.O. are maintained. The length of
the control portion is fixed for ali sizes at 0.75 in. (19 mm).
For exceptions, see Table DT-4.1.4-1 for ferrule lengths
and Table DT-4.1.5-1 for automatic tube weld caps.
DT-4.3 Speclal Angle Fittings Dimensions
Special a ngle fittings can be offered if in accordance with
ali DT tables, with th e exception of "O" (off a ngle) in
Table DT-3-1 . Fittings furn ished to this Standard shall
not be mitered.
{22)
DT-4.4 Valve Dimensions
The dimensions of the valve or valve fabrication shall
conform to the manufacturer's standards, oras agreed to
by the purchaser and manufacturer.
The categorized group in DT-4.4.1 des ignares specifíc
valve d imensions.
{22)
(22)
DT-4.4.1 Two-Way, Weir-Style Diaphragm Valves.
DT-7.2 Tubing Tolerances
Refer to Table DT-4.4.1-1. Ali sizes shown a re nominal
O.D. tube sizes.
For tubing tolerances, refer to ASTM A270, including
Supplement 2. The squareness of the t ube face to
outside diameter shall not exceed 0.015 in. (0.38 mm)
pe r in ch of diamete r. After weld joint prepa ra t ion
accordingto MJ-3.4, this valueshall meet the requirements
for dimension B of Table DT-3-1.
DT-4.5 Fllter Dimensions
Standa rd dimensions for filter components covered by
this Standard are referenced in SD-3.8 and a re given in
Tables DT-4.5.1-1 and DT-4.5.2-1.
DT- 4.5.1 Code 7 Tapered Locking Tab Retainer:
Recessed. Refer to Table DT-4.5.1-1.
DT-7.3 Transfer Panel Nozzle and Jumper
Tolerances
DT- 4.5.2 Code 7 Tapered Locklng Tab Retalner:
Externa!. Refer to Table DT-4.5.2-1.
Table DT-7.3-1 lists the required tolerances for transfer
panel nozzles and jumpers.
DT-8 WELD ENDS
{221 DT-4.6 Tube Dimensions
Where a usten itic stain less steels listed in Tables
MM-2.1 -1 and MM -2.1 -3 a re specified, weld ends of
process components t hat are to be autogenously
welded shall conform to the requirements for chemical
composition as prescribed in MM -5.2.1.l(a). For nonauto·
matic weld ends, the chemical composition shall meet the
requirements of the applicable ASTM specification.
Automaric weld ends furnished to this Standard shall be
furnished with square-cut ends, free from burrs and
breaks. Ali weld end connections for valves shall have
a min imum unobstructed weld end length equal to or
greater than the mínimum control portion as per DT-7.
Tube dimensions shal l meet the nom inal outs ide
diameter (O.D.) tubing sizes a nd tube wall thicknesses
listed in Table DT-4-1.
DT-5 MATERIALS
Materials used in the manufacture of fittings and other
process components shall conform to one of the ma terial
specifications listed in Part MM.
DT-6 TESTS
Hydrostatic testing of each fitting is not required in this
Standard; however, fittings shall be capa ble of withstanding a hydrostatic test pressure of 1.5 times the pressure rating shown in Table DT-2-1 at 100ºF (38°C).
DT-9 HYGIENIC CLAMP UNIONS
DT-9.1 Typical Hygienic Clamp Unions
Typical hygienic clamp u nio ns a re descri bed in
MC-2.2.2.
157
(22)
ASME BPE-2022
the following criteria, as a mínimum. lt is nota requirement that the packaged components be removed from the
original packaging. provided the following can be verified:
(a) manufacturer's name, logo, or trademark
(b) a lloy/material type
(e) description including size and configuration
(d) heat number/code
(e) process contact surface finish designation [only one
s urface finis h (SF) designation allowed)
W reference to ASME BPE
(1) ASME BPE Certificate of Authorization holde rs
shall mark the re fere nce to this Sta ndard by a pplying
their ASM E Certification Mark with BPE Designator.
Re fer to Figure CR-1-1.
(2) Non -ASME BPE Ce rtificate o f Authorization
holders shall only mark "B PE."
(g) pressure rating for valves
(h) no damage or other nonconformances
(22) DT-9.2 Hygienlc Gaskets
Fittings and process components with hygienic clamp
unions furnished to th is Standard shall employ gasket
materials and gasket designs that meet the requirements
ofTable DT-2 -1 and Part MC. Gasket sea! performance in
the clamp union s hall be based on the principies of MC-4
a nd shall conform to the dime nsional requirements of
Figure MC-4.2 -1 when the union assembly is tightened
to a n a moun t re co mmen ded by the man ufacturer.
Gasket seal width as shown in Figure MC-4.2-1 s hall be
a maximum of 0.095 in. in the uncompressed condition
prior to installation.
(22) DT-9.3 Connections
Connecrions meeting ali dimensions of Table DT-7.1-1
are cons ide red interchangeable. Alternati ve sea ling
designs are acceptable, provided the following are met:
(a) dimensions A, B, C, and D of Table DT-7.1-1
(b) dimensions A and B of Table DT-9.3-1
In the case of non-flow-through connections, dimension
B of Table DT-7.1-1 shall not apply. Ali connections shall
meet the applicable requirements of SD-3.1, MC-3.3.2 .1,
a nd MC-3.3.2.2.
DT-10.2 Oocumentation Verification
Refer· to Part GR for documentation verification requirements.
DT-10.3 Physical Examlnation
For this paragraph, a · 1ot'' shall be defined as a specific
combination of size, configuration, and heat number for
fittings and process components including, but not li mited
to, tubing, valves, pumps, filter housings, and instru menta tion in a single shipmem.
When required by the owner/user, a percentage of each
incomi ng lot sha ll be physically examined for a li the
following criteria:
(a) wall thickness (for weld ends only)
(b) outside diamete r (for weld ends only)
(e) surface finish (as specified)
(d) visual
When required examination reveals a defect(s), a n additional 10% of that Jot shall be examined for· the specific
defect(s). lf this examination reveals another defect, a n
a dditional 10% of that lot s hall be examined for the speci fic defect(s). lf additional defects are found, p erform
100% examination or reject the balance of the lot. Ali
examin ed a nd acce pted material in this lo t may be
retained a nd used.
The completed Material Examination Log shall describe
ali of th e features listed a bove. The results of the examination shall be recorded on a Material Examination Log.
This documentation may be one line item for the total
qua ntity of a particular size, configuration, and heat
number. The information required to be on the Material
Examination Logmay be in any format, written or tabular,
as long as ali information is included or referenced.
Refer to Forms MEL-1 and MER-1, which have been
provided as a gu ide for the Materia l Exam in ation Log
(see Nonmandatory Appendix BJ.
(22) DT-9.4 Hygienic Clamps
Hygienic clamps shall be designed and manu factured
through the en tire range of a li un ion compone nt dimensional tolerances to accomplish the following:
(a) completely retain ali components in a fully sealed
state to meet the requirements of DT-2
(b) ma intai n p roper component a lignment during
installation a nd operation per MC-3.3.2.l
(e) cause the ferrules to be aligned to meet a uniform
nomina l gap per Figure MC-4.2-1 when installed and tightened to the proper design specifications
(d) cause the gauging and contact diameter between
the ferrules and the ma ting su rfaces of the cl amp to
occ ur at the gaug ing di ame ter (A) s pecified in
Table DT-9.3-1 when installed and tightened to achieve
the nominal gap per Figure MC-4.2-1
NOTE: As this is a nominal design condition, manufacturing tolerances uf the components will cause sorne variation in the actual
gauging and contact diamcter at asscmbly.
(e) avoid any interference with any clamp union
components or itself that would prevent proper assembly
when assemb led with ali components (see Figure
DT-9.4-1)
DT-10 MINIMUM EXAMINATION REQUIREMENTS
DT-10.1 Visual lnspection
For fittings and process components including. but not
limited to, tubing, valves, pumps, filter· housings, a nd instrumenta tion, each item shall be visually examined for
158
(22)
ASME BPE-2022
DT-11.l.l Exceptlons
DT-11 MARKING
( 22)
(22)
(a) Where the available marking area does not permit
complete marking, the process co mponen! s ha ll be
marked, at a míni mum, with the items identified in
Table DT-11 .1.1 -1..
(b) Where the markings have been removed due to
fabrication into another component or system, the heat
number or manufacture r's code a nd material type s hall
be re-marked on the fitting or process component.
(e) Polymeric fittings do not require marking per this
section (see PM-2.2.2).
DT-11.1 Fittings, Valves, and lnstrumentation
Marking lnformation
Exceptas specified in DT-11.1.1, each process component shall be permanently marked to ma intain traceability
by any suitable me thod not inju rious to the process
contact surface to show the following:
(a) a number or unique identifier t hat provides trace·
a bility to t he applicab le MTR (material test repo rt),
surface test report, or other certifications. This number
may be a heat num ber /ma nufactu re r's code or serial
number, marked on each process contact component.
(b) mate rial type.
(e) valve pressure rating.
(d) manufacturer's name, logo, or trademark.
(e) reference to this Standard (ASME BPE).
(1) ASME BPE Certificate of Authorization holders
shall mark the refere nce to this Standard by applying
the ir ASME Mark w ith BP E Des ignato r. Refe r to
Figure CR-1-1.
{2) Non-ASME BPE Certificate of Autho rization
holders s hall only mark "BPE:'
(/) process contact surface designation for the appropriate BPE specifica tion [only one s urface finish (SFJ designation a llowed].
NOTE: Ali marking of a process component should be made
DT-11.2 Modified Surfaces
(22)
When the s urface finish of a process component is modified, the su rface fin ish designation ma rking shall be
changed to match the fi nal surface fi nish designation
according to Table SF-2.4.1-1. Only the final finish designation shaJI be indicated.
After removal of the original markings, ali dimensions
and tolerances shall conform to Table DT-3-1 and, as applicable, Table DT-3-2.
DT-12 PACKAGING
Ali end connections of fíttings or process componentS
sha ll b e protected with end caps. Additionally, fittings
shall be sealed in transparent bags or shrink wrapped.
Addi tional packag ing for process co mponents, other
t han fitti ngs, shall be as agreed to by the purchaser
and manufacturer.
outside of tlte control portion to optimize welding fit-up and
idcntification.
Table DT-2-1
Metallic Fittings: Rated Interna! Working Pressure
Temperature
3 In.
<3 In.
•F
•e
pslg
kPa
1.00
38
93
149
204
200
1379
1379
200
300
400
200
188
170
1293
1173
pslg
200
200
188
170
(22)
4 In.
kPa
1. 379
1379
1293
11 73
J>Slg
200
200
188
170
6 In.
kPa
pslg
kPa
1379
1379
150
1 034
1034
970
1293
1173
GENERAL NOTES:
(a) These pressure ratings apply to metalllc íittlngs, lncluding bun weldcd or hyglcnk clampcd conncctlons.
(bJ For installation practlccs of hygicnic clamp conncctions., refer to Figure DT-9.4· 1.
(e) Manufücturers may publish higher pressure ratings; see OT ·2.
159
150
14 1
128
880
ASME BPE-2022
Table DT-3-1
Final Tolerances for MechanicaUy Polished Fittings and Process Components, Excluding Tube
(22)
87
------------------------:;:.-- - - --,
' _p
~ , .'.
a
'.
':
. -- - - E - - - + !
~
Nominal
Size, in.
Squareness
Face to
o.o.
Wall Thickness
T an2ent, B
Equlvalenl
Ang)e
Off Angle, O
(for O)
in.
mm
deg
in.
mm
in.
mm
in.
mm
•0.005
±0.005
±0.005
• 0:13
+0.003/- 0.004
+0.08/-0.10
0.005
0.13
:!:0.13
+0.003/- 0.004
+0.005/- 0.008
+0.005/- 0.008
+0.08/-0.10
+0.13/- 0.20
+0.13/- 0.20
0.005
0.005
0.005
0.13
0.13
0.13
0.009
0.012
0.0)4
0.018
+0.005/- 0.008
+0.005/-0.008
+0,005/- 0.008
+0.13/- 0.20
+0.13/- 0.20
+0,13/-0.20
0.008
0.008
2½
±0.005 ±0.13
t0.008 t 0.20
±0,008 ! 0.20
±0.0 10 ±0.25
+0.005/-0.008
+0.13/- 0.20
3
±0,010 ! 0.25
+0,005/-0.008
4
±0.015
±0.38
6
!0.030 t 0.76
'I,
3/a
½
'1,
11/z
2
.o.oos
±0.13
t 0.13
E'
Off Plane, P
Centerllne
Radius
(CLR), R
in.
mm
in.
0.23
2.1
0.030
0.76
0.563 14.30
0.30
0.36
0.46
1.8
1.6
0.030
0.030
0.030
0.76
0.76
0.76
1.125 28.58
1.125 28.58
1.125 28.58
0.20
0.20
0.025 0.64
0.034 0.86
0.030
0.76
0.008
0.010
0.20
0.25
0.043 1.09
0.054 1.37
1.4
1.3
1.2
1.2
o.oso
o.oso
o.oso
1.27
1.27
1.27
1.500 38.10
2.250 57.15
3.000 76.20
3.750 95.25
+0.13/-0.20
0.016
0.41
0.068 1.73
1.3
o.oso
1.27
4.500
+0.008/- 0.010
+0.20/- 0.25
0.016
0.4 1
0.086 2.18
1.2
0.060
1.52
6.000
+0,015/- 0.015
+0.38/- 0.38
0.030
0.76
0.'135 3.43
1.3
0.060
1.52
9.000
1.4
mm
114.30
152.40
228.60
GENERAL NOTES:
(a) Tolerance on end-to-end and center-to-end dimension E:is i 0.0S0 in. (1.27 mm) for aH fittings and process componentsdepicted. for those
not depicted in this Standard. see manufacturer for standards.
(b) See Table DT-3-2 for electropolished wall thickness tolerancos.
(e) See DT-7 (Tolerances) for C control p-0rtion lengths.
(d) Sec Table DT-4.l •l tor TL tangent length dlmcnsions.
(e) Tolcrancc for centcrllne radlus (CLRJ is :!:10% of thc nominal dimension (R).
(f) Refer to DT·7.2 for tubing tolerances,
160
ASME BPE-2022
( 22)
Table DT-3-2
Final Tolerances for Electropolished Fittings and
Process Components, Excluding Tube
Table DT-4-1
Nominal O.O. Tubing Sizes
Wall Thiclmess
Nominal
Tube Wall
Thickness
Tube O.O.
Nom i nal
(22)
Slze, In.
In.
mm
Siz.e, in.
in.
mm
in.
mm
¼
+0.003/- 0.006
+0.08/- 0. I 5
'1,
0.250
6.35
0.035
0.89
¾
+0.003/- 0.006
+0.08/- 0.15
3¡1:1
0.375
9.53
0.035
0.89
0.500
12.70
0.065
1.65
0.750
19.05
0.065
J.65
1.000
25.40
0.065
1.65
1.500
38.10
0.065
J.65
'I,
+0.005/-0.010
+0.13/-0.25
½
¾
+0.005/- 0.010
+0.13/- 0.25
'1,
1
+0.005/-0.010
+0.13/-0.25
11/z
1%
+0.005/- 0.010
+0.13/- 0.25
2
+0.005/- 0.010
+0.13/- 0.25
2
2.000
50.80
0.065
1.65
2.500
63.50
0.065
1.65
2%
+0.005/-0.010
+0.13/-0.25
21/2
3
+0.005/-0.010
+0.13/- 0.25
3
3.000
76.20
0.065
1.65
4.000
101.60
0.083
2.11
6.000
152.40
0.109
2.77
4
+0.008/-0.012
+0.20/-0.30
4
6
+0.015/-0.017
+0.38/-0.43
6
GENERAL NOTE: Refer to OT-7.2 for tubing tolerances.
GENERAL NOTE: Refer to DT-7.2 for tubi ng tolerances.
161
ASME BPE-2022
Table DT-4.1-1
Tangent Lengths
Nomina)
Table DT-4.1.1-1
Automatic Tube Weld: 90-deg Elbow
Tangent, T,.
H"------A------
O.O. Tube
Size, in .
in .
mm
't,
1.500
38.10
3¡á
1.500
38.10
't,
1.500
38. 10
'1,
1.500
38.10
1.500
38.10
11/z
1.500
38.10
2
1.500
38.10
21/z
1.500
38.10
3
1.750
44.45
4
2.000
50.80
6
2.500
63.50
A
GENERAi. NOTES:
(a) Mínimum tangent léngths íor ferrules do n()t ápply. See
Table DT•4.1.4•1. dhnenslons 8 and C, for availablc lcngth
A
options.
Nominal Size, in.
(b) Minimum tangent length for 1/4 in. to 31.1 in. size automatic nibe
weld: 180 deg re turn ben d does no t co nform (see
Table DT-4.1.1-7. dimension 8).
[e) Mínimum tangent lengths for Tables DT-4 .1.2-2, DT-4.1.2-3,
DT-4.1.2-7, l)T-4. 1.3-1, and DT-4.1.3-2 do not apply.
162
in.
mm
2.625
66.68
2.625
66.68
3.000
76.20
3.000
76.20
3.000
76.20
3.750
95.25
4.750
120.65
5.500
139.70
3
6.250
158.75
4
8.000
203.20
6
11.500
292.10
ASME BPE-2022
Table DT-4.1.1-2
Automatic Tube Weld:
Hygienic Clamp Joint, 90-deg Elbow
Table DT-4.1.1-3
Hygienic Clamp Joint: 90-deg Elbow
A
A
A
Nominal Slze. In.
In.
mm
¼
%
½
¾
1.625
1.62S
1.62S
41.28
41.28
1.625
4 1.28
41.28
1
2
2.000
2.750
3.500
S0.80
69.85
88.90
4 1.28
21/¡?
4.2S0
107.9S
3
5.000
127.00
4
6.62S
10.500
168.28
266.70
8
A
Nominal Size, in.
in.
mm
in.
mm
¼
2.62S
2.625
66.68
1.62S
1.625
4 1.28
41.26
41.28
%
3.000
3.000
66.68
76.20
76.20
2½
3.000
3.7S0
4.750
5.500
76.20
9S.2S
120-65
139.70
2.000
2.7S0
3.500
4.250
S0.80
69.8S
88.90
107.95
3
4
6.250
8.000
158.75
203.20
5.000
6.625
6
11.500
292.10
10.S00
127.00
168.28
266.70
'li
';.
1
t½
2
1.62S
1.62S
11¡.,
6
163
ASM.E BPE-2022
Table DT-4.1.1-4
Automatic Tube Weld: 45-deg Elbow
Table DT-4. 1.1-5
Automatic Tube Weld:
Hygienic Clamp Joint, 45-deg Elbow
A
L
._______.
A
A
No mln.al Slze, In.
In.
mm
¼
¾
½
2.000
50.80
2.000
2.250
2.250
50.80
57.1 5
57.15
2.250
2.500
3.000
57.1 5
63.50
76.20
3.375
85.73
3.625
4.500
6.250
¾
1
1%
2
2 '1,
3
4
6
Nominal
Size, in.
A
B
in.
mm
in.
mm
¼
¾
½
¾
2.000
2.000
2.250
50.80
50.80
57.15
1.000
1.000
1.000
25.4-0
25.40
25.4-0
2.250
57.15
1.000
25.4-0
92.08
114.30
1
2.250
57. 15
1.1 25
28.58
158.75
11/i
2 1/;i
2.500
3.000
3.375
63.50
76.20
85.73
1.438
1.750
2.063
36.53
44.45
52.40
3
3.625
4.500
3.125
6
6.250
92.08
114.30
158.75
2.375
4
60.33
79.38
133.35
2
164
5.250
ASME 8PE-2022
Table DT-4.1.1-6
Hygienic Oamp Joint: 45-deg Elbow
Table DT-4.1.1-7
Automatic Tube Wetd:
180-deg Return Bend
------A------'
l
45 deg
8
A
L
Nominal
Size, in.
A
Nominal Slze, In.
¼
¾
In.
mm
'I,
A
8
in.
mm
in.
mm
4.500
4.500
1'14.30
2.625
66.68
114.30
114.30
114.30
2.625
3.000
3.000
66.68
76.20
76.20
76.20
114.30
127.00
1.000
25.40
1.000
1.000
1.000
25.40
25.40
25.40
'1,
4.500
4.500
l.125
l.438
1.750
28.58
1%
3.000
4.500
76.20
114.30
3.000
4.500
36.53
44.45
2%
6.000
7.500
152.40
190.50
5.000
5.750
2.063
52.40
3
2.375
60.33
4
4
3.125
5.250
79.38
133.35
6
9.000
12.000
18.000
228.60
304.80
457.20
6.500
8.500
U.500
½
¾
1
11/:z
2
2'1,
%
½
2
3
6
146.05
165.10
215.90
292.10
GENERAL NOTE: Nominal sizes 1/4 In. to 3/ 4 in. do not conform to
Table OT-4.l •l .
165
ASM.E BPE-2022
Table DT-4.1.1-8
Hygienic Clamp Joint:
180-deg Return Bend
Table DT-4.1.1-9
Automatic Tube Weld: 88-deg Elbow
(22)
i -- - - - - A - - - - ---'
r ---- ~--- --------- 1
1
1
1/
/
/
,/
I¡
I¡
1
1
1
1
1
B
A
:
88deg
1
1
1
1
A
A
Nomln.al
Size, in.
¼
¾
½
¾
B
A
Nomlnal Size, In.
In.
mm
68.58
in.
mm
in.
mm
'/4
2.700
4.500
114.30
3.125
79.38
%
2.700
3.065
3.065
68.58
77.85
77.85
2
3.050
3.800
4.810
77.47
96.52
122.17
2½
5.560
141.22
4.500
4.500
4.500
114.30
114.30
114.30
3.125
3.500
3.500
t¡i
79.38
88.90
88.90
j/4
1
11/2
2
21/2
3
4
6
3.000
4.500
6.000
7.500
9.000
12.000
18.000
76.20
114.30
152.40
190.50
228.60
304.80
457.20
3.500
5.000
5.500
6.250
7.000
9.125
13.000
t½
88.90
127.00
139.70
158.75
3
4
177.80
231.78
330.20
6
166
6.310
160.27
8.065
11.580
204.85
294.13
ASME BPE-2022
{ 22)
Table DT-4.1.1-10
Automatic Tube Weld: 92-deg Elbow
Table DT-4.1.2-1
Automatic Tube Weld: Straight lee and Cross
¡
~:~~;, ---------- --7
1
---- -----------------+------------------- ____
A
~
::
A
''
'
¡
'
92 deg
!
1
1
:...,_ _ _ A ~
1
1
¡
A
A
Nominal Size, in.
in.
mm
¼
'la
2.530
64.26
2.530
2.930
2.930
64.26
74.42
74.42
2.950
3.690
74.93
93.73
4.690
5.440
119.13
138.18
6.190
7.930
11.4 10
157.23
'I,
¾
1
1½
2
2½
3
4
6
A
--- -
.
-------------------,.-------------------
l
------H
A
201.42
289.8 1
A
Nominal Si.ze, in.
in.
mm
'I,
44.45
%
1.750
1.750
½
1.875
44.45
47.63
•;,
2.000
50.80
2.125
53.98
60.33
1 1/i
2
2.375
1
3.125
2 /2
167
2.875
73.03
79.38
3
3.375
85.73
4
4.125
6
5.625
104.78
142.88
ASM.E BPE-2022
Table DT-4.1.2-2
Automatic Tube Weld:
Short•Outlet Hygienic Clamp Joint Tee
Table DT-4.1.2-3
Hygienic Mechanical Joint: Short·Outlet Run Tee
7
y
l
1
8
X ...........................................
_l
.. .
........................ · ······ · =
. .
LA_J
Nominal
Size, in.
¼
¾
½
¾
A
mm
1.750
1.750
1.875
44.45
44.45
47.63
50.80
1
in.
mm
1.000
1.000
1.000
25.40
25.40
25.40
1.125
~8----+-A~
Nominal
Slze, In.
28.58
11/2
2
2.375
21/:i
3.125
2.875
53.98
60.33
1.125
1.375
mm
In.
mm
In.
mm
0.875
0.875
22.23
1.750
1.750
1.750
1.875
2.000
44.45
44.45
0.875
1.000
22.23
22.23
25.40
44.45
44.45
73.03
79.38
1.625
1.875
1.125
1.375
1.625
28.58
34.93
41.28
1.875
3
4
'la
28.58
34.93
41.28
½
¾
3.375
85.73
4.125
6
5.625
104.78
142.88
2.125
2.750
4.625
47.63
50.80
1.750
1.875
2.000
47.63
50.80
2.125
2.375
2.875
53.98
60.33
73.03
2.125
2.375
2.875
53.98
60.33
73.03
47.63
3.125
79.38
3.125
79.38
2.125
53.98
3.375
2.750
4.625
69.85
117.48
4.125
5.625
85.73
104.78
3.375
4.125
85.73
104.78
142.88
5.625
142.88
47.63
1
3
4
e
8
A
In.
¼
2.125
J
8
in.
2.000
e
l 1/2
2
2'1,
53.98
69.85
117.48
6
168
ASME BPE-2022
Table DT-4.1.2-4
Hygienic Clamp Joint: Straight Tee and Cross
Table DT-4.1.2-5
Hygienic Clamp Joint:
Short-Outlet Tee
'
''
1
''
''
'
- --------------------~-------------------''
''
l
1
A
-------------------~'' ------------------''
''
J
8
__J_
A
Nominal
Size, in.
mm
in.
mm
2.375
2.500
60.33
63.50
t.000
1.125
25.40
28.58
11/2
2
2.625
2.875
3.375
66.68
73.03
85.73
1.125
1.375
21/i
3.625
92.08
1.625
1.875
28.58
34.93
41.28
3
4
3.875
98.43
120.65
180.98
2.125
2.750
4.625
½
'1,
1
l
B
A
in.
47.63
A
- --------------------,--------------------
J
6
'
~
A
A
Nominal Size, in.
in.
mm
¼
57.15
57.15
'I,
2.250
2.250
2.375
¾
2.500
60.33
63.50
1
2.625
66.68
l 1/2
2
2.875
3.375
3.625
73.03
85.73
92.08
4
3.875
4.750
98.43
120.65
6
7.125
180.98
¾
21/2
3
169
4.750
7.125
53.98
69.85
117.48
ASM.E BPE-2022
Table DT-4.1.2-6
Automatic Tube Weld: Reducing Tee
(22)
Table DT-4.1.2-6
Automatic Tube Weld: Reducing Tee (Cont'd)
Nominal Slze,
in.
y
_._
¡
8
Nominal Size,
in.
B
A
X
y
in.
mm
in.
mm
'1.
¼
1.750
44.45
1.750
44.45
'1,
¼
1.875
1¡2
¾
1.875
47.63
47.63
1.875
1.875
47.63
47.63
'1,
¼
2.000
50.80
2.000
50.80
31.
¾
'1,
½
2.000
2.000
50.80
50.80
2.000
2.000
50.80
50.80
%
½
¾
2.125
2.125
2.125
2.125
53.98
53.98
53.98
53.98
2.125
2.125
2.125
2.125
53.98
53.98
53.98
53.98
1 /2
1
'I,
2.375
¾
1/2
1
1
2.375
2.375
60.33
60.33
60.33
2.375
1 1/i
2.375
2.375
60.33
60.33
60.33
2
2
2
½
¾
2.875
73.03
73.03
2
11/2
2.875
2.875
2.875
2/2
1
½
3.125
3.125
3.125
1
in.
mm
in.
mm
4
4
½
4.125
4.125
104.78
104.78
3.625
92.08
¾
4.125
4.125
4.125
104.78
104.78
104.78
3.625
3.625
3.625
92.08
92.08
92.08
98.43
4.125
4.125
104.78
104.78
5.625
5.625
5.625
142.88
142.88
142.88
4.625
5.625
5.625
5.625
142.88
142.88
142.88
4.875
4.875
117.48
123.83
123.83
5.625
5.625
142.88
142.88
4.875
S.125
123.83
130.18
4
4
A- j
1
1
y
4
4
4
X
¼
1
2'li
¾
2'/2
1
2 /i
2'li
1
1%
3
3
3
½
¾
3
3
3
1%
2
1
2
2%
3.125
3.125
3.375
3.375
3.375
3.375
3.375
3.375
66.68
66.68
73.03
73.03
2.625
2.625
2.625
2.625
79.38
2.875
73.03
79.38
79.38
79.38
2.875
2.875
2.875
73.03
73.03
73.03
79.38
2.875
73.03
85.73
85.73
3.125
3.125
85.73
85.73
85.73
3.125
3.125
3.125
79.38
79.38
79.38
85.73
3.125
66.68
66.68
79.38
79.38
79.38
170
B
A
X
1
11/2
2
1
2 /2
3
6
½
6
6
6
¾
1
1
1 /2
2
6
6
6
2 11,
3
6
4
3.875
3.875
3.875
4.625
4.625
4.625
98.43
98.43
117.48
117.48
117.48
ASME BPE-2022
Table DT-4.1.2-7
Automatic Tube Weld: Short-Outlet Hygienic Clamp,
Joint Reducing lee
Table DT- 4.1.2-7
Automatic Tube Weld: Short-Outlet Hygienic Clamp,
Joint Reducing lee (Cont'd)
Nominal Size, in.
y
8
X ----
----------------- -----------------
___I
A
No: inal Siz: in.
l
A
mm
in.
mm
31.
¼
1.750
44.45
1.000
25.40
'1,
'1,
¼
1.875
1.875
47.63
47.63
1.000
1.000
25.40
¾
2.000
2.000
2.000
50.80
50.80
50.80
1.000
1.000
1.000
25.40
53.98
53.98
53.98
1.125
½
2.125
2.125
2.125
1.125
28.58
28.58
28.58
¾
2.125
53.98
1.125
28.58
31,
¼
3
1/,
¾
'l.
1/2
1
¼
¾
1
1
1.125
25.40
25.40
25.40
1½
½
11/2
¾
2.375
2.375
60.33
60.33
t.375
1.375
34.93
34.93
1 1/2
1
2.375
60.33
1.375
34.93
2
½
2
2
2
¾
2.875
2.875
73.03
73.03
11/;i
2.875
2.875
1
t.625
41.28
73.03
73.03
1.625
1.625
t.625
41.28
41.28
41.28
2½
21/2
½
3.125
79.38
1.875
47.63
¾
2½
1
2½
21/2
l 1/2
3.125
3. 125
3.125
79.38
79.38
79.38
1.875
t.875
1.875
47.63
47.63
47.63
2
3.125
79.38
1.875
47.63
½
3.375
3.375
85.73
2.125
53.98
85.73
85.73
85.73
85.73
2.125
2.125
2.125
53.98
53.98
53.98
53.98
85.73
2.125
53.98
4.125
4.125
104.78
104.78
2.625
2.625
66.68
66.68
4.125
4.125
4.125
104.78
104.78
104.78
2.625
2.625
2.625
66.68
3
3
3
3
3
3
¾
1
111.,
2
1
2 /2
4
½
4
¾
4
4
111.,
4
2
1
3.375
3.375
3.375
3.375
2.125
66.68
66.68
171
8
y
in.
mm
in.
mm
4
4
2'/2
4.125
3
4.125
104.78
104.78
2.625
2.625
66.68
66.68
142.88
142.88
142.88
3.625
3.625
3.625
92.08
92.08
92.08
3.625
3.625
3.625
92.08
92.08
92.08
3.625
3.750
92.08
95.25
6
't.,
5.625
6
6
6
31.
S.625
1
5.625
6
6
6
6
8
in.
A
X
1 '12
5.625
2
S.625
2 11,
3
4
5.625
142.88
142.88
142.88
5.625
5.625
142.88
142.88
ASM.E BPE-2022
Table DT-4.1.2-8
Hygienic Clamp Joint: Reducing Tee
(22)
Table DT-4.1.2-8
Hygienic Clamp Joint: Reducing Tee (Cont'd)
y
'
'
Nominal Slze,
in.
y
X
in.
mm
in.
mm
2 11,
3.875
98.43
3.625
92.08
4.750
4.750
120.65
120.65
4.125
4.750
4.750
4.750
120.65
120.65
120.65
4.125
104.78
104.78
104.78
3
1
X-
~-------------------~------------------'
''
B
4
½
l
4
¾
!'
1·
A ~
Nominal Size,
In.
X
y
¾
¼
'I,
¼
½
¾
¾
¼
'1,
'1,
1
1
'la
11/2
In.
mm
2.250
57. 15
2.375
60.33
60.33
2.375
60.33
60.33
¾
2.500
2.500
63.50
63.50
2.500
2.500
63.50
63.50
½
2.500
63.50
2.500
63.50
¼
2.625
2.625
66.68
66.68
2.625
2.625
66.68
66.68
2.625
2.625
66.68
66.68
2.625
2.625
66.68
66.68
2.875
73.03
73.03
2.875
2.875
73.03
73.03
73.03
2.875
73.03
3.375
85.73
3.125
3.375
3.375
3.375
85.73
85.73
85.73
3.125
3.125
3.125
79.38
79.38
3.625
3.625
3.625
92.08
92.08
92.08
3.375
3.625
3.625
92.08
92.08
3.875
98.43
98.43
½
½
¾
t½
2
2
2
½
¾
2
1½
2 11,
½
2½
2½
2 11,
=¼
2½
mm
57.15
2.375
2.375
:¼
11/z
In.
2.250
1
1
1 '1,
2
3
3
3
½
¾
3
3
t½
2
1
2.875
2.875
3.875
3.875
3.875
3.875
98.43
98.43
98.43
3.375
3.375
3.375
85.73
85.73
85.73
85.73
85.73
3.625
92.08
3.625
3.625
3.625
92.08
92.08
92.08
3.625
92.08
1
4
11/;i
4
2
4
21/i
4
3
4.750
4.750
120.65
120.65
6
6
'1,
7.125
¾
7.125
7.1 25
7.125
6
6
6
79.38
79.38
3.375
4
6
6
6
B
A
172
B
A
1
11/i
2
3
7.125
7.1 25
7.125
4
7.125
1
2 /:i
4.125
4.125
104.78
4.375
4.375
4.375
111.13
111.13
111.13
180.98
180.98
180.98
5.125
5.125
5.125
130.18
130.18
130.18
180.98
180.98
180.98
5.125
5.375
5.375
130.18
136.53
136.53
180.98
180.98
5.375
5.750
136.53
146.05
ASME BPE-2022
Table DT-4.1.2-9
Hygienic Clamp Joint: Short-Outlet Reducing Tee
Table DT-4. 1.2-9
Hygien ic Clamp Joint: Short-Outlet Reducing Tee
(Cont'd)
y
X-
•
J •
•• 1
••
••
••
------------------,------------------••
••
•
•
1
.
Nominal Size,
in.
Nominal Size,
In.
1
8
l
X
In.
mm
In.
mm
4
4
't,
4.750
4.750
120.65
2.625
66.68
4.750
4.750
4.750
120.65
120.65
120.65
120.65
2.625
2.625
2.625
2.625
66.68
66.68
66.68
66.68
4.750
4.750
120.65
120.65
2.625
2.625
66.68
66.68
7.125
7.125
7.125
180.98
180.98
180.98
3.625
3.625
3.625
92.08
92.08
92.08
7.125
7.125
7.125
180.98
180.98
180.98
3.625
3.625
3.625
92.08
92.08
92.08
7.125
7.125
180.98
180.98
3.625
3.750
92.08
95.25
½
3/.
mm
in.
mm
6
'
¼
2.250
57.15
1.000
25.40
6
6
6
1,
J/.1
'1/,
¼
¾
2.375
2.375
¼
2.500
2.500
2.500
63.50
63.50
63.50
1.000
l.000
2.625
66.68
2.625
2.625
2.625
66.68
1.125
1.125
1.125
¾
't.
½
1
¼
¾
1
½
1
¾
3
B
A
in.
1
2
2 1/2
y
'1,
1
1 /2
4
4
X
1/.
•1.
1
4
4
4
A
60.33
60.33
66.68
66.68
1.000
1.000
1.000
1.125
25.40
25.40
25.40
25.40
25.40
1
1 1/2
2
6
6
6
2 1/ i
3
6
4
Table DT-4.1.2-10
Automatic Tube Weld: lnstrument Tee
28.58
28.58
28.58
28.58
y
t
''
_____ J
'
X-- -------------------' -----------------''
11/2
½
2.875
¾
l '12
1
2.875
2.875
73.03
73.03
73.03
1.375
1.375
1.375
34.93
11/2
2
2
2
½
¾
3.375
3.375
85.73
85.73
41.28
41.28
LA
11/2
85.73
85.73
41.28
41.28
Nominal Size, in.
2
3.375
3.375
1.625
1.625
1.625
21/2
't,
21/2
¾
2½
1
2½
1'/i
21/2
2
3
½
¾
3
3
3
1%
3
3
2'/i
1
2
1.625
3.625
3.625
3.625
92.08
92.08
92.08
1.875
1.875
l.875
3.625
3.625
92.08
92.08
1.875
1.875
3.875
3.875
3.875
3.875
3.875
3.875
B
A
y
34.93
34.93
X
in.
mm
in.
mm
11/i
2.500
2.500
2.500
63.50
63.50
63.50
0.875
1.000
22.23
25.40
28.58
2.750
2.750
69.85
69.85
1.000
1.125
2.750
2.750
69.85
69.85
1.250
1.500
X
47.63
¾
X
1 '/2
47.63
47.63
47.63
1
X
1 /i
X
2
X
2
2
2
'/2
't.
98.43
98.43
2.125
2.125
53.98
53.98
98.43
98.43
98.43
2.125
2.125
2.125
53.98
53.98
53.98
98.43
2.125
53.98
173
1
X
1½
X
B
11
y
1/i
47.63
8
1
1.125
25.40
28.58
31.75
38.10
ASM.E BPE-2022
Table DT-4.1.2- ll
Hygien ic Clamp Joint: lnstrument Tee
Table DT-4.1.2-12
Aut omatic Tube Weld:
Standard Outlet Hygienic Clamp Joint Tee
y
'
l
X --
t
r
''
''
''
--------------------~
--------------------,,,
\
;,,;
1
1
1
1
1
1
1
1
1
1
1
1
_J
1
A
1'
Nominal Size, in.
y
X
in.
mm
in.
mm
22.23
A
7
1
8
8
(22)
B
J
---------- ¡----------
½
X
11/2
3.000
76.20
0.875
¾
X
1½
3.000
76.20
1.000
25.40
1
X
11/2
3.000
76.20
1.125
28.58
½
X
2
3.250
82.55
1.000
25.40
¾
X
2
3.250
82.55
1.125
28.58
Nominal Size, in.
in.
mm
in.
mm
1
X
2
3.250
82.55
1.250
31.75
'1,
1.750
44.45
2.250
57.15
t½
X
2
3.250
82.55
1.500
38.10
%
1.750
44.45
2.250
57.15
'I,
1.875
47.63
2.375
60.33
'1,
2.000
50.80
2.500
63.50
1
2.125
53.98
2.625
66.68
1½
2.375
60.33
2.875
73.03
2
2.875
73.03
3.375
85.73
½
3.125
79.38
3.625
92.08
3
3.375
85.73
3.875
98.43
4
4.125
104.78
4.750
120.65
6
5.625
142.88
7.125
180.98
A
1
A
2
174
B
ASME BPE-2022
(22)
Table DT-4.1.2-13
Automatic Tube Weld:
Standard Outlet Hygienic Clamp Joint Reducing Tee
Table DT-4.1.2-13
Automatic Tube We!d:
Standard Outlet Hygienic Clamp Joint Reducing Tee
(Cont'd)
y
'
No;inal Size~ in.
1
1
1
1
1
1
1
1
1
1
X-
J
In.
mm
¼
1.750
44.45
2.250
57.15
'I,
¼
½
%
1.875
1.875
47.63
47.63
2.375
2.375
60.33
60.33
¾
:¼
¾
¼
%
½
2.000
2.000
2.000
50.80
50.80
50.80
2.500
2.500
2.500
63.50
63.50
63.50
1
¼
1
1
%
½
2. 125
2.125
53.98
53.98
2.625
2.625
66.68
66.68
2.125
2. 125
53.98
53.98
2.625
2.625
66.68
2.375
60.33
60.33
60.33
2.875
73.03
2.375
2.375
2.875
2.875
73.03
73.03
73.03
73.03
73.03
3.125
3.125
1
2.875
2.875
2.875
l 1/2
2.875
73.03
3.125
3.125
79.38
79.38
79.38
½
¾
3.375
21/:i
21/i
3.125
3.125
3. 125
79.38
2'12
1'/i
3.375
3.375
3.375
21/2
2
3.125
3.125
79.38
79.38
79.38
79.38
3.375
85.73
85.73
3
3
½
¾
3.375
3.375
85.73
3.625
92.08
3
3
1
11/2
3.375
3.375
85.73
85.73
85.73
3.625
3.625
3.625
92.08
92.08
92.08
1
2
½
¾
2
2
2
2%
1
3.625
3.625
92.08
92.08
4.125
4.125
4.125
104.78
104.78
104.78
4.125
4.125
104.78
104.78
104.78
4.125
4.125
4.125
104.78
104.78
104.78
4.375
4.125
104.78
4.375
3
5.625
142.88
4
5.625
142.88
5.375
5.750
3
2 /2
1
4
½
4
"l.
4
1
t 1/i
2
4
4
6
6
B
A
mm
11/2
85.73
85.73
2 11,
3
4.125
4.125
4.375
104.78
111.1 3
111.13
111.13
1
In.
½
½
mm
3.375
3.375
8
A
1%
1%
in.
2
4
¾
mm
3
4
%
B
A
in.
1
----------4---------1
No;lnal Slze/"· 1
l
66.68
79.38
85.73
85.73
85.73
175
136.53
146.05
ASM.E BPE-2022
Table DT-4.1.3-1
Automatic Tube Weld: Concentric and Eccentric Reducer
jR
m.
L4
1
L1 - -
L1
X
"
R1
,__ _ _ _ _ A _ _ _ _ __
,
i------A-----_,
1.0.
Overall
Length,
Tangent,
1.0 . 'fangent
O.O. Tangent, O.O. Tangent
Large End,
L1, min.
Small End,
L2, mio.
Small End,
L3, min.
Interna)
Radius,
Externa!
Radius,
R2, mio.
Nominal
Size,
in.
y
X
in.
mm
in.
mm
in.
mm
in.
mm
in.
mm
deg
in.
in.
mm
'la
¼
1.625
4 1.28
0.375
9.53
0.875
22.23
0.750
19.05
0.750
19.05
30
0.250 6.35
0.03 1
0.79
30
30
0.250 6.35
0.031
0.79
0.250 6.35
0.03 1
0.79
30
30
0.250 6.35
0.031
0.250 6.35
0.031
0.79
0.79
30
30
0.250 6.35
0.031
0.250 6.35
0.031
30
30
0.250 6.35
0.031
0.250 6.35
0.031
30
30
0.250 6.35
0.031
0.250 6.35
0.031
30
30
0.250 6.35
0.03 1
0.250 6.35
0.031
0.79
0.79
30
30
30
0.250 6.35
0.250 6.35
0.031
0.031
0.79
0.79
0.250 6.35
0.03 1
0.79
30
30
0.250 6.35
0.031
0.250 6.35
0.250 6.35
0.031
0.031
0.79
0.79
0.250 6.35
0.250 6.35
0.031
0.03 1
A
Large End,
L4, min.
½
¼
1.875
47.63
0.375
9.53
0.875
22.23
0.750
19.05 1.000
25.40
'I,
'la
1.875
47.63
0.375
9.53
0.875
22.23
0.750
19.05
1.000
25.40
¾
¾
'la
2.000
50.80
0.875
22.23
0.750
19.05 1.000
25.40
2.125
53.98
0.375
0.375
9.53
½
9.53
1.125
28.58
1.000
25.40
1.000
25.40
1
1
½
¾
2.500
63.50
1.125
1.125
28.58
1.000
25.40
1.000
25.40
53.98
0.375
0.375
9.53
2.125
28.58
1.000
25.40
1.000
25.40
11/2
1'1,
¾
3.000
76.20
1.000
25.40
1.000
25.40
63.50
1.125
1.125
28.58
2.500
0.375
0.375
9.53
1
28.58
1.000
25.40
1.000
25.40
0.375
0.375
9.53
1.125
28.58
1.000
25.40
1.000
25.40
9.53
1.125
28.58
1.000
25.40
1.000
25.40
2
9.53
9.53
3.375
85.73
2
1 '1,
2.500
63.50
2½
1½
2
3.375
85.73
1.125
28.58
1.000
25.40
1.000
25.40
63.50
0.375
0.375
9.53
2.500
9.53
1.125
28.58
1.000
25.40
1.000
25.40
l 1/2
2
4.250
3.375
107.95
85.73
0.375
0.375
9.53
9.53
1.125
28.58
28.58
1.000
1.000
25.40
25.40
1.500
38. 10
38.10
2½
2.625
66.68
0.375
9.53
28.58
1.000
25.40
4
2
5.125
0.375
0.375
28.58
1.000
25.40
21/z 4.250
130.18
107.95
9.53
4
4
3
3.875
98.43
0.375
28.58
1.625 41.28
1.000
1.500
25.40
38.10
1.500
1.500
1.500
38.10
38. 10
6
6
3
4
7.250
5.625
184.15
142.88
0.375
1.625 41.28 1.500
1.625 41.28 1.500
38.10
38.10
2.000
2.000
50.80
50.80
2½
3
3
3
0.375
9.53
9.53
9.53
9.53
1.125
1.125
1.125
1.125
176
1.500
1.500
38.10
38.10
lnternal
'íaper, a,
max.,
30
44
44
Rl, mio.
mm
0.79
0.79
0.79
0.79
0.79
0.79
0.79
0.79
0.79
ASM E BPE-2022
Table DT-4.1.3-2
Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
-
r
l 3 -1
l1
l1
~ L2
-·-·-·- ·-
X
R2
l3-¡
y
·- ·--
X
1- l2
l
y
R1
\_ R2
A
A
Nominal
Size, in.
Ove rall
Length, A
l.O. Tangent,
Large End,
L1, min.
l.O. Tange nt,
Sma ll End,
L2, min.
O.O. Tange nt,
Small End, L3,
min.
Interna)
'íape r,
Interna)
Radjus,
Externa)
Radius,
Rt, min.
R2, min.
X
y
in.
mm
in.
mm
in.
mm
in.
mm
a,
max.,
deg
in.
mm
in.
mm
%
'1,
2.125
53.98
0.375
9.53
0.875
22.23
0.750
19.05
30
0.250
6.35
0.031
0.79
'I,
•1.1
60.33
60.33
0.875
22.23
22.23
0.750
0.750
19.05
19.05
30
30
0.250
0.250
6.35
6.35
0.031
0.031
0.79
0.375
9.53
9.53
0.875
't.
2.375
2.375
0.375
½
¾
¾
3te
2.500
63.50
0.375
9.53
0.875
22.23
0.750
19.05
6.35
0.031
0.79
2.625
66.68
0.375
9.53
1.125
28.58
1.000
25.40
30
30
0.250
'ti
0.250
6.35
0.031
0.79
28.58
28.58
1.000
25.40
6.35
0.031
0.79
25.40
30
30
0.250
1.000
0.250
6.35
0.031
0.79
28.58
28.58
1.000
25.40
6.35
0.031
25.40
30
30
0.250
1.000
0.250
6.35
0.031
0.79
0.79
28.58
28.58
1.000
25.40
6.35
0.031
25.40
30
30
0.250
1.000
0.250
6.35
0.031
28.58
28.58
1.000
25.40
0.250
6.35
0.031
1.000
25.40
30
30
0.250
6.35
0.031
28.58
28.58
28.58
1.000
25.40
0.250
6.35
0.031
1.000
1.000
25.40
25.40
30
30
30
0.250
0.250
6.35
6.35
0.031
0.031
30
30
0.250
6.35
0.031
0.79
0.250
0.250
6.35
6.35
0.031
0.03 1
0.79
0.79
0.250
0.250
6.35
6.35
0.031
0.03 1
0.79
0.79
1
1
'ti
3.000
76.20
0.375
9.53
1.125
'1,
2.625
66.68
0.375
9.53
1.125
11/2
't.
3.500
88.90
1.125
11/z
3.000
76.20
0.375
0.375
9.53
1
9.53
1.125
2
2
1
11/2
3.875
98.43
1.125
76.20
0.375
0.375
9.53
3.000
9.53
1.125
2½
2 1/2
11/2
2
3.875
98.43
9.53
1.125
3.000
76.20
0.375
0.375
9.53
1.125
3
3
3
11/i
4.750
120.65
9.53
1.125
2
21/2
3.875
3.125
98.43
79.38
0.375
0.375
0.375
9.53
9.53
1.125
1.125
2
21/2
5.750
146.05
0.375
9.53
1.125
25.40
3
123.83
114.30
0.375
0.375
9.53
9.53
1.125
t.625
28.58
28.58
41.28
1.000
4.875
4.500
1.000
1.500
25.40
38. 10
3
4
8.000
6.375
203.20
16 I.93
0.375
0.375
9.53
9.53
1.625
t.625
41.28
41.28
1.500
1.500
38.10
38. 10
4
4
4
6
6
177
30
44
44
0.79
0.79
0.79
0.79
0.79
0.79
0.79
0.79
ASM.E BPE-2022
Table DT-4.1.3-3
Hygienic Clamp Joint: Concentric and Eccentric Reducer
L1
X- + - - - -
1-- - - - - - - A - - - - - - --l
Nominal Size,
in.
y
X
Overall
Length, A
I.D. Tangent,
Large End,
Ll, min.
1.0. Tangent,
Small End,
L2, min.
lnternal
Taper,
a,
lnternaJ
Radius,
Rl,
External
Radius,
min.
R2, min.
in.
mm
in.
mm
in.
mm
max.,
deg
in.
mm
in.
mm
%
Y,
2.625
66.68
0.375
9.53
0.875
22.23
30
0.250
6.35
0.03 1
0.79
'1,
'1,
¼
%
2.875
2.875
73.03
73.03
0.375
0.375
9.53
9.53
0.875
0.875
22.23
22.23
30
30
0.250
0.250
6.35
6.35
0.031
0.03 1
0.79
0.79
3.000
3.125
76.20
79.38
0.375
0.375
9.53
9.53
0.875
1.125
22.23
28.58
30
30
0.250
0.250
6.35
6.35
0.031
0.03 1
0.79
0.79
3.500
3.125
88.90
79.38
0.375
0.375
9.53
9.53
1.125
1.125
28.58
28.58
30
30
0.250
0.250
6.35
6.35
0.031
0.03 1
0.79
0.79
1.125
1.125
28.58
30
30
0.250
6.35
0.031
0.79
0.250
6.35
0.03 1
0.79
1.125
1.125
28.58
30
30
0.250
6.35
0.031
0.79
0.250
6.35
0.031
0.79
1.125
1.125
28.58
30
30
0.250
6.35
0.031
0.79
0.250
6.35
0.031
0.79
30
30
30
0.250
6.35
0.031
0.79
0.250
0.250
6.35
6.35
0.031
0.03 1
0.79
0.79
6.35
6.35
6.35
0.031
0.03 1
0.031
0.79
0.79
0.79
6.35
6.35
0.03 1
0.03 1
0.79
0.79
•1,
'la
'1,
½
1
1
'1,
1
½
'1,
1
4.000
101.60
0.375
9.53
t 'li
3.500
88.90
0.375
9.53
2
2
1
l 'l2
4.375
111.13
88.90
0.3 75
9.53
0.375
9.53
2 1/ i
1
2 /2
11/2
2
4.375
111.13
88.90
0.375
9.53
3.500
0.375
9.53
3
3
3
11/2
2
1 /i
21/i
4
2
4
4
21/i
6
3
6
4
3
3.500
28.58
28.58
28.58
5.250
133.35
0.375
9.53
111.13
92.08
0.375
0.375
9.53
9.53
1.125
1.125
1.125
28.58
4.375
3.625
6.250
5.375
5.000
158.75
136.53
127.00
0.375
0.375
0.375
9.53
9.53
9.53
1.125
1.125
t.625
28.58
28.58
41.28
30
30
30
0.250
0.250
0.250
8.500
7.000
215.90
177.80
0.375
0.375
9.53
9.53
1.625
t.625
41.28
41.28
44
44
0.250
0.250
28.58
28.58
178
ASME BPE-2022
Table DT-4.1.4-1
Automatic Tube Weld: Ferrule
I'
Table DT-4.1.5-1
Automatic Tube Weld: Cap
.
A, 8, C
L
1- a- l
e
8
A
Nominal
Size, in.
in.
mm
in.
mm
in.
mm
¼
1.750
44.45
1.125
28.58
0.500
12.70
¾
1.750
44.45
1.125
28.58
0.500
12.70
\',
1.750
44.45
1.125
28.58
0.500
12.70
¾
1.750
44.45
1.125
28.58
0.500
12.70
1
1.750
44.45
1.125
28.58
0.500
12.70
1 1/2
1.750
44.45
1.125
28.58
0.500
12.70
2
2.250
57.15
1.125
28.58
0.500
12.70
1
2.250
57.15
1.125
28.58
0.500
12.70
2 /i
3
2.250
57.15
1.125
28.58
0.500
12.70
4
2.250
57.15
1.125
28.58
0.625
15.88
6
3.000
76.20
1.500
38.10
0.750
19.05
A
Nominal Slze, In.
In.
mm
½
1.500
38.10
•1,
1.500
38.10
1
l.500
38.10
1 1/2
1.500
38.10
2
1.500
38.10
2'/2
1.500
38.10
3
1.750
44.45
4
2.000
50.80
6
2.500
63.50
GENERAi, NOTE: Mínimu m 1.0. control portíon length, 8, is 0.375 in.
(9.53 mm) for all sizes.
179
ASM.E BPE-2022
Table DT-4.1.5-2
Hygienic Clamp Joint: Solid End Cap
~
TypeA
f
~
TypeB
T
A, mio.
Nominal Size, in.
Type
in.
mm
4.75
'1 ,
A
0.187
'le
A
0.187
4.75
'/2
A
0.187
'l.
A
0.187
4.75
4.75
1
A
0.250
6.35
1
8
0.250
6.35
11/2
B
0.250
6.35
2
B
0.250
6.35
2'/2
8
0.250
6.35
3
B
0.250
6.35
4
8
0.312
7.92
6
B
0.437
11.10
180
ASME BPE-2022
Table DT-4.4.1-1
Hygienic Clamp Joint: Two-Way,
Weir-Style Diaphragm Valve
( 22)
A
A
Nominal Size, in.
in.
mm
¼ fractional
¾ rractlonal
2.500
63.50
2.500
63.50
½ fractional
2.500
63.50
1/2
3.500
88.90
¾
4.000
101.60
1
4.500
114.30
11/2
5.500
139.70
2
6.250
158.75
2½
7.630
193.80
3
8.750
222.25
4
11.500
292.10
181
ASME BPE-2022
Table DT-4.5.1-1
Tapered Locking Tab Retainer: Recessed
A
A
B
G
D
R0.060 in. (1.52 mm)
1- - - - - c
SECTION: A-A
Tolerance
Dimension
in.
mm
in.
A
1.250 (min.J
1.400 (max.J
31.75 (mln.J
35.56 (max.J
mm
B
0.173
4.39
±0.004
±0.10
+0.003/-0.000
+0.08/-0.00
Notes
(1)
e
2.250
57.15
D
0.550 (min.J
13.97 (mhi.J
E
F
0.134
3.40
±0.004
±O.JO
Rl.430
R36.32
±0.0 10
±0.25
G
H
0.060 (max.)
1.52 (max.)
0.125 (max.)
3.18 (max.)
(1)
(2)
G6NBRAL NOTES:
(a) (,0cking tab retainer opti(mS are shown as posslble options and do not represtmt ali possible de.signs.
(b) Ali surfáces shall me.et the specified Anish of wetted surfaces. exdudi ng the weld :eones.
NOTES:
(1) Clearance for locking tabs.
(2) O-ring lead-in chamfer.
182
ASME BPE-2022
Table DT-4.5.2-1
Tapered Locking Tab Retainer: Externa!
B
10 deg to 20 deg
B
IG
r-r-7-;r,¡:::==::====t======i==:µ::::;z::::~
o
R0.060 in. (1.52 mm)
1------C ------1
SECTION: B-B
Tolerance
Dimension
in.
8
mm
in.
mm
0.173
4.39
±0.004
±0.10
e
2.250
57.15
+0.003/-0.000
+0.08/-0.00
D
O.SSO (min.)
13.97 (min.)
E
0.134
3.40
±0.004
,0.10
F
Rl.430
R36.32
±0.010
±0.2S
G
0.060 (max.J
H
0.1 25 (max.J
1.52 (max.J
3.18 ( max.)
Notes
(1)
(2)
GENERAL NOTES:
(a) Locki ng tab retal ncr options are shown a.s possible options and do not represent all posslble dcsigns.
(b) Ali surfaces shaU meet the spe<ifie11 finish of wetted suríaces, excluding the weld zones.
NOTES:
(1) Clearance for locking tabs.
(2) 0 -ring lead-i n chamfer.
183
Table OT-7.l · l
Metallic Hy gienic Clamp Ferrule Standard Dimensions and Tolerances
(22)
IYoeA
~ --
-
Groove E
detail
G·
ft
1¾:
O F
A
~ (/,/_,_ .j
_i
Á'
e
Groove Oetail
Flange
,_.
o,
.¡,.
Tube Diameter., A
Nominal
Slie,
I.D. Rore, 8
,.olerance, :t
Olmenslon
·roleranoe, t
i n.
mm
Dimension
±
0.005
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
0.13
20
20
20
20
20
0.5
1 i n.
0.984
0.5
0.984
25.0
0.5
0.984
25.0
0.5
0.984
25.0
1.0
1.339
3-1.0
in.
mm
in.
mm
in.
6.35
0.13
0.13
0.13
0.13
0.13
0.1 80
12.70
0.005
0.00S
0.005
0.005
0.005
't.
A
%
'/2
A
A
0.250
0.375
0.500
'4
A
0.750
19.05
1
A
1.000
25.40
9.53
'l,
3/.
1
Ohnenslon
,.olerance, t
Type
i n.
mm
A
A
A
A
A
0.085
2.16 0.005
In.
0.085
2.16
0.005
2.16 0.005
0.00S
0.085
2.16
0.085
2.16 0.005
0.00S
mm
4.57
7.75
0.305
0.370
0.620
0.870
9.-10
15.75
22.10
Face Offset, H
Groove Depth, C
%
1
3:
.,"'..,
Groove Diameter, F
1 Otmeu.slon
1 ,.olerance, :t
~
Toleranoe,
Type
'l,
flange Angle,
C, deg
Otmenslon
in.
Nominal
Sb:e,
In.
~
Thkkne.ss,
Flange Diameter, D
E. reí.
1
1
1 Olmenslon 1 ,.olerance. :t 1 Ohnenslon
mm
Olmenslon
In.
mm
In.
0.13 0.031 0.79 0.005
0. 13
0.03 1
0.79
0.00S
0.13 0.031 0.79 0.005
0. 13
0.03 1
0.79
Groove Detall, R3
,.olerance. t
0.00S
0.13 0.031 0.79 0.005
mm
Oimenslon
In.
mm
In.
0.13
0.03 1
0.79
0.005
0.13 0.031 0.79 0.005
0.13
0.03 1
0.79
0.005
0.13 0.031 0.79 0.005
25.0
0.005
0.005
0.005
0.005
0.005
Groove Detall, R4
Tolerance, :t
0.13 0.031 0.79 0.005
mm 1 in.
mm
Otmeu.slon
In.
mm
0.13 0.020 O.SI
0. 13
0.020
0.51
0.13 0.020 O.SI
0. 13
0.020
0.51
0.13 0.020 O.SI
Groove Detall,
Al, deg
Tolerance, :t
In.
mm
0.005 0.13
mm 1 in.
0. 13
0. 143
0.143
0.13
0. 13
0. 143
0.143
0.13
0. 13
0. 143
I
mm 1 i n.
mm 1
in.
mm
3.63
3.63
3.63
3.63
3.63
20.32
0.005
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
0.13
0.800
0.800
0.800
0.800
1.160
max.
20.32
29.4<\
Radius, R2
Mruc:lmum
Mlnlmum
Toleranre,
Dimenslon
35
•
In.
mm 1 In.
0.031
o.79 0.031 o.79 0.005 o.13
0.13
35
0.03 1
35
0.031
0.13
35
0.03 1
0.005 0.13
35
0.031
0.005
20.32
Radlu$, Ri
0.005 0.13
0.005
20.32
mm
In.
mm
o. 79
0.03 1
o. 79
0.005
0.13
0.79
0.03 1
0.79
0.005
0.13
o.79 0.031 o.79 0.005 o.13
o.79 0.031 o.79 0.005 o.13
N
0
N
N
Table DT-7.1-1
Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances (Cont'd)
fu2L8.
G ove
I:~
r-~
----
,/
1/
mm
_l
j
11
Groove Detail
l
A
O F B
¡lcl--
...
1;;
3:
"''".,,
flan.ge
00
V,
Tube Diameter, A
Olmenslon
Nomina)
Sh:e,
in.
I.D. Rore, 8
·rolerance, :t
Olmenslon
,.olerance, :t
Fla nge Angle,
C, deg
Thkkness,
E, ref.
Flange Diameter, D
Olmenslon
Tolerance, + Tolerance, -
Otmenslon
'"
;.,
Groove Diameter, F
Olmenslon
Tolerance, :t:
Tolcr.ance,
Type
In.
mm
In.
mm
8
25.40
0.005
0.008
0.008
0.010
0.010
0.015
0.030
0.13
0.20
0.20
0.25
0.25
0.38
0.76
I½
2
8
2½
3
8
4
8
1.000
1.500
2.000
2.500
3.000
4,000
6
8
6.000
8
8
38.10
50,80
63.50
76.20
101.60
152.40
i n.
mm
Dimenslon 1
0.870 22.10 0.005
1.370 34.80 0.005
1.870 47.50 0.005
2.370 60.20 0.005
2.870 72.90 0.005
3.834 97.38 0.005
S.782 146.86 0.005
0.13
0.13
0.13
0.13
0.13
0.13
0.13
20
20
20
20
20
20
20
In.
mm
:t
In.
mm
In.
mm
In.
mm
In.
mm
In.
mm
In.
mm
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.984
1.984
2.516
3.047
50.39
50.39
63.91
77.39
90.91
118.92
166.88
0.008
0.008
0.008
0.008
0.010
0.015
0.20
0.20
0.20
0.20
0.25
0.38
0.76
0.005
0.005
0.008
0.008
0. 13
0. 13
0.20
0.20
0.25
0.38
0.76
0.112
0.112
0.112
0.112
0.112
0.112
0.220
2.84
1.718
43.64
2.84
1.718
43.64
2.84
2.84
2.84
2.84
5.59
2.2 18
2.781
56.34
3.281
4.344
6,176
83.34
110.34
156.87
0.005
0.005
0.005
0.005
0.005
0.005
0.005
0. 13
0. 13
0.13
0.13
0.13
0.13
0.13
3.579
4.682
6.570
O.OJO
o.oto
0.015
0.030
70.64
o
N
N
Table OT-7.l · l
Metallic Hygienic Cl amp Ferrule Standard Dimensions and Tol erances (Cont'd)
G_r-oove Oepth, C
No111lnaJ
Size,
ln.
'l'ype
8
1½
8
2
8
2½
8
3
8
4
8
6
8
Oimen.sion
Gr-oove OetalL R4
Groove Detall, #3
Tolcranc:c, :t
Fac:e orfsc.t. H
Oimcn.sion
Tolerance. t
Oimen.sion
Tolerance. t
Tolerance,
ln.
mm
In.
mm
Olmens1on 1
:t
ln.
rnm
ln.
mm
In.
mm
In.
mm
0.063
0.063
0.063
0.063
0.063
0.063
0.063
1.60
0.005
0.005
0.005
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
0.13
0. 13
0. 13
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
0.047
0.047
0.047
0.047
0.047
0.047
0.047
1.19
0.005
0.005
0.005
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
0.13
0. 13
0. 13
0.020
0.020
0.020
0.020
0.020
0.020
0.020
0.5 1
0.51
0.51
0.51
0.51
O.SI
O.SI
0.005
0.005
0.005
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
0.13
0.13
0.13
1.60
1.60
1.60
1.60
1.60
1.60
N/A
N/A
1.19
1.19
1.19
1.19
1. 19
1. 19
Groove OetaU,
At, dt-g
Tolerance,
Olmenslon 1
t
46
46
46
46
46
46
46
1
1
1
1
1
1
1
i:tadl us, Rl.
max,
R.adlus, R2
Maximum
Minimum
ln.
mm
ln.
mm
In.
rnm
0.063
0.063
0.063
0.063
0.063
0.063
0.063
1.6 0
0.031
0.03 1
0.03 1
0.03 1
0.03 1
0.031
0.031
0.79
0.79
0.79
0.79
0.79
0.79
0.79
0.005
0.005
0.005
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
0.13
0.13
0.13
1.60
1.60
1.60
1.60
1.60
1.60
GENERAL NOTES:
(a) Oimensions and tolerances appl_y to machined finishes only.
(b) I.D. bore dhnension 8 should be m~sur cd on the ferrulc facc slde only.
~
,_.
o,
a,
3:
.,"'..,
~
N
0
N
N
Table DT-7.1-2
Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances
(22)
TypeA
Groove
detail E
......._
........
'
'
R1
~
1
_I
/,
·
/
/
/
Flatness detail
Flat ness
detail
/
...
1;;
3:
"''".,,
(X)
"
'"
;.,
o
f lange
1,0, Bore, B
Flange Oiameter, D
Flange Ang,le,
C, deg
Tolerance, ±
Dimension
Dimension
Nominal
Sti e,
E, rcr,
Tolerance, !:
Dime ns-ion
Type
in.
¼
A
A
A
A
A
0.250
0.375
0.500
0.750
mm
6.35
9.53
12.70
19.05
1.000
25.40
%
½
'4
1
in,
mm
in,
0.180
0.305
0.370
0.620
0.870
4.57
7.75
9.40
15.75
22.10
0.010
0.010
0.010
0.010
0.010
Groove Oepth, G
Oimension
Nominal
mm
0.25
0.25
0.25
0.25
0.25
Oimcnsion
Oimcnsion
•
LO
1.0
LO
1.0
LO
Groove Detall, R3
F'ace Offset, JI
Tolerancc, t
1
20
20
20
20
20
Tolcr.ance, t
Oimcnsion
-
in,
3.0
3.0
3.0
3.0
3.0
0.984
0.984
0.984
0.984
1.339
mm
25.0
25.0
25.0
25.0
%
%
Dimension
Oimc nsion
mm
in.
0.25
0.25
0.25
0.25
0.25
0.143
0.010
0.0 10
0.010
34.0
0.0 10
Groove Detall, R4
Tolcr.ance, t
in.
0.0 10
Tole ranc:e, t
0.143
0.143
0.143
0.143
Groove Oeta.11,
Al, dcg
Tolerance, ±
Dimension
mm
3.63
3.63
3.63
3.63
3.63
in,
0.800
0.800
0.800
0.800
1.160
mm
20.32
20.32
20.32
20.32
29.46
in,
0.010
0.010
0.010
0.010
0.010
mm
0.25
0.25
0.25
0.25
0.25
R.adl us, R2
i:tadius, Rl.
max,
Maximum
Minimum
ln.
0.031
0.031
0.031
0.031
0.031
ln.
0.031
0.031
0.031
0.031
0.031
mm
In.
mm
0.79
0.79
0.79
0.79
0.79
0.005
0.005
0.005
0.005
0.005
0. 13
0.1 3
0.13
0.1 3
0.13
Tolerance,
Sb:e,
'l,
Groove Oiam cter, F
Tolerance
in.
ln.
N
N
Thlcknes:s,
Tube Olameter,
A
Type
A
A
A
'4
A
1
A
ln.
0.085
0.085
0.085
0.085
0.085
mm
hL
mm
In.
mm
In.
rnm
In.
mm
In.
rnm
2.16
2.16
2.16
2.16
2.16
0.005
0.005
0.005
0.005
0.005
0.13
0. 13
0.13
0. 13
0.13
0.031
0.o31
0.031
0.031
0.031
0.79
0.005
0.005
0.005
0.005
0.005
0. 13
0.13
0. 13
0.13
0. 13
0.031
0.o31
0.031
0.031
0.031
0.79
0.79
0.79
0.79
0.79
o.oos
0. 13
0. 13
0.13
0. 13
0.13
0.79
0.79
0.79
0.79
0.005
0.005
0.005
0.005
ln.
0.020
0.020
0.020
0.020
0.020
mm
ln.
mm
Olmenslon
0.51
o.oos
O.SI
O.SI
O.SI
O.SI
0.005
0.005
0.005
0.005
0. 13
0.13
0.13
0.1 3
0.13
35
35
35
35
35
•
1
1
1
1
1
mm
0.79
0.79
0.79
0.79
0.79
Table OT-7.1· 2
Polymeric Hygienic Clamp Ferrule Standard Oimensions and Tolerances (Cont'd)
Type B
Groove
--- ~
e-¡
• i~
R1
7
'ti
R2
Groove detaj¡/...---
-----
➔-,... ,:.:1,, ~,~l
J
~
3:
.,"'..,
de tail
,_.
o,
o,
~
Tube Oiameter,
1.0. Bore, 8
A
Olmenslon
Nominal
Siz e,
in.
Otmen,slon
1'olerance, :t
Flange Diameter, D
Flange Ang:le,
C, deg
Olmenslon
N
0
Flange
Thickne.s.s.
E, rer.
Toleranoe, :t:
Olmenslon
N
N
Groove Oiameter, F
Olmenslon
Toleranoe, t
To lerance
Type
in.
mm
in.
mm
in.
mm
B
1.000
1.500
2.000
2.500
3.000
4.000
25.40
0.870
1.370
1.870
2.370
2.870
3.834
22.10
34.80
47.50
0.010
0.010
0.010
0.010
0.010
0.010
0.25
0.25
0.25
0.25
0.25
0.25
1 .,,,
B
2
2'1 ,
B
3
B
4
o
B
38. 10
50.80
63.50
76.20
10 1.60
60.20
72.90
97.38
Dime ns-ion
20
20
20
20
20
20
1
•
1.0
LO
LO
LO
LO
1.0
.
3.0
3.0
3.0
3.0
3.0
3.0
in.
mm
in.
mm
in,
mm
in.
mm
in.
mm
1.984
50.39
50.39
63.9 1
77.39
90.9 1
118.92
0.010
0.010
0.010
0.010
0.010
0.015
0.25
0.25
0.25
0.25
0.25
0.38
0.1 12
0.112
0.112
0.112
0.112
0.112
2.84
1.718
43.64
43.64
56.34
70,64
0.0 10
0.010
0.010
0.010
0.010
0.010
0.25
0.25
0.25
0.25
0.25
0.25
1.984
2.516
3.047
3.579
4.682
2.84
2.84
2.84
2.84
2.84
1.718
2.2 18
2.78 1
3.28 1
4.344
83.34
110.34
Table DT-7.1-2
Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances (Cont'd)
Nominal
Si:u.•,
In.
Groove Detall, R3
Face Offset, H
Groove Depth,, C
Dimension
Tolerancc, t
Dimension
Tolcr.ancc, t
Oimcnsion
Groove Detall, R4
Tolt'r.anc:e, t
Dimcnsion
Toleranc:e, t
Groove Detall,,
Al. deg
Radius, R"t,
max,
Radlus, R2
Maximum
Minimum
Tolerancc,
Type
i n.
mm
i n.
mm
In.
mm
In.
mm
B
0.063
0.063
0.063
0.063
0.063
0.063
1.60
1.60
1.60
1.60
1.60
1.60
0,005
0.13
0.13
0.13
0.13
0.13
0.13
0.000
0.000
0.000
0.000
0.000
0.000
0.00
0.00
0.00
0.00
0.00
0.005
0,005
o.oo
0.005
0. 13
0. 13
0. 13
0. 13
0. 13
0. 13
11/z
2
21/z
3
B
4
6
B
B
B
0.005
0.005
0.005
0.005
0.005
0,005
0,005
0,005
In.
0.047
0.047
0.047
0.047
0.047
0.047
mm
In.
mm
In.
mm
In.
mm
Dimenslon 1
:1:
In.
mm
In.
mm
In.
mm
1. 19
1. 19
1. 19
1. 19
1. 19
1.19
0.005
0.005
0.005
0.005
0.005
0.005
0. 13
0. 13
0. 13
0. 13
0. 13
0.13
0.020
0.020
0.020
0.020
0.020
0.020
O.SI
0.005
0.005
0.005
0.005
0.005
0.005
0. 13
0. 13
0. 13
0. 13
0. 13
0.13
46
46
46
46
46
1
1
1
1
1
1
0.063
0.063
0.063
0.063
0.063
0.063
1.60
1.60
1.60
1.60
1.60
1.60
0.031
0.031
0.031
0.031
0.031
0.031
0.79
0.79
0.79
0.79
0.79
0.79
0.005
0.005
0.005
0.005
0.005
0.005
0. 13
0. 13
0. 13
0. 13
0. 13
0.13
O.SI
O.SI
O.SI
O.SI
O.Si
46
GENERAL NOTES:
(a) Oimensions and tolerances apply to molded polymer mate1ials only.
(b) 1.0. bore dimension 8 should be measured on the ferrul e face side only.
(e) Fern des shottld only be used 1Atith elastomeric gaskets .
1;;
...
00
'°
3:
"''".,,
'"
;.,
o
N
N
ASM.E BPE-2022
Table DT-7.3-1
Transfer Panel and Jumper Tolerances
(22)
ParalleUsm
Tolerante (1'0l.l)
Connection
Nominal Size,
Maximum Gap
Allowed
Position Tolerance
(Tol.2) Maximum
Oeviation From the Oesign
Distance Between
Centerlines
in.
in.
mm
in.
mm
1/i
0.010
0.25
0.0 15
0.38
0-010
0.25
0.015
0.38
:¼
1
0.020
0.51
0.0 15
0.38
t½
2
0-020
0.025
0.5 1
0.64
0.0 15
0.015
0.38
0.38
2½
0.025
0.64
0.0 15
0.38
3
0.030
0.76
0.015
0.38
4
0.040
1.02
0.0 15
0.38
190
ASME BPE-2022
Table DT-9.3-1
Hygienic Clamp Ferrule: Design Criteria
Nominal design
clam p to ferrule
contact point per
OT-9.4(d)
Clearance
per OT-9.4(el
Clearance
per OT-9.4(e)
-
-
0.065 in. (1.65 mm)
per OT-9.4(c)
Basic Gauging and
Contact
Diameter, A (ref.)
Nominal
Size, in.
1/,
%
½
•;,
Oimension
Gauging Width, 8
Dimension
1
Tolerance, :t
1
in.
mm
Size, in.
4.17
0.004
0.164
0.164
0.164
4.17
4.17
4.17
0.004
0.004
0.004
0.10
0.10
0.10
0.164
4.17
0.004
0.10
0.10
¾
¾
¾
¾
Type
in.
mm
in.
mm
A
A
A
0.867
22.02
22.02
22.02
0.164
0.867
0.867
0.867
1
A
A
1.222
22.02
31.04
1
8
1.748
44.39
B
B
1.748
2.280
2.811
44.39
57.91
71.39
0.155
0.155
0.155
0.155
3.94
1 1/2
3.94
3.94
3.94
0.005
0.005
0.005
0.005
0.13
0.13
0.13
0.13
3.264
4.288
6.255
82.91
108.92
158.88
0.169
0.184
0.277
4.30
4.66
7.04
0.005
0.005
0.005
0.13
0. 13
0.13
2
2 1/ i
3
8
4
B
B
6
8
191
Hygienic Clamp
ISO DN 15
t½
1½
2
2½
3
4
6
ASM.E BPE-2022
Figure DT-9.4- 1
Clamp Conditions at lnstaUation
(22)
+
t
Spacing shou ld be
maintained aft er
torquing per
OT-9.4(e)
Acceptable
o
Acceptable
Not Acceptable
!
When clamp ends
are c-ontacting,
the req uired load
is not imparted
onto the gasket
per OT-9.4\e)
1
Spacing sho uld be
maintained aher
torquing per
DT-9.4(e)
Not Acceptable
_l
l
Not Acceptable
Acceptable
Not Acceptable
192
ASME BPE-2022
Table DT-11.1.1-1
Minimum Required Marking lnformation
(22)
Heat
Process
Component
Number
or Unique
ldentifier
Material
Type
Required
Required
Valves
Rcqulrcd
Rcqulrcd
l nstr umentation
Required
F i t ti
ngs
GENERAL, NOTE: When the síie
Valve
Manufacturer's
Pressure
Rating
Name, Logo. or
Trademark
Reference
Process
to This
Standard
(ASME BPE)
Surface
Desi,gnation
Contact
Rcqulrcd
Required
o í
a component does not allow complete
193
mark i
ng
per DT •l 1.1,
t h i
s
table defines the
marki ng
r
e ct
uiremen t
s.
ASME BPE-2022
(22)
PART PI
PROCESS INSTRUMENTATION FOR MULTIUSE
tions s ha li be of hygienic design, per the requireme nts
of Parts SD and MC, in order to ensure cleanability of
the system.
(e) Gauge siphons (pigtail s) shall not be used. lsolation
valves should be used if required by the owner/user for
routine maintenance or calibration.
(f) Whe re required for proper operation, ali instrume nts, valves, and in-line devices shali be permanently
ma rked for proper installation (ílow direction or orientation).
Pl-1 PURPOSE AND SCOPE
The purpose ofthis Part is to provide requ irements for
process instrumenta tion. This Pare defines che mínimum
requirements for the application of process con ta et instnimentation in hygienic systems. This Part applies to instniment components that are in contact with the process.
(22)
Pl-2 PROCESS INSTRUMENTATION GENERAL
REQUIREMENTS
Pl-2.1.3 Exterior Design. Materia l selection considera- (22)
tions shall include ali intended uses, ambie nt cond itions,
a nd cl ea ning agents as specified by the owne r/user.
Sensors a nd transmitters shall be housed in an enclosure
with an appropriate protection rating as specified by che
owner/user and s hali conform to Parts SD a nd MC.
Pl-2.1 General Considerations
(22)
Pl-2.l.l lnstallation. AII process inst rumentation
should be installed per the ma nufacture r's instructions
for proper operatio n. AII p rocess instru me nta tio n
should also be oriented to meetd rainability requireme nts
as specifi ed in Part SD.
lnd icating devices shall be oriented a nd located such
thatthey ca n be easily viewed for maintenance and opera tion purposes. lnstruments shali be located and oriented
so connections can be easily made and adequate space is
provided for calibration, maintena nce, a nd replacement.
lnstruments, connecting tub ing. a nd systems shali be
s u pported b y mountin g bra cke ts as necessa ry to
prevent po ten cia l stresses on the instr um e nt a nd
tubing system, and to allow for ease of re mova l
without disturbing the adjacent components.
Remote-mounted devices (tra nsmitters, etc.) shall be
mounted with appropriate supports to a permanent structure. Ladders, handrails, gua rdrails, etc., shali not be accepta ble moun ting supports. lf necessa ,·y, dedicated
instrument supports s hali be provided.
Pl-2.2 lnstrumentation Categories
Process instrumentation may be broadly categorized by
process ínstallation type as in-line, insertion, at-line, a nd
off-line devices. Process instruments within these categories share sorne basic instaliation recom me ndations
for hygienic design and in-process performance.
Pl-2.2.l ln-Line Devices. ln-line process instruments
a re self-conta ined devices installed directly into the
process tubing system si milar to a sta ndard fitting.
Basic installation require me nts far hygienic operation
as found in Part SO pertain to in-line process instrumenta tion.
ln-line devices may be installed directly in the process
stream or in a bypass line to facilitate periodic services
(see Figure Pl-2.2.1-1}. Device-specific recommendations
are defined later in this Part.
Pl-2.1.2 Interna! Design and Process Connections
(a) Sensors s hali be des igned in s uch a way that a
fai lure will n ot ca use conta mination hazards to the
process and environment.
(b) Liquid-filled elements in measuring devices s hould
not contain materials that can potentially impact product
quality.
(e) The interna! volume of the liquid -filled elements
should be minimized.
(d) lnstruments s hould have integral hygienic fittings.
Threaded ferrules are not acceptable to conve rt standa rd
instrumentation to hygienic sta ndards. Process connec-
Pl -2.2.2 ln sertlon Devlces. lnsertion devices are
instruments that are inserted directly into the process
tubing system or process vessel to measure a parameter.
lnsertion devices generally require proper immersion
in the process íluid far optimal performance. lnstallation
of insertion devices must balance performance requirements and hygienic design. Refer to later sectio ns of
this Part and/or the manufacturer's recommended guidelines farspecificrecommendations (see Figure Pl -2.2.2-1).
194
ASME BPE-2022
Figure Pl-2.2.1-1
ln-Line and At-Line lnstrument lnstallation Examples
ln-Line lnstrument
lnstalled on bypass
with iso lation vatvos with
product reintroduced
At-Une lnstrument
line with product to drain
195
ASM.E BPE-2022
Figure Pl-2.2.2-1
Accepted lnsertion Device lnstaUation Examples
L • per manufacturer recommendation
lnstrument Soc-ket With
8eveled Interior
Sidewall With Angled
Hygienic Ferrule
a = 15 deg type/device dependen!
Flush~mount
196
Top-mount insertion
w ith flush-style
hygienic ferrule
Angled Sidewall With
Hygienic Ferrule
ASME BPE-2022
{22)
Pl -2.2.3 At-Llne Devlces. At-line devices are instruments tha t measure various parameters by the means
of a sidestream sampling loop, which is generally not reint roduced back into the process. Co nn ec tion of the
sampling stream shall conform to Pa rt SO and shall be
designed to ensure continuous sampling flow to maintain
hygienic operation for optima! measure ment (see Figure
Pl -2.2.1-1).
Pl-4 FLOWMETERS
Pl-4.1 Coriolis Flowmeter
Pl -4.1.l General Cons lde ratlon s. T his section
provides che requirements for installation a nd operation
ofCoriolis flowmeters specific to bioprocessing and pha rmaceutical industries as well as other applications with
hygienic requirements.
The design, construction, a nd fabrication of Coriolis
flowmeters a re governed by other Parts of this Standard.
Pl-4. 1.2 a nd Pl-4.1.3 may be used as a general reference.
Pl-2.2.4 Off-Une Devices. Off-line devices are instr uments located away from the main process a nd are not
covered in this Part
Pl-4.1.2 Essential Components. lmproperdesign and/
or installation of a tlowmeter can affect the drainability
and cleanability ofthe system to which it is attached. Three
components of Corioli s flowmeters affect drainabílity and
cleanability: the flow tube(s), the manifold or flow splitter,
a nd the process con nections in combination with the
installation angle.
The Coriolis flowmeter shall meet the process contact
surface require ments as specified in Part SF for all the
process-wetted components including flow tube(s), manifold/flow splitter, a nd process connection.
Pl-3 INSTRUMENT RECEIVING, HANDLING, AND
STORAGE
Pl-3.1 lntroduction
Material compatibility and environmental storage conditions shall be considered when receiving. handling. and
storing process instrumentatio n. AII instruments shall
have markings such as labels, tags, barcodes, or radio·
frequency identification (RFID) to ease identification.
Pl-3.2 lnstrument Receiving
Pl-4.1.3 Components
The instrument(s) shall be identified by part/model
numbers.
Pl -4 .1.3.l Flow Tube(s). Coriolis flowmeters are
eit her of single-tu be o r d ual-tube const ruct ion. The
tube(s) can be either straight or bent. The geometry of
tube bend s shall be considered when assessing drainability and determining installation requirements.
Pl-3.2.l Original Packaging . The in tegrity of t he
original packagíng of any componen t. with cleaning certificat ions such as passivated, cleaned for oxygen service, or
hydrocarbon free, shall be maintained during inspection
and storage.
Pl-4.1.3.2 Manifold or Flow Splitter. The mani folds
or Aow splitters for dual-tu be construction Aowmete rs are
the interface between the sensor process conn ections and
the sensor measuri ng tubes and they can create product
holdup as shown in Figure Pl-4.1.3.2-1. The geometry of
manifolds o r flow splitters shall be considered when
assessing drainabi li ty and dete rmin ing installation requirements.
Pl-3.3 lnstrument Handling: Protection of Process
Connectlons and Surface Finish
Care shall be taken to protect the process connection(s)
and surface finish of the instrument during receivi ng,
handling, calibration, a nd storage.
Pl-4.1.3 .3 Process Connections. The interface
between the process connections and the sensor tube
(s) may result in product holdup, eve n with single straight
tube Aowmete rs. This is shown for concentrically reduc·
ing process connections in Figure Pl-4.1.3.3 -1. Eccentri·
cally reducing process connections may allow a singletube construction Aowmete r, with a tube inside diameter
d iffering from the process line in side diameter, to be
mounted in horizontal piping. The geometry of process
connections, including reductions in Aow area, shall be
considered when assessing drainability and determining
insta llation requirements. The Coriolis flowmeter shall
use acceptable hygienic connections a nd fittings as per
Part MC.
Pl-3.4 lnstrument Storage
Pl -3.4 .l Special Considerations. Special considera·
tions for storage shall be made for certain instrumenta·
tion, such as analytical inst ruments, according to the
manufacturer's recommendations.
Pl-3.4.2 lnst.rument Shelf Llfe and Envlronmental Requlrements. lnstruments with limited shelflives or environmental req uirements (temperature, humidity, etc.)
shall be identified.
Additional information regarding instrument receiving,
handli ng , and s torag e i s contain e d in
Nonmanda tory Appendix R.
197
ASM.E BPE-2022
Figure Pl-4.1.3.2-1
Manifold or Flow Splitter for Dual-Tube Construction
Flowmeters and Potential for Product Holdup
Product holdup
not acoeptable
Figure Pl-4.1.3.3-1
Concentrically Reducing Process Connection
8
A
A = customer ferrule
8 • sensor process connection
d = customer pipe 1.0.
dM = sensor measuring tube 1.0 .
ds • sensor process connection 1.0.
Product holdup
not acceptable
198
ASME BPE-2022
Pl-4.1.4 lnstallatlon. The ma nufacturer shall provide
the owner/user with the mounting a nd cleanability requirements necessary to maintain, operare, and properly
drain the flowmeter.
Certain passivation procedures may damage Coriolis flowmeter materials. lí the Coriolis flowmeter is to be passi vated, the complete pass ivation procedure sho uld be
p rovided by the owner/user to the manufacturer for
review a nd approval.
lí the owner/user and the ma nufacturer cannot agree
on a n acceptable passivation procedure, the owner/user
shall remove the flowmeter during passivation.
Pl-4.1.4.1 Drainability. The flow tube or tubes, the
man ifold or flow spli tter, a nd the process connections
shall be considered a system. lf a design can be supplied
with d ifferent types of process co nn ections, then the
orientation shall consider the worst case for drainability,
or each type of process connection shall be considered
individually.
Coriolis flowmeters should be drainable with gravity.
Coriolis flowmeters that a re not draina ble with gravity
shall be indicated by the ma nufacturer a nd should be
of sin gle-tube or other syste m d es ign to minimize
p roduct ho ldup. An add itio nal motive force (e.g., air
purge) may be required to ensure complet e drainability.
Drainability requirements should be determined by
process r eq uire men t an d sha ll be defi ned by the
owner/user.
Pl-4.1.5 Performance. The Coriolis flowmeter performance varíes depend ing on the pa ra meter to which it
applies (e.g., mass, volume, density, temperature, or viscosity).
Gui delines a nd common terminology for selection,
installation, calibra tion, a nd operation oí Coriolis flowmeters are identified in ASME MFC-11 and ISO 10790.
Pl-4.1.5.1 Accuracy. For Coriolis flowmeters, the
accuracy specificatio n usually includes the combi ned
effectS oflinearity, repeatability, hysteresis, and zero sta bility.
Pl-4.1.5.2 Process lnfluences. Coriolis flowmeters
deliver their best pe rformance whe n completely filled
with a uniformly d istributed process flu id. Entrai ned
gas should be eliminated or minimized. Multiphase a pplications involving nonhomogeneous mixtures can cause
meas urement errors. The use of filters, air and/or
vapo r elimi nator s, or o ther protec tive devices to
reduce errors in measurementshould be placed upstream
from the Coriolis flowmeter.
Pl-4.1.4.2 Cleanability. Cori olis flowmeters using a
dual-tube construction with small-diameter tubes have a
potential for plugging and can adversely affect the cleanabil ity of the flowmeter. lt is the responsibility of the
owner/user to assess the risk of plugging a nd the effectiveness oí cleaning processes, based on their process and
the informa tion provided by the manufacturer.
Requireme nts relati ng to cleanability, sterility, a nd
draina bility a re addressed in Part SO.
Pl-4.1.5.3 Ambient lnfluences. Large differe nces in
the te mperature between the measuring tube(s) and the
ambient temperature can cause errors in the temperature
compensation (e.g., CI P/SIP). The use oí insulation materials can reduce these effects.
Pl-4.1.4.3 Mounting Location. lt is recommended to
install the Coriolis flowmeter vertically with the process
fluid flowing upward through the flowmeter (refer to
Figure Pl-4.1.4.3-1 ). lf the Coriolis ílowmeter is to be
installed horizontally, then drainabili ty shall be cons idered (e.g., by gravity or air purge).
Pl-4.1.6 Selection. The maja r co nsideration when
selecting and sizing a Coriolis flowmeter is th e tradeoff between pressure drop and flowmeter performance
(accuracy).
The necessary engineering data shall be supplied by the
owner/user to ensure correct sizing of the Coriolis flowmeter. The manufacturer shall use this informa tion to
p rovide ali necessa ry calculatio ns fo r mínimu m a nd
maximum velocities, accuracy, a nd pressure drop. This
will optimize the flowmeter performance over the flow
ra te ra nge with a pressure drop tha t is accepta ble for
both CIP/SIP a nd normal operating conditions.
Chemical compatibility should be established between
process-wetted materials [i.e., the flow tube(s), the ma nifold or flow splitter, the process connections] and the
p rocess fluid and the cleaning fluid (e.g., process, CI P,
SIP, a nd passivation).
Pl-4.1.4.4 Orientatlon. The Coriolis flowmeter will
operate in a ny orientation as long as the flow tube(s)
remain full of process fluid.
For Coriolis tlowmeters that are drainable with gravity,
the man ufacturer sha ll provide the owner/user with
information on how the ílowmeter is to be installed to
ensure effective drainability.
For tlowmeters t hat are mounted in-plane with the
process line, t he infor matio n sho ul d incl ude the
minimum angle of inclina tion, a, and how to orie nt the
tlowme ter in that plane (refer to Figure Pl-4.1.4.4-1 for
definition of a ngle of incli nation, u). lt is recommended
that the informa tion be provided in pictorial format.
The ma nu facturer's recomme ndation for installation
and su pport of Coriolis flowmeters should be followed.
Pl-4.1.4.5 Special Considerations for Passivation of
Coriolis Flowmeters. Corio lis flowmeter materials of
construction vary significantly between ma nu facturers.
Pl-4.1.7 Maintenance. There are no specific maintenance req uirements for a Corioli s mass flowmeter.
199
ASME BPE-2 022
Figure Pl-4.1.4.3-1
Vertical lnstallation
Figure Pl-4.1.4.4-1
Minimum Angle of lncllnation, a
a (for fu ll drainability)
Pl-4.1.7.l Seals/Gaskets. The manufacture r shall
ad vise the owne r/user if the process connections are
not fully welded to the senso r body a nd if use of a
sealjgasket assembly tha t requires per iodic ínspection
is needed.
Calíbration of the mass reference or a master flowmeter
shall be traceable to nationally recognízed standards or
a nothe r sta ndard as agreed to by the own er/user a nd
ma nufacturer.
Ca libration procedures can be found in ASME MFC-11.
Pl-4.1.7.2 Recalibration/Verífication Schedule. A
Pl-4.2 Turbine Flowmeter
Corio lis flowmeter p roperly ínsta lled a nd o pe ra ted
within the manufacture r's guidelines on clean, noncorrosive, a nd nonabrasive fluids is sta ble. The frequency of
r·ecalibration or verification of the flowmeter ís governed
by the criticality of the measurement and the nature of the
operating conditíons. The frequency of calibration verífication s hall be determined by the own er/user.
As the Coriolis mass flowmet er ís a rnass flow device, it is
preferable to perform the calibratíon verification against a
mass traceable reference. Calíbrat íon agaínst a volurne
traceable refere nce combined with a de nsíty traceab le
reference rnay be used where applícable. Maste r flowmeters may be used to ver ífy calíbratíon of Coriolis flowmeters.
Pl - 4.2.l General. Th is sectío n p ro vid es for the
hyg íe ni c des ig n an d in sta ll atío n re qu ire rne n t s of
turbíne llowmeters s pecific to bioprocessingapplicatíons.
Pl-4.2.2 Components. Turbine tlowmeters typically
consíst of p rocess contac t a nd no n-p rocess con tact
componen ts (see Figu re Pl -4.2.2 · 1 for exa mples of
retainíng vers us non-retaíning ring desígns).
Pl-4.2.2.l Process Contact Components
{a) Meter Housi119 With Bore. The bore síze s hall be
based on the rnanufacturers' specified flow range.
{b) Rotor Assembly. The rotor assembly shall be a solíd
rotor.
200
(22)
ASME BPE-2022
Figure Pl-4.2.2-1
Typical Turbine Aowmeters
(22)
Pickoff
Meter housing
with bore
Retaining ring
Rotor
~íll.,.
{optional)
1
~<I
L
Support hanger
~)
J
(a) Retaining Ring Oesign
Pickoff
Meter housing
w ith bore
Rotor
assembly
<I
L
rR1
Support hanger
l>
J
Flow straightener
housing
lb) Nonretaining Ring Oes.ign
201
~
ASME BPE-2022
(e) Retaining Ring(s) (Optional). The reta ining ring
g roove a n d reta ining r ing shall no t co ntr ibute to
process fluid holdup.
(d) Interna/ Support Hangers. Each s upport hanger
shall be of a solid piece construction.
(e) Flow Straightener Housing (Optional). In a no nretai ning r ing des ig n, the flow straightener ho using
shall be designed to keep the turbine flowmeter internals
in place.
Pl-5 LEVEL INSTRUMENTS
Pl-5.1 Radar Level lnstruments
Pl- 5.1.1 General. Radar leve) instruments a re also
referre d to as noncontact rada r, free space radar, and
through-air radar leve) instruments.
These instruments use high-frequency electromagnetic
signals to measure the distance between the instrument
a nd the upper s urface of the targeted process íluid directly
below the instrument.
These instrume nts s hould be configured for the specific
combina t io n of vessel and process fl uid to e nsu re
measurement performance.
Pl-4.2.2.2 Non-process Contact Components. The
pickoff shall not contact the process.
Pl-4 .2.3 lnstallation. The flowmeter shall be installed
with a mín im um straight ru n of 10 pipe diameters
upstream of the inlet and 5 pipe diameters downstream
of the outlet.
(22)
Pl-4.2.3.1 Orlentation. Turbine ílowmeters shall be
oriented to ensure that the meter is completely filled with
the process íluid during operation.
The ma nufacturer's recommenda tions for the orientation and the structural suppo1t of turbine flowmeters s hall
be followed.
(22)
Pl -4.2.4 Performan ce. Turbine flowmeter performance details are provided in ASME MFC-22.
Pl-5.1.2 Essential Components. A radar level instrument is comprised of a n antenna, a process connection,
a nd supporting electronics.
The process contact components of a radar level instrument shall meet the surface requ irements as specified in
Par t SF and material of constru ction requirements as
specifie d in Pa rt MM or Part PM. Requ ire me nts of
process contact welds are specified in Part MJ.
Pl-5 .1.2.1 Antenna. Th e antenna of a radar leve)
instrument is available in bulb, horn, or rod construction
(see Figure Pl-5.1.2.1-1). The antenna is either isolated by
or encapsulated in polymeric or other nonmetallic material.
Pl-4.2.4 .1 Accuracy. Tu rbine ílowmeter accuracy
details a re provided in ASME MFC-22.
Pl-4.2.4.2 Process lnfluences. Entrained gas shall be
eli minated by havi ng s ufficient back pressure downstream of the flowmeter to prevent cavita tion, or by
the use of a vapor eliminator upstream of the meter.
The owner/user s hould consult the manufacturer for
reco mmendations on the mínimum operational pressure.
as the met er outlet pressure is dependent upon the
process fluid conditions, s pecific gravity, a nd viscosity.
For process liquids where a brasives or other entrained
particles may exist, hygienic filters, stra iners, or other
devices s hall be installed upstream of the ílowmeter to
preven! damage.
Pl-5.1.2.2 Process Connectlon. The rada r leve )
instruments and isolating seals shall use hygienic connections as per Parts SO, DT, and MC.
Pl -5.1.3 lnstallatio n. The mo unt ing location and
orienta tio n of t he an te nna s hou ld be in accordance
with the ma nufacturer's recommendations. This is importa nt in orde r to achieve the specified performance, as well
as to e ns ure cleanability.
Pl-5.1.3.1 Drainability. To preventany liquid holdup
on the sensor's process contact surfaces, the radar leve)
instrume nt s hould be mounted perpend icular to the
surface of the process flu id.
Pl-4.2.4.3 Ambient lnfluences. Externa) e nvi ro nmental conditions do not affect the performance of the
tu rbine flowmeter when the flowmeter is opera ted
within the manufacturer's specifications.
(22)
Pl-5.1.3.2 Cleanablllty. Cleanability is determined
by the comb ination of antenna des ig n and geome try
and the location of the process connection. For effective
cleanability, shadowing effects, recessed areas, and
annular spaces created by the installed antenna should
be taken into consideration.
Pl-4.2.5 Selection. Maximum process íluid velocity
should be taken into consideration during air purge or
clean steam sanitization to prevent over ranging of the
bearings a nd damaging the rotor assembly. Turbine ílowmeter selection details are provided in ASME MFC-22.
Pl-5.1.3.3 Mounting Location. The process connection s hou ld b e located on top of t he vessel. For the
most accurate results, the mounting location should be
selected to minimize or avoid obstructions within the
space below the antenna.
202
ASME BPE-2022
Figure Pl-5.1.2.1-1
Bulb, Horn, lsolated Horn, and Rod-Style Antenna
To ensure a reliable leve! measurement, the mounting
location s hould be 1/ 3 to % of the vessel radius, as
meas ured from the vesse l centerli ne (see Figure
Pl-5.1.3.3 -1).
The mínimum detectable vessel level is given by the
mounting location. To determine ifthe vessel is complete·
ly empty, the sensor should be pointed to the lowest
section of the vessel.
(b) vortices in the process fluid
(e) large changes of the reflective properties of the
process fluid
(d) foam, steam, or mist on top of the process fluid
(e) buildup on the antenna
Pl-5.1.4.3 Ambient lnfluences. Ambient influences
do not affect the measuring performance if they a re
within the manufacturer's specifications.
Pl- 5.1.3.4 Orientation . The sens o r should be
mounted perpendicular to the surface ofthe process fluid.
Pl-5.1.5 Selection. The main consideration when
selecting a radar level instrument is the required performance for the specific application as described in Pl-5.1.4.
Pl-5.1.3.5 lnsertion Length/Depth. A vessel's
maximum working level shall be below the insertion
depth of the rada r level instrument.
Pl-6 PRESSURE INSTRUMENTS
Pl-5.1.3.6 Special Considerations. Each instrument
has a specific mínimum measuring distance (also referred
to as blocking distance or dead band) (see
Figure Pl -5.1.3.3· 1) immediate ly in front of the
antenna, in which measurements are not possible.
When radar leve! instruments are installed in nonme·
tallic vessels, the signal may detect objects outside the
vessel. The owner/user should consult with the manufacturer for additional require menrs.
The ow ne r/user shou ld co nsult the ma nufacturer
regarding energy emitted by the radar level instru ment
to evaluate potencial impact on the process fluid.
Pl-6.l Pressure Sensors
Pl-6.1.1 General. Pressure sensors used in bioprocessing applications shall be isolated from the process by
means of an integral diaphragm. The pressure may be
t ra nsmitted between the isolation diaphragm and the
sensing element using a fill fluid.
Pl-6.1.2 lnstallation. Pressure sensor installa tion
methods incl ude flush tee, in-line instrument tee, and
short-outlet tee. See Figure Pl-6.1.2-1. To min imize
branch legs, flush tee or in-line installations a re preferred.
See Figure Pl-6.1.2-1, illustrations (a) th rough (d).
Pl-5.1.4 Performance. Performance is determined
primarily by the reflective properties of the process
fluid, mounting location, and orientation within the vessel.
Pl-6. 1.2.l Mounting Location . Pressu re se nsors
sho uld be mo unted away from flow restrictions to
reduce t he impact of pressure fl uctuatio ns on t he
Pl-5.1.4.1 Accuracy. The accuracy shall include the
combined effects oflinearity, repeatability, a nd hysteresis.
measurement
Pl-6.1.2.2 Speclal Consideratlons. Diaphragms shall
be protected and ha ndled in accordance with the manufacturer's guidelines to prevent da mage.
Pl-5.1.4.2 Process lnfluences. The following process
conditions may reduce the radar signa) strength returned
to the a nte nna, wh ich may impact on t he meas uri ng
performance:
(a) a wavy or rippled surface
203
ASM.E BPE-2022
Figure Pl-5.1.3.3-1
Dead Band, Measuring Range, and Mounting Location
Mounting location
1
Dead ba nd
½ radius
¼ radius
Vessel radius
1
1
1
1
- - - - . J L -- = -~-~---------L ____ _
Vessel diameter
204
1
1
1
ASM E BPE-202 2
Figure Pl-6.1.2-1
Accepted Orientation and Flow
Flow
(at Flush Tee Horizontal lnstallation
(b) Flush Tee Vertical lnstallation
Flow
Flow
(e) ln-line Horizontal lnstallation
(d) ln•line Vertical lnstallation
(e) Sanitary lnstrument lee
Vertical lnstallation
(1) Short Outlet Tee Vertical lnstallation
205
ASME BPE-202 2
Figure Pl-7.3-1
Typical lnstallation Styles
The owner/u ser sho uld follow t he manufacturer's
guideli nes regard ing insta llation measurement adjustments.
Welds on diaphragms may not meet the R., max. surface
finish requirements of Part sr- due to unique design requi rements for instrument sensitivity. The we lds o n
diaphragms shall meet ali t he other requirements of
Part sr-.
Ali other process contact surfaces shall meet the requirements of Part sr-.
Pl-6.1.3 Performance. The owner/user should supply
the manufacturer with process operational pararneters to
ensure the performance of the measurement.
Pl-6.1.4 Selection. Pressure sensor range shall encompass t he required measurement ra nges. The vacu um
generated th rough a SIP cycle shall be considered in
sensor range selection.
Pressure sensor operational temperature límits shall
meet the requirements of the process and ambient envi-
(a) Director lndirect lnsertion in Tee
ronment.
The owner / user shall select the fill fluid for t hei r
process to minirnize the impact on the process fluid, in
case the diaph ragm fails and the fill fluid leaks into the
process.
Pl-7 TEMPERATURE SENSORS AND ASSOCIATED
COMPONENTS
(b) Direct or lndirect lnsertion in an Elbow
Pl-7.l General
This section presents requirements for commonly used
temperature-sensing instruments. Additional information
on temperature sensors and influences on sensor performance can be found in Nonmandatory Appendix Q.
Pl-7.2 Components
Pl-7.2.1 Sensors. Temperature sensors addressed in
this section include res ista nce tempera ture detectors
(RTDs) and thermocouples. RTDs are t he preferred
sensing technology. Thermocouples are acceptable with
owner/ user approval.
Pl-7.2.2 Thermowells. Th errnowells are used to
protect the sensor and enable calíbration or replacement
without stopping the process or breaching the system
boundary. Common thermowell styles are straight thermowells and elbow thermowells.
(e) Nonintrusive
Pl-7.3 lnstallation
GENERAL NOTE: Shown with nonspedfk hygienlc connectlons.
lnstallation methods include tee style, elbow style, or
nonintrusive (see Figure Pl -7.3 -1). Tee· and elbow-style
installations can be direct insertion (sensor is in direct
contact with the process fl uid) or ind irect insertion
(sensor is isolated from the process by an installed thermowell). Nonintrusive sensors covered in this section are
206
ASME BPE-2022
Figure Pl-7.3.4-1
Accepted Elbow Orientations and Flow Directions
Flow
Flow
(al For AII Tubo Sizes
(bl For Tube Sizes 2.5 in. (64 mml and larger
GENERAL. NOTE: Shown with nonspecific hygienic connections.
integral sensors with a section of process tubi ng. Clampon-style nonintrusive sensors are not addressed in this
section.
(a) Tee-Style Jnstallations. When tee-style installations
are used for director indirect insertion, a hygienic process
connection or weld end shall be used.
(b) Elbow-Style lnstallations. When elbow installations
a re us ed, t he process connections shall be hygienic
connections or weld ends. When using a direct insertion
sensor in a n elbow, the instniment connection shall be a
hygienic connection.
(e) Noníntrusive-Style lnstallatíons. The process
connections for nonintrusive sensors shall be hygienic
connections or weld ends.
with agitators, consideration should be given to the effect
of the sensor location on the mixing pattern.
Pl-7.3.4 Orientation
Pl-7.3.1 Drainability. The installed sensor shall meet
the d rainability requirements of Part SD.
Pl-7.3.2 Cleanability. The installed sensor shall meet
the cleanability requirements of Part SD.
Pl-7.3.3 Mountlng Locatlon . The sensor mounting
location shall be specified by the owner/user to ensure
the measurement meets t he process system requi remen ts. Loca tions near process influences per Pl-7.4.3
and ambient influences per Pl-7.4.4 should be avoided
whe never possible as they can affect the accuracy of
the measurement.
When selecting mou nting locatio ns in vessels, t he
mínimum working volume oí the vessel shall be considered. The inserted sensor shall not interfere with operations, such as filling and draining oíthe vessel. In vessels
207
(a) All lnsertion-Style Sensors. The installation orientation shall ensure that the insertion length (see Pl-7.3.5) is
in contact with the process íluid under ali operating cond itions.
(b) Elbow Thermowells. Fo r process systems with
tubing size less than 2.5 in. (64 mm), the flow shall be
toward the sensor tip [see Figure Pl-7.3.4-1, illustration
(a)].
For systems with tubi ng size oí 2.5 in. (64 mm) or
greater, flow toward the sensor tip or perpendicular to
t he sensor is acceptable as long as the full insertion
length is covered by the process fluid under ali operating
conditions [see Figure Pl-7.3.4-1, illustration (b)].
(e) Nonintrusive Sensors. Nonintrusive sensors shall be
mounted such that the process fluid is always in contact
with the instniment wall/tube where the sensing element
is loca ted. The preferred orientation is vertica l, in a
vertical section oíthe process tubing where the flow direction is upward. For alternate orie ntations, the sensor
manufacturer's installation recomme ndations shall be
followed (see Figure Pl-7.3.4-2).
ASME BPE-202 2
Figure Pl-7.3.4-2
Accepted Nonintrusive Orientations and Flow Directions
Flow
-
(at Vertical Orientation With F1ow Upward
Flow -
(bt Horizontal Orientation With Sensor
Located on Bottom Side of lnstallation
GENERAL NOTE: Shown with nonspedfk hygienlc connectlons.
Pl-7.3.5 lnsertion Length/Depth
Pl-7.3.6 Special Considerations
(a) lnsertion and Sensitive len9ths. "lnsertion length" is
the length of the sensor or thermowell in contact with the
process flu id. "Sensi tive le ngth" is the length of the
measuring element, inte rna! to the sensor.
(a) Thermowells
(1) Response Time. When the temperature measurement response time (see Pl-7.4.2) is critica! to the process
system operation, thermowells can be constructed using
thin walls and smaller diamete rs. The owner/ user shall
cons ult wit h the sensor/thermowell ma nufacture ,·
rega rd ing design a nd mate ria l selectio n to e nsure
proper opera tion under the required system opera ting
conditions.
(2) Measurement Accuracy. Proper thermal contact
between the se nso r an d t hermowell is im portan! to
ensure measurement accu racy. The thermowell bore
diameter should be designed to be 0.01 in. (0.25 mm}
g reater t han t he se nsor d iameter. A s pring-loaded
senso r design should be used to e nsure senso r t ip
contact with the inside end ofthe thermowell. Use ofther·
mally conductive compound between the oute r sensor
wall an d interna! surface of t he thermowell a nd/o r
metal-to-meta l contact is recommended. Consult with
the sensor manufactu re r regardi ng the application of
thermal compound.
(b) Nonintrusive Sensors. Nonintrusive-style sensors
will typically prov ide a slower response ti me t ha n
most insertion-style sensors.
NOTE: These terms are not applicable for nonintrusive-type
sensors.
(b) Tee lnstallations. The insertion length should be 10
ti mes thediameter ofthe sensor tipor the rmowell tip, plus
the element sensitive length (see Figure Pl-7.3.5-1).
Alternare insertion lengths are acceptable with proper
consideration of the installation details and sensor design
(co nsul t t he ma n ufacturer) a nd w ith ow ner/ use r
approval.
The mínimum insertion shall locate the midpoint ofthe
sensitive length a t the centerline of the process tube.
The maximum insertion shall maintain a mínimum of
one sensor tip diame ter o r thermowell t ip d iameter
spacing between the instrument tip a nd tube wall opposite
the installation point.
(e) lnsertion Length in Elbow Thermowells. The insertion le ngth should be 10 times the diameter of the sensor
tip or thermowell tip, plus the measuring element sensitive length (see Figure Pl-7.3.5 -2}. Alternare insertion
le ngths a re acceptable with owner/user approval.
208
ASME BPE-2022
Figure Pl-7.3.5-1
Sensor lnsertion Lengths for Tee lnstallations
S = Sensitiva leng th
D = Tip diameter
lnsertion length = (O x 10) + S
(a) Optimum l nsertion length
T= Tube O.O.
1.0. • T - (Wx 2)
Centerline o f tubing
S = Sensitiva length
lnsertion length = (l.0J2I + (S/2)
(bl Mínimum lnsertion length
T= Tuba 0.D.
1.0. = T - (W X 2)
D = Tip diameter
lnsertion length = I.D. - D
(e} Maximum lnsertion Length
GENERAL NOTE: Shown with nonspecific hygienic conne<:tíons.
209
ASM.E BPE-2 022
Figure Pl-7.3.5-2
Sensor lnsertion Lengt hs for Elbow lnstallations
I
lnsertion depth ■ (O x 10) + S
O X 10- - --i--
1
-
- ii- S = Sensitivo length
O • Tip diameter
(a) Direct lnsertion Elbow
~
-
lnsertio n depth = (D X 10) + S
'-<
D x 10
S = Sensitive length
~
~
I
1
1
1
'»\:
(b) lndirect lnsertion Elbow Thermowell
GENERAL NOTE: Shown with nonspecific hygienic connections.
210
D = Tip d iameter
ASME BPE-2022
(a) Thermowells installed within the process system
boundary shall be fabricated with hygienic connections
or be welded to the process tubing.
(b) ASME PTC 19.3 TW, where applicable, sha ll be
considered to ens ure sufficient thermowell strength
under ali process conditions.
(e) Thermowell design a nd style (straight or elbow
type) shall be specified based on line size, process conditions, and installation location. Elbow the rmowells are
preferred for line sizesthat are0.5 in. (13 mm) in diameter
or less. Straight the rmowells are acceptable when the
insertion length criteria can be achieved.
(d) Thermowell installations may cause a pressure
drop, which shall be considered in the system design.
Pl-7.4 Peñormance
Pl-7.4.l Accuracy. The measurement accuracy will be
iníluenced by the characteristics of the selected sensor,
sensor insertion depth, a mbient temperature, installation
location, ílow condition, a nd wiring.
(a) SensorAccuracy. ASTM E1137 and IEC60751 define
the nominal resistance vs. temperan.re relationship and
standard sensor interchangeability criteria for RTD-type
sensors.
ASTM E230 defines the nominal millivolts vs. temperan.re relationship a nd accuracy for various thermocouple•
type sensors.
(b) Wiri119 and Cablin9. Sensor wiring lengths and
configura t io n shall be consi dered when assessing
measurement accuracy.
Pl -7. 6 Sensor Calibration Verification
Pl -7.4.2 Response Time. When temperature tra nsients a re important to monitor or control, the response
ti me specification for t he selected sensor (or sensor
wit h a thermowell ) shall be less t han one-half the
desired or anticipated process system response time.
Ca lib ra tion methods for tem pe rature se nsors are
described in ASTM E644 and ASTM E220.
Pl-7.4.3 Process lnfluences. Entrained gas bubbles
shall be minímized near the fluid temperature measure·
ment location as gas can cause a delay in sensor response
d ue to variations in t her ma l cond uc tivity and/or
instability in the temperature measurement.
Pl-8.l Conductivity
Pl-8 ANALYTICAL INSTRUMENTS
Pl-8.l.l General. This section only provides devicespecific requirements rela ted to conductivity sensors.
See Pl -2.1 for information on general requireme nts.
Pl-8.1.2 Components. Conductivi ty senso r componen ts combin ed in one body vary depend ing on the
sensor type (see Figure Pl-8.1.2-1).
Pl -7.4.4 Amblent lnfluences. The insertion cri te ria
sho uld be followed to red uce t he stem cond uct ion
effects caused by the temperature dífferences bet\veen
the process a nd ambient area. When the recommended
insertion le ngth per Pl-7.3.5 is not feasible, insu lating
the exterior portian of the sensing instrument is recommended.
Nonintrusive-style sensor accuracy can be affected by
the temp erature difference between the process and
a mbient ar ea. lnsu lat ing the exterior portion of t he
sensor can reduce this effett
Pl-8.1.2.l Process Contact Components
Pl-7.5.l Sensor Selectlon. Sensor type, materials,
construction methods, and performance criteria (stability,
repeatability, hysteresis, and self-heating) shall beconsidered when choosing a sensor.
(a) lnsertion-style sensors are prefe rred as t hey
provide the best measurement accuracy a nd responsive•
ness.
(b) Nonintrusive sensors are acceptable when insertion-type sensors are not feasible due to potential ílow
restrictions or small-dia meter process tubing.
(a) Two-Electrode. A two-electrode-type conductivity
sensor typ ically consists of an outer shaft/body a nd
inn er electrode. Conductivity measure me nts are made
in t his interstit ial space and require this area to be
fully wetted.
(b) M11/cielectrode. A multielectrode-type conductivity
sensor typically consists of a wetted body with inner and
oute r electrodes generally arranged on the same plane.
Conductivity meas urements are made immediately in
front of and in bet\veen the electrodes and require this
area to be fully wetted. A nonconductive material of
construction is req uired between t he electrodes with
the sensor body generally used as the insulator.
(e) Electrodeless. An electrodeless-type conductivity
sensor typically consists of t\'llo encapsulated coils. One
coil gene rates a current a nd t he second coil d etects
changes proportional to the conductivity of the process
flu id. An electrodeless sensor req uires process fl uid
through and around the coils for proper measurements.
Pl-7.5.2 Thermowell Selection. A thermowell shall be
used for insertion-type temperature sensors that require
sensor removal without breaching the process system
boundary.
Pl-8.1.2.2 Non-Process Contact Components. The
interna) temperature sensor is an integral non-process
contact component that is typical for ali types of conductivity sensors.
Pl-7.5 Selection
211
(22)
ASME BPE-2022
Figure Pl-8.1.2-1
Conductivity Sensor Components
Two-electrode sensor
Sensor body
lnsulator
Multielectrode sensor
Electrodes
lntemal temperature
sensor
Sensor body
lnsulat or
Electrodeless sensor
Interna! temperature
sensor
Sensor body
Interna! temperatura sensor
Pl-8.1.3 lnstallation
Pl-8.1.3.4 Special lnstallation Considerations
Pl-8.1.3.l Mounting Locatlon. Special installation
considerations and process intluences should be an integral part of the decísion for conductivity sensor mountíng
locations. See Pl-8.1.3.2 through Pl -8.1.3.4 for detaíls.
(a) Sensor electrodes mounted too close to tube or
vessel wa lls can cause conductivity field distortions
resu lting in measurement inaccuracies. The owner/
user shall consult the manufatturer's clearance requirements and recommendations (see Figure Pl-8.1.3.4-1).
(b) Conduttivity sensors shall not be located directly in
the flow path of another sensor or inletthatcauses a significa nt change in co nductivity (e.g .. following a glass
measuríng electrode pH sensor or injectíon port).
(e) lnstallation of conductivity sensors in locations
where ínco mplete líquid míx íng and reactions ca n
occur should be avoided. lncomplete liquid mixing and
reactions ca n result in measurements that are not representative of the average conductivíty.
(d) Stagnant iones should be avoided. Stagnant iones
can result in measurements that are not representative of
the average conductivity and increase sensor main te-
Pl-8.1.3.2 Orientation. Conductivity sensors should
not be mounted in locations or orientations that promote
gas bubble collection around the sensor. Gas bubbles can
affect sensor performance. Figure Pl-8.1.3.2-1 provides
examples of acceptable orientations.
Pl-8.1.3.3 lmmersion Length/Depth . AII conductivity sensors require full immersion of their measure·
ment electrodes or coils into t he pro cess fluid for
proper functionality. Cond uctivity se nsors shou ld be
inserted to allow for sufficient clearance of electrodes
and coil fields (see Pl-8.1.3.4 for details).
nance.
See Pl-8.1.4.3 for other relevant information.
212
ASME BPE-2022
Figure Pl-8.1.3.2-1
Acceptable Orientations for Conductivity Sensors
Pl-8.l.4 Performance
Figure Pl-8.1.3.4 -1
lnstallation Clearance Requirements
Pl-8.1.4.l Accuracy. ln-line installations shall ensure
continuous process íluid ílow around sensor electrodes or
coils to maximize rneasurement accuracy.
R
Pl - 8.1.4.2 Response Time. Conductiv ity sensor
response times are impacted predom inat e ly by t he
respo nse time of the temperature-sensi ng element.
Details can be found in Nonmandatory Appendix DD.
R
(
1
Pl-8.1.4.3 Process lnfluences
(a) Entrained air impacts conductivity measurements.
(b) Change of product and process temperature impact
conductivity measurements.
AII conductivity sensors shall use either an interna! or
ex terna! temperature sensor fo r compe nsatio n, as
required.
R • per manufacturer
recommendation
Pl -8.1.4.4 Ambient lnfluences. Electromagnetic
interferences that affect conductivity sensor performance
should be avoided.
Pl-8.1.5 Selection. Cond uctivity senso rs shall be
selected based on process conditions and specific performa nce req ui re me nts (e.g., conductivity range a nd
213
ASME BPE-2022
Pl-8.2.3.2 Mounting Location. Special insta llation
considerations and process in fluences should be an integral part of the decision for sensor mounting location. See
Pl -8.2.3.5 a nd Pl-8.2.4.2 for details.
Figure Pl-8.2.2-1
pH Sensor Components
Pl·B.2.3.3 Orientation. pH sensors t hat have a ir
bu bbles in the measuring electrode or reíeren ce electrode
shall be installed ata mínimum angle of 15 deg from the
horizontal (see Figure Pl -8.2.3.3-1).
Pl-8.2 .3.4 lnsertion Length/Depth . pH se nsors
should be inserted only as far as needed to ensure the
measuring electrode a nd reference j u nction are
submerged into the process liquid.
Pl-8.2.3.5 Special lnstallation Considerations.
lnstallation of pH sensors in locations where incomplete
liquid mixing and reactions may occur should be avoided.
lncomplete liquid mixing and reactions can res ult in
measurements that are not representative of t he
average pH.
Pl-8.2.4 Performance. pH sensor performance can be
in fluenced by the conditions described in Pl -8.2.4.1
through Pl-8.2.4.4.
Tcmperature sensor
Reference electrode
_,,,,--- Réference junction
Pl·B.2.4.l Response Time. pH sensor response time
is affected by sensor design and process cond itions.
Sensor selection shall take into account process cond itions
and required r·esponse times.
Measuring electrode
Pl-8 .2.4.2 Process lnfluences
(a) High process liquid veloci ty should b e avoided.
Process liquid veloci ty in excess of 8 ft/sec (2.4 m/s)
can cause excess ive meas urement noise and p hys ica l
darnage to the pH sensor.
(b) Pressure fluctuations should be avoided. Pressure
fluctuations can cause measurement insta bility.
(e) Stagnant zones s hould be avoided. Stagnant zones
can result in measurements that are not representative of
the average pH and increase sensor mainte nance.
chemica l compatibility). Guidance for application-based
sensor selection can be found in Nonmandatory Appendix
DO.
(22)
Pl-8.2 pH Sensors
Pl-8.2.1 General. This section provides device-specific
re qu iremen ts for pH sensors inco rpora t ing a glass
measuring electrode.
Pl-8.2.4.3 Ambient lnfluences. Electromagne tic
interfere nce that affects pH sensor performance s hould
be avoided.
Pl-8.2.2 Components. pH sensors typically include a
measuri ng electrode, a reference electrode, a reference
junction, a nd an interna) te mperature sensor, combined
in one body (see Figure Pl-8.2.2-1).
The measuring electrode and reference junction are
process contact components. The reference electrode
and in terna ) temperature sensor are non -process
contact components.
Pl-8.2.4.4 Special Performance Considerations
(a) pH sensors shall be kept hydrated at all times to
ensure design performance; sensors will be nonresponsive if allowed to dry out.
(b) After any process stability upset (e.g., cleaning), the
reference electrode shall be a llowed recovery ti me.
Recovery times after an upset can vary depending on
upset conditions and sensor design. pH sensor readings
will drift during recovery.
(e) After recovery from a process stability upset, pH
sensors should be checked for appropriate span, response,
offset, a nd stability. Sensors that do not meet performance
requirements shall be recalibrated or replaced.
Pl-8.2.3 lnstallation. Criteria described in Pl-8.2.3.1
through Pl-8.2.3.5 should be taken into consideration
for pH sensor installation.
Pl-8.2.3.1 CleanabiUty. pH sensors shall be selected
to be compatible with cleaning procedures. Some cleaning
procedures will not e ffectively clean the sensor, which will
affect sensor performance.
214
ASME BPE-2022
Pl- 8.2.5 Selection. pH sensors shall be selected based
on the process conditions and specified performance requirements (e.g., measuring electrodes s hall be compatible with design pH ranges).
Figure Pl-8.2.3.3-1
Accepted Mounting Orientations
Pl-9 OPTICAL
Pl-9.1 Optícal Devíces
Pl-9.1.1 General. Optical devices are used to measure
various process characteristics parameters includ ing
co lor, t urbid ity, concentration, percent s uspended
solids, optical density, particle and cell size/shape, cell
density, and cell viability. Applications include filtration,
chromatography, cell culture fermentation, and water
systems.
Pl-9.1.2 Components
Pl-9.1.2.1 light Source(s). Optical devices include a
lightsource(s) such as visible (VIS), ultraviolet (UV}, near
infrared (NIR), or infrared (IR}, which is transmitted into
the process fluid.
Pl-9.1.2.2 Sensor. Sensor types include photo detectors, photomultipliers, and CCD (charge-coupled device)
imaging chips. The syste m can involve various optical
compone nts to foc us, íilter. and enhance t he light
beam either one-dimensionally or multidimensionally.
(a) Horizontal Flow Orientation
Pl-9.1.2.3 Sight Glass. Sight glasses are one of the
key co mponents of a n optical device. Process flu idcontacti ng co mponents of t he sigh t glass asse mbly
shall conform to Parts MM and PM.
(a) When glass is used as a sight glass for viewing
(viewport), a glass fused to a metal hermetic compression
sea) shall be used. The fused glass shall be circular in shape
within the metal frame.
(b) Bubbles in the fused sight glass are acceptable but
t he size and quantity sho uld be kept to a mí nimum.
Bubbles shall not be present on the glass surface.
(e) The seal point of the glass fused to metal sight glass
is at the s urface. The s urface of the sight glass s hall be
integral. continuous, and free of defects s uch as crevices
and pits.
(d) Cracked glass shall not be used.
(e) Sight glasses shall be marked with the glass type,
maxim um pressure, and temperature rating as per
Part DT.
(f) Typical sight glass mountings a re s hown in
Figure SD-3.4.6-1.
(bt Upward f low or Vessel Orientation
Pl -9.1.3 lnstallatlon. The measuring probe s hould be (22)
installed past the boundary )ayer. Seals used for installation of viewport sight glass shall meet the requirements of
Part MC.
Pl-9 .1.3.1 Cleanability. Process fluid-contacting
s urfaces of optical devices shall be cleanable as required
per Part SD.
215
ASME BPE-2022
Pl-9.1.3.2 Mounting Location. Optical devices shall
be moun ted in a pipe or vessel where a representat ive
measurement can be made.
A light or combined light and sight glass for viewing
shall be mounted as shown in Figure Pl-9.1.3.2-1.
For ligh t sources used for viewi ng on ly, a thermal
swi tch, timer, momentary switch, IR fil ter, or sorne
other suitable means should be considered to control
overheating.
Pl-9.1.4 Performance. ln-line optical devices generally
require the tube to be full of liquid and free of excess air
pockets. Certain optical devices can tolerate the presence
of sorne air bubbles. The owner/user should consult with
the optical device manufacturer for guidance.
Pl-9.1.3.3 Orientation. The preferred mounti ng of
in -li ne optical devices is in t he vertica l sectio n of
tubing to avoid particle segregation. The probe should
be in constan! contact with the process fluid.
Pl-9.1.3.4 lnsertion Length. For tube diameters less
than 1 in. (25 mm), experimental test data should be used
to assess performance.
For in-line installation oftube diameters ranging from 1
in. (25 mm) to 4 in. (100 mm), optical probes should be
mounted a mínimum (l,.,1.,) of 0.3 in. (8 mm) away from
any interior tube wall (reference Figure Pl-9.1.3.4-1).
Fo r vessels and tu bing in excess of 4 in. (100 mm)
diameter, optical probes should be mounted where the
glass measurement surface is a mínimum (l,,,1,,) of 1.5
in. (38 mm) from any interior t ube wall (reference
Figure Pl-9.1.3.4-2).
Pl-9.1.4.1 Accuracy. Optical devices are inherently
accurate and repeatable but dependen! on device-specific
calibration.
Pl-9.1.3.5 Special Conslderatlons. Specia l ca re
should be taken for process fluids that are adversely
impacted by temperature to avoid high t emperatures
on the process side of the sight glass or optica l
window caused by the optical devices. Testing of the
optica l device at t he maxim um operating wattage of
the probe or probes should not result in still water
within 0.5 in. (13 mm) of the probe rising more than
2ºF (1 ºC) in 1 hr.
Pl-9.1.4.4 Ambient lnf\uences. Sorne optical sensing
electronics have limited process and ambient temperature
ranges. The owner/user should consult the manufacturer
to ensure the selection is compatible with the temperature
conditions.
Pl-9.1.4.2 Response Time. Optical sensing elements
provide instantaneous readings with no delays due to
process conditions such as temperatu re or flow. The
owner/user should consult the manufacturer if a specific
response time is required.
Pl-9.1.4.3 Process lnfluences. Velocity and particulate content in the process fluid may impact the cleaning
frequency requirement of the optical device.
Pl-9 .1.5 Selectlon. Optical device sensing technologies
vary based o n the intended app lication and suitable
measurement ranges. The owner/ user shall determine
the desired measurement range and unit of measurement
before selecting the optical device and associated technology.
216
ASME BPE-2022
Figure Pl-9.1.3.2-1
Vessel Light Glass Design and Mounting
(22)
(Acceptedl
(al Hygienic Full-Flange Light Glass
lbl Hygienic Clamp Light
on Hygienic Clamp Pad
on Hygienic Clamp Pad
(el Hygienic Clamp Light
Id) Fiber-Optic Light on Hygienic Clamp
(el Typical Vessel Light Glass Mounting Tangent to Tank Head
217
ASME BPE-2022
(22)
Figure Pl-9.1.3.4-1
ln-Line lnsertion Length
(22)
Figure Pl-9.1.3.4-2
lnsertlon Probe Length
OOfilll
Lmin = mi nimum recommended
distance from interior tube wall
218
ASM E BPE-2022
PART MC
COMPONENTS FOR MULTIUSE
the process integrity is ma inta ined. They include seals
between two ferrules.
The geometry of the most common hygienic union is
governed by Table DT-7.1 -1 a nd is shown in Figures
MC-2.2.2-1 a nd MC-2.2.2-2. Other geometries for the
opposing ferrules are a lso used in the industry a nd are
contro ile d by re leva nt industry sta ndards [e.g., ISO
2852, DIN 11864 (-1, -2. -3, 0 -r ings)]. (See Figures
MC-2.2.2-3 and MC-2.2.2-4.)
Other hygie nic unions and cross-sectional geome tries
shall meet ali ofthe requirements ofthis Standard, except
for the ferrule dime nsions.
Nonhygienic connections shown in Figure MC-2.2.2 -5
are not recommended ( e.g.. threaded fittings exposed
to process fluid).
MC-1 PURPOSE AND SCOPE
The purpose of this Part is to provide the requirements
for the sealing compone nts of seals, valves, and fittings
used in the bioprocessing industry. These sealing components crea te or mai nta in process boundaries between
system comp on ents a nd/or subassemb lies to e nsu re
mu ltiuse process sys tem integrity. This Pa rt defines
the design of seals, valves, and fittings. This Part a lso
e na bles equ ipment manufactu rers, sys te m designers,
a nd owner/users to s pecify the requ ired sea!, va lve,
and fitting type and performance for specific applications.
lt is not the intent of th is Part to inhibit the development or
use of new technologies.
MC-2 SEALING COMPONENT TYPES
MC-2.2.3 0 - Ring Seals. An 0 -ring is a ring sea! with a
circular cross section (a toroid), designed to be seated in a
groove and compressed during assembly. 0 -r ings are
most ofte n used as sta tic seals. These are used extensively
in hygie nic applications a nd can sea) both radiaily and
axially opposed faces. Common static 0-ring applications
include sealing fasteners, sha ft couplings, and pump and
filtration components.
Other ring sea) geometries of varying cross sections
(e.g., manway gaskets) may be used in hygienic applications. However, signifícant differences may exist in their
performance (e.g.. pressure and cleana bility}, and they
should be evaluated accordingly.
Examples of 0 -ring industry standards include SAE
AS568, Aerospace Size Standard for 0 -Rings, and ISO
3601, Fluid Power Systems - 0 -Rings.
For use in bioprocessing applications, 0 -rings and their
mating s urfaces shall meet the requirements of this Sta n·
dard.
MC- 2.1 General
Sealing components used in bioprocessing equipment
take a va riety of forms based on their fu nction within the
system and the process boundaries to the a tmosphere and
other systems, which they must maintain. The following
sections define the main types of sealing compone nts and
th eir acceptability for use in th e bioprocessing industry.
For this section, seals are divided into static and dynamic
seals. Ali acceptable seals s hall meet the des ign criteria,
materials, a nd performance characteristics contained in
this Standard.
MC-2.2 Static Seals
MC-2.2.l General. A static sea! is characterized by the
absence of relative motion between sealing s urfaces, or
between the sealing s urface and a ma ting surface, after
initial insta ll at ion. Small amou nts of movemen t that
might be caused by thermal expansion, vibration, bolt
stretch, or sea! response to fluid pressure do not alter
the static definition.
MC-2.2.4 Other Statlc Seals. Other static seals used in
bioprocessing applications shall meet the require ments of
this Sta ndard (e.g., flat gaskets, L-cups, U-cups, stoppers,
septums, and bioseals).
MC-2.2.2 Hyglenlc Unions. Hygienic unions provide
connections betwee n process compo nents (e.g., pi pe
fittings, tank fittings, instruments, and hoses) to ensure
219
ASME BPE-2022
Figure MC-2.2.2-1
Hygienic Union per Table DT-7.1-1
(22)
See Figuro MC•4.2•1
intrusiolVrec-ess ,.,,--'t-- ~ ,
~ - - - - See Figure M C-4.2· 1
iiltrusion/rC(:O-SS
la> Typieal Hygtenic Clamp Union 1 In. and Smaller (Type A) p&r Table OT•7.1•1
(Acc•pted}
(22)
(b) Typlcal Hyglenlc Clamp Union 1 In. !Type 81 per Table OT-7.1•1
(Acc•ptedl
Figure MC-2.2.2-2
Hygienic Clamp Union per Table DT-7.1-1
Symmetric ferrules
(Accepted J
220
(e) Typlcat Hyglenic Clamp Union 1,5 In. and Larger CType B) per Table DT•7,1 •1
(Acceptedl
ASME BPE-2022
Figure MC-2.2.2-3
Hyg ienic Union per DIN 11864
(Acceptedl
Figure MC-2.2.2-4
Hyglenlc Clamp Unlon per DIN 11864
Asymmetric ferrules
(Accepted)
221
ASME BPE-2022
Fi gure MC-2.2.2-5
Nonhygienic Connections
INot Accepted lor Hygíeníc Servícel
Actual sealing point
lal Roll-On Fitting
(b) Compression Fitting
Rough interior
finish
fcl Thraadad Joint
Clearance at bolt
Gasket not positively
located may slip
holes may permit_
m isalignment
and cause large crevice
fdl Aanged Joínt
le) Bevel Seat
Crevice area
Tubing or pipe
\ Difficult to clean
lfl Nozzle Detail
fgl Socket Joint
222
ASM E BPE-2022
MC-2.3.l.4 Rising Stem Single, Dou ble-Seat Mlx·
Proof, and Needle Valves . Pl ug(s) ar e used to close
lnflatab le static seals are static sea ls where gas is
supp lied to the inne r part o f t he sea), p rov id ing a
pillow bar-rier between the pl'Ocess and the a tmosphere.
They are commonly used in large process components,
and in connections to s upport stnrctures.
flow agains t seat(s) . Dyna mic seal(s) are used on
linear stem(s). Static sea Is are used between body components (see Figure MC-2.3.1.4-1).
MC-2.3.1.5 Butterfly Valves. The seat/seal creates a
dynamic sea) when the disk is rotated into the closed position (see Figure MC-2.3.1.5-1). The seat/seal also forms
the primary ste m seal to prevent leakage through the
stem journal.
MC-2.3 Dynamlc Seals
Adyna mic seal is characterized by the movement ofthe
seal surface anda mating surface after initia l installation.
MC-2.3.l Val ves
MC-2.3.1.6 Thermostatic Steam Trap. The valve seat
is closed by a plug attached to a dynamic bellows sea!. The
body cavity for a serviceable steam trap is typically sealed
by a static seal (see Figure SD-3.1.2.2-1).
MC-2.3.1.l General. Valves are process components
that provide dyna mic seals within the process. They also
provide seals between the process and the a tmosphere.
MC-2.3.1.2 Diaphragm Valves
MC - 2 . 3.l.7 Back Pressure Control Valve. A
nonsliding seal (such as a d iaphragm) is used to seal a
li near ste m. For closure, the valve may use a so~ seal,
s uch as an 0 -ring or diaphragm, or a meta l-to-metal
sea l/seat (see Figu re MC-2.3.1.7-1 ). To regulate the
flow, the operating diaphragm responds to pressure to
control th e regul a ting pl ug a nd fu nctio ns as a static
seal around its perimeter.
(a) Weir Diaphra9m Va/ve, Weir Diaphra9m Tank
Bottom Va/ve. The diaph ragm seal is a flexible membrane
that forms positive closure when compressed against the
wei r (see Figure MC-2.3.1.2 -1). The diap hragm is a
product/process contact seal creating both static (atmospheric) a nd dynamic (differential) seals.
(b) Radial Diaphragm Va/ve, Radial Diaphragm Tank
Boctom Va /ve. The diaphragm seal is a flexible membrane
that forms positive closure when compressed aga inst a
radial seat (see Figure MC-2.3.1.2-2). The diaphragm is
typically a product /process contact sea) creating both
sta tic (atmospheric) a nd dynamic (differentia l) seals.
Howeve r, in some des igns sta tic seals may be used
between body compone nts.
(e) Weirless Diaphragm Va/ve. The diaphragm seal is a
flexible membrane tha t modula tes flow across a weirless
va lve body a n d also fo rms pos it ive clos ure whe n
co mp ressed aga in st t he weirless va lve body (s ee
Figure MC-2.3.1. 2-3). The diap hragm is a p rod uct
contact seal creating both atmos pheric a nd differential
seals.
(d) Linear Control Va /ve. A sliding seal (such asan 0 ring) or nonsliding seal (such as a diaphragm) is used to
seal a linear stem (see Figure MC-2.3.1.2-4). For closure,
the linear control valve may use a soft sea) such as an 0 ring or d iaphragm or a metal-to-metal seal/seat.
(e) Regulator Va/ve. A control diaphragm is a flexible
membrane that typically is used as a pressure ba rrier
and a lso for ms a static seal to th e atmosphere. A plugtype dynamic seal may be used for closure. Static seals
a re used between body com ponen ts. To regu late the
flow, the opera ting diaphragm responds to pressure to
contro l the regu lating plug a nd fu nctions as a static
seal a round its per imete r (see Figure MC-2.3.1.2-5).
MC- 2.3.1.8 Pinch Valve. Pinch valves use a flexible
tube or sleeve that forms a differential seal when closed
(see Figure MC-2.3.1.8-1).
MC- 2.3.1.9 Check, Pressure Relief, and Safety Pres- (22)
sure Relief Valves
(a) A check valve is a unidirectional flow device (see
Figure MC-2.3.1.9-1). When the app lica tion req uires
d ra inabili ty, a check va ive may incl ude provisions for
draining, such as fla ts, dra in holes, or a drain port
(b) A pressure re lief valve is a type ofvalve that relieves
pressure in a system in order to protect against mecha nical damage of equipment. An override device may be used
to allow flow through the valve for the purpose of cleaning.
Pressure relief valves a llow bypassing of the overpress ured fluid back into the process line or a safe location
(e.g., from a pump discharge back to the pump s uction ).
(e) Asafety pressure reliefvalve is a type ofvalve used
to relieve the pressure in a system or vessel, caused by a
process upset, instrument or equipment failure, or fire. lts
purpose is to protect people and equipme nt from a pote n·
tial explosion or leak. The flow is one-direttional. In case of
overpressure, the fluid is discha rged to a safe location
outside the pressurized system.
MC- 2.3.1.3 Ball Val ve and Ball Tank Bottom Val ve.
The seat/sea l functions as a dynamic sea) against the
rotating ball. Sta tic seals are used between body compo·
nents. A dyna mic sea) is used o n a rota ry stem (see
Figure MC-2.3.1.3· 1).
223
ASME BPE-2022
Figure MC-2.3.1.2-1
Weir Valves
(a) Weir Diaphragm Valve
fb) Weir Diaphragm Tank Bottom Valve
Figure MC-2.3.1.2-2
Radial Valves
(a) Radial Oiaphragm Tank Bottom Vatve
lb) Radial Dlaphragm Valve
(e) Bellows Radial Diaphragm Tank Bottom Valva
(di In-Une Radial Diaphragm Valva
224
ASM E BPE-202 2
Figure MC-2.3.1.2-3
Weirless Diaphragm Valve
Figure MC-2.3.1.2-4
Linear Control Valves
(a) Linear Control Valve
With O-Ring Seal
(b) Linear Control Valve
With Elastomer Diaphragm Seal
225
(e) Linear Control Valve
With Metallic Diaphragm Seal
ASM.E BPE-2022
Figure MC-2.3.1.2-5
Regulator Valve
Figure MC-2.3.1.3-1
Ball Valves
(a) Ball Tank Bottom Valva
lb) Ball Val va
226
ASM E BPE-2022
Figure MC-2.3.1.4-1
Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves
(at Rising Stem Single Valve
(b) Oouble•Seat Mix•Proof Valva
Figure MC-2.3.1.5-1
Butterfly Valve
(e) Need le Valve
Figure MC-2.3.1.7-1
Back Pressure Control Valve
227
ASM.E BPE-2 022
Figure MC-2.3.1.8-1
Pinch Valve
(a) Pinch Valva Open
lb) Pinch Valva Closed
228
ASME BPE-2022
Figure MC-2.3.1.9-1
Pressure Relief and Check Valves
Open (Flowl Position
Closed (Check! Position
la) Spring-Type Check Valve
Open (Flow) Position
Closed (Check) Position
(b) Poppet-Type Check Valve (Vertical Configuration) (Note 111)
N ormal Flow Direc1ion
Closed (Check) Position
Open (Flowl Posit ion
(el Poppet-Type Check Valve (Horizontal Configuration) (Note 1111
NOT6: (1) Gray color represents backílow blocked by the poppet.
229
ASME BPE-2022
Figure MC-2.3.1.10-1
Plug Valve
MC-2.3.2.3 Dual Mechanical Seals
(a) Dual Mechanical Seals-Pressurized
(1) Dual mechanical seals-pressurized consist of an
inboard mechanical seal andan outboard mechanical seal.
Pressurized barrier fluid is injected between these two
seals. The inboard mechanical sea) has process contact,
and the outboard mec hanical sea l has atmospheric
contact.
(2) Pressurized barrier fluid means the barrier fluid
pressure is higher than the process pressure acting on the
inboard mechanical seal.
(3) Dual mechanical seals- pressurized offer absolute separation of process and atmosphere.
(4) The pressurized barrier fluid will weep into the
process and will weep into the atmosphere.
(5) The owner/user shall arrange for a pressurized
barrier flu id to be introduced bet\'lleen the inboard seal
and the outboard seal to ensure a positive barrier exists
between the process and the a tmosphere. A liquid barrier
fluid such as water also cools and lubricates the seal. Agas
barrier fluid such as air provides a barrier between the
atmosphere an d process only and does not provide
cooling or lubrication to the sea] faces.
(6) Barrier fluid shall be atan appropriate flow, pres·
sure, and temperature and should be based on the recommendation of the equipment manufacturer.
(7) A typical dual mechanical seal- pressurized is illustrated in Figure MC-2.3.2.3-1 for pumps a nd in Figure
MC-2.3.2.3-2 for top-entry agitators.
o
MC- 2.3.1.10 Plug Valves. The plug-body valve or
plug-seal valve functions as a dynamic seal against the
rotating plug (see Figure MC-2.3.1.10-1).
MC-2.3.2 Mechanical Seals
(22)
MC-2.3.2.1 General. An end face mechanical seal is a
device tha t controls leakage offluids a long rotating s hafts.
Sea ling is accomplished by a stationary face bearing
against the face of a ro ta ting ring mounted to t he
shaft. The sealing faces are perpendicular to the s haft
axis. Axial mechanical force and fluid pressure maintain
the contact between the wearing seal faces.
(b) Dual Mechanical Seals- Unpressurized
(1) Dual mechanical seals- unpressurized consist of
an inboard mechanical seal a ndan outboard mechanical
seal. Buffer fluid is injected between these two seals. The
inboard mechanical seal has process contact, and the
outboard mechanical seal has atmospheric contact.
(2) Unpressurized buffer fluid means the buffer fluid
pressure is lower than the process pressure acting on the
inboard mechanica l seal. The highes t pressure in t he
sealing system is the process pressure on the inboard
side of the inboard seal. The lowest pressure of the
system is the atmosphere pressure on the outboard seal.
(3) Dual mechanical seals-unpressurized offerabsolute separation of the at mosphere from the process but do
not provide absolute separation of the process from the
a tmosphere.
(4) Process fluid will weep into the unpressurized
buffer fluid, and the buffer fluid will in turn weep into
the atmosphere along with dilute process fluid.
(5) The owner/user shall arrange for an unpressurized buffer fluid to be introduced bet\'lleen the inboard seal
and the outboard seal to ensure a buffer between the
process and the atmosphere. The process fluid will penetrate between the inboard sea] faces. The buffer fluid with
traces of process fluid will penet rate the out.board seal
faces.
MC-2.3.2.2 Single Mechanical Seals
(a) Single mechanical seals are seal arrangements in
which the re is only one mechanical seal per seal chamber.
(b) Single mechanical seals offer simplicity and an
observable leakage path to the a tmosphere.
(e) Single mechanical seals weep fluid across the face in
the direction from high pressure to low pressure.
{d} Single Mechanical Seals for Pumps
(1) The process fluid provides lubrication and
cooling for the faces. A single seal operating in dry or
vacuum conditions will result in seal failure.
(2) Notall process fluids will provide adequate lubrication and cooling. ln this case an alternative seal design or
flush plan shall be considered.
(3) A typical single seal for pumps is ill ustrated in
Figure MC-2.3.2.2-1.
(e) Single Mechanical Seals for Top-Mounted A9itators
(1) Single mechanica l seals for top-moun ted agitators operate in th e head space of the vessel typically
exposed to the gas phase of the process fluid.
(2) Top-mounted agitator single seals may contain a
debris well to catch wear material from dry contacting
faces.
(3) A typica l single-sea! design for top -mounted
agitators is illustrated in Figure MC-2.3.2.2-2.
230
(22)
ASM E BPE-2022
Figure MC-2.3.2.2-1
Single Mechanical Seal
Figure MC-2.3.2.3-2
Dual Mechanical Seal- Pressurized
for Top-Entry Agitator
Rotating raoe
At mospheric side
Process side
Atm ospheric side
Rotating face
Figure MC-2.3.2.2· 2
Single Seal for Top-Entry Agitator
Process side
Barrier inle t
Atmospheric side
-4-1-+ - -- -Rotating face
,¡,-.,<,¡--- - - Stationary faca
Process side
(22)
Figure MC-2.3.2.3- 1
Dual Mechanical Seal- Pressurized for Pumps
Process side
Atmospheric side
Stationary side
Barrier inlet
231
(22)
ASME BPE-2022
(22)
Figure MC-2.3.2.3-3
Dual Mechanical Seal- Unpressurized for Pumps
The flow of process fluid cools and lubricates the seal
faces. See Figure MC-2.3.2.4 -4.
(e) Flush Plan 32. Sea! tlush from externa) source. This
plan is used for single seals. A fluid that is compatible with
the process is injected into the sea! cavityto cooland lubricate the seal. Plan 32 flush fluid will go into theprocess.See
Figure MC-2.3.2.4-5.
(f) Flush Plan 52. This plan is fordual seals-unpressurized only. Unpressurized buffer fluid circulates through a
reservoir. The buffer fluid is at a pressure less than the
process side ofthe in board sea l. This plan offers protection
from product entering the atmosphere and, when used
under vacuum conditions, from the atmosphere entering
th e sea l chamber. See Fig ures MC -2.3 .2.4 -6 and
MC-2.3.2.4-7.
(s) Flush Plan BPE52. Flow and pressure are taken from
the pump discharge and injected between the dual seals.
Theseal cavity is vented toalow-pressure point. This flus h
plan is used exdusively for dual seals- unpressurized. See
Figure MC-2.3.2.4·8.
{h) Flush Plan 53. This plan is for dual seals- pressur·
ized only. Pressurized barrier fluid is circulated through a
reservoir where the barrier fluid is cooled then returned
to the seal cav ity. Circulation must be provided by a
pump ing device located in the d ual-seal design. This
arra ngement ensures that the atmosphere and pumped
process fluid ca nnot cross-contami nate. The barrie r
fluid s hall be compatib le with the product. See
Figures MC-2.3.2.4-9 and MC-2.3.2.4-10.
(i) Flush Plan 54. This plan is fordual seals-pressurized
only. Pressur•ized barrier fluid is circulated through the
dual-sea) cavity from an externa) source. The source of
flow and pressure is undefined in this flush plan. The
barrier fluid pressure between the inboard and outboard
seals shall be higher than the process pressure acting on
the in board sea!. The barrier fluid shall be compatible with
the process flui d . See Figures MC-2.3.2.4 -11 a nd
MC-2.3.2.4-12.
(j) Flush Plan 55. This plan is for dual seals-unpressurized only. Unpressurized buffer fluid is circulated through
the dual-sea) cavity from an externa)source. The source of
flow and pressure is undefined in this flush plan. The
buffer fluid is at a pressure less than the process side
of the inboard sea!. This plan offers protection from
the process fluid e nteri ng the atmosphere and, when
used under vacuum conditions, from the atmosphere
entering t he seal chamber. See Figu res MC-2.3.2.4-13
and MC-2.3.2.4-14.
{k) Flush Plan 74. This plan is only for dual gas mechan·
icalseals- pressurized. The barrier fluid pressure between
the inboard and outboard seals s hall be higher than the
process pressure acting on the inboard seal. The barrier
fluid shall be compatible with the process flu id. See
Figures MC-2.3.2.4-15 and MC-2.3.2.4-16.
Buffer outlet
Process side
Rotating face
Atmospheric side
Stationary face
Buffer inlet
{6) Buffer fluid shall be atan appropriate flow, pres·
s ure, and temperature and should be based on the recom·
mendation of the equipment manufacturer.
(7) A typical dual mechanical seal- unpressurized is
illustrated in Figure MC-2.3.2.3 -3.
(ZZ)
MC-2.3.2.4 Flush Plans. A flus h plan describes how
the end face mechanical seal is lubricated and cooled. The
flush plan numbers directly reflect plans that were developed by the American Petroleum lnstitute (API 682), were
s ubsequently approved by the American National Standards lnstitute (ASM E 873 series), and a re global standard
shorthand for seal support systems. lf properly imple mented to the requirements of this Standard, ali of the
following flush plans are acceptable for use in the biopro·
cessing industry. The numbering system used below is
also recognized and used by the Fluid Sealing Association
(FSAJ and the European Sealing Association (ESA as a
group associated with FSA). ISO 21049, API 682, and
ISO 13709 also contain important information about
support systems for mechanical seals.
(a) Flush Plan 01. In terna) seal chamber circulation for
s ingle sea l from pump d ischa rge. A high-pressure
d ischarge of the process fluid flows to the low-pressure
seal chamber. The ílow of process fluid cools and lubricates the seal faces. See Figure MC-2.3.2.4-1.
(b) Flush Plan 02. Dead-ended seal chamber with no
other sources offlus h for single seal. The ambient conditions of the seal chamber are satisfactory for the process
fluid to remain a coolant and lubricant for the seal faces.
See Figure MC-2.3.2.4-2.
(e) Flush Plan 03. Dead-ended sea! chamber with circulation between the seal chamber and the pump created by
the design ofthe sealing chamber. The flowof process fluid
cools and lubricates the seal faces and may prevent the
accumulation of solids in the sea l c ham ber. See
Figure MC-2.3.2.4-3.
(d) Flush Plan 11. Seal flush from pump discharge for
single seal. Often uses an orífice, but the flush line itself
may be considered an orífice. Ahigh -pressure dischargeof
the process fluid flows to the low-pressure sea! chamber.
232
ASM E BPE-202 2
MC- 2.3.3 Other Dynamlc Seals
Figure MC-2.3.2.4-2
Flush Plan 02
MC-2.3.3.l Reciprocating Seals. Reciprocating seals
have axial movement betwee n t he inner a nd ou te r
e leme nts, as in a plunger o r a piston and a cyl inder.
The sea!, usua lly an 0 -ring, slides a long the sealing surface.
Seal chamber
MC-2.3.3.2 Oscillating Sea ls. Oscillating seals have
angula r moveme nt a round a n a re, as in a valve handle. The
sea!, usually a n 0 -ring, slides between the inner a nd outer
elements and has limited or no longitudinal movement.
Figure MC- 2.3.2 .4-3
Flush Plan 03
Figure MC-2.3.2.4- 1
Flush Plan 01
Seal chamber
(with circulation to pump)
233
ASM.E BPE-2022
Figure MC-2.3.2.4-4
Aush Plan 11
Figure MC-2.3.2.4-5
Flush Plan 32
Externa! source
Figure MC-2.3.2.4·6
Flush Plan 52 for Pump
Reservoir
Buffer outlet
Buffer inlet
234
ASM E BPE-2022
Figure MC-2.3.2.4-7
Flush Plan 52 for Top-Entry Agitator
Figure MC-2.3.2.4-9
Flush Plan 53 for Pump
Reservoir
Reservoir
Buffer inlet
Figure MC-2.3.2.4- 8
Flush Plan BPE52 for Pump
Figure MC-2.3.2.4-10
Flush Plan 53 for Top-Entry Agitator
Pump discharge
Hygienic pressure and
flow control device
Reservoir
Buffer outlet
Buffer inlet
Barrier outlet
Barrier inlet
235
ASM.E BPE-2022
Figure MC-2.3.2.4-11
Aush Plan 54 for Pump
Figure MC-2.3.2.4-13
Flush Plan 55 for Pump
Buffer oullet
Barrier outlet
Buffer inlet
Barrier inlet
Figure MC-2.3.2.4-14
Flush Plan 55 for Top-Entry Agitator
Buffer outlet
Figure MC-2.3.2.4-12
Flush Plan 54 for Top-Entry Agitator
Buffer inlet
Barrier outlet
Barrier inlet
236
ASME BPE-2022
Figure MC-2.3.2.4-15
Flush Plan 74 for Pump
MC-3 SEALING COMPONENTS GENERAL DESIGN
REQUIREMENTS (GENERAL PROVISIONS)
MC-3.l Process Conditions
(22)
The equipment supplier/manufacturer shall provide
documenta tion stati ng the reco mm ended operational
limits of the sealing components and maintain appropriate
data (e.g., test results, calculations) supporting these
limits.
The equipment supplier/manufacturer should provide
available information relevant to common applications
(e.g., sterilization, cleaning, and passivation). Form S-1,
Application Data Sheet, may be used by t he owner /
user to co mmunicate pertinent informat io n fo r t he
supplier/manufacturer to assess compatibility with the
specific owner/user process.
The equipment supplier/manufacturer should provide
available information regarding the component's life cycle
performance a nd the methodology used in its determinat ion (e.g., test p rotocol) . No nma ndatory Appe ndix K
provides standard process test conditions for seal performance evaluation that may be used for this purpose.
Gas barrier oullet
Gas barrier inlet
MC-3.1.1 Thermal Cycl.ing. Sealing components shall
be designed to perform as intended when thermally cycled
between the rated upper and lower temperature limits.
The equipment supplier/manufacturer should provide
avai lable informatio n regarding al lowable number of
thermal cycles.
Figure MC-2.3.2.4-16
Flush Plan 74 for Top-Entry Agitator
Barrier outlet
MC-3.2 System Requirements
(22)
Sealing components designed for CI P shall meet the requir•ements of SD-2.4.2.
Sealing components designed for SIP shall be able to
withstand continuous exposure to saturated steam at a
mínimum temperature of 266º F [1 30ºC; representing
24.S psig (1.70 bar) under saturated steam conditions)
for a duration of at least 100 hr.
Seali ng components shall be accessible for mainte -
Vent valve
Barrier inlet
nance.
MC-3.3 Seal Construction
MC-3.3.1 Materials
(a) Biocompatibility. Biocompatibility testing shall be
performed per PM-3.1. The testing shall be valid for ali
similar seals represented by the unique combination of
the materials and manufacturing processes used in the
test article. Biocompa tibility testing shall be repeated
for significant cha nges in raw materials or manufacturing
processes. Otherwise, biocompatibility testing is used on
initial qualification of the material a nd process by the seal
supplier/manufacturer.
(b) Process Compaeibility. Seal mate rials shall be resistant to corrosion from process, cleaning, and sterilization
fluids. Selection shall be based on ali media that could
237
(22)
ASME BPE-2022
come in contact with the seal, including cleaning and sterilization media. Special consideration shall be made when
the exposure is at elevated temperature. Material selection shall be governed by Part PMand reference Fonn S-1,
Application Data Sheet. lt is unlikely that any single seal
material can withstand a li cond itions present in the
faci lity. Material selection should be done in concert
with the sea l supplier/man ufacturer to ensure t hat
seal performance is maximized for each location within
a process. However, materia l se lection remains the
responsibility of the owner/ user.
(e) Permeation Resistance. Seal permeation shall be
inclu ded in seal leakage criteria and is not addressed
as an individual topic.
(d) Surface Finish
{1) Seals shall be free of molding imperfections or
burrs within the system boundary and on sealing surfaces.
(2) Seals s hall be free of foreign matter on surfaces
within the system boundary and on sealing surfaces.
(3) Surfaces to be sealed shall meet specifications
provided by the sea! supplier /manufacturer based on
performance and the requirements in Part SF.
(4) Molded seals and components shall have molding
flash removed to prevent contact with the process stream.
(e) Portie/e Generation. Seal designs should min imize
wear that ge nerates partic les t hat co uld e nter the
process stream.
(fJ Lubrication. When required to facilitate installation,
seals may be lubricated with an acceptable lubricant that
is compatible with the seal material and p rocess. The
s upplier/manufacturer shall disclose lubrication requirements. The selection of lubricants is the responsibility of
the owner/user.
MC-2.2.2-1 through MC-2.2.2-4 illustrate typical static
hygienic and 0 -ring connections. Figu re MC-2.2.2-5 illustrates unacceptable connections. In addition, the following
general requirements apply to ali hygienic static seals:
{1} Gaskets and 0 -ring seals shall seal and meet the
cleanability and bioburden control requirements of the
application. Fíttings should be selected or desígned to
consider the gasket or 0 -r ing geometry, materials of
construction, and seal performance under operating conditions.
(2) Static seals should be self-aligning and self-positioning,
(b) Hy9ie11ic Unions. Most common hygienic union
geometries used in bioprocessing are lís te d in
MC-2.2.2. Ali hygieníc unions shall conform to t he
general design requirements in this Part, the material requirements of Parts MM and PM, and the su rface finish
requirements of Part SF. 1ntrusion categories of hygienic
seals are defined in MC -4.2 and illust rated in Figure
MC-4.2-1.
(e) O-Rin9 Seals
(1) General O-Rin9 and Gland Desí9n Criteria. An O·
ring is a sea l with a circular cross section (a toroid),
designed to be seated in a groove and compressed
duri ng assembly. These are most often used in static
sea Is. 0-rings are used extensively in hygienicapplications
and can seal by applying compression (squeeze) on the
radia lly and/or axially opposed faces. In addition to
seali ng performance during bioprocessing production,
performance during other processes, typica lly CIP a nd
bioburden control processes, s hall be considered in the
des ign of a hygienic 0-ring seal. The following design
crite ria should be evaluated:
(-a) seal performance under a li process conditions
(-b) proximity of the sealing point to the bulk fluid
flow for· CIP and bioburden control processes
(-e) consistent location of the sealing point and
exposed s urfaces under ali relevant process conditions
(-d) ability to handle the effects of thermal expan sion and chemical swell
(-e) drainability
Often designs that target specific criteria sacrifice
others. For example, installation of 0 -rings in tight
grooves to improve cleanability often causes problems
dueto the thermal expansion of elastomers being significantly greater than the thermal expansion of stainless
steel or other nonmetallic materials.
The owner/ user should consult wit h the sea!
designer to optimize the design for an application. The
owner/user should determine whether an 0 -ring sea!
provides adequate overall performance for a specific
application.
Sorne examples ofO-ring groove designsare shown in
Figure MC-3.3.2.2· 1.
MC-3.3.2 Design
(22)
MC-3.3.2.l General
(a) Crevices. A smooth, contoured, pocketless interior
surface s hall be created when sea Is are placed between the
seal contact s urfaces. Ali recessed seal contact s urfaces
shall avoid sharp corners and be easily cleanable with
the seal removed. Ali sea l and sea! cont act surfaces
shall b e designed to minimize cracks or crevices that
might harbor system media.
(b) Dead Spaces. Dead spaces are defined here as a void
in the process contact surface(s) portian of the structure
notcompletely occupied bya seal and are us ually required
to allow for thermal expansion of the seal material. These
should be avoided. Ali seal and sea! contact surfaces s hall
be designed so that the system is drainable when seals are
properly installed.
(ZZ)
MC-3.3.2.2 Statlc Seals
(a) Static Sea/ General Desi9n Requirements. MC-2.2
lists sorne standards describing the design of hygienic
uni ons, 0-rings, and other static seals. Fig u res
238
ASME BPE-2022
Figure MC-3.3.2.2-1
Examples of Static 0-Ring Grooves
[e.g., the European Hygienic Engineering and Design
Group (E HEDG)]. 0 -ring connections sha ll conform to
t his paragraph and SD-3.1.1. The co nstruction of the
fitting shall be such tha t excessive deformation of the
sea l will not be caused as a resul t of overtightening
the connection.
(7) 0 -Rings Fabricaced From Molded or Extruded
Section Using Vulcanized Molded Joincs
(-a) 0 -Rings. Fully molded 0-rings should be used,
wherever possible.
(2) O-Rin9/Gla11d Sizin9 (Fil/). Proper gland design
and a ppropriate 0-ring selection a re critica) for proper
sealing. 0-ring selection includes the proper sizing and
proper material selet"tion for the process e nvironment
An 0-ri ng gla nd s hall incl ude s ufficie nt room for
therma l expansion and chemica l swell to prevent seal
material e xt r us ion and da mage. Seal desig ns t hat
compress in multiple directions require extra caution.
(3) 0 -Ring Str etch (Elastomeric 0 -Rings). lt is
suggested that 0 -ring stretch du ring installation be
li mited. The des igner shou ld consider t he max imum
amount of allowable stretch to prevent 0-ring breakage
during partassembly. When located in position for use, the
0 -ring stretch should not exceed 5%. Simila rly, the 0 -ring
diameter should not be too large for a groove, which would
cause the ring to buckle. Overstretching or oversizing an
0 -ring can lead to premature seal failure.
( 4) O-Ri119 Compression (Squeeze). Proper 0 -ri ng
compress ion is critica) to prope r sealing. At ambient
temperature, 0-ring compression is frequently in the
range of 10% to 25%; however, this can vary greatly
depending o n materials, cond itions, a nd applicatio ns
(e.g.. static vs. dynamic). 0 -ring compression over 30%
should generally be avoided. Relative 0 -ring compression
can increase during heating due to ther mal expansion.
Factors to consider for 0 -ring compression include chem•
ical swell, te mperature change, elastomer hardness, etc.
Caution should be ta ken when substituting elastome ric
seals for nonelastomeric seals or vice versa. A nonelasto•
meric seal may require a crush groove, a nd direct substi·
tution of an elastomer into such a groove may result in
prema ture seal failure.
(5) 0 -Ring Thermal Expansion. 0 -r ing thermal
expansion is dependent on the particular material and
formulation. The 0 -ring sup plier/man ufacturer can
p rovide information o n t he ma terial's coefficie nt of
thermal expansion (CTE) characteristics.
(6) Hygienic 0 -ring connections a re available (see
Figures MC-2.2.2· 3 a nd MC -2.2.2 -4 ) in t h readed,
flanged, or clamped sty les. The 0 -r ing co nnections
shall be manufactured to a hygienic standa rd (e.g., DIN
11864 partS 1 to 3) or shall be accepted as a hygien ic
con nection by a recognized independent organization
239
( -b) Vulcanized Bonded Joints. When the fully
molded seal dia meters a re not available, 0 -rings fabricated fro m molded section using mo lded vulcan ized
joints can be fitted as long as the following para meters
are kept:
(· l) Mater ials. Ali bonded joint seal materials
shall conform to MC-3.3.1 and any add itional requirements s peci fied by the owne r/user. The vulcanized
bonded joint should consist of either an unvulcanized
porti on of the seal material or a co mpatible material
whe re this gives an imp roved joint. In both cases, the
join ing material shall meet the same requirements as
the seal ma terial.
(-2) Joint /11te9r ity. The joint integrity shall meet
the strength require mentS ofthe application. Avulcanized
0 -ring should contain only one joint Where tooling availability limits sea( d iameter, extra joi ntS can be included
with ap prova l of the owner/user.
( -3) Excessi ve Material and Too/ Marks. Ali
excess ive joint material shall be re moved. The surface
fin ish a nd any residual material, tool ma rks, or reductions
in cross-sectional tolerances should not beata leve) that
compromises seal performance a nd cleanability.
( -e) Adhesive-Bonded Join ts. Ad hesive-bonded
joints should be avoided a nd used only with approval
by the owner/user.
( d) Other Sta tic Sea Is
{ 1} Flat Gaskecs. Ali flat gaskets shall conform to the
general design requirements in this Part, the material requirements of Part PM, and the surface finish requirements of Parts SD and SF.
(2) lnftatable Seals. lnflatable seals shall conform to
the general design requireme ntS of this Standard.
MC-3.3.2.3 Valves
(a) Gener al
(1) Process fl ow va lves should be drai nable and
p revent pooli ng when insta lled in their pro per drain
orientation.
(2) When possible, weld ing valves into the process
line is the preferred method ofinstallation to minimize the
use of seals.
(3) Ali process contact surfaces of co mpo nents
designed for CIP /S IP shall be access ible by CIP fl uids
and SI P steam.
(22)
ASME BPE-202 2
(4) Valve surfaces that may become process contact
surfaces if a component (e.g., diaphragm) fails in service
shall be readily accessible for examination, maintenance,
a nd cleaning.
(5) The metallic fluid-contact surfaces of the valve,
including the body cavity, shall conform to the applicable
requirements in Part SF.
(6) The in terna! geome try of cl uster, block, and
multiport val ves should be designed to minimize the conditions that contribute to a dead leg a nd enable draining
when installed per design.
(7) The inte rna! volume ofthe valveshould be kept to
a mínimum while meeti ng other req uirements o f the
process design.
(8) Any crevices (e.g., between mating pa rts of a
valve) shou ld be mi nimized in a reas in contact with
the process.
(9) Any guiding ofvalve trim and operating mechanisms should be minimized in a reas in contact with t he
process.
{10) Valves intended for CIP/SIP/sanitization shall
be capable of opening as required during those processes.
(11) Valves not capable of CIP shall be able to be
d isassembled for cleaning/steaming.
{12} The valve des ign should enable im med iate
leakage detection berween the process side and e nvironment at a ny sea! when possible. The a rea between a
primary and secondary stem sea! should be fitted with
a leakage detection port to indicate prima ry sea! leakage.
(13) Pneu matically co ntro ll ed va lves s hall be
designed to prevent air t ra nsfer from the actuator to
the process.
{14} See Form S-1, Applica tion Data Shee t, to
communicate process conditions to the supplier/manufacn,re r.
(b) Diaphragm Va/ves
(1) Diaphragn1 valves use nonsliding seals and a re
the preferred valve for bioprocessing fluid applications.
(2) Two-way, weir-style d iaphragm valve bodies
s hall be per ma ne ntly marked o n both sides of t he
body to indicare drain position. When submittal drawings
are requi red for welded and machi ned m ultiple-port
valves, the proper installat ion orie nta t io n s hall be
included. Other types of dia phragm valves should be
installed to the manufacturer's recommendations.
(3) Poi nt-of-use (POU) valves should be designed
with the sea! at or below the lowest poi nt in the tube
to e nable draining.
(4) Diaphragms should be marked in accorda nce
with Section 12.3 of MSS-SP-88.
(5) Weirless diaphragm valves use nonsliding seals.
The installation a ngle is not critica] dueto the elimination
of the weir in the body design; however, the valve should
be installed to the manufacturer's recommendations.
(e) Rising Stem Sea/ Va/ves. Rising stem sea! valves use
slidi ng a nd nonsliding seals (see Figure MC-3.3.2.3-1).
Suitable designs are available for fluid utility a pplications
such as clean steam a nd CIP as well as for product. The
owner/ user should define the degree of suitability of the
design for the a pplication.
{1 } Seals for risi ng stem valves are classified as
follows:
(-a) Primary Rising Stem Sea Is. Prima1y rising stem
seals serve as pressure barrie rs for process fluids. Such
sea Is shall be exposed for cleaning a nd shall meet the pressure a nd te mperature require ments of the specified materials as outli ned in this Sta ndard a nd the aseptic a nd
bio burde n co ntro l re quire me n ts s pecified by t he
owne r /use r. In addi tion, t hey shall meet ali of t he
general requirements for seals outlined in this section.
Prima,y sealing can be provided in different ways.
{·1) No nslidi ng sea ls such as bellows and
diaphragms eliminate contamination risk by preventing
the product/process contact surface(s) portian of the
ste m fro m contacting the atmos ph ere. When t he
primary stem sea l is a nonslid ing sea l, a seco ndary
stem seal is not required.
(-2) Sliding seals such as lip-seals and O-rings
can be used for the reciprocat ing s te m betwee n
process fluid and atmosphere. Single sl iding stem sea ls
can be used for fluid utility applications such as clea n
steam and CIP. lf slid ing seals a re to be used as the
prima ry seal for prod uct contact appl ications, t he re
should be a seconda ry stem seal to facili tate cl eaning
a nd sanitization behind the primary slid ing sea!.
(-b) Secondary Rising Stem Seals. Secondary seals
serve as the sealing between atmosphere a nd a stem disinfection chamber (e.g., steam barrier or disinfection means
ba rrier). These seals shall be designed to serve as pressure
ba rr iers for sanitizing fluid.Such seals shall meet the pressure a nd te mperature require ments of the specified material outlined in Part MC of this Standard. Secondary stem
seals are typically sliding seals (e.g.. O-rings or lip-seals).
(2) Wherever elastomeric or polymeric seals a re
re tain ed unde r static com press ion, adjoi ning me ta l
surfaces shall be machined to a roughness specified by
the sea! manufacturer to ensure req uired performa nce,
a nd shall meet the requi re ment s o f Part SF. if t he
surface can become exposed to the system fluid under
the normal course of system operation.
(3) Primary stem O-ring seals should be fitted in
g rooves locat ed as clase to t he valve body cavity as
possible.
(4) When made from metal, static seals shall meet
the surface finish require ments for the valve housing
interior on the side facing the process fluid.
(d) Regulator Va/ves. When using regulator valves, a
means of override is normally required to allow clean·
ability and drainability of the valve.
240
ASME BPE-2022
Figure MC-3.3.2.3-1
Seals for Rising Stem Valves
(al Rising Stem Valve
(bl Rising Stem Valve
With Elastomeric Diaphragm
With O-Ring Seal
(e) Ba/1 Va/ves. Ball valves (Figure MC-2.3.1.3-1) ar·e not
recommended for product contact streams. The owner/
user should determine whether a hall valve is acceptable
for other process contact applica tions. Applications where
hall valves are typically acceptable include liquid and gas
utility and process support applications, such as clean
steam. The valve bore I.D., includ ing hall a nd b ody,
shall match the I.D. of the connecting tubing to enable
draining. Cavity fillers shall not be used.
(j) Butterfly Va/ves. Butterfly valves use sliding seals.
Bu tterfly valves are co mmonly used for powder and
vacuum applications. The valve s hould be installed per
the manufacturer's recommendations to enable draining.
(g) Steam Traps (Thermostatic). A thermostatic steam
trap shall be designed to minimize the risk of soil a ttachment to the process fluid surfaces. The bellows s hould
have a low subcool to preven! the backup of condensate
into the process equipmentand cleansteam system.Steam
traps shall be installed with an unins ulated section
upstream of the trap to facilitate proper steam trap func·
tion (see Figure SD-3.12·1).
(h) Back Pressure Control Va/ves. Back pressure control
valves s hall be designed to enable draining through the
outlet or in let po rt. Crevices c reated by a p ierced
diaphragm or solt seat plug s hall be minimized.
(i) Pinch Va/ves. When using pinch valves, care shall be
taken to preven! permanent deformation of the flexible
tubeor sleeve that restricts the flow or affects drainability.
(el Rising Stem Valve
With Molded Seal
(j) Check Va/ves. Check valves may use sliding and/or
nonslid ing seals. A check valve, clack valve, nonreturn
va lve, or one-way va lve is a valve that allows flu id
flow in one direction. Check valves using an exposed
coi! spri ng shall be of a design to prevent the coi!
spring from full compression creating a n enclosure.
(k) Plug Va/ves. Rotating plug valves use sliding seals
and are not preferred in product con ta et applications. Plug
valves are suitable for liquid and gas utility applications
such as clean steam and CIP. The plug valve uses a ¼-turn
cylindrical plug with 0 -ring seals to provide straightthrough flow. lf the plug I.D. does not match th e I.D. of
the tubing, the valve may not be drainable.
MC-3.3.2.4 End Face Mechanical Seal General
Design Requirements
(22)
(a) General
{1} Mechanical sea! hardware used to mount the
mechanical sea) to equipment s ha ll be consistent with
nonpooling and drainability requirements of Part SD.
(2) Springs and drive mechanisms (e.g., pins) s hall
not be located in the prncess fluid.
(3) Wh en applicable, the seal should be designed in
accordance with this Standard for CJP and/or SJP.
(4) Surface requirements for the process side of the
mechanical sea! s hall be consistent with the requirements
of Part SF.
241
ASME BPE-2022
(5) Process-side hardware radii shall meet the re quirements of SD-2.4.2.
(6) Secondary seals a re used in static a nd dynamic
positions. The dynamic position in a typical mecha nical
sea) is where the seconda ry sea) is in contact with the
spring-loaded sea) face. The dynamic seco ndary sea )
accommodates motion during operation a nd face movement as the primar-y faces wear. Secondary sea) cavities
shall be located and designed so that the process side is
accessible to fluid flow and is drainable consistent with the
requirements of Part SO.
(7) Secondary sea) mate ria l s hould be selected to
minimize compression set on ali phases of operation,
which may include CIP and/or SIP.
(8) Materials of construction s hall meet Part PM for
polymers or other nonmetallics and Part MM for meta l
components. The owner/user is responsible for selection
of appropriate materials.
{9) Form 5-1. Application Data Sheet, should be filled
out with appropriate information to ma ke a correct sea)
selection.
{10) Assembly lubrica tion should be specified by the
owner / user. The owner/user should determine compat·
ibility of the lubricant with the process. The equipment
suppl ier/man ufacturer s hou ld determine the compatibility of the lubricant with the sea) components.
(3) Dual mechanical sea ls-pressurized are used
when the process fluid does not have desirable lubricating
characteristics.
(4) Dua l mecha nical seals-pressurized shall be
designed for liquid or gas barrier fluid. Dual mechanical
seals-pressurized cannot be designed for gas and liquid
lubrication.
(5) Dual gas mechanical seals- pressurized can be
contacting or noncontacting face design.
(6) A barrier fluid compatible with the process fluid
a nd a tmosphere shall be specified by the owner/user. The
owner/user s hould consult with the equipment s upplier/
ma nufacturer to determine suitability of the barrier fluid
for the dual mechanical seal- pressurized.
(7) Form 5-1, Application Data Sheet, s hould be filled
out with appropriate information to determine the appro·
priate pressure, flow rate, a nd temperature of the barrier
fluid.
( d) Dual Mechanical Seal- Unpressurized
(1) Dua l mec ha nica l seals - unp ressurize d are
preferred to prevent dilution of the process flu id by
the buffer fluid weeping across the inboard faces. The
buffer fluid will prevent a tmosphere from entering the
process fl ui d. Th e process flu id will weep into the
buffer fluid that may weep to the atmosphere.
{2) Dual mecha nical seals-unpressurized protectthe
process boundary with a n unpressurized buffer fluid.
(3) Dual mecha nical sea ls-unpressurized a re used
when the process fl uid has desirable lubricating characteristics.
(4) Dual mechanical seals-unpressurized s ha ll be
designed for liquid or gas buffer fluid. Dual mecha nical
seals- u npressurized ca nnot be designed for gas and
liquid lubrication.
(5) Dual gas mechanical seals-unpressurized can be
contacting or noncontacting face design.
(6) A buffer fluid compatible with the process fluid
a nd a tmosphere s hould be specified by the owner/user.
The owner/user s hou ld consult with the eq uipment
supplier/ma nufacturer to dete rmine s uitability of the
buffer fluid for the dual mechanical seal- unpressurized.
(7) Form 5-1, Application Data Sheet. s hould be filled
out with appropriate information to determine the appropriate pressure, flow rate, and temperature of the buffer
fluid.
(b) Single Mechan/cal Sea/
{1) Single mechan ica l seals are applied for the ir
simplicity, observable leakage path to the atmosphere,
a nd no requirement for a seal s upport system.
{2) Si ngle mecha nica l sea ls protect the process
boundary at the seal's secondary seals and at the seal's
primary face.
(3) When operating in pressurized process fluid,
single mechanical seals will weep process fluid to atmosphere. lf a process upset occurs thatcreates a te mporary
vacuum in the equipme nt, the sea) will weep atmosphere
into the process fluid.
(4) Single liquid mechanical seals are applied when
the process fluid has desirable lubricating characteristics
to s upport the rubbing of the primary sea) faces.
(•a) Fluids that have desirable lubricating characte ristics do not include fluids that change state, are in
gase ous phase, precipitate solids, and cause thin film
bond ing, congealing, solidification, or crystallization
between the seal faces.
(·b) An exampleofa possible desirable lubricantis
pure steam condensate at lOOºF (38°().
(5) Single dry contacting gas seals will operate in a
gaseous phase environment.
MC-3.4 Conformance Requirements for Sealing
Elements
MC-3.4.1 General Requirements. A Certificare of (22)
Conformance s hall be issued by the seal ma nufacture r
to certify conformance to this Standard. At a mínimum,
sea ls exposed to process contact fluids a nd/or that
have a high probability of exposure will conform to the
United States Pharmacopeia ( USP) di rective wi t h
regard to USP <87> (o r ISO 10993·5) and USP <88>
Class VI (or ISO 10993-6, ·10, and ·11) o n biological
(e) Dual Mechan/cal Seal- Pressurized
(1) Dual mechanical seals- pressurized are preferred
to preve nt process fluid from weeping to atmosphere and
to prevent atmosphere from weeping into the process.
{2) Dual mecha nical seals- pressurized protect the
process boundary with a pressurized barrier fluid.
242
ASM E BPE-2022
reactivity (see Part PM for additional details). Examples of
seals comi ng in direct contact with a process stream
include gaskets, O-rings, diaphragms, pinch tubes, a nd
valve ste m seals.
which it is exposed beyond an accep table level (see
PM-3). F'ollowing exposure to t he process conditions,
the seal shall be capable of being inspected, serviced,
a nd/or replaced. Specifi c sea l performance criteria
should be established by the owner/ user. F'orm S-1, Application Data Sheet, may be used to communicate expected
process conditions.
Any given seal is not designed to perform in ali possible
operating conditions.
Pa ra me te rs for evaluating the performa nce of a seal
include leak rate, sealing location, dimensional stability,
material stability (includingshedding), a nd serviceability.
The requirements for each of the paramete rs depend on
the seal type and application. To predict how a seal wíll
perform in service it shall be evaluated (e.g .. testing. past
performance). Standardized performance test conditions
and methods permita consistent approach to gathering
data used to evaluate seal performance. When evaluating
performance test data, the owner/user should consider if
t he test parame te rs are relevant to t he con ditions
expected in the application. Pe rformance data should
be cons idered w hen de term ining t he ap propria te
service inte rval for the desired a pplication.
MC-3.4.2 Certificate of Conformance. See PM-2.2.1.
(22)
MC-3.4.3 Test Requirements. Conformance testing is
done on initial quaiification of the hygienic un ion. Testing
is int ended to show desig n conforma nce a nd is not
required on everyseal. Testingshall be repeated for significan! changes in raw materials or processes used to fabrica te sea ls. The seal man ufac tu re r s hall p rovi de a
certificate of design conformance that the sealed union
meets the intrusion requirements of MC-4.2. The intrusion
value is defined as the measured quantity that provides
the maximum radial d istance from the fitting I.D. to the
point of maximum intrusion under the ma nufacturer's
specified conditions (e.g., torque, fitting design, clamp
design). The poi nt of maximum intrusion/recess shall
be measured using a method that does not cause deformation of the components being measured.
MC-3.4.4 Additional Requirements. [Reserved for
future content]
MC-4.2 Static Seal Performance
MC-3.5 Seal ldentification
Staticseals shall meet the general performance requirements of MC-4.1.
On initial installation, a hygienicstaticseal shall provide
a substa ntially fl ush interface with the hygienic clamp
ferrules. Hygienic seals shall meet and be designated
by one of the following intrus ion categories when
tested by the seal manufacturers:
(a) lntrusion Category l. Seals havinga maximum intru·
sion/recess of 0.025 in. (0.6 mm).
(b) lntrusion Category 11. Seals havi ng a maximum
intrusion/recess of 0.008 in. (0.2 mm).
The p urpose of a flush interface is to min imize the
e ntrapment of ma te rial in a dead space that can lead
to mic r obial growth a nd co n ta mi nat io n (see
Figure MC-4.2 -1). Excessive intrusion into the process
strea m may lea d to eros io n of e lastomeric seals,
thereby contami nating the process stream. The amount
of intrusion depends on the d ime nsional control of the
seal, the hygienic clamp ferrule dimens ions [see Table
DT-7.1-1 and Figure MC -2.2.2 -1, il lustrat io ns (a)
t hrough (c)], t he amou n t of to rq ue applied to t he
flange, the material properties of the sea). the application
of steam, and the surface of the seal (wet or dry) dur ing
installation.
Testing parameters used to ide ntify the desired performance should be based on the intended operating condit ions. Nonmandatory Appendix K identifies standard
p rocess tes t co nditions (SPTC) a nd a method for
performing testing to gather data used to evaluate the
appropriate level (e.g., 10, 100, or 500) of the seal for
t he given service life. Performance data are collected
Marking on the seal package should incl ude ali items
listed in MC-3.4.2.
Manu facturer's name a nd lot number shall be marked
on either the seal itself or the seal package containing the
seal. The lot number should enable the manufacturer to
identify the raw material and processing conditions used
to fabricare the a rticle. Manufacturers are encouraged to
mark the seal itself to avoid potential loss of traceability
and to aid in positive identification of seals after removal
from a process stream. When marking diaphragms, a ny
mar•king shall be done on those portions ofthe diaphragm
that a re not exposed beyond the sealing portion of the
housing.
MC-3.6 Other Seal Requirements
[Reserved for future content]
MC-4 SEAL PERFORMANCE REQUIREMENTS
(22)
MC-4.1 General Requirements
Sea Is form an integral part of process systems a nd maintain static a nd/or dynamic system boundarieswhile being
exposed to chemical, thermal, a nd mechanical (hydrauiic
and pneuma tic) conditions in both cyclic and continuous
modes of operation. On exposure to operating conditions,
the seal shall not swell, shed, crack, erode, or otherwise
deteriora te to an extent that it impacts the product or
process during its expected iifetime. The seal shall not
add to no r re move fro m the p rocess or pr od uct to
243
ASME BPE-2022
Figure MC-4.2-1
Typical Hygienic Clamp Union: Allowable Gasket
lntrusion
-
Appendix K requires modification to reflect a specific
use mode and intended operation of a valve seal. Form
S-1, Application Data Sheet, identifies a number of operational conditions (e.g., chemistry, temperature, pressure)
to consider when developing nonstandard performance
tests.
Nominal gasket width (compressedl
0.065 in. (1.65 mm)
MC-4.3. l.l New Valve Seal Performance. The valve (22)
ma nu facturer s hall test each valve assembly as part of the
producrion process or s hall validare the design and manufacturing process. One-hundred percent leak testi ng is not
required for validated manufacturing processes.
When EN 12266-1 is specified below, use leakage rate A
when evalua ting seat leakage performance. For control
valves, other leakage rates may be used with approval
by the owner/ user.
(a) For diaphragm valves, the following requirements
shall apply:
{1) seat leakage rates per MSS-SP-88, EN 12266-1, or
ANSI/FCI Standard 70-2, Class VI
(2) shell leakage rates per MSS-SP-88 category C or
EN 12266-1
(b) Por ball valves, the require me nts of MSS -SP-72,
MSS·SP-110, or EN 12266-1 s hall a pply.
(e) For rising stem, mix-proof, and needle valves, the
requirements of EN 12266-1 shall apply. For seat tightness, Test P12 of EN 12266-1, use the globe valve test
method.
( d) For butterfly val ves, the requirements ofMSS-SP-6 7
or EN 12266·1 s hall apply.
(e) For pinch valves, the requirements ofEN 12266·1
shall apply. For seattight ness, Test P12 ofEN 12266· 1, use
the diaphragm va lve test method.
{f) For plug valves, the requirements of EN 12266-1
shall apply.
,
I
Positive intrusion
at 10-, 100-, and/or 500-cycle intervals. The 10-cycle
interval is intended to provide data for s hort durarions
(e.g., single-use or inspect-between-use applications).
The 100- and 500-cycle inte rva ls are in te nd ed to
provide data o n t he se rvice life of t he seals (e.g.,
multiple-use app lica tio ns) tha t are not routine ly
inspected.
MC-4.3 Dynamic Seal Peñormance
(22)
MC-4.3.2 Mechanlcal Seal Performance. Mechanical
sea l performance may be cha ra cte rized by leakage
rate, service life, cleanability, particle shedding,suitability
for application, a nd heat ge neration. Acceptable val u es for
each of these characteristics may vary wide ly, so it is
strongly a dvised that the mechanical seal's various characteristics a nd the ramifications of each to the service are
understood.
Nonmandatory Appendix K, K-2.1 provides important
information about mechan ica l sea l pe rformance. lt
provides exce ptions to norma l seal performance that
are commonly found in the ind ustry. Familia rity with
these items will help the reader understand the impact
that design, install ation, a nd operation can have o n
mec h an ical seal performance. Also in c lu ded i n
No nma ndato ry Append ix K, K-2.1 are outli nes fo r
various methods of testing sea! integrity.
MC-4.3.l Valve Seal Performance. Valve seal perfor-
mance is acceptable when the seal maintains the system
boundaries and design flow characteristics for which it
was intended (e.g., static a nd/or dynamic). A valve seal
sh all operate t hro ugh the des ired ra nge of motlon
against differential pressure. lt sha ll meet the req uire me nts stated in MC -3.3.2.3. A valve sea l sha ll meet
these performance conditions following exposure to opera ting condirions in both cycl ic and continuous modes of
operation.
Performance data shall be collected a t intervals that
re flect the use mode (e.g., discrete/open/ closed or modulating), opera tion (e.g., continuous or cyclic), and intended
service life (e.g., continuous hours of exposure or number
of cycles) of the val ve sea l.
Testingparameters shall be based on the operating condi t i o ns of t h e in ten d e d appl i ca t io n.
Nonmandatory Appendix K identifies standard process
test conditions and a method for co nducting performance
tests of seals in simula ted process conditions. For valve
seal testing, the method ide ntified in Nonmandatory
MC- 4 .3.2. l New Mechanical Seal Performance . (22)
There are four key points between procurement and
operation of a new mecha nical sea l whe re t he se al
244
ASME BPE-2022
seals sha ll b e held to the original point-of-use performance requir•e ments. lt is the owner/user's responsibility
to monitor equipment for failure.
might be evaluated for performance. The four key points
are manufacturing, installation, assembly, and use.
(a) Point of Manufacture. Mechanical seal manufacturers have performance requi rements for new seals.
The manufacturer's tests s hould be accepted. lf special
performance requirements a re necessar·y, those special
requirements shall be specified.
lf the mechanical seal manufacturer a lters the design,
mate rial, or manufacturing technique of a mechanical seal
in service, it is the responsibility of the mechanical seal
manufacturer to inform ali relevant pa1"ties that changes
have occurred. Specific information may be requested
fro m t he seal manu fa ctur er to support the premise
that seal performa nce has not been a ltered.
(b) Poi11t of Sea/ lnstal/ation. The mechanical seal will
be installed in a piece of equipment An original equipment
manufacture r (OEM) will typically have its own test to
verify the performance of the mechanical seal. The test
of the OEM should be accepted. A review of the OEM
test proced ure may be requested. The OEM s hou ld
consult with its seal supplie r/manufacturer for seal
performance issues and questions.
Contractors may install a new seal in a piece of equ ip·
ment. Theseal performance test may be reviewed with the
installation contractor.
lf unique cond itions exist where special performance
requirements a re necessary, it is the customer's responsibility to specify the additional requirements. An acceptable performance test may be developed.
lf the OE Malters the des ign, materia l, or ma nufacturing
technique of a mechanical seal in service, or is informed by
the seal man ufacturer that the des ign, material, or man ufacturing technique has been altered, it is the responsibility of the OEM to inform ali re levant parties that
changes have occurred.
(e) Point of Systems Assembly. The eq uipment that
contains the seal is installed in a system. The system's
supplier/ma nufacturer will have standa rd test procedures for testing the system integrity. Th e test procedures
of the syste m's suppli er/ man u facturer shoul d be
accep ted. A revi ew of the tes t procedure may be
requested. The system assembler s hould consult with
the OEM/supplier for seal performa nce issues and ques•
tions.
If the system assembler alters th e design, material, or
manufacturing technique of a mechanical seal in service,
or is informed by the OEM that the design, material, or
manufactu ring technique has been al tered, it is t he
responsibility of the system assembler to inform ali rele•
vant parties that cha nges have occurred.
(d) Point ofUse. lt is the owner/user's responsibility to
determine if the mechanical seals meet performance re·
quirements.
MC-5 SEAL APPLICATIONS
MC-5 .1 General Considerations
This section provides guidance for selecting sealing
components for common applications. Each component
is recommended for its suitability for th e particular appli cation,and theselection reflectscurrentcommon industry
practice.
Every component has its own limited process capabil·
ities and service life for each application in which it is used.
Application characteristics s uch as size, speed, pressure,
temperature, cycles, and cycle time help define an appli·
cation envelope and will determine the s uitability of a part icu lar component. Appropriate co mponent selection
requires understanding of the application requirements
and component capabilities.
1n orderto use the component selection guidance in this
section
(a) The owne r/user shall collect the required appl ication data (e.g., Form S-1, Application Data Sheet).
(b) lf the owner/user's application data fall inside the
component's application envelope, then the guidance
provided is valid.
(e) lfthe owner/user's application data fall outside the
component's application envelope, then the own er/user
should consult with the vendor to find the appropriate
component.
Sections describing each seal type may list additional
characteristics of the system and equipment necessary to
ensure proper application of that component.
Seals shall be accessible for mainte nance.
MC-5.1.l Static Seals. Static seals used in ali appl ica- (22)
tions shall
(a) meet t h e specific des ig n re qui reme n ts of
MC-3.3.2.2.
(b) meet the operational requirements of the appl ication envelope as defined in the releva nt section of MC-5.
Static seal performance (che mica l resistance, physical
properti es, and ma in tenance considerations) va ríes
significantly with both material class (e.g., EPDM, FKM,
PTFE) and each supplier's formulation and manufacturing
choices.
Application-specific static seals selection guidance is
provided in Nonmandatory Appendix AA.
Hygienic union fitti ng deta ils (e.g., torque settings,
choice of clamping mechanism, and a lignment) significantly affect the p erforma nce and longevity of static
sealing components and should be considered (see a lso
ASME 831.3). Por examp le, overtightening of t hese
clamps may damage seals or cause excessive int rusion
(see MC-4.2).
MC-4.3.2.2 lnstalled Seals. Original point-of-use
performance requirements shall be used to dete rmine
if t he seal is suitable for co ntinu ed use. Refurbished
245
ASME BPE-2022
MC-5.3.2 Single Mechanlcal Seals for Compendlal
Water per MC-3.3.2.4(a) and MC-3.3.2.4(b)
MC-5.2 Process Systems
[Reserved for future content]
MC-5.3.2.1 Additional Application Conditions Relevant to Mechanical Seals. The fluid in contact with the
mecha nical sea! is process compendia! water du ring
operation. The corrosive component is compendia! water.
MC-5.3 Compendial Ambient/Hot-Water
(22)
Distribution Systems
The application a nd selection of sealing components a re
based on compend ia! water at temperatu res between
68ºF and 18SºF (20ºC and 8SºC) and pressures greater
than O ps ig (O bar·g) u p to 87 psig (6 ba rg). Sys tems
may be exposed to hot-water sanitization and/or intermittent steam at up to 266°F (130°().
These systems are typically constructed of meta llic
materials.
Sealing components used in compendia! water syste ms
should be selected based on requirements for long-term
seal reliability in a continuous-duty cycle.
(a) Most compendia! water systems are sanitized with
hot water (self-sanitizing). When systems are steam-sanitized, the owner/user should select a ppropriate materials/fittings based on operacional requirements.
(b) Sea Is used in systems that are periodically heated
for san itization sho uld be select ed to acco mmodate
thermal cycling.
MC-5.3.2.2 Additional Equipment Characteristics
Relevant to Mechanlcal Seals. The selections shown in
MC-5.3.2.3 and MC-5.3.2.4 apply only for equipment with
(a) shaft sizes: s2 in. (50 mm}
(b) shaft speed: O RPM to 3,600 RPM
(e) radial runout: <0.002 in. (O.OS mm} total indicator
reading (TIR}
(d) perpendicu larity of mounting flange: <0.002 in.
(O.OS mm} TIR to sha ft
(e) axial movement: <0.005 in. (0.13 mm}
MC-5.3.2.3 Materials of Construction. Materials of
construction shall co nform to Part MM an d/o r Part
PM, as appropriate.
There are two sets of conditions tha t should be considered for material selection in compendia! water dueto the
tribological characteristics of the seal face pair
(a) operating 68ºF to 160ºF (20ºC to 71 ºC), steam a t
266ºF (130ºC} and O RPM, and O ps ig to 87 ps ig (O
barg to 6 barg}
(b) operating 68ºF to 185º F (20ºC to 85°(), steam at
266º F (130ºC} a nd O RPM, and O psig to 87 ps ig (O
ba rg to 6 barg}
MC-5.3.1 Valves for Compendial Water
MC-5.3.1.1 Seals for Compendial Water. A polymer
seal material is acceptable provided that the manufacturer
rates the seal ma terial for the pressure and temperature
limits and the ma terial is compatible with the service
stated in MC-5.3.
MC-5.3.2.4 Flush Plans. Flush Plan numbers 01, 02,
03, and 11, as defined in MC-2.3.2.4, a re recommended.
Compendia! water is the sea! face lubricant.
MC-5.3.1.2 Valve Types for Compendial Water
(a) Valves shall meet the general design req uirements
of MC-3.3.2.3(a).
(b) Diaphragm valves, which have nonsliding sea Is, as
designated in MC-2.3.1.2(a) through MC-2.3.1.2(c), are
preferred.
(e) Other valve types with nonsliding seals are accept·
able [e.g.. pinch valves designated in MC-2.3.1.8; bellows
seals like those shown in Figure MC-2.3.1.2-2, illustration
(e); membrane or diaphragm seals like those shown in
Figure MC-2.3.1.2 -4, illustrations (b) and (e), Figure
MC-2.3.1.2-5, or Figure MC-2.3.1.4·1, illustration (a)).
(d} Valves with sliding seals in process contactare not
acceptable (e.g., ball, butterfly, or plug valves) unless the
design enables maintaining both sides ofthe slid ingseal in
a clean and sanitized cond ition or the valves are used in a
continuously self-sanitizing system.
(e) Valves with nonsliding a nd sliding seals are acceptable if only the nonsliding seal is in process contact (e.g ..
needle, control, or rising stem valves with 0 -ring seals).
MC-5.4 Pure Steam Distribution Systems
The application a nd selection of sealing components is
based on puresteam with pressures to 45 psig (3.1 bar), at
292ºF (145ºC) (saturated steam) in high-pressure distri·
bution areas, and 25 psig (1.7 bar). at267ºF ( 130ºC) (satu·
ra ted steam) in low-pressure distribution areas.
Seals used in service conditions beyond these limits
require special consideration.
Sealing components used in pure steam distribution
syste ms should be selected based on requ ire me nts for
long-term seal reliability in a continuous-duty cycle.
Pure steam systems should be designed to provide
access for examination a nd replacementof sealing components as many seal types used with pure steam lin es may
leak afte r the rmal cycling.
MC-5. 4.1 Static Seal Recommendations for Pure
Steam Distribution Systems. Static seals used for pure
steam a pp licat ions s ho u ld be selected (see
Nonmandatory Appendix AA) for their a bility to
(a) resist pure steam
(b) withstand continuous high temperatures
246
ASM E BPE-2022
MC-5.4.2.2 Valve Types
(e) minimize retightening
Hardware for use with static sea ls in p ure steam
syst e ms sho uld be se lecte d to acco mmo da te creep
(cold tlow} when plastic seals (e.g., PTFE or PTFE composites} are u sed.
(a) Valves shall meet the general design requirements
of MC-3.3.2.3 (a} and SD-4.2.3. Valve design and mate rials
o f co nstr ucti on shall be ra ted for t he press ure a nd
temperature ranges of the service stated in MC-5.4.
(b) Valve types with nonsliding or sliding seals are acceptab le (e.g., diaphragrn, ball. r ising ste m, steam trap,
pressure control, check. pressure relief, a nd plug valves}.
MC-5.4.2 Valves for Pure Steam Dist.ribution Systems
MC-5.4.2.1 Valve Seals. A polymeric sea! material is
acceptable provided that the manufacn,rer rates the sea!
material for the pressure and temperature limits and the
service conditions stated in MC-5.4.
MC-5.5 CIP
[Reserved for future content)
247
ASME BPE-2022
(22)
CHAPTER 6
FABRICATION, ASSEMBLY, AND ERECTION
FOR MULTIUSE
---------------------PART MJ
MATERIALS JOINING FOR MULTIUSE
(22)
(e) Duplex Stainless Stee/s. Only the duplex stainless
stee l grades lis t ed in Table MM - 2.1-1 or Tab le
MM-2.1-3 may be used for welded components, except
as permi tted in MM -5.1. The cau tions of MM-5.2.1.3
shall be considered when welding duplex stainless steels.
MJ·l PURPOSE AND SCOPE
The purpose ofthis Part is to provide requ irements for
the joi ning of metallic and po lymeric materials. This
includes joining methods, welding procedure and performance qualifications, examination, inspection, testing.
and acceptance criteria.
MJ-2 MATERIALS
MJ-2.1.2 Nickel Alloys. Only the nickel alloys Usted in
Table MM -2.1· 2 or Tab le MM-2.1 ·3 may be used for
welded components, except as permitted in MM-5.1.
MJ-2.l Base Metals
MJ-2.1.3 Copper AUoys. Only the copper alloys listed
in Table MM-2.1-4 may be used for brazed systems.
MJ-2.1.l Stainless Steels
MJ-2.1.4 Other Metals. Other metals (e.g., titan ium,
tantalum, palladium, or gold, as used in instnimentation)
may be joined, when specified by the owner/ user.
(a) Austenítíc Staínless Steels. Only the austenitic stain•
less steel grades listed in Table MM -2.1· 1 or Table
MM-2.1-3 may be used for welded components, except
as permitted in MM-5.2.1.l(a) .
Weld ends that are to be a utogenously welded (without
filler metal or consumable inserts) shall meet the requirements of MM -5.2.1.l(a).
However, a process component or tube of one of the
above al loys with a sulfur content either be low the
lower li mit or above the upper limit for sulfur in
MM-5.2.1.1 may be used in a welded connection, provided
ali of the following conditions are met:
(1) Use ofthe process componentor tube is agreed to
by the owner/user.
(2) Ali welds on thecomponentortubeare internally
inspected a nd meet the requirements of M)-8.4.
(b) Superauscenitic Scainless Sceels. Only the supera ustenitic stainless steel grades listed in Table MM-2.1-1 or
Table MM-2.1 -3 may be used for welded componentS,
exceptas permitted in MM -5.1.
The superaustenitic stainless steels are prone to the
precipitation of u ndesi rable seconda ry intermetall ic
p hases s uc h as s igma and chi. T he ca utio ns of
MM-5.2.1.2 shall be considered when welding superaustenitic stainless steels.
MJ-2.2 Filler Metals
MJ-2.2.1 Stainless Steels. When filler metals a re used,
the matching filler metals Usted in Tab les MM-5.3 -1,
MM -5.3 -2, MM -5.3 -3, and MM -5.3-5 shall be used,
except t hat h igher all oy filler meta ls may be used
when specified by the owner/ user.
Austenitic stainless steel grades may be welded with or
without filler metals. See MM-5.3 and MM-5.3.1 for further
instructions.
Superaustenitic stainless steels rnay be welded with or
without filler metals or consumable inserts. When welded
a utogenously (without filler metal orconsumable insertS),
postweld heat treatment in accordance with MM-5.4 is
req uired. See MM -5.2.1.2, MM -5.3. and MM-5.3 .2 fo r
further instructions.
Duplex stainless steels may be welded with or without
filler metals or consumable inserts. When welded autogenously, postweld hea t treatment in accordance with
MM-5.4 is required. Welding of duplex stainless steels
generally resu lts in an increase in the amoun t of
ferrite in the micr·ostrucn,re, and, as a result, appropriate
welding procedures should be selected. The balance of
a ustenite and ferrite in the weld metal shall be maintained
so that the re is no less than 30% of the lesser phase. See
248
ASME BPE-2022
MM-5.2.1.3, MM-5.3, a nd MM -5.3.2 for furthe r instructions.
Socket weld ing is not perm itted in process stream
systems or where CJP or SJP requirements are defined.
MJ-2.2.2 Nickel Alloys. When filler metals are used,
t he matching filler metals listed in Tab le MM -5.3 -4
shall be used, except that higher alloy filler metals may
be used when specified by the owner/user.
Nickel alloys may be welded with or without filler
metals. Postweld solution heat treatment is not required.
See MM-5.3 for further insrructions.
MJ-3.2 Pressure Vessels and Tanks
(22)
lntermittent welds shall not be used on process contact
surfaces on vessels and tan ks. Head and shell welds
leaving a n unwelded process contact joint shall not be
used.
See Figu res MJ-3.2-l and MJ-3.2-2 for examples of unacceptable and acceptable head-to-shell weld jointS.
MJ-2 .2.3 Copper Alloys. Brazing joi nt filler meta ls
shall conform to Table MM -5.3.4-1. Co pper-to-copper
join ts shall be b razed us ing cop per-phos pho rus or
copper-phosphorus-silver b razing filler metal (BC uP
series) without flux.
MJ-3.2.1 Pressure Vessels. Weld jointdesigns shall be (22)
those permitted by ASME BPVC. Section VIII a nd shall
conform to MJ-3.1.
MJ- 3.2.2 Tanks. Weld joi nt designs shall be t hose (22)
perm itted by the code or sta ndard of construction for
the tank and shall conform to MJ-3.1.
MJ-2.3 Nonmetallics
Joining of polymeric materials shall be performed in
accordance with MJ-9. Joining of other nonmetallic materials shall be in accordance with procedures a nd processes
recom mende d by the ma teria l ma nufacturer, and
app roved by the owner/user, using materia ls or
compounds that are ine rt to the intended service.
MJ-3.3 Piping
Weld joint designs shall be those permitted by ASME
831.3 and shall conform to MJ-3.1.
MJ-3.4 Tubing
MJ-3 JOINT DESIGN AND PREPARATION
(22) MJ-3.l General
Ali joints shall have complete fusion on process contat"t
surfaces. AJI weld joints shall have the process contact
surfaces properly purged or protected for the prevention
of discoloration or contamination. Externa! attachments
(e.g., lift lugs, dimple jackets, or ladder clips) shall have any
discoloration of the process contact surface removed.
Welds attachingany connection that passes through the
wall ofa tank or vessel, ora branch connection on a pipe or
tube system, in which one or both sides ofthe weld joint is
a process contact surface, shall either be joined with a ful!
penetration groove weld with a reinfo rcing fil let weld
[similar to Figure SD-3.4.2 -2, ill ustration (a)). or have
at least one vent hole provided if double fi llet welded
only (s imila r to Fig ure $D-3.4.2-2, illustration (b)]. A
vent hole is required on ali lap, tee, co rne r, or edge
(para llel) joi nts t hat have one we ld as a process
contact surface and are not attached by ful! penetration
welds. The vent hole shall provide a path for process !luid
or test media tlow ifthe inner weld containmentfail s. Vent
holes are not required when ali welds are on process
contact surfaces [e.g., Figure SD-3.4.3-2, illustration (c)
detail or similar]. The vent hole shall be no larger than
NPS 1/ 4 in. (6 mm) a nd may be tapped for a preliminary
compressed air a nd soapsuds test for tightness of inside
welds. These vent holes may be plugged when the vessel is
in service. The plugging mate rial used shall not be capable
of sustaining pressure between the lapped surfaces.
249
Weld joint designs for hygienic tubing and fittings shall
be square butt joints. The tubing and fittings shall have
ends prepared by machining or facing to provide a square
end that meets the requi rements of Tables DT-3-1 and
DT-3-2. The butt weld joints shall be properly cleaned
within Y2 in. (13 mm) of the joi nt area on the inside
and o uts ide s urfaces prior to welding. We ld ing on
t ubing shall be done usi ng a uto matic (or machine)
welding techniques (s uch as orbi tal tube welding or
lathe weld ing), except where size o r space will not
permit. In that case, manual welding can be performed,
but it shall be agreed to by the owner/user a nd contractor.
MJ-3 .5 Tube-Attachment Welds
(a) Tube-attachment welds are those that
(1) make branch connections other than those used
to fabricate the fittings described in Part DT
(2) attach tubes to other product forms
(3) attach nozzles to transfer panels
(4) attach a tube to any part of a hygienic system
(b) Tube -attachment welds not governed by this
section include
{1} !hose governed by MJ-8.4
{2) tube-to-tubesheet welds that a re governed by
ASME BPVC, Section VIII, in addition to the visual examination requirements of Part SF and MJ-8.2
These welds may be performed manually, by machine,
or by an automatic welding process. Joint designs shall
conform to MJ -3.1. The weld joints for complete penetration welds shall be prepared by means compatible with
hygienic service. The weld joints shall be properly cleaned
ASM.E BPE-2022
(22)
Figure MJ-3.2-1
Unacceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
Shell
Shell
Process contact surface
Process contact surface
Plug weld
Process contact surface
Shell
Process contact surface
GENERAL NOTE: This figure does not provide de.sign criteria for weld j oints. lt only depict:S examples oí unacceptable weld conl1gurations.
250
ASME BPE-2022
Figure MJ-3.2-2
Acceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
Vent hole per MJ-3.1
Process contact surface
Optional process contact surface
Process contact svrface
Optio nal process contact surface
3: 1 taper (when req vired)
Optional p rooess contact svrface
Process contact surface
GENERAL NOTES:
(a) This figure does not provtde deslgn criteria for weld joints. lt only depicts examples of acceptable weld configurations.
(b) The joint is only acceptable l f it conforms to the design criteria of the governi ng code or standard.
251
(22)
ASME BPE-2022
within 1/ 2 in. (13 mm) on the inside and outside surfaces,
where accessible, prior to welding. Fillet welds, groove
welds, ora combination of both may be used.
MJ-5.2 Piping
Welding procedures for piping systems shall be qualified in accordance with ASME 831.3.
MJ-3.6 Brazed Joints
MJ-5.3 Tubing
Joint design shall conform to the latest edition of NFPA
Welding procedures for hygienic tubing systems shaJI
be qualified in accordance with ASME 831.3, with the
following additions:
(a) A change in the type or nominal composition of the
backing (purge) gas shall require requalitlcation.
(b) lffiller metal is used, a change from one AWS classification offiller metal to another, orto a proprietary filler
metal, s hall require requalification.
This includes quali fica tion of procedures for welding of
components to Part DT but does not apply to longitudinal
welds on tubes made in accordance with a recognized
standard.
99.
MJ-4 JOINING PROCESSES AND PROCEDURES
MJ-4.1 lntroduction
Ali welds, including tack welds, s hall be made in accordance with a welding procedure qualified in accordance
with MJ -5. Ali welders and welding operators, including
those who make tack welds, shall be qualified per MJ-6.
MJ-4.2 Welds Finished After Weldlng
For press ure vessels, tanks, and pipi ng a nd t ub ing
systems where the process contact s urface of the weld
is to be finis hed after weldi ng, the welding processes
used shall be limited to the are or high-energy beam (electron beam and laser beam) processes as defined in AWS
A3.0. The owner/user a nd contractor s hall agree that the
welding process selected will provide the desired resul ts.
In addition to the welding procedure specification test
requirements of ASME BPVC, Section IX, the weld metal
and heat-affected zones from qualification test coupons of
duplex stainless steels shall meet the req uirements of
ASTM A923 Methods A a nd/or C.
MJ-4.3 Welds Used in the As-Welded Condition
MJ-5.5 Brazing
For pressure vessels, tanks, and piping and t ubing
systems where the process contact s urface of the weld
is to be used as is, weld ing processes shall be limited
to the inert· gas are processes (such as gas tungsten ·
a re we lding and p las ma are we lding) or t he high
energy beam processes (such as electron beam or laser
beam weld ing), as defined in AWS A3.0. Every effort
shall be made to use an automatic or machine welding
process. Autogenous welds, welds with filler wire, or
welds with consumable in serts are acceptable provided
they meet the req uirements for ali appl icable codes.
The owne r/user a nd contracto r shall agree t hat the
welding process selected will provide the desired resul ts.
Brazing procedures for piping systems shall be qualified
in accordance with NFPA 99.
MJ-5.4 Duplex Stainless Steels
MJ-6 PERFORMANCE QUALIFICATIONS
MJ-6 .1 Pressure Vessels and Tanks
Welder and welding operator performance qualifica·
tions for pressure vessels and tanks shall be in accordance
with ASME BPVC, Section VIII.
MJ-6.2 Piping
Welder and welding operator performance qualifications for piping systems shall be in accordance with
ASME B31.3. When the piping is to be used for hygienic
systems, the essential variables for welding operators in
MJ-6.3 shall a lso a pply.
MJ-4.4 Brazing
Joining of copper and copper alloy materials by brazing
shall be in accordance with NFPA 99. Ali brazing proce·
dures shall be qualitled per MJ-5. Ali brazers shall be qual·
ified per MJ-6.
MJ-6.3 Tublng
Welder and welding operator performance qualifications for hygienic tubing systems shaJI be in accordance
with ASME B31.3. This includes qualification of welders
and welding operntors who fabricare components in
accordance with Part DT but not those who manufacn,re
n,bes in accordance with a recognized standard.
Forthe qualification of welding operators, the following
essential variables a lso apply:
MJ-5 PROCEDURE QUALIFICATIONS
MJ-5.1 Pressure Vessels and Tanks
Welding procedures for pressure vessels and tanks
shall be qua lified in accordance with ASME 8PVC,
Section VII I.
252
ASME BPE-2022
(a) welding of a joint using an edge preparation other
than a sq uare groove.
(b) the addition or deletion of solid backing.
(e) a change in the fit-up gap from that qualified.
(d) a change in pipe/tube diameter. See Table MJ-6.3 -1.
(e) the addition or deletion of filler metal.
(f) the addition or deletion of consumable inserts.
(g) a change in the thickness of the deposited weld
metal. See Table MJ-6.3-2.
(h) the addition or deletion ofbacking gas (purge gas).
(i) a change in the current type or polarity.
O) a change in the weld head type from open head to
closed head or vice versa.
(k) a change from single-pass to multipass welding or
vice versa, when using filler wire.
In addition, e ither the original ASME BPVC, Section IX
qualification coupon oranother tube-to-tube weld coupon
made by that same welding operator shall be visually
examined and shall meet a li the r equi re ments of
Table MJ -8.4-1.
Any change in the variables listed in [a) through lk)
requires welding of a new test coupon, for which only
visual examination in accordance with Table MJ-8.4-1
is required. Conforman ce to the variables in this paragraph shall be documented.
MJ-6.4 Brazing
MJ-7.2 Personnel Requirements
MJ-7.2.1 Pressure Vessels and Tanks. Personnel
perform ing examinations of pressure vessels and tanks
designed to ASME BPVC, Section VIII s hall meet the requirements of the appropriate section of that Code.
Ali inspectors s hall be qualified in accordance with
GR-4.1.
Ali Quality lnspector's Delegatesshall meet the requirements of GR-4.2.
MJ-7.2.2 Piping. Ali examiners, inspectors, and Quality (22)
lnspector's Delegates shall bequalified in accordance with
GR-4.
MJ-7.2.3 Tubing . Ali examiners, inspe ctors, and (22)
Quality Inspector's Delegates shall be qualified in accordance with GR-4.
MJ-7.2.4 Tube Attachments. Ali exam in ers. inspec- (22)
tors, and Quality Inspector's Delegates shall be qualified
in accordance with GR-4.
MJ -7.2.S Copper Tubing/Piping . Ali examiners, (22)
inspectors, and Quality lnspector's Delegates shall be
qualified in accordance with GR-4.
MJ-7.2.6 Examination Personnel Eye Examination
Requirements. Personnel perform ing examinations (22)
shall have eye examinations as described in GR-4.2.3(d).
Brazer performance qualifications, for piping systems,
shall be in accordance with NFPA 99 and shall be made
under an interna! purge and exhibit full joint penetration.
Table MJ-6.3·1
Metalllc Tube/Plpe Dlameter Llmit s for Orbital GTAW
Performance Quallflcatlon
MJ-7 EXAMINATION, INSPECTION, ANO TESTING
Owner/user, inspection contractor, and/or engineer
shall agree to t he typ es of exami nations, inspections,
and testing unless otherwise specified in the applicable
code.
Outside Oiameter of Test
Coupon
in.
mm
s 112
Sl3
>13 to 89
>89
1
>1/2 to 3 /1
MJ-7.l Examination Procedures
>3'/2
Outside Oiameter Qualified
Maximum
Mi.nimum
in.
mm
None None
>½
>31/z
>13
>89
in.
mm
13
89
Unlimited Unlimited
'1,
3 1/1
MJ-7.1.1 Pressure Vessels and Tanks. Examination
procedures for pressure vessels and tanks shall be in
accordance with ASME 8PVC, Section VIII.
Table MJ- 6.3·2
Metallic Weld Thickness limits for Orbital GTAW
Performance Quallflcatlon
MJ-7.1.2 Plplng. Examination procedures for piping
systems s hall be in accordance with ASME 831.3.
Deposited Wel d Thickness
QualiHed
MJ-7.1.3 Tubing. Examination procedures for tubing
systems shall be in accordance with ASME B31.3.
Thickness of Test Coupon, Tw
Minimum
MJ-7.1.4 Tube Attachments. Examination procedures
In.
mm
In.
mm
for tubing systems s hall be performed in accordance with
ASME 831.3.
<½.,.
<1.5
Tw
Tw
ZTw
Y11;sts%
1.5 < t < 10
>10
½6
o/¡6
1.5
2Tw
s
Unlimited
>%
MJ-7.1.S Brazing. Examination procedures for brazed
systems s hall be in accordance with NFPA 99.
253
Maximum
ASME BPE-2022
MJ-7.3 Examination, lnspection, and Testing
Requirements
crite ria of this Part. This plan shall include borescopic or
direct visual inspection of the process contact surfaces on
a t least 20% ofthe welds in each system installed. Arepresentative sample of each welder's a nd/or welding operator's (as applicable) work shall be included. There shall
also be a plan for inspecting a representative sample of
each welder's a nd/or welding operator's (as applicable)
firstshift of production. Aprocedure shall be submitted for
inspecting blind welds. The random selection ofaccessible
welds to be inspected shall be u p to the owne r/ user's
inspector's discretion.
The examination required for conformance to ASME
831.3 may be included in the mínimum inspection per•
ce ntage, provided those exa minations we re dire ct
visual or borescopic and of the process contact surface.
(e) Testing. Leak testing of tubing systems shall be
pe rformed in accorda nce with the specified fluid
service requirements in ASME B31.3.
MJ-7.3.l Pressure Vessels and Tanks
(a) Examínation. Examinations shall be performed in
accordance with the provisions of ASME BPVC, Section
VIII. In addition, ali welds havi ng a process co ntac t
surface shall be visually examined by the fabricator.
(b) /11spectio11. In addition to the inspection required by
ASME BPVC, Section VIII, the owner/user or inspection
co ntractor shall perform inspection (s) necessary to
ensure conformance to this Sta ndard as well as a ny additional requirements of the owner/user's specification.
(e) Testing. In addition to the testing required by ASME
BPVC, Sec t io n VIII, t he owner/ use r or ins pecti on
contractor shall perform testi ng necessary to ensure
conformance to this Sta ndard as well as any additional
requirements of the owner/user's specification.
MJ-7.3.4 Tube Attachments
MJ-7.3.2 Piping
(a) Examination. Examinations shall be performed in
accordance with the provisions of the specified fluid
service in AS ME B31.3. The e xte rna ) su rfaces of ali
welds shall be visually examined.
(b) lnspection. Visual inspection shall be performed on
ali process contact surfaces affected by the a ttachment
welding.
(e) Testing. Testing shall be performed in conjunction
with the system test.
(a) Exami11atio11. Examinations shall be performed in
accorda nce with the provisions of the specified fluid
service in ASME 831.3.
(b} /11spectio11. The owner/user, inspection contractor,
and/orengineer shall agree to the mínimum percentageof
process contact welds to be selected for borescopic or
direct visual inspection, and they shall inform the installation contractor. The inspection con tractor shall submit an
inspection plan 10 ensure that welds meet the acceptance
criteria of thi s Part This plan shall incl ude borescopic or
direct visual inspect ion of the process contactsurfaces on
at least 20% of the welds in each system installed. Arepresentative sample of each welder's and/or welding opera tor's work (as applicable) shall be included.
The examination required for conforma nce to ASME
B31 .3 may be incl uded in the mínimum inspection percentage, provided t hose e xa minat io ns were d irect
visual or borescopic a nd of the process contact surface.
(e) Testing. Lea k testing of piping syste ms shall be
performed in accordance with the specifi ed fl uid
service requirements in ASME 831.3.
MJ-7.3.5 Brazlng
(a) Examination. Examinations shall be performed in
accordance with NFPA 99.
(b) lnspection. The owner / user, inspection contractor,
a nd/or engineer shall agree to the mínimum percentage of
brazed joints to be selected for direct visual inspection,
and they sha ll inform the in stallation co ntractor. The
inspection contractor shall sub mit an inspection pla n
to ensu re that jo ints meet the acceptance criteria of
th is Part. A representative samp le of each b razer's
work shall be included.
(e) Tescin9. Leak testing of copper systems sha ll be
perfor med in accorda nce with the specified flu id
service requirements in ASME B31.3.
MJ-7.3.3 Tubing
(a) éxamination. Examinations shall be performed in
accorda nce wi th the provisio ns of the specifi ed fluid
service in ASME 831.3. The externa! surfaces of ali
welds shall be visually examined.
lf ASME 831.3, High Purity Fluid Service (Chapter X), is
specified, radiographic, ultrasonic, orin-process examination is not required unless speci fied by the owner/ user.
(b) lnspection. The owner/u ser, inspection contractor,
a nd/or e ngineershall agree to the mínimum percentageof
process contact welds to be selected for borescopic or
direct visual inspection, and they shall inform the installation contractor. The inspection contractor shall submit an
inspection plan to ensure that welds meet the acceptance
MJ-7.4 Records
See GR-5.
MJ-8 ACCEPTANCE CRITERIA
MJ-8.1 General
Weldi ng for a sterile environme nt requires that the
weld shall not result in a surface tha t will contribute
to microbiological growth and contam ination of the
process íluid. The weld shall not have a ny discontinuities
254
ASME BPE-2022
such as cracks, voids, porosity, or joint rnisalignment that
will promote con tam ina tion of the process fluid. Ali
welding procedures shall be qualified to MJ-5.
MJ-8.4.l Sample Welds. Sample welds for tubing shall
meet ali the acceptance criteria of Table MJ-8.4-1. An
interna! bead wid th of 1.0 to 2.5 times the nomin al
wall thickness is required.
MJ-8.2 Pressure Vessel and Tank Welds
MJ-8.4.2 Rewelding. Rewelding (reflow) may be (22)
attempted one time only for the following defects:
(a) incomplete penetration (lack of penetration)
(b) incomplete fusion (lack of fusion)
(e) unconsumed tack welds that can be inspected on
the process contact side
{d) convexity a nd concavity
Ali rewelds shall either totally consume the original
weld or overlap t he original weld with no base metal
between the welds.
Weld acceptance criteria for pressure vessels and tanks
shall be in accordance with ASME BPVC, Section VIII, with
the additional requirernentS of Table MJ-8.2-l.
( 22)
MJ-8.3 Piping Welds
Weld acceptance criteria for piping shall be in accordance with the specified fluid service of ASME B31.3.
See SD-3.1.1 for cautionary info rm ation if usi ng pipe
instead of tube for hygienic systems.
Welding of metallic pipe and piping cornponents typically will produce weld beads or heat-affected zones with
greater levels of discoloration compared with welds made
on tube and tubing components. The additional require·
ments of Table MJ-8.3-1 shall apply.
MJ-8.5 Tube-Attachment Welds
Theacceptance criteria for tube-attachmentwelds shall
be in accordance with Table MJ-8.5-1 (see also Figure
MJ-8.5 -1).
MJ-8.4 Tubíng Welds
Weld acceptance criteria (including borescopic acceptance criteria) for t ubing and components shall be in
accorda nce w ith Tab le MJ-8.4- 1 (see also Figures
MJ-8.4-1 th rough MJ -8.4 -4). This incl udes welds on
components but not longitudinal welds on tubes manu•
factured in accordance with a recognized sta ndard.
Welds performed in the fabrication of extruded branch
outlets (such as tees) and reducers are exempt from
the misalignment criteria.
Preproduction sample welds, when required, shall be
submitted by the con tractor to t he owner/ user to establish weld quality. The owner/user, contractor, and inspection contractor shall agree to the number and type of
sample welds.
During construction, sample welds shall be made on a
regular basis to verify that the eq uipment is operating
p roperly and that the p urgi ng setup is adeq uate to
p revent d iscoloration beyond the leve! agreed on by
the owner/ user and contracto r. The owner/user a nd
co ntractor shall ag ree to the frequency of sample
welds. lt is strongly recommended that these sa mple
welds be made at the beginning of each work shi ft. whenever the purge source bottle is cha nged, a nd when the
automatic or machine welding equipment is changed
(such as when the orbital tube weld head is changed).
The sample welds described in the preceding paragraphs, and any associated we lding machine prin ted
records (e.g., welding pa ra meter printouts directly
from t he we ldi ng mac hin e or down loaded from a
weld ing mach ine), if a ny, may be dispos ed of after
written accep tance of the coupons by the owner, the
owner's representative, or the inspector.
255
MJ -8.5 .l Sample Welds. Samp le we lds a r·e not
required for tube-attachment welds or sea] welds.
MJ-8.5.2 Rewelding. Rewelding is allowed, except for
welds that are process contact surfaces, for which the
rewelding restrictions of MJ-8.4-.2 apply.
MJ-8.6 Brazed Joints
Brazed joint acceptance criteria shall be in accorclance
with NFPA 99.
MJ-9 JOINING OF POLYMERIC MATERIALS
MJ-9.1 General
Polymeric materials are described in Part PM. Ali joining
techniques may not be available for ali polymeric materials, nor a re ali methods acceptable for ali processes. The
selection of materials of construction a nd joining techniques is based on application requirem ents.
MJ-9.2 Weld Joint Desígn and Preparation
The weld surfaces to be joined shall be properly alignecl.
This may include planing orfacing ofthe components. The
weld surfaces shall be protected against adverse environmental influences, including excessive moisture, extreme
temperature conditions, excessive drafts, and contamination sources (e.g.,d irt, dust, oíl, foreign ma terial shavings).
MJ-9.2.l Tublng and Plplng. Joint designs for tubing.
piping, and fittings shall be square butt joints. Joining
surfaces shall have ends prepared by molding, cutting.
machining, or facing t o provi de a sq uar e end that
meets requirements for the a pplicable welding procedure
specification (WPS).
ASME BPE-2022
Table MJ-8.2-1
Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
(22)
Wel ds on Non-Process Contact
Surfaces
Welds on Process Contac...1: Sur faces
Welds Left in the As-
Discontinuities
Welded Condition
Prior to Postweld
Finishing
After Postweld
Fi n ishing
Wel ds Left in the
/\s-Welded
After Postweld
Condition
Finis h ing
Cracks
None
None
None
None
None
Lack of fusion
Nonc
Nonc
None
Nonc
Nonc
l ncomplctc
Nonc on proccss contact
slde; othc™risc, sec
Note (1J
Nonc on process
None on proccss contact [Notes (1) and (2)) [Notes(! ) and
side; othcrwisc, scc
(2))
Note (1J
pcnetratlon
contact slde;
otherwh;e, see
Note (1)
Porosity
None open to the surface; [Note ( 1) )
otherwise, see Note (1)
Table SF-2.2-1 for
None open to the
None open to
acceptance criteria
for pits/porosity
su1face;
otherwise, see
otherwise,
Note (1)
the surface:
see Note (1)
l nd uslons
[metallic (e.g.,
Lungsten) or
nonmetállit]
Nonc open to the surface; ¡ Note ( 1) )
otherwise, see Note (1)
None open to thc
surface; othcnYisc.
se• Note(!)
None open to the
surfacc;
otherwise. see
Note (1)
None open to
the surface;
otherw ise.
see Note (l)
Undercut
None
[Note ( 1) )
None
[Note ( 1) )
[Note (1JI
Groove weld
concavity
[Note (1)1
[ Note (1) )
Maximum of 10% of the ( Note (1))
nominal wall
thick ness of thinner
member
[Note (1))
Fillet weld
c::onvexity
'lu, in. (1.5 mm) max.
Pcr applicable design
and fabricatlon code
1
[Note(!))
Oiscolor al.ion
(heat-affected
zone and weld
bead)
Oiscoloration of light
N/A
str.tw to light bl ue color
is permitted (see
figur es MJ-8.4-2 and
MJ-8.4-3). Acceptable
discoloration levels
beyond that shall be
estáblished between the
owner/user and
contractor. Any
discoloration present
must be tightly adhering
to the surface such that
nonnal opcrations will
n()t rémOvé it. In any
case. the discolor ation
shall have no evidenceof
ntst. free iron, or
sugoring [Note (3)].
Discolor.1tion of light
Per customer
straw to light bl ue
spec-il1eation
color is permitted (see
Figures MJ-8.4-2 and
MJ-8.4-3). Acceptable
discoloration levels
hcyond that shall be
established between
the owner/user and
contTactor. Any
discoloration present
must be tighdy
adhering to the
surface such that
normal operations
will not r emove i t In
any case, the
discoloration shall
have no evidenc.e of
rust free iron, or
sugarlng tNote (3)).
Per customer
spedf1cation
Oxide lsland
Oxide islands are
N/A
permitted as long as
they aré adherent to the
surface. Reflective color
of oxMe island is not
c.ause for rejection. Alloy
tyµes are i dentified in
Tables MM-2.1·1
through MM-2.1-3.
None aHowed
Oxide lslands
permiued
Oxide islands
permitted
Reinforcement
[Note (l )I
[Note (1JJ
1
/ 32 in. (0.8 mm) ma.x.
[Note (1) )
[Note ( l ) J
Tack welds
[Note ( 1)1
N/A
[Note ( l ) )
N/A
Are strikes
None
N/A
N/A
None
None
None
256
/.3 2 In. (0.8 mm) max.
[Note(! ) )
ASME BPE-2022
Table MJ-8.2-1
Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks (Cont'd)
Welds on Non-Process Contact
Discontinuities
Welds on Process Contact Surfaces
Surfaces
Welds Le!\ in the As·
Prior to Postweld
Welded Condition
Finishing
Welds Left in the
As-Welded
After Postweld
Condition
Finishing
Alter Postweld
Finisbing
Overlap
None
None
None
None
None
Weld bcad width
N/A
N/A
N/A
N/A
N/A
Minlmum flllet
[Note (l)J
[Note (l)J
¡ Note (1))
[Note(!)]
[Note (l)J
[Note (l)J
[Note (l)J
¡ Note (1))
[Note (!)]
[Note (!)]
weld slze
Misalignmcnt
(mismatth)
NOTES:
(!) The llmíts oí ASME BPVC. Sectlon VIII shall apply.
(2) Does not apply to insulation sheathing ;md similar welds.
(3) Welds on pressure vessels or tanks that have been in service may require unique criteria.
257
ASME BPE-2022
Table MJ-8.3-1
Visual Examination Acceptance Criteria for Welds on Metallic Pipe
(22)
Wel ds on Non-Process Contact
Welds on Process Contact Surfaces
Surfaces
Wel ds Left in the
As-Welded
Condition
Alter Postweld
Welds Left in the AsWelded Condition
Prior to Postweld
After Postweld
Finishing
Finishing
Cracks
None
None
None
None
None
Lack of fuslon
Nonc
None
None
None
None
lncomplcte
penctration
Nonc
None on proccss
contact side;
otherwise, see
Note (1)
None on proccss contact
slde; othcrwlsc, scc
Note (1)
[Notes(!) and (2))
[Notes ( ! Jand (2))
í->orosity
None open to the
surface; otherwise,
see Note (1)
[Note (1))
See Table Sf-2.2-1 for
None open to the
surface;
otherwise, see
Note (1)
None open to t he
surface:
othenvise, see
Note (1)
lnclusions l metalllc
(e.g. tungsten) or
nonmétallit)
Nonc open to the
surfacc; otherwise,
soe Note ( 1)
[Note (!))
None open to thc surface; None opcl\ to tl1c
otl1erwise, see Note (1)
surface;
otherwíse, see
Note ( 1)
None open to t hc
surface;
othérWISé, Séé
Note (1J
UndérCut
NOné
[Note (1)1
None
(No1e (1 JI
[Note (1))
Concavity
!Note (!)]
[Note (1)1
(Note (!]]
(Note (IJI
(Note (!JI
F'iUet weld convexity
'/2. i n. (1.5 mm) max.
(Note (!JI
'62 in. (0.8 mm] max.
[Note (IJI
Oiscoloration (heataffected zone and
weld bead)
Oiscoloration of li,ght
straw to light blue
color is permitted.
Acccptable
di$tOIOrdtlOn levels
beyond that shall be
established beti,,veen
the owner/ user and
contractor. The color
photos in Figure
MJ-8.4· 3, PFI
Standard f.S-50, or
AWS D18.2 may be
used as a guide. Any
discoloration pr esent
must be tightly
adhe1ing to the
surfacc such that
normal Opéralions
wlll not rém()vé it. In
any case, the
di scoloration shall
have no evi dence of
rust, free ir on. or
sugaring [Note (3)).
N/ A [Note (3)1
Oiscoloration of light
Per customer
straw to light blue color
specification
is permi tted. Acceptable
discoloration levcls
beyond that shall bé
éStablishéd betweén the
owner/user and
contractor. 1'h e color
photos in Figure
MJ-8.4-3, PFI Standard
ES-50, or AWS D18.2
may be used as a guidé.
Any discoloration
present must be tightly
adhering to the surface
suc.h tltat normal
oper ations w ill not
remove lt In any case,
the discoloration shall
have noevidentéOf rust,
free i ron, or sugaring
[Note (3)].
Per customer
specification
Oxide lsland
Oxide islands are
N/ A
permitted as long as
chey are adhér ent t()
the surface. Reílective
color of oxide island is
not c.ause for
r ej ccdon. Alloy ty pes
are i demified in
Tables MM-2.1-1
through MM-2.I-3.
None aHowed
Oxide lslan ds
pérmitted
Oxide lslands
pérmitted
Reinforcement
( Note (1)]
1
/3z in. (0.8 mm) max.
[Note (1)1
(Note (!))
Oiscontinuities
acceptance criteria for
pits/porosity
(Note (1)1
258
Finishing
(Note (!JI
ASME BPE-2022
Table MJ -8.3-1
Visual Examination Acceptance Criteria for Welds on Metallic Pipe (Cont'd)
Wehls on Non-Process Contact
Welds on Process Contact Surfaces
Surfaces
Welds Left in the
Welds Left in the As-
Oiscontinuities
Tack welds
Are strikes
Welded Condition
Prior to Postweld
Finishing
Alter Postweld
As-Welded
Alter Postweld
Finishing
Condition
Finishing
Per customer
Must be fuHy consumed Must be fully
Must be fully consumed by Per customer
by final wcld bcad
consumed by final
final weld bcad
spcclficatlon
wcld bcad
None
None
None
None
speclficatlon
None
Overlap
None
None
None
None
None
Weld bead w idth
N/A
N/A
N/A
N/A
N/A
Minímum fillet weld
[Note (l JI
[Note ( 1))
[Note ( 1))
[Note (1))
[Note (1))
[Notes (1) and (4)1
[Notes (1) and (4)]
[Notes (1) and (4)1
[Notes (1) and (4)]
[Notes (1) and (4))
size
Misalignment
(mismotch)
NOTES:
(1) The limits of ASME 831 .3 shalJ apply.
(2) Does not apply to insulation sheathing and similar welds.
(3) $pedal surface preparatíon may be needed to meet the criteria. Welds on píping that has been i n service máy require unique crlteriá.
( 4) lt is rccognized that the I.D. mlsaHgnment is more rclcvant to hyglcnk design than O.O. misallgnmcnt. Howevcr, notall cormcctions facllitatc
r cady measurcmcnt oíl.O. misalignmcnt For situations w hcr c conformance to O.O. misaligmncnt criteria r csults In an l.D. mls.alignment that
could affect drainability or cleanability, see Nonmandatory Appendix e for further details.
259
ASME BPE-2022
Table MJ-8.4-1
Visual Exam ination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
(22)
Dlscontlnultles
Wel ds on Process Contact Surface.s
Welds on Non- Process Contact Surfaces
Cracks
None
None
l,ack of fusíon
None
None
lncomplete
penetration
None [see figure MJ-8.4-1, illustrati on (g)]
None [see Figure MJ-8.4-1, illustration (g)]
Porosity
Noneopen tothesurface; otherwise, see Note ('1). Jf postweld None open to the surface; otherwise, see Note (1)
finishing is performed, see Table SF·2.2-l for acceptance
crlteria for plts/poroslty.
lndusions lmetaUic
(e.g., tungsten) or
None open to thc surface; othcrwisc, sec Note (1)
¡Note (1))
Undercut
None
[Note (1)1
Concavity
10% Twmax. [see figur e MJ-8.4-1, illustration (d)]. However, 10% r. max. [see figure MJ-8.4-1, illustration (e)] over
O.O. and LO. concavity shall besuch that the wall thickness
entire circumference with up to 15% r"' permitted
is not reduced below tite minimum tltickness required in
over a maximum of 25% of the circumference
DT-3 [Note (2)],
[Note (2)1
Convexlty
10% rw max. (scc Figul'e MJ,8.4•1, illustration (f))
[Note (2))
Discoloratlon (heat•
aífected zone and
weld bead)
Dlscoloration of light straw to light blue color Is permlttcd Discoloratlon lcvel shaH be agreed on beti,veen thc
[see Figuros MJ-8.4-2 and MJ-8.4-3). Any discoloration
owner/user and contractor. Postweld conditioning
present must be tightly adhering to the suríace such chat
máy be allowed to meet discolorat'iOn requirernents
normal operations will not remove it. In any case, the
at the discretion of the owner/user [Note (3)1.
discoloration shall have no evidence of rust, free iron, or
sugaring [Note (3)).
Reinforcement
See convexity
See convexity
Tack wclds
Must be fully consurned by final weld bead [Note (4JJ
Same a.s process contact side
Are strlkes
None
(Note ( SJJ
Overlap
None
None
Weld bead wldtl1
No llmlt provided that complete joint pcnetratlon Is achievcd Jr proces.s contact suríacc cannot be examlned (such as
1.0. of a tube beyond 1.he reach of remote vision
equipment), then the non·process contact sur face
weld bead shall be straight and unifonn around die
entire weld circumference fsee Figure MJ~B.4-4,
illustration (a)]. The minimum weld bead width shall
not be lcss tltan 50% of t11c maximum weld bead
wldth ¡sec Figure MJ-8.4-4, lllustratlon (b)). The
máxi mum weld bead meander shall be 25% of the
weld bead wldth, measured as a deviation from the
weld centerUne, as defined i n figure MJ·8.4·4,
illustration [e).
nonmetallicl
0.015 In. (0.38 mm) max. (scc Figure MJ-8.4•1,
lllustradon (e)] [Note (2))
Minimum throat
N/A
N/A
Misalignment
(mismatch)
(Notes (6), (7), and
[8)]
N/A [Note (6)]
15% Tw max. [see Figure MJ-8.4-1, illustration (b) l ,
except tltat 4-in. tube may have a maximum of 0.015
in. (0.38 mm) misaHgnment on d1c O.O. and 6•ln. tubc
may have a máxi mum of 0.030 in. (0.76 mm)
misalignmenton the O.O. Figure MJ·8.4- 1, illustration
(b) does not apply to 4-in. and 6-in. tt1be [Notes (2)
and (6)].
Oxide island
Oxide islands are permitted as long as they are adherent to Oxide islands permitted
the surface. Retlective color of oxide island is not cause for
rejection. Alloy typcs are ldcntified In Tables MM-2.1· 1,
MM-2.1•2, and MM-2.1-3.
GENERAL NOTE: Jncludes all product forms (e.g., tube, fittings, castings, forgings, and bar) whose final dimensions meet Part DT requirements.
NOTES:
(1) The limits of ASME 831.3 shall apply.
(2) T"' is tite nominal wall thickness of the thinner of the two members being j oined. Weld metal shall bl end smoothly into base metal.
(3) Welds on tubing that has been i n servke rnay re<¡uire unique criteríá.
260
ASME BPE-2022
Table MJ-8.4-1
Visual Examination Acceptance Criteria for Groove Welds on MetaUic Tube-to-Tube Butt Joints (Cont'd)
NOTES: (Cont'd)
( 4) Anyweld that shows unconsumcd tack wclds on the non ...proccsscontactsurface shall be cxamincd on thc process contact surface; othcrwlsc
it is rejected l f the weld cannot be examined on the process contactsurface, rewelding per MJ-8.4.2 is not allowed, Rewelding per MJ·B.4.2 is
allowed if the weld can be examined on the process contact suríace after rewelding.
(S) Are strikes on the non- proces.s contactsurface may be removed by mechanical polishing as long as the minimum desi.gn waJJ thickness is not
compromised.
(6) Note that misalignment is controlled on the O.O. and is based on allowable O.O. dimensions and tolerances oífittings and tubing. The owner/
u ser is cautioned that this C"~m result in greater 1.0. misalignment beca use thisalso takes int() consideration thewall thk kne.ss dimenslons and
tolerantes()( fittings a nd tubing. However, there are no specified 1.0. misalignment átteptante críteria.
(7) lt is rccognlzed that the I.D. misalignment is more r clcvant to hyglcnicdesign than O.O. misalignmcnt. Howevcr, not all conncctlons fadlitatc
rcady measuremcnt ofl.O. misalignmcnt Por sltuations whcrc conformance to O.O. misalignmcnt criterla r csults In an I.D. mls.alignment that
could affect drainability or cleanability, see Nonmandatory Appendix e for furcher details.
(8) Misalignment criteria do not apply in the fabrica tion of extruded branch outlets (such as tees) and reducers.
261
ASM.E BPE-2022
Figure MJ-8.4-1
Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
(22)
15% Twmax.
(for < 4 in. (100 m m l O. D. J
1
T,.
I.D.
f i . D.
(bl Acceptable Misalignment (Mismatch)
la) Acceptable Weld Profile
-
I.D.
I.D.
(di Acceptable I.D. Concavity (Suckback)
(et Acceptable O.O. Concavity
[
0.01 5 in. (0.38 mm) max.
f
I.D.
(el Acceptable O.D. Convexity
(f) Acceptable I.D. Convexity
(g) Unacceptable lncomplete Penetration
262
ASME BPE-2022
Figure MJ-8.4-2
Discoloration Acceptance Criteria for We!ds and Heat-Affected Zones on Electropolished
UNS S31603 Tubing
Sample # l a
Sample #1b
Sample #2
Sample #3
Sample #4
Sample #5
The weld beads shown in the above photographs are the weld beads on the 1.0. of the tubing. 'rhe area for comparison i n each photograph is the
ar ea inside the red circle. Welds and heat-affected zones on electropolished UNS S31603 tubing \.\rith discoloration levels no worse titan Samples
#1 through #4 in the as-wclded condltion areacccptable. Oiscoloratlon lcvclsmorescverc than thatshown in Sample #4 are unacceptablc. Samplc
#5 shows unacceptablc dlscoloratlon lcvels for comparison. Thc uscr is caudoned that thc rolors obscl'ved duri ng direct visual examination or
borescope examination wíll be different víewtng di rectly down (90 deg) at the surface compared wí th víewing ata lower angle along the edges.
GENERAL NOTE: The uscr is cautioncd that electronic versions or photocoplcs of thcsc acceptance criteria shall not be used for cval uation of
sample or production welds since subtle differences in color can iníluence weld acceptability. Nonmandatory Appendix N explains the technique
by which d1ese acceptanre c1iteria were determined.
This figure is also available as a stand-alone document from ASME as ASME BPE-EP.
263
(22)
ASME BPE-2022
Figure MJ-8.4-3
Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished
UNS S31603 Tubing
(22)
Sample #la
Sample #lb
Sample #2
Sample #3
Sample #4
Sampte#5
Thc wcld beads shown i n the above photographs are the weld bcads oo tltc 1.0. of thc tubing. Thc ar ca for comparison in cach photogr aph is the
area lnsíde the red c-ircle. Welds and héat-aífl~cted iones on mechanically polished UNS $31603 tublng with discolorati(m levels no worse than
Samples #1 through #3 in the as-welded condition are acceptable. Oiscoloration levels more severe than t.hat s how n in Sample #3 are un•
acceptable. Samples #4 and #S show unaccept.1ble discoloration levels for comparison. The user is cautioned that the colors observed during
djrect vi sual examination or borescope examination will be different viewing directly down (90 deg) at the surface compared with viewing ata
lower angle along the edges.
GEN ERAL NOTE: The user is cautioned that electronic versions or photocopies of these acceptance criteria shall not be used for evaluation of
sample or production welds sincesubtle differences i n color can intluence weld acceptability. Nonmandatory Appendix N explains the technique
by which chese acceptance criteria w ere determíned.
Thls llgure Is also avallable as a stand-alone document from ASME as ASME BPE-MP.
264
ASME BPE-2022
Figure MJ-8.4-4
Acceptable and Unacceptable Metallic Weld Bead Width and Meander on Non- Process Contact Surfaces
of Groove Welds on Tube-to-Tube Butt Joints
Straight, uniform
wetd bead
Accep1able when narrowest
part of weld bead 2::50%
of widest pan. of weld bead
Unacceptable when narrowest
part of weld bead <50% of
widest part of weld bead
(a) Acceptable Weld Bead
lb) Acceptable and Unacceptable
Weld Bead Width Variation
50%0 50%
A=lptable
>75%
o
<25%
Unaooeptable
(e) Acceptable and Unacceptable
Weld Bead Meander
GEN ERAL NOTE: Applies only to non·proces.s contact surfaces and only if weld on proces.s contact surface cannot be examined.
265
(22)
ASME BPE-2022
Table MJ-8.5-1
Visual Examination Acceptance Criteria for MetaUic Tube-Attachment Welds
(22)
Fillet Wel ds
Groove Welds (Note (1))
Dlscontlnulttes
Welds on Process
Contact Sur faces
Welds on Non-Process
Contact Su ríaces
Welds on Process
Contact Sur faces
Wel ds on Non-Process
Contact Suríaces
Cracks
None
NOné
None
None
Lack of fusion
None
None
None
None
l ncomplete
penetration
None
None
N/A
N/A [Note (2)]
Porosity
None open to the suiface; None open to the surface;
otherwise, see Note (3). lf
otherwise, see Note {3)
postweld flnlshing Is
performcd, scc Table
SF•2.2•1 for acceptance
criteria for pits/pOnlSity.
None open to the surface: None open to the surface:
other½'lse, see Note ( 3),
othern1ise, see Note (3)
lf post\Yeld ñnishing is
performcd., see Table
SF-2.2·1 for acccptancc
criterla for pits/
porosity.
lnclusions
[metallic (e.g..
tungsten) or
nonmetalllcj
None open to the suiface
None open to the surface
None open to the surface
None open to the surface
Undercut
Nonc
[Note (3)J
None [Note (4)1. [For
autogenous lillct welds
see Figure MJ-8.5-1 ,
illustration (e)]
[Notes (3) and (5)]. [For
autogenous Hllct wclds
see Figure Mf-8.5- 1,
illustration ( el]
Concavity
10% Tw max. (see
10% Tw [see F(gure MJ-8.4-1, N/A [see figttre M)-8.5-1, N/A [see Figttre MJ-8.5-1,
f igur e MJ-8.4-1,
illustrations (e) and (d)] over
illustrations (a) and (c)l
illustrations (a) and (e))
illustrations ( e) and ( d)l,
entire circumference w ith up
[Note ( 4)]
[Note (5)]
Howevcr, O.O. and 1.0.
to 15% r w pcnnltted overa
concavity shall be such
maximum of 25% of the
that the wall thickness Is
clr<:umference [Note (6)]
n<)t reduced below the
minimum thickness
r equired in OT-3
[Note (6)1,
Convexity
10% Tw max.
0.015 in, (0.38 mm) max.
[Note (3)]
10% Tw max. ísee
Flgure MJ-8.5-1,
illustration (b)J
[Note (6)]
N/A
Discoloralion
Oíscolorati<)n of light .str aw Olscol()ration leve! shall be
(heat-affected
to light blue color is
agreed on between the
zone and weld
permitted (see
owner/user and contractor.
bead)
Figttres MJ-8,4-Z and
Postweld conditioning may
MJ-8.4-3), Any
be allowed to meet
discoloration present
dlscoloration requlrements
must be tightly adhcrlng
at the discrction of thc
to the sur face such that
owner/user [Note (7)].
normal operations 1A'iU
not remove it~In any case,
the discoloration shaU
have no evidence of rust,
free iron, or sugaring
[Note (7}].
Oiscoloration of líght
Oiscoloration level shall be
straw to light blue color
agreed on between the
is permitted (see
01Nner/user and
Figures M)-8,4-Z and
contrnctor. Postt-veld
MJ-8.4-3). Any
conditioni ng may be
discoloration prescnt
allowcd to meet
must be tlghtly adheling
dlscoloration
t0 the surface such that
requirements at thé
normal operations will
discretion of the owner/
not remove it. In any
ttser [Note (7)].
case, the discoloration
shall have noevidence of
rust. free iron. or
sugaring [Note (7}].
Oxide lsland
Oxide islands are
Oxide lslands permitted
pent1 itted as long as:
they are adherent to the
surface. Reflective color
of oxide island is not
cause for rejection. Alloy
typcs are ldentlficd In
Oxide islands are pennitted Oxide islands permlttcd
as long as they ,1re
adherent to the surface.
Reflective color of oxide
island is not cause for
rejection. Alloy types are
266
ASME BPE-2022
Table MJ-8.5-1
Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds (Cont'd)
Croove Welds [ Note (1))
Welds on Process
Contact Suríaces
Dlscontlnultles
Flllet Welds
Welds on Non-Process
Contact Surfaces
Welds on Process
Contact Suríaces
Welds on Non-Process
Contact Surfaces
Tables MM-2.1-1,
MM-2.1-2, and
MM-2.1-3.
identified in
Tables MM-2.1-1.
MM-2.1-2, and MM-2. 1-3.
Reinforcement
See convexity
Tack welds
Must be fully consumed by Must be fully consumed by final Must be fully consumed by Must be fuUy consumed by
final weld bead
final weld bead
final weld bead [Note (8)1
weld bead [Note (9)1
[Note (8)]
(Note (9)1
Are strlkcs
None
[Note (10)]
Nonc
(Note (10)1
Overlap
None
None
Nonc
Nonc
Wcld bcad wi dth N/A
N/ A
N/A
N/A
N/A
N/ A
Per d ient specification
[Note (4)]. [For
autogenous fillet welds
see Figure MJ-8.5-1,
illustration (e) )
Per dient specification
[Note (5)). [For
autogenous fillet welds
see Figure MJ-8.5-1,
illustration (el)
N/ /\ as long as other
conditions ar e met
N/ A as long as other conditions N/A
are met
Mínimum fillet
See convexity
N/A
weld size
Misalignment
(mismatchJ
N/A
N/A
GENERAL NOTE: Tube attachment welds i nclude groove welds and fillet welds in various joint configurations, such as proximity stems on
jumpers on transfer panels, transfer panel nozzles, and locator pins on spr ayballs.
NOTES:
( 1) Any weld where penetration is required ínto the joint.
(2) Penetratlon to the process contactsurfaces is neitl1cr required nor prohibitcd. Wel ds that penetra te through to the process contact surfacc
may cxhlblt l ntcrmlttent pcnetradon. Wcld penetration tl1rough to thc process contact surface shall mcct ali otlicr process contact surfacc
re-quirements of this Tabl e.
(3) The limits of ASME 831.3 shall apply.
(4) For welds designated by the owner/user as autogenous fillet welds (seal welds), there is no minimum fillet weld size or throat. Concavity
requirements are not applicable. Undercut in process oontact surfaces shall not exceed the lesser of 0.01S in. or 15% Tw and shall have a
smooth transition between weld and base metal.
(5 J For weldsdeslgnated by the owner/ userasautogenous ílllet welds (seal w elds), ther e is no míni mum fillet weld siie or throat Concavity and
undercut 1'cqulr cments are not applicable.
(6) r w is the nominal thlckncss of tl1c thi nner of the two mcmbcrs being jolned. Weld metal shall blend smootldy into base metal.
(7) Welds Oll n1be attachmcnts that have bccn in service may require unique cri teria.
(8) Rewelding per MJ-8.S.2 is allowed.
(9) Any weld showing unconsumed tack weld(s) on the non·process contactsuríacecan be rewelded per MJ·8.S.2 if the process contact surface
can be r eexamined. Otherwise, it is rejected.
(10) Arc strikes on the non·process contactsurface rnay be removed by mechanical polishing as long as the minimum design wall thick ness is not
cornpromised.
267
ASME BPE-2 022
(22)
Figure MJ-8.5-1
Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds
Nomaximum
10% Tw max.
concavity
(al Ae<:eptable Fillet
Weld Concavity
--;¡..- Undercut
Fillet size
1
Process contact surfaces: lesser o f 0.015 in. or 15% r,.
Non-process contact surfaces: accep table
Nomaximum
ooncavity
(el Ae<:eptable Autogenous
Fillet Weld
cations. Refer to the WPS or manu facturer's writte n procedures.
MJ-9.3 Jolnlng Processes and Procedures
Tube and pipe systems composed of polymeric materials a re joined by a varie ty of hea t fusio n we lding
methods, including beadless fusion, noncontact infrared
(IR) fusion, contact butt fusion, and socket fusion. Fusion
does not require solvents or glue to join material. and
nothing is added or changed chemica lly between the
two components being joined. Other joining methods
may be used whe n agreed on by t he owner/u ser.
Joining of polymeric materials shall be performed in accordance with a documented WPS that is qualified in accordance with MJ-9.4. The owner/user, co ntractor, and
ma nufacturer shall agre e that t he wel ding process
selected will provide the desired results.
MJ-9.3.3 Socket Fusion Welding. Socket fusion is not
suitable for systems requiring drainability. Socket fusion
may be acce ptab le for single-use a pplicatio ns where
a pproved by the owner/user for the intended service.
Refer to the WPS or manufacturer's written procedures.
MJ-9 .4 Procedure Qualifications
Welding procedures shall be qualified in accordance
with AWS 82.4. A WPS shall be provided for each polymeric material a nd process being used. Environmental
condition recommendations shall be included in the WPS.
MJ- 9 .5 Performance Qualifications
MJ-9.3.1 BeadlessWelding. Beadlesswelding (a mate-
rial-dependent process) shall be used where d rainability
is requi red (see Figure MJ-9.7.1-1) (reference SD-2.4.3).
Welder a nd welding opera tor performance qualificatio ns s hall be in acco rdance w ith AWS 82.4. The
quality ofpolymeric weld joints depends on the qualification of the welders and welding operators, the suitability
of the equipme nt used. environmental influences, a nd
adhe rence to the a pplicable WPS. Welders and welding
operators shall betrained a nd possess a valid qualification
certificare from the manufacture r for the process a nd
material being welded.
MJ - 9 .3 .1.1 Records. Weld equipm ent sho uld
monitor and record critica! weld parameters such as
heat, coo l time, a nd tem pe ra tu re. If the eq uipment
does not have moni toring or recording capabilit ies,
weld data shall be recorded in welding protocols or on
data carrie rs.
MJ-9.3.2 Noncontact IR and Contact Butt Fuslon
Weldlng. No ncontact infrared and contact butt fusion
a re not suitable joining processes for systems requiring
drainability. Either may beaccepta ble for single-use appli-
268
ASME BPE-2022
they shall inform the installation contractor. The inspection con tractor shall submit a n inspection plan to e nsure
that welds meet the acceptance criteria of this Part. This
plan shall include borescopic or direct visual inspection of
the process contact surfaces orvisual inspection with light
illumination of the weld cross sections on a t least 20% of
t he welds in each system installed. A representative
sample of each welder's and/or welding operator's (as
applicable) work shall be included. There shall also be
a plan for insp ecti ng a representative sample of each
welder's a nd/or welding operator's (as applicable) first
shift of production. A procedure shall be submitted for
inspecting blind welds. The random selection of accessible
welds to be inspected shall be up to the owner/user's
inspector's discretion.
The examination requi red for confor mance to ASME
B31.3 may be included in the mínimum inspection percentage, provided t hose exami nations were direct
visual or borescopic and of the process contat"t surface.
MJ-9.6 Examination, lnspection, and Testing
Examination, inspection, a nd tes ting cri teria and
methods a re d ictated by material type and join ing
method. The owner/user, inspection contractor. a nd/or
engineer shall agree to the types of examinations, inspections, a nd testing unless otherwise specified in the applicable code.
MJ-9.6.1 Examination Procedures. Written visual ex-
amination procedures shall be used.
MJ-9.6.2 Personnel Requirements
( 22)
MJ-9.6 .2.1 Personnel Qualifications. Ali examiners,
inspectors, and Quality lnspector's Delegates sha ll be
qualified in accordance with GR-4 a nd shall be trained
and possess a valid qualification certificate from the
manufat"turer for the process and material being welded.
MJ- 9.6.2.2 E.xamination Personnel Eye Examination
{ 22) Requirements. Personnel performing examinations shall
have eye examinations as described in GR-4-.2.3(d).
MJ-9.6.3 Examlnatlon, lnspectlon, and Testlng Requlrements
MJ-9.6.3.1 Examination. Exa minations s hall be
performed in accordance with the provisions of the specí·
fied fluid service in ASME B31.3.
The externa] sur faces of ali welds shall be visually examined. lf ASME 831.3, High Purity Fluid Service (Chapter X),
is specified, radiographic, ultrasonic, or in-process examination is not required unless specified by the owne r/user.
Preproduction sample welds, when required, shall be
submitted by the con tractor to the owner/ user to establish weld quali ty. The owner/user, contractor, and inspection co ntractor shall agree to the number and type of
sample welds. During construction, sample welds shall
be made on a regular basis to verify that the equi pment
is operating properly and that the setup is adequate to
prevent d iscolora tion beyond the level agreed on by
the owner/ user and contracto r. The owner/user and
contractor shall agree to the frequency of sample
welds. lt is strongly recommend ed tha t these sa mple
welds be made at the beginning of each work shift and
when changing t he welder and/or welding opera tor
(as applicable) and welding equipment.
The sample welds described in the preceding pa ragraphs, a nd a ny associated welding machi ne printed
records (e.g .. we ld ing pa ra meter printouts directly
from the we lding machin e or down loaded from a
wel ding machine), if any. may be dis posed of after
written accepta nce of the co upons by the owner. the
owne r's representative, or the inspector.
MJ-9.6.3.2 lnspection. The owner/user, inspection
co ntr ac tor, and/or e ngi neer s hall agree t o th e
mínim um percentage of process contact weld s to be
selected for borescopic or direct visual inspection, and
269
MJ-9.6.3.3 Testlng. Hydrostatic leak testing shall be
performed in accorda nce with the specified fluid service
req uirements in ASME B31.3. Hydrostatic leak testing
shall never exceed the manufactu rer's r ating of t he
system installed.
The use of pneumatic testing is not recommended on
these syste ms.
MJ-9.6.4 Records. See GR-5.
MJ-9.7 Weld Acceptance Criteria
Common visual acceptance crite ria include complete
bonding of joining surface, straight and aligned joints,
and exclusion of dirt a nd fo reign substances in t he
weld zone.
MJ- 9. 7.1 Acceptance Criteria for Beadless Welds. (22)
Weld acceptance criteria for beadless welds shall be in
accordance wit h Tab le Mf -9.7.1-1 (see also f-igure
Mf -9.7.1-1).
MJ-9.7.2 Acceptance Criteria for Nonbeadless Welds.
Acceptance criteria for nonbeadless welds in piping shall
be in accordance with AWS Gl.lOM or DVS 2202-1 .
MJ-9. 7 .3 Acceptance Criteria for Sample Welds.
Sample welds shall meet ali the acceptance criteria of
MJ -9.7.1.
MJ-9.7.4 Reweldlng. Rewelding is not allowed.
MJ-9.8 Documentation Requirements
The following documentation shall be presented to the
owner/user or their designee, as a mínimum:
(a) Welding Documentation. Welding procedure specifications (WPSs) used, their procedure q ual ification
records (PQRs). and welder performance qualifications
(W PQ s)/perfo r ma nce qua li ficatio n test records
ASME BPE-2022
(22)
Table MJ-9.7.1-1
Visual Examination Acceptance Criteria
for Polymeric Pipe Beadless Welds
(PQTRs) and/or welding operator performance qualifications (WOPQs).
(b) Weld Maps. When required by the owner/user,
weld maps ofbioprocessing components, weld inspection
logs of bioprocessing components (including type and
date of inspection), and welder and/or welding operator
identification of each weld shall be provided either on the
weld map or on the inspection log.
Fusion equipment that electronically stores welding
histories and serializes welds should be used. Welding
history shall be turned over. in printed or electronic
formar, to the owner/user on completion of work and
as part of the installation qualifica tion (IQ) process.
(e) Materíals. Ali molded fittings, molded valves, and
extruded piping shall be intrinsically identified to
provide, as a min imum, material of construction, lot
number, and date of production to ensure traceability.
Certificares of Conforman ce shall be provided for
molded/extruded components not individually labeled.
(d) Testin9 Records. Other records (e.g., pres su re test,
surface finish) shall be provided as required by the owner/
Acceptance Criter ia
Discontinuities
Cr;:icks and crevices
None (see Figure MJ-9 .7.1-1, illustratio n (b)J
Pits and pores
None [see Figure MJ-9.7.1-1, illustration (e))
Voids (microbubb}e.s)
[Note (1))
Single void diameter 10% T.,, max. or total of all
void diameters in a given cross-sectional examlnatlon 10% T..,max. [ see Figure MJ-9.7. 1• 1,
lllustratlon (d))
Flt-up and mlsmatch
[Note (2)]
10% Tw max. ísee F'igure MJ-9.7.l •l , lllustratlon
lndusions (Note (3))
Visible indusion(.s) or speck(s) unacceptable
(see Figure MJ-9.7.1 -1, illustration (f))
Oi.scoloration
Weld zone may be permittcd to have light straw
color. Oark color on the s urface or at the weld
interface is unacceprable (see Figure
MJ-9.7.1-1, lllustratlon (g))
(e)]
user.
10% T.., ma.'<. fo t 1.0. co,~cav1ty (see
Figure MJ -9.7. l •l, illustration (h)l
MJ-10 DOCUMENTATION REQUIREMENTS
The requi rements for metallic materialsa nd weld documentation are listed in GR-5. For polymeric materials, see
NOTES:
(1) Voids or micr obttbbles in the weld zone are the r esult of molten
M)-9.8.
mate1i aJshrinking as it cools, leaving small voids, usuaJJy in the
center of the wel d, due to vol ume displacement. They are not
uncommon in beadless weld ing, and their presente .-alone Is
n()t reason for rejection.
(2) Components shall be aligned to prcvcnt holdup t hat would
contaminate the pr~ess fluid. Jt is not recommended to join
components of different wall thicknesses.
(3) Slight discoloration in theweld zone is notuncommon in beadless
wel di ng.
MJ-11 PASSIVATION
Refer to SF-2.6.
270
ASM E BPE-2022
Figure MJ -9.7.1-1
Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
T
l
(Note {1)1
(Note (1))
,-_,
,-_,
~:2.§-------------)
(b) Unacceptable Crack or Crevice on 1.0. or O.O.
(al Acceptable Weld Prolile
Single void 10%
(Note (1>J~_ _ rwmax. ortotal
~
voids 10% Tw m ax.
(Note (1))
,-_,
¼----=----)
(e) Unacceptable Pits or Pores on Wetted Surfaces
(di Acceptable Voids (Microbubbles) in Melt Zone
(Note (1))
(Note 1111
w;:l,} ~
,-_,
,~,m,. m,.
(e) Acceptable Misalignment
(Note 1211
f
(1) Unacceptable Visible lnclusions
or Specks in Melt Zona
(Note (1))
,-_,
(g) Acceptable light Straw Oiscoloration
in Melt Zona
(M Acceptable lnside Diameter Concavity
NOTES:
(1) Weld examination area: melt zone (area that was supported dttring fusion).
(2) Note that misalignment is controlled on the O.O. and is based on allowable O.O. dimensions and tolerances of fi ttings and piping. The owner/
u ser is cautioned that this éán result i n greater 1.0. misalignment because thisalso takes into consideration the \•\láll thickness dimensions and
tolerances of fitti ngs and piping. However, there are no specified 1.0. misalignment acceptance criteria.
271
(22)
ASME BPE-2022
c22>
PART SF
PROCESS CONTACT SURFACE FINISHES FOR MULTIUSE
Ali examiners, inspectors, and Quality lnspector's Delegates shall be qualified in accordance with GR-4. Written
prncedures are required for ali examinations and inspections being performed. Qualification of the written examination procedure is not required.
Acceptance criteria for metallic prncess contact surface
finishes are s hown in Table SF-2.2-1.
Acceptance criteria for electropolished metallic process
contact s urface finishes shall meet require ments shown in
Tab le SP-2.2-2 in addition to t hose shown in Table
SP-2.2-1.
SF-1 PURPOSE AND SCOPE
The purpose of this Part is to provide process contact
s urface finish acceptance criteria for metallic and polymeric materials.
SF-2 METALLIC APPLICATIONS
SF-2.1 Applicable Systems
This Part shall be applica ble to ali systems designated by
the owner/use r or representative thereof.
Process contact s urface requirements shall apply to ali
accessib le and inaccessible areas of the systems that
directly or indirectly come in contact with the designated
product.
These systems shall include, but are not limited to, one
or more of the following:
(a) USP water-for-injection (WFI)
(b) USP purified water
(e) USP pure steam
(d) other product/process contact surface systems
(22)
SF-2.3.2 Direct Visual Exam ination. Direct visua l (22)
examinations should be performed with a light sou rce
having a color temperature between 5,000 K and 6,500
K. ll lumination s ho uld be at least 500 lux a t t he
surface to be examined. Personnel performing direct
visual examinations s hall meet the eye examination requi remen ts of GR-4.2.3(d) . The size, s hape, and
contour· of many process components (piping, vessels,
valves, etc.) may limit the accessibili ty of direct visual
examinations; however, dire ct vis ua l examinat io ns
should be conducted with the eye at a distance of not
more than 24 in. (600 m m) from the s urface at an
angle of not less than 30 deg.
SF-2.2 Acceptance Criteria
Acceptance crite ria for common austenitic stainless
st ee ls as per Tab le MM -2.1-1 are listed in Tab les
SP-2.2 -1 and SP-2.2 -2. Accepta n ce criteria for other
a lloys as described in Part MM may differ and should
be specified by the owner/user. Vis ua l comparison
charts or samples may be used to define acceptable
a nd unacceptable process contact surfaces.
SF-2.3.3 Remote Visual Examination. In some cases
where areas subject to exam ination are inaccessible
for direct visual examination, remote visual examination
may be used. Such examination systems shall have a resolution capability at least equivalen! to that obtainable by
direct visual examination. Remote visual examination
systems using cameras need particular attention paid
to the following specific features:
(a) The observed colors may differ significantly from
the actu al colors due to the combined electronic data
handling of camera, monitor, and software.
(b) Magnification leve! of viewed a reas or objects
should be verified. See ASTM A1015, para. 7, Calibration,
for reference.
(c) lllumination typically is self-adjusted by the camera
by changing readout time. lllumination requirements for
direct visual examinations do not apply.
SF-2.3 Examination Techniques Employed in the
Classification of Process Contact Suñace
Finishes
SF-2.3.l General. Process contact surface finish examinations shall be made by one or more of the following
methods:
(a) visual examination
(1) direct visual examination
{2) remote visual examination (e.g .. videoscopes,
borescopes)
(b) liquid penetrant testing
(e) s urface roughness meas urement device (p rofilometer)
272
ASME BPE-2022
Table SF-2.2-1
Acceptance Criteria for Metallic Process Contact Surface Finishes
Anomaly or lnd lcatlon
(22)
Acceptance Crlterla
Pits/porosity
1f diameter <0.020 in. (0.51 mm) and bottom is shi ny [Notes (1) and (2)). Pits >0.003 in. (0.08 mm) diameterare
relevant whereas pits <0.003 in. (0.08 mm) diameter are i rrelevant and acceptable.
Cluster of pits/porosity
No more than 4 relevantpits per 0.5 i n. (12.7 mm) x 0.5 in. (12.7 mm) inspectionwindow. Thecumulative total
diamcter of all rclcvant pits shaH not cxceed 0.040 i n. ( 1.02 mm).
Oents
None accepted (Note (3))
f inishing marks
lf R« max. is met
Welds
Wel ds used in the as-welded condition shall meet the re-quirements of MJ-8.
Welds finlshcd after wclding shaH be tlush Vi,rlth the base metal, and concavity and convexlty shaH meet thc
réqui rements of MJ-8. Such finlshing shall meet tñe R0 ret¡uiremenl$ of Table SF•2.4.1• 1.
Nicks
None accepted
Scratc.hes
For tubing. i f cumulative length is <12.0 in. (305 mm) per 20 ~ (6.1 m) tube length or prorated and if depth is
<0.003 In. (O.OS mm)
For fitti ngs, val ves, and other process comp-0nents, lf cumulatíve length I~ <0.25 in. (6.4 mm), depth <0.003 in.
(0.08 mm), and R0 max. IS mét
For vessels, iflength <0.50 in. (13 mm) at 0.003 in. (0.08 mm) depth and if <3 per i nspection wi ndow [Note (4)1
Surface cracks
None accepted
Surfacc lnclusions
1f Ro max. is mct
Surface resl duals
None accepted, visual inspection
Surface roughness (R11)
Seo Table SF-2.4.1-1
Weld slag
For tublng, up to 3 per 20 ft (6.1 m) Jcngth or prorated, if <75% of tl1e wldtll of the weld bead
For fittlngs, valves, vessels, and other process components, none accepted (as welded shall meet the
requi rements of M)-8 and Table MJ-8.4- 1)
Blistering
None ac:cepted
GENERAL NOTE: This table cover s surface finishes t.hat are mechanically polished or any 01.her finishing method that meets the R0 max.
NOTES:
(! J Black bottom plt of any dcptl, Is not acccptable.
(2) Pits in superaustenitic and nickel alloys may exceed this value. Acceptanre criteria for pit size should be established by the owner/user. AII
other pit criteria remain the same.
(3) For vessels, dents in the area covered by and resulting from welding dimple heat transfer j ackets ar e acceptable.
(4) An inspection window is defined asan area 4 in. x 4 in. (100 mm x 100 mm).
Table SF-2.2-2
Additional Acceptance Criteria for Electropollshed
Metallic Process Contact Surface Finishes
Anomaly or lndicaUon
SF-2.4 Surface Condition
The process con ta et s urfaces of metallic materials lis ted
in Tables MM-2.1-1 through MM- 2.1-3 shall be cleaned
prior to being placed into service. The process contact
s urfaces of stainless steels listed in Tables MM-2.1-1
and MM-2 .1-3 s ho uld b e passivated after cleaning.
Re fer to Nonmandatory Appendix E for cleaning a nd passi vating guidelines. Passivation of e lectropolished surfaces
is not required unless the process contactsurface has been
altered (e.g., welded or mechanically polished) or exposed
to externa) contamination a fte r electropolishing. Specific
passivation require me nts shall be defined in the engineering design docume nts or specifications a nd s hall
be in accordance with SF-2.6.
Acceptance Criteria
Cloudiness
Acceptable if R.o max.. is rnet
End grain effect
Acceptable i f R.i, max. is met
Fixrurc marks
Acccptablc if clcctropollshcd
Haze
Acceptable i f R..1 max.. is met
lnterrupted electropolish
Acceptable if l?a max. is met
Orangc pecl
Acccptable if R0 max. is met
Stringer indication
Acceptable lf R.., max. Is met
Weld whitening
Acceptable if ~' max. is met
Varlancc In l ustcr
Acccptable if R0 max. is met
SF-2.4.1 Surface Flnlshlng. Process contact s urfaces (22)
shall be fin ished usi ng mecha n ica l po lish in g, co ld
working, machining, or electropolishing in conformance
with applicable sections of this Part.
273
ASME BPE-2022
(22)
Table Sf-2.4.1-1
R0 Readings for Metallic Process Contact Surfaces
including procedures for c hem ical clean ing and
degreasing. passivation, and final rinse(s) shall be qualified in accordance with a written procedure and documentation package. This procedure sha ll specify the
acceptable ranges of the passivation essential variables.
Nonmandatory Appendix E has been provided as a guide
to passivation practices and eval uation of passivated
surfaces. Spo t pass ivation is permitted. The pickling
process shall not be accepted as a substitute for passivation. There is no universally accepted nondestructive test
for the presence of a passive !ayer.
For passivated process contact surfaces, the acceptance
criteria in Table SF-2.6-1 apply in addition to Tables
SF-2.2-1 and SF-2.2 -2, as applicable. Tests to ensure
the presence of a passive layer should be specified by
the owner/user.
Meohanically Polished [Note (1))
Ra Max.
Surface
Oeslgnatlon
Sf0
µi n.
µm
No Rnish requirement No finish requirement
SF1
SF2
20
O.SI
25
0.64
SF3
30
0.76
Elec.tropolished
µin.
11m
SF4
1S
0.38
SFS
SF6
20
O.SI
0.64
25
SF-2.7 Normative Referentes
GENERAL NOTES:
(a) Ali R., rcadlngs are to be In accordancc wlth ASME 846.1.
(b) All R,a readings are raken across the lay, wherever possible.
(e) No single R., reading shall exceed tite R0 max. value in this table.
(d) Other Rareadings are available, not to exceed values in this rabie.
The following standards conta in provisions that,
through reference, specify terms, definitions, and parameters for the determination of surface texture (roughness,
waviness, and primary profile) by profiling methods.
NOTE: (1) Or any other finishing method that meets the R0 max.
ASME 846.1, Surface Texture (Surface Roughness, Waviness, and Lay)
Publisher: The American Society ofMechanical Engineers
(ASME), Two Park Avenue, New York, NY 10016-5990
(www.asme.org)
Electropolished surfaces may have varia nces in luster
that are acceptable, if the surface roughness values meet
the requirements in Table SF-2.4.1-1 . Mechanical buffi ng
asa final polishing finish is unacceptable. Ali surfaces shall
be clean. Clea nliness applies to fi nished components/
equ ipment as produced and packaged by the manufacturer. Subsequent shipping, storage, handling. and installation may affect the cleanliness.
ISO 3274, Geomet rical Prod uct Specifications (GPS) Surface texture: Profile method - Nominal characteristics of contact (stylus) instruments
ISO 4287, Ceometrical Prod uct Specifications (CPS) Surface textu re: Profile method - Terms, definitions
and surface texture parameters
ISO 4288, Ceometrical Product Specifications (CPS) Surface texture: Profi le method - Rules and procedures for· the assessment of surface texture
ISO 11562, Geometrical Product Specifications (GPS) Surface texnrre: Profile method - Metrological characteristics of phase correct filters
Publisher: International Organization for Standardization
(ISO), Central Secretaria t. Chemin de Blandonnet 8, Case
Postale 401, 1214 Vernier, Ceneva, Switzer land
(www.iso.org)
SF-2.5 Electropolishing Procedure Qualification
Electropolishing service providers shall maintain and
imp lement a quality assu ra nce/control program for
the ir electropolishi ng procedures. They s hall also
quali fy their electropolishing method(s) in accordance
with a written procedure. This procedure shall specify
the acceptable ra nges of the electropolishi ng essential
variables.
Nonmandatory Appendix H has been provided as a
guide.
Flash electropolishing shall not be acceptable. Spot electropolishing shall be acceptable if it meets the requirements in this section.
SF-2.8 Rouge and Stainless Steel
Rouge is a naturally occurring phenomenon in existing
stainless steel high-purity process systems (including
wat er or p ure steam). The degree to which it forms
depends on
(a) the stainless steel material used for each component within the system
(b) how t he sys tem was fabricated (e.g., we lding,
surface finish, passivation treatment)
(22¡ SF-2.6 Passivation Procedure
Pass ivation for this Part sha ll be limited to newly
insta lled or newly modified sections of systems and
components. Flushing for construction debris or particulates s hould reference SD -2. Passivation s hall be
performed in accordance with a n approved quality assurance/contro l p rogra m. Th e passivation method(s)
274
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ASME BPE-2022
Table SF-2.6-1
Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes
Anomaly or lndlcatlon
Surface particle.s
Acceptance Crlterla
tilo parricle.s observed under visual inspectlon_, without magnificatíon, and usíng
adequate room lighting
Stains
None accepted (weld discoloration to conform to appropriate table of MJ·B)
Visible constructlon debris
None acccpted
Visible oils or organic compottnds
None accepted
Gf.Nf.RA~ NOTES:
(a) Surface C()ndition s hall meet Tables SF-2.2- 1 and SF-2.2-2, as appllcable.
(bJ Additlonal tests/acceptance crlteria may be selected from Nonmandatory Appcndlx E, Table E~S• l.
(1) direct visual examination (e.g., ill umination
through pipe/tube wall}
{2} remote visual examination (e.g., videoscopes.
borescopes)
(b) surface roughness measurement device: profilometer or other surface measurement devices
Accepta nce cr iteria of polymeric process contact
surface finishes a re shown in Table SF-3.3-1.
Visual examination shall be performed under adequate
room lighting. Additional lighting shall be used when
appropriate to illuminate blind or darkened areas and
to clarify questionable areas.
The same techniques shall be used for both examina tions and inspections.
(e) what process conditions the system is exposed to
(e.g., water purity, process chemicals, temperatures, pres·
sures, mechanical stresses, tlow velocities,and concentra·
tion of dissolved gases, such as oxygen or carbon dioxide)
(d) how the system is maintained
The presence of rouge in a system needs to be evaluated
against itS potential to affect the product, process, and
long-term operation of the system. Non ma ndatory
Appendix D provides the methods to measure rouge in
a syste m both in t he process so lution and on the
actual process contact surface. lt also suggestS various
fabrication and operation practices to minimize rouge
formation a nd methods/techniques for its remedia tion.
See the definition of rouge in GR-8.
For more info rmation, refer to the ISPE Water and
Steam Syste ms Baseline® Pharmaceutical Engineering
Guide.
SF-3.4 Surface Condition
The following surface finishes of polymeric materials
are available:
(a) piping/tubing a nd fittings
{1) as molded
{2} as extruded
(3) as machined
(4) as fabricated from mo lded, extruded, or
machined components
(b) sheet, rod, and block
(1) as molded
(2) as extruded
(3) as machined after molding or extrusion
These are generally used terms and may not be applicable in ali cases. The final criteria shall be determined by
the R0 values shown in Table SF-3.4-1.
SF-3 POLYMERIC APPLICATIONS
SF-3.1 Applicable Systems
This section shall be applicable to ali systems desig·
nated by the owner/user or representative thereof.
Process contact surface requirements shall apply to ali
accessible and inaccessible a reas of t he systems t hat
directJy or indirectly come in contact with the designated
product.
These systems shall include process systems and clean
utilities.
SF-3.2 Materials
The preferred mate rials o f construction for t hese
systems shall be as described in PM-2.
SF-3.3 Examination Techniques Employed in the
Classification of Process Contact Surface
Finishes
Process contact surface finish examinations shall be
made by one or more of the following methods:
(a) visual examination
275
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ASME BPE-2022
Table SF-3.3-1
Acceptance Criteria for Polymeric Process Contact Surface Finishes
(22)
Anomaly or lndlcatlon
Scr.11.ches
Acceptance Crtterla
For rigid tubing/piping, ifcumulatlve length is <12.0 in. (305 mm) per 20 ft (6.1 m) tube/pipe length or pn,rated
and if depth <0.003 in. (0.08 mm)
For ot11er process components, surface finish should be specified by the owner/user
Surface cracks
Nonc acceptcd
Surface i ndusions
None accepted
Sttrface roughness, R"
See Table Sf-3.4-1
GENERAL NOTE: Ali pr 0tess contact surface finishes shall be specified using the c-riteria described in SF-3.1.
(22)
Table SF-3.4-1
R0 Readings for Polymeric Process Contact Surfaces
Ra max.
Surface
Designation
SFPO
µin.
µm
No finish r equirement
No finish requir ement
SFPl
15
0.38
SFP2
25
30
0.64
0.76
40
SFP3
SFP4
SFPS
so
1.0 1
1.27
SFP6
60
1.52
GENERAL NOTES:
(a) No single Ra reading shall cxceed thc R0 max. value in this table.
(b) Othcr R. readlngs arcavailablc as spccitlcd by die suppllcr, not to
exceed values in this table.
276
ASME BPE-2022
CHAPTER 7
DESIGN FOR SINGLE-USE
PART SU
SYSTEMS DESIGN FOR SINGLE-USE
SU-1 GENERAL
SU-3.2 Common Leak Test Methods
The purpose of this Part is to define the requirements
that are applicable and unique to the use and manufacturing of single-use components a nd assemblies.
The decision to implementa leak test s hould be based
on an overall risk mitigation strategy. Nonmandatory
Appendix FF desc ribes com mo n lea k test methods
used for single-use components and assemblies. The s pecific test methods used d uríng t he li fe cycle shall be
selected based on sensitivity, suitability, and practicality
of the method.
SU-2 GENERAL GUIDELINES
Single-use components and assemblies are in tended for
ene-time use and may be referred to as disposables.
Single -use compo nen ts and assemblies are d ifferent
from multiuse components and assemblies as they are
not intended for SI P and CIP cycles. In t his Part, "campo·
nent" is defined as an individual unit, and "assembly" is
defined as the combination of two or more individual
components. This Part addresses the methods for identifying, inspecting. packaging, joining. biocompatibility, and
steril ization appl icable to single-use components a nd
assemblies.
SU-4 BIOCOMPATIBILITV
The bi ocompati bility of single- use components and
assemblies shall be considered carefully dueto the potential for large product contaet a reas and long contaet times.
Many of these components and assemblies are composed
oí multiple materia ls or multilayer structures, and the
prima ry concern is how the process interacts with the
contact s u rfaces. The design oí the component a nd
assembly shall not compromise the integrity, saíety, or
efficacy oí the process fluid. The focus of e valua tions
sho uld be o n t he mate ria l oí co nstr uctio n of the
process contact surface, but it is preferred to evaluare
the complete component a nd assembly. At a mínimum,
the process contact surface shall conform to the following
tests:
(a) biological reactivity, in vitre (cytotoxicity, i.e., USP
<87>)
(b) b io logical reactivity, in vivo (i.e., USP <88>) or
equivalent per recognized compendia
Additionally, the user should consider protein adsorption, preservative a bsorption, leaching of low-molecularweight co mpoun ds, e ndotoxins, and the presence of
animal -derived íngre dients in si ngle-use components
and assemblies.
SU-3 INTEGRITV
lntegrity of single-use components and assemblies shall
be maintained throughoutthe lifecycle ofthe product (i.e.,
packaging. s hipping. setup, assembly, and use). Acompromise in the integrity of single-use components and assemblies that may result in loss of material, microbial ingress,
or impact to operator safety should be mitigated.
SU-3.l Maintenance of lntegrity
Ma intenance of system integrity is para mount to both
bioburden control and ma in taining a sterile e nvelope.
Qualification of design, manufacturing, testing, and d istribution s hould be conducted by the suppliers ofsingle-use
components and assemblies. Leak-detection tests should
be conducted, commens urate with the leve) of risk for the
intended use of the single-use component or assembly.
Monitoring throughout the product life cycle should be
performed to delive r re liability of performance. The
owner/ user shall ensure that single-use compone nt or
assembly system integrity is appropriately considered
during design and maintained during installation a nd use.
SU-5 EXTRACTABLES AND LEACHABLES
SU-5.1 General
Testing of process e quipment/components made of
polyme ric materia ls for extractables and leachables
should be done to identify ch emica l s ubs tances t hat
277
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ASME BPE-2022
could migrate into the process fluid, potentially affecting
the process or altering the final product. Some examples of
chemical substances identified in this testing include
oligomers, monomers, curing (cross-linking) agents, catalysts, antioxidants, initiators, dyes, pigments, plasticizers,
and mold release agents. The data generated may be used
to make risk-based decisions of the potential impact tha t
any identified substances may have on the final drug
prod uct a nd may a id in the selection of equ ipment/
components. PM -3.2 provides information on extractables
a nd leachables from polymeric materials. Nonmandatory
Appendix P, P-4 provides a n overview of bioprocessing
equipment/component evaluation re lated to extractables
a nd leachables characte riza tions.
SU-8.1 lnspectlon
Single-use co mpo nents a nd asse mb lies s hall be
in spected for t he prese nce of particulates or othe r
contaminants before primary packaging. This inspection
shall take place in a controlled enviromnent in accorda nce
with the inte nded use of the final componen! or assembly.
SU-8.2 Packaging
The purpose of packaging of single-use components a nd
assembl ies is to control the poten tial introduction of
bio burden, particulates, or othe r contami na nts. The
packag ing s hall not adu lte rate th e compo ne nt and
assemb ly. Primary packa gin g shall take place in a
controlled environment ata level s uitable for the fina l
use of t he co mponen! or assembly. The packaging of
single-use components and assemblies shall be labeled
accord ing to SU-6.l.
SU-6 IDENTIFICATION
Single-use components a nd assem blies shall be
designed and packaged to provide lot traceability. The
traceability s hall enable t he owner/use r to identify
raw materia ls, processing conditions critica! to support
the manufactu rer's specifícations, a nd the date of manufacture.
SU-9 STERILIZATION (BIOBURDEN CONTROL)
Single-use assemblies and components shall be compatible with the intended sterilization method. Common
sterilization methods include autoclaving and ga mma
irradiation . Autoclaving is generally performed by the
owner/user. Gamma irra dia tion is generally contracted
to a third party by the ma nufacture r. The owner/user
shall determine the appropriate method a nd leve! of documentation required for the given application.
SU-6.l Labeling
The primary packaging of single-use components a nd
assemblies shall be labeled with th e following information:
(a) manufacturer
(b) part identifier
(e) lot identifier
Additional information for the label may be requested
by the owner/user.
SU-9.1 Gamma lrradlation
Single-use assemblies that will be gamma irrad iated
s hall be manufactured in a contro lle d e nvironment.
The maximum recommended gamma irradiation dose
should be speci fied by the ma nufacturer of the singleuse assemb ly or component. When esta blis h in g a
maximum dose, the manufacturer should cons ider the
effects on p hys ical a nd mechan ical properties (e.g.,
appearance, tensile strength) a nd chemical characteristics
ofthe materials used (e.g., leachable/extractable effects).
The supplier s hall provide lot-specific certification of
processing to the owner/user. The degrees ofvalidation
are the following:
(a) validated sterility assurance leve! pera recognized
standard (e.g., ISO 11137).
(b) gamma irradiated to the specified dose range. No
validation of the effectiveness is conducted.
SU-7 CERTIFICATE OF CONFORMANCE
The single-use componen! or assembly manufacturer
shall issue a Certificate of Conformance that contains
the following information:
(a) manufacturer
(b) part ide ntifier
(e) lot identifier
(d) date of manufacture and/or expiration date
(e) conformance information
Additional information for the Certi ficate of Conformance may be requested by the own er/user.
SU-8 INSPECTION AND PACKAGING
SU-10 SHELF LIFE, STORAGE, ANO EXPIRATION
DATE
The packaging of single -use compone nts a nd assemblies shall mitigate the risk of bioburden, pa rticulates,
or other conta minants (see SU-10 a nd Nonmandatory
Appendix P. P-2). lnspection shall be performed to
confirm the qua lity of the packaging a nd that th e conte nts
meet the specified criteria.
The s helf life of a single-use component or assembly is
the duration under specified storage cond itions from the
date of manufacture to the last date the product can be
placed in service and remain suitable for its in tended use.
The expiration date is the date after which the s helflife has
been exceeded. The ma nufacture,· shall, on request,
278
ASME BPE-2022
provide the methodology used to determine shelf life or
expiration date such as aging tests, stability tests, or other
industry standa rds.
(a) Nonsterilized Components and Assemblies. The
manufacn,rershall provide an expiration date (preferred)
or the manufacturing date and shelf life. plus storage requirements and any special ha ndling requirements. Shelf
life shall be based on raw material, component, a nd/or
assembly data.
(b) Sterilized Components and Assemblies. The manufacturer shall provide expiration dates, storage requirements, and any special handling requireme nts. Shelf life
shall be based on raw ma te ri al, compo ne nt an d/or
assembly data, ste rilization method, and package integrity. Package integrity testing shall be performed per a
relevan! standard (e.g., ISO 11607). See SU-8.2.
SU-11.3 Mitigation Techniques
The materials, design, manufacturing operations, envi ronment. and product use should be conside red for their
impact on particulate generation and control. The level of
observation a nd particula te control should beappropriate
for the degree of risk for the particular application (e.g.,
fill/finish).
SU-11 PARTICULATES
Single-use componentsa nd assembliesshould be free of
loose, nonembedded, and solid particulates as seen by
direct visual observation without magnification. Particulates greater tha n or equal to 100 µm are considered to be
visible. The TAPPI Size Estimation Cha rt may be used for
reference. Particulatessmaller tha n 100 µm,considered to
be subvisible, should be minimized.
SU-11.l General
Particulates may unintentionally be present on surfaces
ofthe single-usearticleand may impactthe manufacturing
process or product. Particulate sources include machines,
materials, methods, e nvironment, and people. More infor·
mation and characteristics ofparticulates may be found in
Nonmandatory Appendix O, 0 -2.
SU-11.2 Particulate-Monitoring Program
The supplier shall have a n established risk-based partí·
culate-monitoring program. The program should include
testing, trending analysis, particulate characterization,
and analysis of particulate quantity a nd size.
279
SU-11 .3.l Suppliers . Supp liers shall imp lement
controls to ensure their single-use products meet estab·
lished particulate criteria. Typical controls include the
following:
(a) proper use and ma intenance of manufacturing
equipment
(b) use of controlled environments for the manufactu ring a nd assembly process such as a classified clean
room or clea n zone
(e) appropriate packaging; see SU-8
(d) training of manufacniring personnel on particulate
control practices
(e) product inspection and documentation of batch
records
(fl establishment of a particulate investigation process
SU-11.3.2 Owner/User. Owner/users should imple ·
ment controls to ensure their use of single-use products
meets established particulate criteria. Typical controls
include the following:
(a) procedures to determ ine riskassociated with partí·
culate matter
(b) supplier quali ty agreements
(e) required incoming inspection documentation
{d) training ofpersonnel in best practices for the ha ndling a nd use of single-use products
(e) establishmentofa parriculate investigation process
ASME BPE-2022
(22)
CHAPTER 8
PROCESS COMPONENTS FOR SINGLE-USE
PART se
COMPONENTS FOR SINGLE-USE
(4) product flow path cleanliness (particu lates,
endotoxins, bioburden}
(5) flow rates
(d) define the gender of the connector halves
(1) unique male and female halves
(2) genderless, where each half is identical
(e) define whether the connection is designed for one·
time connection or multiple connections
(1) Connectors designed for a one-time connection
shall incorporate an irreversible locking mechanism,
unless it is specifically designed for aseptic disconnect.
(2) Connett ors designed for multiple connections
and disconnections shall have the maximum number of
con nections specified.
(fJ provide assembly instructions to ensure proper
connection
SC-1 STEAM-THROUGH ANO STEAM-TO
CONNECTORS
Steam-through and steam-to connectors are designed
to connect single-use systems to multiuse (metallic)
systems. Steam -through and steam· to connections shall
(a) forma hygienic clamp un ion, meeting the requirements of PartS DT and MC
(b) maintain a seal (see MC-4)
(e) be drainable (see Part SD)
{d) be sterilizable (see SU-9)
(e) be compatible wit h SIP, poststerilization (e.g.,
gamma irradiation) at 266º F (130ºC) for l hr (exposed
surfaces)
(/) meet the biocompatibility requirements of PM-3.1
(9) meet the Certificate of Conformance req uirements
oí Table PM-2.2.1-1.
SC-2.2 Owner/User Responsibilities
SC-2 ASEPTIC CONNECTORS
The owner/user should
(a) review the manufacturer's specifications against
the service requirements for ali applicable process and
sterilization conditions
(b) ensure the connection will be performed to a qual·
ified procedure by a properly trained operator to maintain
system integrity
Aseptic connectors allow single-use assemblies to be
joined wh ile maintaining a sterile process contac t
surface before. during. a nd after connection, without
regard to the manufacturing environment.
SC-2.l Manufacturer Responsibillties
The manufacturer shall
(a) conduct microbial ingress testi ng to qualify that a
sterile fluid path postconnection is not compromised
(b) define whether the connectors are dry connectors
or wet connectors
{1) Dry means liqu id cannot be in the connector.
Pinch clamps or another suitable technique must be
used to isolate the liquid from the connector prior to use.
(2) Wet means the connection can be made with
liquid in the connector.
(e) provide product specifications including, but not
limited to, the following:
(1) temperature ratings
(2J pressure ratings
(3) sterilization method compatibility (e.g., gamma,
autoclave}
SC-3 FLEXIBLE BIOPROCESS CONTAINERS (BAGS)
Flexible bioprocessing containers, also referred to as
single-use bags, are avai lable in 2D or 3D format, in
different configu rations and volume capacities. These
bags are used in assembl ies for preparation, storage,
sampling, transfer, and transport of biopl'Ocess fluids
or powders. The bags have connection portS and are
used in conjunction with tubing or tubing manifolds to
a llow for filling, dispensing, samp li ng, and other
process functions. Th is section provides requirements
on materials of construction and qualification.
280
ASME BPE-2022
SC-3.1 Materials
Multilayer films are often used to manufacn,re singleuse bags. The manufacturershould identify the material of
construction of ali film a nd tie layers of the bag. For bags
intended for process con ta et, the manufacturer shall identify ali materials (e.g., primary materials, tie layers, and
additives) that have the potential to adulterare the bag
conte nts.
SC-3.2 Qualifications
The ma nufactu rer shall provide the operating temperature a nd pressure limits ofthe single-use bag. The ma nufactu rer shall specify appropriate sterilization methods,
281
including range of exposure, poststerilization shelf life,
a nd o the r lim itatio ns. T he manufac tu rer s hould
p rovide handling and sa fe use proced ures, includi ng
ha nging restrictions, fill ing limitations, a nd secondary
containment recommendations.
SC-4 POLYMERIC HYGIENIC UNIONS
See PM -4.4.
ASME BPE-2022
(22)
CHAPTER 9
FABRICATION, ASSEMBLY, AND ERECTION
FOR SINGLE-USE
PART SJ
JOINING METHODS FOR SINGLE-USE
SJ-1 GENERAL
SJ-2.3 Qualification
The joini ng of components may be performed in many
ways forsingle-useapplications. Examples ofthesejoining
techniques include, but a re not limited to, welding, heat
sealing, over-molding, solven t bond ing, mechan ical
connect ions , and adhesives. With any of t hese
methods, the procedure for the joini ng of polymers,
components, or assemb lies shall be controlled to
ensure repeatable results. The joint shall not leak, shall
meet the pressure requirements for the intended use,
and shall maintain the integrity of the componen t or
assembly.
Single-use hose barb connections shall be qualified by
the supplier to ensure they meet performance criteria as
stated in their specification. The suppli er shall have a n
established testing program to substantia te performance
of the mechanical connection. The testing should r·eference at least one of the following:
(a) Pressure Testing. Reference ASTM D1599, ISO 1402
(b) leak Testing
(1) Pneumatic. Reference ASTM ES15
(2) Vacuum. Reference ASTM D4991
(3) Hydraulic. Reference ASTM 1003
(e) Tracer Gas Testing. Reference ASTM E499
SJ-2 MECHANICAL HOSE BARB CONNECTIONS
SJ-3 THERMAL WELDING OF THERMOPLASTIC
ELASTOMER TUBING
This section applies to the mechanical joining of singleuse assemblies using a hose barb, flexible tubing, and a
retention device, commonly referred to as a hose barb
connection. Flexible hose assemblies intended for
repeated use are addressed in PM-4.3.2 a nd SD-3.2.
Refer to No nmandatory Append ix GG, Single-Use
Mechanical Hose Barb Design Recommendations, foraddi·
tional design considerations.
Thermoplastic elastomer (TPE} tubing is used as part of
single-use assemblies when there is a need to join or separa te the assembly from the single-use system or othe r
process equipment without the use of mechanical fittings.
Weld ing of rigid thermoplastic tubing and piping is
add ressed in MJ-9.
SJ-2.1 Operating Conditions
SJ-3.1 Specifications
The owner/user should define the operating temperature range, operating pressure range, and sterilization
method (if applicable} for the inte nded use of the hose
barb connection.
Thermal welding shall be performed using the proce·
dure provided by the welding equipment manufacturer.
Tubing material, d imensions (e.g., inner and outer
diameters), and tubing preweld ing sterilization shall be
compatible with the capabilities of the welding equip·
ment.
SJ-2.2 Assembly
Manual assembly of single-use hose barb connections
shall follow documented standard operating procedures.
Assembly equipment (e.g., tubing stretchers, fitting inserters, reten tion devices, and applica tion tools) shall be
maintained in a state of calibration. Fluids used to aid
in the insertion of a hose barb into flexible tubing shall
be identified by chemical type and meet the requirements
of PM-2.1.
SJ-3.2 Design Parameters
TPE tube welding equipment for closed processing shall
be designed to
(a) fuse two integral tubingassemblies and maintain an
aseptic flow path during the welding process to form one
closed system
282
ASM E BPE-2022
(b) maintain the flow and pressure characteristics of
the assembly after fusing
SJ-3.3 Acceptance Criteria
The weld shall be evaluated to confirm it is leak free and
meets the owner/ user's acceptance criteria. Acceptance
criteria may include
283
(a) tolerance requirements for nibe-to-nibe alignment
(b) presence of bubbles, gaps, contaminants or foreign
material, and interna! flash or occlusion of tubing lumen
ASM.E BPE-2022
MANDATORY APPENDIX 1
SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING
c22>
EQUIPMENT (BPE) COMMITTEE
DELETED
284
ASME BPE-2022
MANDATORY APPENDIX 11
STANDARD UNITS
See Table 11 -1.
Table 11-1
Standard Units
Quantity
U.S. Customary
SI Units
i,ength
i,ength
inches {in.)
feet (ft)
Area
square i nchcs (in.2)
Volume
Volume
cubic inches (in.3)
galions (gal)
Prcssure, gaugc
pounds pcr ln.2 (psi,,)
f>ressure, absolute
pounds per in. z (psi~)
Vacuum
pounds per in. 2 (psi)
Temperaturc
degrces F'ahr cnhelt (ºPJ
Angle (plano anglo)
degrees or 1,:1dians
degrees Celslus [°C)
degrees or radians
Surface finish
microinch (µin.)
mkron or micrometer hm1)
Slope
Flow rate, liquid
F'low rate, gas
lnchcs pcr root (ln./Ft)
gallons per minute (galjmin)
std. cubic feet per hour (std. ft"/hr)
millimctcrs/mctcr {mm/m)
liter:s per minute (l./min)
std. liters per minute (std. L/min)
Speed/velodty
Fcct per second (Ft/scc)
metcrs per sccond (m/s)
CoefJkient of thermal expansíon
inth per inch per degree
[in./(in.f°F)J
mllllmeters per millímeter per de-gree
[mm/(mmrCJJ
millimeters (mm)
meters (m)
squarc ccntimeters (cm2)
cubic centimeters (cm3)
liters (L)
285
kllopascal (kPa,J
kilopascal (kPa,.)
kilopascal (kPa)
ASME BPE-2022
(22)
MANDATORY APPENDIX 111
SINGLE-USE COMPONENTS AND ASSEMBLIES
The information formerly in this Appendix has been
r·evised and relocated to Parts SU, SC, and SJ.
286
ASME BPE-2022
MANDATORY APPENDIX IV
NOMENCLATURE
Unlts (Note(!))
A
u.s.
Oeflnition
Symbol
Oistance of the annu.lar space
Reforcnce
SI
in.
mm
Outside diameter of t.ube
or pipe
in.
mm
Diamcter
in.
mm
(22)
Paragraph/ App.
Table/ Figure
Figure S0-3.4.3-1
between the O.O. of a dip
tube or shaft and the i.O. of
a nozzle neck
D
SD-3.9.2.1
SD-3.9.2.2
lnside diameter
in.
mm
LO. of the excension or leg of
in.
mm
SD-3.1.2.2
Nomi nal dimension of a valve
or instrument
in.
mm
SD-3.1.2.2
d.-
lD. of instrument sensor
measuring tube
in.
mm
Figure Pl -4.1.3.3-1
ds
1.0. of i nstrument sensor
proccss connection
in.
mm
Figure Pl -,tl.3.3-1
H
Height
in,
mm
Figure S0-4.1.2.2-1
l
l.ength
In., ít
mm, m
d
Figure SD-4.1.2.2-1
tubi ng or fitti ng
PM-4.2.3
Table SD-3.1.2.2-1
S0-3.1.2.2
Table S0-3.1.2.2- 2
Figure SD-3.3.2.2-4
Figure SD-3.4.2-1
Figure S0-3.4.2-4
Í.m fl\
Mínimum length or distance
In.
mm
Figure Pl -9.1.3.4-1
Figure Pl-9.1.3.4-2
L/A
Ratio of thc 1102.zle neck
length divíded by the
distance of the
annular space betiA•een
the O.D. of o dip tube
or shaft and the 1.0 .
of a nozzle- neck
SD-3.4.3
S0-3.5.1
287
Figure SD-3.4.3•l
Equatlon
ASME BPE-2022
Reference.
Units (Note ( 1) )
u.s.
Definition
Symbol
l/d
SI
Paragraph/ App.
Dead Jeg determlnation
Table/ Figure
SD-3.1.2.2
T able SD-3.1.2.2· 1
SD-3.3.2.2
Table SD-3.1.2.2-2
SD-3.4.Z
Figure SD-3.1.Z.Z·l
SD-3.7.3
Figure SD -3.3.2.2•4
SD-3.7.4
Figure SD-3.4.2-1
SD-3.15
Figure SD-3.4.2-4
Equation
SD-4.1.2.2
SD-6.1.4.2
S0-6.1.5.1
SD-6.3.S.2.l
Q
Flow raté
Qi
L.eak rate
R
Radius
gprn
1pm
mbar-L/s
in.
SD-5.6.7
eq. (1)
T able DT-4.S.1·1
mm
T able DT -4.5.2-1
Figure Pl-8.1.3.4-1
Ra
Roughness average
~1in..
¡,m
SD-4.1.Z.2
T able SF·Z.Z·l
SF-3.4
T able SF-2.2·2
Nonmand. App. N
Table Sf-2.4.1-1
T able SF-3.3-1
T able SF-3.4•1
Si
Sensitive length
in.
mm
T
Temperature
ºF
·e
Time
sec. min
S, min
Tangent length
in.
mm
Ti
figure Pl-7.3.5-1
PM-4.2.3
OT -4.1
Table DT-3-1
T able DT-4.1-1
Tw
Nominal wall thickness
In.
mm
T able MJ-6.3-2
Table MJ-8.4-1
Figure MJ-8.4-1
T able MJ-8.S•l
Figure MJ-8.5-1
Figure MJ-9.7.1-1
V
Volume
w
Wavelength
a
Coefficient of thermal
expansion
Primary angle
L
SD•S.6.7
nm
Nonmand. App. M•3
in./in./°F
mm/
mm/°C
PM-4.2.3
deg
deg
gal
eq. (1)
eq. (2)
eq. (3)
Figure Pl-2.2.2- 1
G6NBRAL NOTE: For refer ence to this Mandatory Appendix, see GR-8.
NOTE: (l) Useofthe specific units of measure are not required by this Standard, However, while the units of measure are not required theyarean
essential element with regard to the e-quations represented in this Standard.
288
ASME BPE-2022
NONMANDATORY APPENDIX A
COMMENTARY: SLAG AND OXIDE ISLANDS
(a) lnert-gas sh ie lded welding processes do not
produce slag. See GR-8 and AWS A3.0 for definition of slag.
(b) Welds on sta inless steel tubing can produce a thin
film that appears as localized islands on the surface of the
weld. In welds on nickel a lloys, stainless steels, or welds
alloyed with nicke l filler me ta ls, these films have been
identified as high-melting-point nonmetallic oxides, typically referred to as oxide islands.
(e) Oxide islands encountered on welds in stainless
steels and nickel a lloys identified in Tab les MM -2.1-1
through MM -2.1-3 are commonly found in one of the
following forms:
(1) On stainless steels, a small, round, black spot at
the termination ofthe weld bead, on the outside or inside
surface, or both. Th is spot is generally unavoidable.
(2) On products made from castor wrought stainless
steels and nickel alloys, a thin film, gray or the same color
as the weld surface, may be evident because it covers the
weld ripples.
(3) On nickel a lloys or stainless steels welded with
nickel a lloy fillers, a thin film, having varying color with
tints from gray to dark brown, may be evident because it
covers the weld ripples.
(d) Slag in or on welds may be the result of faulty weld
preparation, such as contamination, poor cleaning. or
faulty tack welding procedures.
(e) Slag may also result from melting base metals of
certain compositions that include e lements not normally
reported on Mat e rial Test Reports. Th ese elements
incl ude, b ut are not limited to, a lu minum, calcium,
cerium, and zirconium.
(j) The owner/user and contractor should investigate
the origin of any slag found during weld examination,
determine its acceptability, and agree on any corrective
action.
289
ASME BPE-2022
NONMANDATORY APPENDIX B
MATERIAL AND WELD EXAMINATION/INSPECTION
DOCUMENTATION
See Forms MEL· l , MER· l. and WEL· l beginning on next
page.
290
BPE
Form MEL-1 Material Examination Log
Projecl Number/Name:
Fro m (Supplier o r Manufacturar):._____________________
A/E Project Number: _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ __
D.ateReceived: _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __
Reoeived by(Co mpany): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Person Receiving M aterial (Primed): ___________________
Staged Locatio n of Material:
Person Receiving M aterial (Signature):
U st only material received from a single source,
Mlll crial Of
Ma,,u111e1u1t11
All,)of
S.,~le
De8C1i"'i0n
Heat No.
Ot Lol No.
w_,
o.o.
ThieWH
To1e,11nce
S...-1110$
••
Vh1ua1
I N01el1ll
Pt odutt M111king
MTRs
[Nace {2)1
vemiea
Ouanihv
Reoeiw:IO
Ou11.-ilv
E"-'llni,,ed
Olv. Aoc.uit
bominer's
011te
NCR
Q lv. fte¡,,,CI
lilitials
E.ocatnor'lf:IO
Nulnbel
-------
~
N
....
'°
1;;
3:
"''".,,
'"o
;.,
Comments:___________________________________________________________________
GENERAL NOTES:
la) "A" or Acc, in<1ic~1os a col'lformc'lnce with lhO applie3ble scctions of Pan OT.
(b>"R" or Rej , indicate5 a nonconformance with the applicable sections of Part OT,
NOTES:
11) Por applieable scctions of P3rt SF.
12) Mtukings vorificd to be in acoordanco with OT-1 1.
O Attachments: (
Copies: O Owner
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) Pages
□ AJE
Approving Superviso r: ______________________________
O Co ntractors
D co nsulianis
o
O
Page _
of_
o
D.ate: _ _ _ _ _ _ __
o
o
0 File
Form MEL·l
N
N
ASM.E BPE-2022
BPE
Form MER-1 Material Examination Record
Project Number/Name:______________
Record Numb8r: _ _ _ _ _ _ _ _ __
A/E Project Number: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Recoived by: _______________
Owner/1Jser: __________________
Date Reooived:______
Name and Oate of Approval: _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Customer Company Name:
/Enter the name of the company rec.eiving the material.)
A ddress:
(Entqr th9 address of the company receiving the mat8riaf.J
Contact Names ,and Numbers:
/Entcr the namcfsJ ond conwcr inlom'lbtion of por$onnel roc1:iviftfJ tho m.ttcrial,/
Supplier/Manufacturer Name:
(lf receiving a product or material, enter the name of the company supplying the material.J
A ddress:
(lf roct,iving a productor matori-,/, ente, the Dddress ol thc compMy suppJying thc mDteriat,J
Contact lnformation:
flf receMng matedt>I, e,>ter rhe name(s} and C()l)ll)Ct inlormatlc,> ofpers()ll1>el $vpplying the marerit>I.J
NCR Number: _ _ _ _ _ _ _ _ _ _ _ _ __
Project lnformation:
(Rolatod SpecifiClltions., Codcs, Md SUtndardsJ
Heat Number/Heat Code:
(NCR rcport numbcr if necded)
Material Specification: _______________
[Record heat number(s} for the sampl.e.J
(ASTM spec., customer spec.J
P.O. Number.
(Entl#' 8$$0Clated purchttSe order numt,,er here.J
Pacldng Ust Number:
(Entcr p<rclting list andlor tr(Jcking nvmber hofl:.J
l ot Number:
/For mu/ripie Jor sh1pments, enter associated Jor number here.J
Examiner's lnformation:
MateriaVAlloy Type:
[Ente, the type or grade of material (UNS S3 1603, N08367, etc.}/
Material Description:
[Entl#' rhe si1e, materit>I prod11ct form (t111>1'1>g, 90, 45, TEE, lerrule, vt>Jve, ere.JI
or.11 Compliant:
(Rooord Aoocpt or Rojcct alter mM'kings verifie,;,tion.J
Wall Thickness:
[Record Accept or Reject aher physical examination of the Jot (if required).J
O.O. Tolerance:
/Rooord Aoocpt or Rojcct alter physicDI examination of thc lot (if requirod).J
Surface Re:
[Reoord Accept or Reject aher physical examination of the lot (if required)./
Visual Examination:
/Record Accept or Reject aher physical examinarion.J
MTA(s) Verified:
(Rooord Aoocpt or Rojcct for MTR oomptiance with spacifie<1tions.J
Ouantity Re<:eived:
Ouantity Accepted:
Ouantity Rejected:
Oate Examined:
Comments:
(Record afly notes lor e.Nt>mlMrion. afld atrach addltio1l8I sheets if ,>eeded.J
Copies:
O Owner
November 20 18
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292
□ ----- □ ---- 0 File
Form MEA ·1
BPE
Form WEL-1 Weld and Examination/lnspection Log
Project Number/Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
F&bñcating Contra.ctor:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
AJE Proj ect Number: ___________________________
tsometrie/Drawing Number:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Owner/Uscr:.______________________________
N&me and Date of Approval:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Examin.ation
WeldLoa
Weld
Weld
Welder or Welding
No.
O&te
Ooeratoi ID
Site
Type
Accept/
(Notel1lJ
Reieet
hlili&IS
lnsoection
Date
Type
Accept/
!Note 1111
Reicct
hlili&IS
Commcnts (Note (2))/fleieet Cause
Date
1;;
3:
"''".,,
N
'°w
'"
;.,
o
N
N
GENERAL NOTES:
(a) Welds st,au be uniquety identilied per applicabl e dra-wing.s.
(b> Rcjcctll'd wcld$ l ll;:11 c;;,n be t(rl'l<eldll'd $h,¡,l l \1$4:l tl'(l $;,m,c nvmbctwith .in MR~ ;,her it.
(e> Rcjoctll'd wcld $ th;:11 mv$t be cvt 001 ;:ind r4:ipl;:iocd w ith .i new wcld sh;,U be ;,Hignod tho wmc idemificr fQllowcd by ;:in ~A" for th4:l fin;t, ~ a ~ fo, lhc $CCQfld, 4:lU:. i n c;on$4:lcvtiv,c o rdcr.
Id> ff a wetd i& clll out for a reason other than a rejected weld, it &hall be recorded as a "Oeleted.. weld in the Comment&section. The recptacementwecld &hall be as&igned the ne)(t available identifier.
le) Coupon wefds mav be Usted w ith production welds or Usted separatelv. Eithe.r wav. the ooupon weld shOuld be i dentifled w ith the symbol "CPN"' as either a ,:,refü< ora suffix to 11'18 user'a weld numberln9 format.
NOTES:
11) vo • Vi sv~I o.o. ontv; VI • Vi&u.il O.D. .ind I.D.; B • Vi&u.il O.D. ;:md Borc&oope I.D.
12) Slind welds sh11U be lndteated es .. 8 tlnd" tn tl'le Co«1mentasectlon. Manual welds shall be lndicated as "Manual" In the Comments secdon. Vtdeotaped welds shall be lndicated as "Video" In the Commeni., secdon.
A~ othfH ,e9._uiremMts mav be i ndieat"d in the Comm"1\l8 seeti on.
Copies: O Owner
November 2018
D A/E
o
O Contractors O Consultants O
Page_ of _
o
o
o
0 File
Form WEL-1
ASM.E BPE-2022
NONMANDATORY APPENDIX C
SLOPE MEASUREMENT AND JOINT MISALIGNMENT
(g) For slope measurements made on skids or modules,
ensure that the base is leve) in ali directions. Then, make
sure that ali slope measurements a re made relative to the
base.
(h) Slope shall be verified afte r the fabricator has
completed, or corrected, the piping installation a nd set
the slope.
C-1 GENERAL
(a) Slope measurement shall be made with a digital
leve ) or a digita l protractor. The instrume nt used
sho uld be capable o f d is playing s lope in degrees,
percent, a nd in./ft (mm/m).
(b) Refer to the owner's manual for the proper procedure to perform the self-calibration routine. Thís must be
performed ímmediately prior to use.
(e) Slope measurements shall only be made under the
followíng condítíons:
(1) before insulatíon has been ínstalled
(2) after hangers/pípe supports have been ínstalled,
adjusted, and fixed ín place
(3) before the íntroductíon o f any fluids, such as
líquíds or process gases (pure oxygen, nítrogen, steam,
etc.)
(4) when the system is at a mbien t pressu re and
temperature
(d) For pipíng or tubing systems, slope measureme nts
shall be made at the following locations:
(1) between hangers/pipe supports
(2) at each change in dírection
(3) at any othe r locatíon deemed necessary by the
inspector, such as between we lds or a ny appa re n t
change ín slope
(e) Slope should be measured only on runs tha t are
approximately horizontal.
(f) Slope measurements may be made on eíther the top
or bottom of the tubing/píping.
C-2 JOINT MISALIGNMENT
In order to meet O.O. mísalígnment críteria in thís $tan·
dard, the accumula ted tole rances in piping, tubíng, and
fíttings may result ín a welded joínt with a n 1.0. mísalígnment. Should thís occur, the owner /user, ínstallatíon
contractor, and ínspection contrattor shall apply good
engíneering judgment to determine the bes t solutíon
for the ap plícatíon consí derí ng flow, or íentation, and
draínabilíty.
The orientatíon of the píping, tubíng, or fittings should
be considered prior to final dispositíon of the weld joint
príor to weldíng.
(a) Vertical Orientation
(1) Misalignment should be un iformly d istributed
a round the circumference.
{2) Oirecti on of tlow should be considered when
assembling the components.
(b) Horizontal Orientation. Misa lignment should be
oriented for drainability, normally accomplished by minimiiíng the LO. misalignment at the bottom.
294
(22)
ASM E BPE-2022
NONMANDATORY APPENDIX D
ROUGE AND STAINLESS STEEL
Table D-3.1-1 provides d escriptions, pros, a nd cons of
various tests for the identification of mobile constituents.
0-1 GENERAL
This Appendix provides methods to measure rouge in a
system both in the process solution a nd on the actual
product contact surface. lt also suggests various fabrication and operation practices to minimize rouge formation
and methods/techniques for its remediation.
For the definition of rouge and its classification, see
GR-8.
0-3.2 Solid Surface Analyses
Surface a nalyses provide information on the nature,
mic ros t ructu re, a nd co mpos itio n of su rface laye rs.
They may represen! the future status of the med ia and
the possible threat of rouging to the water quality.
Table D-3.2-1 provides descriptions, pros, a nd cons of
various tests for the identification of the composition of
surface layers.
0-2 CONSIOERATIONS FOR REOUCING ROUGE
FORMATION
Tables D-2 -1 and D-2-2 provide guidance on different
variables and how they may contribute to the presence of
rouge in a high-purity system. They a re listed in the
following categories:
(a) Category 1: l iWe lnf/uence on the Formation o(
Ro uge. Th ere are theories t hat suggest other facto rs
that may have a role in the formation of rouge. These variables are not listed in Tables D-2-1 a nd D-2-2.
(b) Category 2: Modera te lnjluence on the Formation of
Rouge. There is industry data supporting these variables,
and they should be considered.
(e) Category 3: Strong lnjluence on the Formation of
Rouge. There is well-established industry data supporting
these variables, and they should be considered.
0-4 METHOOS TO REMEOIATE THE PRESENCE OF
ROUGE IN A SYSTEM
Re mediation (derouging) processes are designed to
remove iron oxide and o ther surface co nstituents of
rouge while minim izing damage to the surface finish.
Rouge occurs on the surface, from corrosion, or precipitates onto the surface after migrating from other locations.
These conditions are easily categorized by using the sta ndard Classes 1, 11, a nd 111 rouge. The following sections
describe remed iation processes a nd t he conditions
under which they are performed.
0-4.l Class I Rouge Remediation
Class I rouges are weakly attached to the surface a nd are
rela tively easily removed and d issolved. This rouge is
generally hema tite or red ferric iron oxi de with low
levels of other oxides or carbon content. Phosphoric
acid is useful to remove light accumu la tions and may
be blended with othe r acids a nd compounds including
citric, ni tríe, formic, or other organicacids and surfactants
to assist in its derouging effectiveness. Citric acid- based
chemistries with additional organic acids a re effective al
r ouge removal. The use of sodiu m hydrosulfite (i.e.,
sodium d ithionite) is also fast and effective al re moval
of Class I rouge.
These chemistries are processed al elevated temperatures from 104ºF to l 76º F (40-C to 80ºC) for between z hr
a nd 1 Z hr. The process t ime an d temperatu res may
depe nd on t he seve rity of ro uge accu mula tio n, t he
system compone nt's ma te rial of construction, a nd the
concentration of chemistries. The concentration of each
chemistry is based on proprietary testing and p rocess
design criteria.
0-2.1 System Fabrication
See Table D-2-1 for a d iscussion offabrication va riables
that affect the amount of rouge formation.
0-2.2 System Operation
See Table D-2-2 for a discussion of operation variables
that affect the amount of rouge formation.
0-3 EVALUATION METHOOS TO MEASURE ROUGE
Rouge can be measured by its presence in the process
fluid a nd/or its presence on t he process contact surface.
0-3.l Process Fluid Analyses
Fluid analyses provide a meansofidentifying the mobile
constituents within a subject process system. They represent the current quality status ofthe media and the result
of rouging.
295
ASME BPE-202 2
Electrochemical cleaning is a n alternative method of
rouge removal tha t uses phosphoric acid and a pplied
d irect curren! whe re the p rocess contact su rface is
a nodic. As a cathode is moved over the process contact
surface to be cleaned, rouge is readily removed. This
process is very effective in removing ali three classes
o f rouge but is limited to accessible parts of a syste m
an d is p rima rily performed on the pro duc t con tact
s urfaces in vessels.
For specific Class I rouge remediation processes, refer
to Table D-4.1-1.
produce much less potencial for etching of the s urface
finish.
Citric and ni trie blends with hydrotluoric acid or a mmonium bitluoride will remove these Class 111 rouges more
quickly but will definitely etch the s urface wherever the
base metal issubjected to the derouging fluid. Th eamount
of etching or increase ins urface finish roughness is dependent on process conditions, chemical concentration, a nd
variability of the rouge thickness and leve! ofs urface finis h
ro ughn ess initially. The con d it io n of use for t hese
processes is highly var iable in both temperature and
time r equ ired to effectively re move a li of t he r ouge
a nd leave the surface prepared for cleaning and passivation. The less-aggressive chemistries a re used a t higher
te mp eratures [140ºF to 176ºF (60ºC to S0º C)] and
req uire lo nger contact time (8 hr to 48-plus hr); the
nitric acid-based fluoride solutio ns are often used at
lower temperatures [a mbient to 104ºF (40ºC)), whi le
the citric acid· based fluo ride sol utions are used at
higher temperatures and s horter contact times (2 hr to
24 hr).
For specific Class III rouge remediation processes, refer
to Table D-4.1-1.
D-4.2 Class II Rouge Remediation
Class II rouge consists mostly ofhematite or ferric iron
oxide with some a mount of chromium a nd nickel oxides as
well as small carbon content. Ir is removed with chemistries tha t are very similar to the above processes with the
a ddition of oxalic a cid, which improves the effectiveness in
removal of this type ofrouge. Ali of the above chemistries
re move the rouge without damage to the surface finis h
with the exception of oxalic acid, which may etch the
su rface depend ing on cond itions and concent ration
processed. Class II rouges are more difficult to remove
than Class I and may r eq uire additional t ime, even
though these processes are often run at slightly highe r
temperatures a nd increased concentrations.
For specific Class II rouge remediation processes, refer
to Table D-4.1- 1.
(22)
D-4.4 Remediation Variables
The times and tempera tures given in D-4.1 through
D-4.3 a re in direct rela tion to th e percent by weight of
the base reacta nt(s). A cha nge in a fo rmulation will
change the corresponding requirements. Different appli·
cation methods include fluid circulation, gelled applica·
tions for welds or surfaces, and spraying methods for
vessels a nd equipment. Rinsing of th e s urface after proces·
sing and proper waste disposal planning a re critica! to the
derouging process. The waste fluids generated by these
processes can be classifted as hazardous due to chemical
constituents or heavy metals content
Rouge can effectively be removed from process contact
surfaces to reduce the potentia l fo r oxide particulate
gene ra tion into t he process flu ids. Th ese derouging
processesare required prior to proper cleaningand passivation of the stainless steel s urface for restoration of the
passive !ayer after corrosion. Analytical testing of utility
fluids may be useful in identifying the leve! of particulate
generation and levels of metal oxides contained in these
fluids as corrosion degrades the surface.
D-4 .3 Class III Rouge Remediation
Class III rouge is much more difficult to remove than
Class I a nd Class JI rouge, due to both its chemical composition difference a nd its structural difference. These hightemperature deposi ts form magnetice iron oxide with
some s ubstitution of chromium, nickel, or silica in the
compound structure. Significant a mounts of carbon a re
generally present in these deposits due to reduction of
organics present in the water, which sometimes produces
the "smut" or black film that may form during derouging.
The chemistries used to remove Class lll rouge are very
aggress ive and will affect the sur face fi nish to some
degree. Phosphoric acid-based de rouging syste ms are
genera lly only effective on very light accumu lation of
the rouge. The strong organic acid blends with formic
and oxalic acid are effective on sorne of these high temperature rouges, and, bei ng less aggressive, they
296
(22)
ASME BPE-202 2
Table D-2-1
Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
Variables
Consideratlons
Caregory 3 - Strong lníluence 011 rhe forrnatlon of Rouge (Note (1)]
Alloy selection
Selection of the proper alloy (e.g., 3l 6L-type or 6 moly-type stainless steel) s hould
address the corrosive effects of die process conditions. for example, low-carbon stainless
steel (316L·type) has better con·osion resistance than higher -carbon stainless steels (3 16-type).
Beneficia) alloys c.an mitigate premature or accelerated cor rosion. Higher nickel content will
cnhancc corrosion reslstancc.
Mechanic-c1I polishing/buffl ng
Striati(>nS from cold working teéhniques may include r esidual grindi ng/p-Olishi ng debris in
lapping inclusions. Cumulative i ncrease of i nter ior ar ea due to surface flnish inoonsistency
proportionally exposes more alloy to the mechanisms of corrosion and burden of passivation.
Elcctropolishlng
Mlnimizcs tite cxposurc a!'ca or thc alloy to oxldizing Ouids or halldes and mlnlmlzes the
orlgins for micropitting by corroslon mcchanlsms.
Passivation
Jmpedes or retards corrosive development of stai nless steel surfaces. The effectiveness of
passivation methods i n ter ms of depth and enhancement of surface alloy ratios (i.e., chrome
to iron) dete1m i nes the eventual pr opensity of an alloy to oorrode and the rate of cor rosion.
Alloy composition
(% molybdcnum, chromlum, nlcl<cl etc.)
The microstructurc quality affects p!'ecipitation or lmpurlties at grain boundarics. Migration or
impurities co the állOy surface can either support corrosion tells or seed downstream
corrosion. Wel d joints on tubi ng and components w ith dissimilar sulfur concentrations
may resul t in lack of penetration due to wel d pool shift. The resulting crevice may become a
corrosion i ni tiation site.
Welding. weldlng condltions,
purging, etc.
Jmpropcr weld.scan rcsult in chromium•deplctcd hc-at•affectcd zones (HAZs) and other condltlons
that reduce corrosion resistance. Weld discontinuities create opportunilies to trap íluidbom e impuritles. Cracks resulting from poor welds wlll create bréathes In the passive layer
and fonn active corrosion cells. Proper purging prevents weld oontamination by heat
tint oxides and the concurrent loss of corrosion resistance. Passivation cannot reverse the effects
of improper purging.
Product íonn and fabrlcation
The fcrritc contcnt can be grcatly affectcd by thc fonning proccss lc.g., a forgi ng wlll typically
have much Jower ferrite percentages than a casting). 8ar:stock endgr ain voids at the suríace
can enhance the pOléntial of 1.he alloy to pit and corr ode. Mini miiation of dlfferences in
sulfur content will enhance the potential for successful welding.
methods
Category 2 - Mode rnte lnfluence on the Formation oí Rouge (Note (1))
fnstallation/storage
environment
Unidentified corrosion due to the storage or installation environment, i nd udjng carbon steel
contamination, scratchi ng. exµosure to chemical contaminants, stagnated condensation or
liqui ds, cte., may wa.r rant a derouglng stcp prior to passlvatlon. Fallurc to dctcct lnstanccs oí
corrosion will marginalizc thc cífect or a nonnal passlvation.
Expansion and modifications
to an established system
Oxide rormations in newly commissioned systems can fonn at different rates than i n older systems
and initially generate migratory Class I rouge. Where oxide films exist in established
systems, they are likely to be more stable, prodttcing less migratory i ron or chr ome ox.i des.
Because the newer system can generate and distribute l ig.h tly held Class l migratory hematite
íonns throughout thc systcm, thc corrosion orlgln and cause can be difficult to ldcnti ly.
NOTE: (1) There is well·established industry data supporting this, and it needs to be considered.
297
(22)
ASME BPE-2022
(22)
Table D-2-2
Considerations That Affect the Amount of Rouge Formation During the Operation of a System
Varlables
Conslderatlons
C.tegory 3 -
Strong lníluence on the For matlon or Rouge (Note (1))
Corroslve process íluid
(bleach, halides, etc.)
Corrosion cell inceptíons at breache-s l n the- passive laye-r, as in chloride corrosion ce-lis, will
progressively catalyze the cor rosion mechanism. This has a very strong influence for applications
such as high-salt buffer tanks, etc.
High-she-ar/velocity
envi ronment (pump
i mpeller, sprayball, tees,
etc.)
Erosive forces deplete or erode the passive layer and introduce base met'ál composition partides
to the remainder of the system. Severe i nstances can cause pitting on the tips of pump
impellers or fluid impingement spots on vessel walls. In pure steam systems, hig.lt•velocity
sections can scour tubing walls. either preventing sustai ned buildup of stable magnetite layers
or sloughlng off fr agments from developing oxi de formations that are then transported
downstrcam for posslble con·oslon seeding.
Operating temperature and
temperature gradients
Operating temperature and temperature gradients will affect the eventual nanire oí oxide
formations (e,g., Class I hematite versus Class 111 magnetite), the ease of removal, and the
propenslty to become stationary, stable, orllghtly held and migratory. The nature of restoration by
passivatlon and dcrougi ng may be Jargcly detcnn ined by the opcrating tcmpcrature or the
sys1em. Estabtished magnetlte for rnaLiOnS in pure steam sysi.ems may re<¡uire a derouging
step pr ior to the passivation steps.
Gascous phase composition,
indudi ng dissolved gases
(02 and CO,)
For monogr.iphed íluids (PW, WFI, and pure steam), the constituenc;y oí dissolved gases is
generally believed to have an iníluence on rouge formation when wlthi n established conductlvlty
and total organic carbon (TOC) limits in sys1:ems that have an adequate passlve layer. lt is
possible for impurities to migrate across distillation and pure steam generation processes as
dissolved gases. A variety of analytic spectrometry methods are available to identify these
species. ( Reíer to Tables D-3. 1-1 and D-3.2-1.)
Applitatí()n, process me-dia
(pur e steam, WFI, buffer,
media. CIP, etc.),
frequency of operation
The nature of the oxide formation, potentlal for corro.sion, r emedia! methods, and period of
formation are greatly i nfluenced by the application as noted in the other impact descriptions
(temperanire, corrosive process, etc.) . In st eanHn·place (SIP) systems, velocity, temperature,
and trapping can have impacts on the composition and locations of rouge íonnations and
migratoiy deposlts.
Adequatcly dc-slgncd systcms can mlnhnlze this impact. Poorly trapped pure steam hc-adc-rs,
regularly exposed to pressure gr adients, can introduce corroslon mechanisms and pr(1ducts
through steam condensate. Long hold periods in high-salt buffer tanks and the effectiveness
of the tan.k agitation can promote or accelerate rouge fom1ation. SIP following i nadequate CIP
can create corrosion mechanisms and further aggravate removal methods.
Systern CIP, cle-aning
Exposure to CIP cydes and the specific chemical d eani ng solutions str ongly affect.S the
potential for rouge occurrence. System sections exposed to a cyclic CIP regime will be les.s likely
to form or collect rouge. Significant factors include whether there is an acid or hot acid CIP
cycle in the CIP recipe. The duration and temperature of the acid cyde can be important
Acid cyclc-s wlth mild concentratlons ( c-.g., 2% to 20% phosphorlc acid) havc be-en shown to
malntain and r cstorc passivc layers.
methods
Redox potential
The use of ozone to sani tize pur ified water or WFI systems has also demonstrated beneficia!
effects i n impeding alloy corrosion.
Maj ntenance of the system
System components such as wom pure steam regulator plug seats, impr oper or misaligned
gaskets, wom regulator and valve diaphr agms, pump impellers (with wom tips), and eroded
or cr acked heat exchanger tube returns are believed to be sources of Cla.ss I rouge.
298
ASME BPE-2022
Table D-2-2
Considerations That Affect the Amount of Rouge Formation During the Operation of a System (Cont'd)
Consideratlons
Variables
Stagnant now areas
A moving oxidiiing Ruid can maintain the passive !ayer. (Studies with nitrogen-blánketed Wfl
storage tanks have shown negative effects on passive layers as a result of minirnizing oxygen
in the fl uid.)
Liquid condensate that is not immediately removed from a pure steam conduit or that collects
from improper valvc sequencing can conccntratc and transport surfacc oxidation products or
stcam contalned solubles. Thcsc can concentrate and deposlt at a brancll tcnni nus such as a
vessel spraybal~ dip tube, etc These deposits are typically lightly held fomis of hematite.
Though easily removed, they can be diffiettlt to remove in large vessels and appear to go
against the common stipulation of ''visually dean."
Pressure gradients
P-ure steam systems only. Pressur e changes In the distribution system will affect the amount of
steam condensate as well as the quality of the steam. l f system sections are exposed to
pressure ranges, condensate that is not effectively removed from horizontal sections can be
revaporized at higher pressures, which will lower the steam quality and transport any impurities
borne in the steam condensate.
System age
This depends on how the system has been maintained in regard to frequency of passivation or
derougi ng, CIP exposure, and formation of stable oxide layers. New systems have been
observed to generate disproportionate amounts of Class I rouge formations in contrast to
established systems. Jn pure steam systems. although oxide formations be-come stable with
age, they can also thlcken and be prone to partlcle sloughlng in high•vclocity sections. lt
should be notcd that systcm time in use can have both beneflcial and ncgativc effects in
regard to rouge formation and that regular system monítoring is imp()rtant i n idenl:ilk ation of
incipient corrosion.
NOTE: (1) Therc is wcll•established industry data supportlng thls., and it necds to be consldercd.
Table D-3.1-1
Process Fluid Analyses for the ldentlficatlon of Moblle Constituents of Rouge
(22)
Test Criteria
Type of Tes t
Test Description
Pros
Cons
Ultra trace inorganic
analysis (by ICP/
MSJ
Concentrations of trace metals i n process Noninvasive sample acquisition
solutions i nd uding pure water/steam Highly quantitative i nformation
are directly analyzcd by inductivcly
Providcs strong ability to trcnd
coupled plasma mass spectrometry
data
(ICP/MS).
Baseline shaH bedetermined for
each system analyzed.
Standard partlculatc
analysls (vla light)
A liquid sample is subjectcd to a laser light., Noninvaslvc sample acqulsltion
whlch scattcrs on contact with partirles. Highly quantitativc information
The scauered light is collected_,
P-rovides stn>ng ability t() trend
proces.sed, segregated by channel, and
data
displayed as a specific count for each size
range analyzed.
Basclinc shaH bedetcrmlned for
cach systcm analyzcd.
Ultra trace inorganic
analysis (by SEM/
F'luids are filtered via vacuum filtration, P-rovides highly detailed physical Limited with respect t() organic
and particles are collected on a fine·pore
obse1vati on and elemental
particulate identification
filter medium. The particles are then
composition data for mobile
analyzed by scanning electron
particulates
microscopy for size, composition, and
topographlcal featurcs.
EDX)
Fourier transform
Organic analysis of liquid samples or
i nfrared
extracts from wipe samples. Used to
spcctroscopy ( FTIR)
idcntify posslblc organlc tlhns or
deposits
Potentially noninvasive sample Organic contaminants shall be
profiled in a specific target
acquisition
AJlows for organk ldentlfication
compound Hbrary.
of clastomers or alternatc
organic C()ntaminants
299
ASM.E BPE-2022
Table D-3.2-1
Solid Surface Analyses for the ldentification of Surface Layers Composition
(22)
Te.st Crlter1a
Ty¡,e or Test
Test Descrl1>tlon
Pros
Cons
Microscopicand human Visual analysis vía polariied light Good test for morphology
lnvasive test
visual analysis
microscopy (PLM), scanning
deter mination
Requires the periodic removal of
electron microscopy (SEM), or Can be coupled with energy dispersive
solid samples (e.g., coupons)
alternative microscopy
X-roy (spectroscopy) (EDX) analysis
instrumentatlon
for elemental composition
information
Scanning auger
Surface met.11 elemental
microanalysls (5AM)
composltlon analysis. Provides
or auger clcctron
for detailed qualltatlvc
spectroscopy (auger)
elemental compositíon data on
both 1.he surface it:self and the
s ubsurface (or base metal)
SmaJI spot clcctron
spectroscopy for
chemical analysis
(ESCA) or X-ray
photoelectron
spcctroscopy (XPS)
Highly accurate method for positive
lnvasive and destructive test
ldentlflcatlon and quallflcatlon of the Requires the pcrlodlc removal of
surface metal composltion
solld samples (c.g.. coupons)
Used to de.termine the depth and
elemental composition of the surface
including the passive layer itself
lnvasive and destn1ctive test
Thc samplc is subjcctcd to a probc Highly accurate method for the
beam of X-rays of a single
<¡ualification and quantif1cation ofthe Require.s the periodic re.moval oí
energy. Electrons are emitted
surface metal composition
solid samples (e.g,, coupons)
from the surface and measured Used to determine the depth and
to provide elemental analysis of
compositional analysis ofthe passive
the top suríace lay ers.
!ayer
Provides excellent elemental analysls of
the top suríace layers, i ncluding
whlch oxlde(s) are present
Reflection grade
cllipsometry
Multicolor interferometry using
light and lts dlffractivc
properties to asse.ss surface
condilions
Nondestructive analysis
lnvasive test
Known ditfractive characteristics of
Requires the pcrlodlc removal of
ele.ments could pr ovide for<¡ualitatlve
sol id samples ( e.g.. coupons)
analysis of surface chemistry
F'ield qualilkáliOn of this me.thod
properties
is still ongoing
Elecu·ochcmlcal
l mpedance
The analysis of electrochemical
noise In order to quantify the
state of corrosion of a metallic
surface
Nonlnvasive, real-time quantlflcatlon of Field qualification of this method
me.tallic corroslon
Is still ongoi ng
Provi des strong ability to trend data
spectrometry
300
ASME BPE-2022
Table D-4.1-1
Rouge Remediation Processes Summary
(22)
Oerouglng Processes: Speclflc
Class oí Rouge
Class I Removal
Oescription
[Notes (1), (2)1
Comments
[Notes (3), (4}]
Chembtry
[Note (5)]
Phosphoric acid
Effective at removing i ron
5% to 25% phosphoric acid
oxides without etching the
Citric acid with
intensifiers
Effed:ive at removing iron
Condltlons of
Process
[Notes (6), (7)1
2 hrto 12 hrat 104ºFto 176ºF
(4-0ºC to 80ºC)
process contact surfacc
oxides without etching the
process contact surface
Phosphork acld blcnd.s Can be used at a varlety of
temperatures and
condítlons
Sodium hydrosulfite
(i.e., sodium
dlthlonltc)
Electrochemical
cleaning
3% to 10% dtric aéid with
additional organic acids
5% to 25% phosphorlc acid
plus cither citric ac-ld or
nltríc acid at various
c::onc::entrations
Effective at removing i ron
Up to 10% sodium
oxides without etching the
hydrosulfite
surrace but may gcneratc
sulflde fumes
Useful i n removing stubborn
rouge 1Nithout risk of
Phosphoric acid
(4-0'C to 80'C)
2 hrto 12 hr at 104°Fto 176°F
l40'C to 80' CJ
2 hrto 12 hrat104' F to 176'F
(40ºC to 80ºC)
25% to 85% phosphoric acid Limited to accessible parts of
systems, primarily ves.seis
Process times are
approximatcly l mln/fr
etching the process contact
s urface
Class JI Removal
2 hr to l 2 hr at 104ºF t() 176ºF
Effective at removing iron
5% to 25% phosphoric acid
oxides without etchlng thc
2 hr to 24 hr at 104ºF to 176ºF
l40'C to 80' CJ
surface
Citric acid with organic Effective at r emoving iron
5% to 10% citric acid with
oxides without etching the
acids
additional organic acids
surface
2 hr to 24 hr at 104'f to l 76' F
(40ºC to 80ºC)
Phosphork acid blends Can be used at a v-.triety of
temperatures and
2 hr to 24 hr at l 04' F to l 76' F
(40' C to 80' C)
conditions
5% to 25% phosphoric acid
plus cither éltric acid or
nitric aci d at various
concentrations
2 hr to 24 hr at 104ºF to 176ºF
l40'C to 80' CJ
Oxalic acid
Effective at removing iron
oxides; may etch
electropolished surfaces
Electrochemical
cleaning
Usefol in removing stubborn 25% to 85% phosphoric acid Limited to accessible parts of
rouge w ithout risk of
systems, primarily ves.seis
etching the process contact
Process times are
surface
approximately 1 min/~2
Sodium hydrosulfite
Effective at rcmovlng iron
Up to 10% sodium
oxídes wíthout etchíng the
hydrosulfite
surface but may generate
sulfide fumes
(Le.• sodiurn
dithionite)
301
2% to 10% oxalic acid
2 hrto 12 hr at 104°F to 176°F
(40' C to 80' C)
ASME BPE-2022
Table D-4.1-1
Rouge Remediation Processes Summary (Cont'd)
Derouging Processes: Speclflc
CJass of Rouge
Class 11 1 Removal
Oescr iption
[Notes (1), (Z)]
Comments
[Notes (3), (4)]
Phosphoric ad d blends Can be used at a v;:iriety oí
temperatures and
condltlons
Oxalic acid
May etch metaUic surfaces
Cltric acid with organk May etch metaUic surfaces
acids
Citric acid with
Will etch metallic surfaces
i ntensifiers
Chemistry
(Note (5)]
Condltlons of
Process
(Notes (6), (7)1
5% to 25% phosphoric acid
plus either citric ar.id or
8 hr to 48+ hr at 140ºF to
176º F (60ºC to 80ºC)
nitrlc acid at various
concentratíons
10% to 20% oxalic acid
8 hr to 48+ hr at 14-0ºF to
176ºF (60ºC to 80ºC)
5% to 10% citric a cid with
additlonal organk adds
5% to 10% citric acid with
8 hr to 48+ hr at 140°F to
t 76ºF (60ºC to ao•c¡
additional organic acidsand
fluorides
8 hr to 48+ hr at 14-0ºF to
176ºF (60ºC to 80ºC)
15% to 40% nitrlc acid wlth 1 h1' to 24 hr at ambient to
1% to 5% HF or 1% to 5%
104ºF (40ºC)
NH 4 HF2
Nitric/HF or nitrlc/
ammonium
biíluoride
WIII etch metallic surfaccs
ElectrochemicaJ
cleaning
Useful in removing stubbom 25% to 85% phospho1ic acid Llmited to accessible parts of
rouge without 1isk of
systems, primarily vessels
Process times ar e
etching the process contact
surfacc
approxlmately 1 mln/ft2
NOTES:
(1) AJI of these derouging processes should be íollowed with a cleaning and passivation process of the treated surface.
(2) Application methods indude Huid circulation,geJJed applications for welds or process con taet surfuces, and spraying n1ethods for vessels and
equipment.
(3) These derougi ng proc.-esses may produce hat..ardous wastes based on the melals content
(4) Olly or loose black residue dueto carbon buildup may be pr esent on the pr ocess contact surfaces after derouging and may require spe<:íal
clcanlng procedurcs to rcmove.
(5) Chemlcal pcrccntages are bascd on wcight pcrccnt.
(6) The time and oorrelating temperatures given above are in direct relation to the percent by weight of the base reactant(s). A change i n a
formulation w iU change those cor responding requirements.
(7) A deionized w;:iter rinse shall immediately follow each of the above chemical treatments.
302
ASME BPE-2022
NONMANDATORY APPENDIX E
PASSIVATION PROCEDURE QUALIFICATION
( 22)
In a discussion on passivation, it should be realized that
the best passivation treatment or a ny surface treatment
only puts the alloy in its most corrosion-resistant state for
a particula r e nvironme nt. In o the r wo rds, t here are
inherent corrosion-resistance limitations for any alloy,
a nd t he best passivation trea tment does no t replace
t he need for a more co rrosion-resistant material for
certain applications.
E-1 GEN ERAL
Th is Append ix provides basic information and offers
guidelines for owner/users, equipment manufacture rs,
and service providers fornewly manufactured or installed
systems in accordance with the requirements ofGR-1. This
Appendix covers the preparation a nd execution of proced u res assoc ia ted w ith the che mica l clea ning and
degreasing, passivation, and final rinse(s) of specialized
systems, as well as of bioprocessing equi pment after
assembly, erection, or modification. These procedures
will apply to UNS S30400, UNS S30403, UN S S31600,
and UNS S31603 stainlessstee ls. Superaustenitic stainless
steels and nickel alloys may require a modified procedure.
This Appendix defi nes a method for qualifying the passivation process used for system a nd process component
surfaces.
This Appendix provides inform ation on passivation
p roced ures and testing of the surface res ulting from
various passivation procedures.
E-2.l Why Passivation Is Necessary
E-2 PURPOSE OF PASSIVATION TREATMENTS
Passivation, or the formi ng of a passive )ayer on the
surface of stainless steel alloys, is a naturally occurring
phenomenon on a clean surface when oxygen is
present. The passive layer may be augmented by chemical
treatrnent of the stainless steel s urface.
Acritica) prerequisite in prepardtion for chemical passivation processes is a cleaning proced ure. Th is procedure
includes a li operations necessa ry for th e removal of
su rface contamina nts (oil, grease, etc.) from the metal
to a llow the chem ical pass ivation to be most effective.
The purpose of the final chemical pass ivation process
is to e nhance the passive layer a nd provid e a n alloy
surface free of free iron or other contaminants, allowing
the alloy to be in the most corrosion-resistant state.
For improved co rrosion resistance in the sta nda rd
stainless steel grades (e.g., UNS S31603), the passivation
treatment is most beneficia) and important. With s uperaustenitic stainless steels and nickel alloys, passivation is
less critica), provided the surfaces are clean a nd free of
contamina nts. At the owne r/ user's option, passivation
may be performed to remove any free iron on process
contact s urfaces a nd to facilitate the formation of the
passive layer.
303
Although stainless steel components may be clean and
t he pass ive layer intact prior to installa tion, weld ing
destroys the pass ive fil m on the weld bead a nd the
heat-affected zone (HAZ) of the weld. The distribution
of elements across theweld and HAZ, includingchromium,
iron, a nd oxygen, are disturbed when the meta l is melted
so tha t the concentration of iron is elevated, while chromium, which is normally of higher percentage than iron in
the passive )ayer, is reduced .
Discolora tion a nd contamination (especially free iron)
introd uced dur ing fab rication may also comp romise
corrosion resistance unless removed. Passivation after
weld ing, by re moving free iron, helps to res tore the
pass ive )aye r . lt d oes not re move d iscolo ra tion .
Re moval of d iscoloration requires a more aggressive
acid than the usual nitric or citric acids used for passivation. Since the only postweld treatment normally used for
insta lled piping sys tems is passivation, welding proced ures that m inimize discolo ration are specified (see
Part MJ of this Standard).
Fabrication, cutting, bending, etc., can result in contam·
ination that leads to loss of corrosion resistance. Examples
are embedded iron, heat tint, welding tlux from covered
electrodes, are strikes, a nd painting/markings. Exposure
to carbon steel or iron is particul arly detrimenta l. By
removing contamination, especially free iron, a passivation t reatment can help to restore the natural passivity of
stainless steel that is damaged by fabrication.
E-2.2 When Passivation Is Necessary
Passivation is necessary
(a) after welding and fabrication
(b) after welding of new components into a system
(22)
ASME BPE-2022
Table E-3.2-1
Mínimum Surface Requirements for Process Qualification Samples
Materia)
Test Melhod
Cr/fe Ratio
Oxide De¡1th
AES
1.0 or greater
15 Á, min.
UNS S31600 or UNS S31603
GD·OES
1.0 or greater
15 /í. min.
UNS S31600 or UNS S31603
XPS/ESCA
1.3 or greatcr
15 Á. min.
UNS $3 1600 or UNS $31603
GENERAL NOTES:
(a) XPS/ESCA readings of metal oxides typically obtain higher values than readings of metaJs..
(b) Additional a.lternative testing rnethods for cleanliness and passivation are shown in 1'able E·S·l .
(1) AES (auger electron spectroscopy) testing at the
weld, including the worst discoloration area in the weld
and heat-affected zone, and on the base metal to meet the
requirements of Ta ble E-3.2-1
(2) GD-OES (glow discharge-optical electron spectroscopy) testing at the weld, including the worst discoloration area in the weld and heat-affected zone, and on
the base metal to meet the requirements of Table E-3.2-1
(3) XPS (X-ray photoelectron spectroscopy), also
known as ESCA (e lectron spectroscopy for chemica l
analysis), testing at the weld, including the worst discoloration area in the weld and heat-affected zone, and on
the base metal to meet the requirements of Table E-3.2-1
Qualification ofmethod shall besupported bydocumentation for each procedure. The actual values ofthe essential variables and coupon testi ng listed above s ha ll be
documented and maintained as part of the procedure.
E-3 PASSIVATION PROCEDURE (SEE SF-2.6)
(22)
E-3.l Procedure Description
The passivation provider s hall ob tain welded and
nonwelded sample component(s) or cou pons from
each passivation me thod used ( e.g., circulation, spot,
bath) forthe purpose of demonstrating that the procedure
is capable of providing the required surface characteristics, name ly, cleanliness, surface chemist1y, and corrosion
resistance.
The pass ivation process used on t he q ualificat ion
compone nt (s) or coupons shall be reproducible in the
syste m for which it is intended.
The procedure description and qualification document
shall be available for review by the owner/u ser or their
designee. The owner/user s hall be responsible for verifying that the passivation procedure to be used on the ir
system or components has been qualified.
(22)
E-3.3 Procedure Documentation Requirements
E-3.2 Procedure Qualification
The passivation provider shall generate and provide the
following documentation, as a mínimum:
(a) process descriptions
(b) essential variables
(e) ESCA/XPS or AES or GD-OES testing for each procedure qualification sample produced
The passivation provider shall develop a passivation
procedure for each method used. The procedure shall
be developed to ensure that essential variables used to
obtain the qua lification samples can effectively remove
free iron and meet the req uirements of Table E-3.2-1.
Procedure qualification, as a mínimum, shall include
the following:
(a) Process Descríption. The following steps s ha ll be
described as a mínimum (Table E-3.2-2 may be used
as a guide):
(1) pre passivation survey a nd preparation
(2) cleaning
(3) passivation
(4) final rinsing
(5) verification
{b) Essential Variables {Conditions Under Which the
Samples Were Processed). The following essential variables shall remain within the designated range:
{1) process time
{2) temperatu re of solution during process
(3) general chem istry of process fluids
(4) process endpoint determination
(5) conduct ivity of fi nal deionized rinse water
(e) Procedure Qualification Coupon Testing
E-4 PASSIVATION QUALITY CONTROL
E-4.l Quality Control Surveillance
Quality control surveillance to ensure the written and
qualified passivation procedure has been followed is
essential. A thorough rinse with deionized or owner/
user-approved water should follow the chemical treatment. lt is good practice to continue rinsing until, as determined by conductivity analysis, the ionic contaminants,
proces s chem ica ls, and by -products have bee n
removed. This document shall be available for review
by the owner/user or their designee.
(a) Written documentation that ali req uirements of the
qualified procedure have been followed.
(b) Final rinse s hall meet pre-establis hed conductivity
(quality) requirements.
304
( 22)
ASME BPE-2022
Table E-3.2-2
Passivation Processes
Process Type
Process Oescription
[Notes (1), (2)]
Comments [ Note (3)]
(22)
Conditions of Process
[Notes (4), (S)]
Chemi,~ry (Note (6)]
Precleaning
Water Rushing/
filtration
processes
High-velocity 01 (or
Removes debris prior to the
passivation process
owner/user·chosen)
water flushing for
removal of par tlcles and
construction dcbris
Arnbient temperature for 5
01 water
min to 30 min per section;
generaUy includes filtration
of nuids
Hlgh-velocity water
Ambient cemper ature íor 15
min to 60 min per section
DI water ( recommended)
l hr to 4 hr at heated
conditions depending on
the solutlon and
contamination leve!
Blends of sodium
phosphatcs
(monosodlum phosphate
(MSPJ, disodium
phosphaté (DSPJ,
trisodium phosphate
(TSP)] and sur factants
ílushing
Removes debrls prior to 1.he
passlvatíon pn>ce.ss
Chlorides in water ar e
detrimental to austenitic
stainl ess steels
Cleaning
Cleoning/
dcgreasing
processcs
Phosphate cleaners
Removes light organic
deposlts
Can lcave phosphate surracc
contaminacion
AlkaUne cleaners
Can be selected for specific
organk rontaminates
Blends of nonphosphate
detergents, buffers, and
surfactants
Cau.stlc dcancl's
Eífcctivc at r cmoval of hcavy
organic contamínation or
dégr easing
Blends or sodl um and
potassium hydroxides
and surfactant.S
lsopn)pyl alcohol ( IPA)
f.ffeccive as a degreaser
Hand s-wab or wipe suríat e at 70% 10 99%
Volatile
ambient conditions
Highly ílammable and
sensitive to static discharge
Passi vation
Passivation
processc.s
Nitric acid
Proven method under A!>IM 30 min to 90 min at ambient 10% to 40% nitric acid
A380/ASTM A967
tcmpcrature or hlgher,
Can be pl'OCCSSCd at amblcnt
depending on
condítions depending on
contentrati()n used
fomrnlation
Phosphoric acid
Effective at removi ng ir on
oxides i n addition to free
iron
t hr to 4 hr at heated
5% to 25% phosphoric acid
conditions
Phosphoric acid blends
Can be used at a variety of
temperatures and
conditions
5% to 25% phospho,ic acid
pl us either citr ic acid or
nltric acid at varlou.s
concentratlons
Citric acid
Spécilk for free in)n r emoval
Should bé processed at
elevated temperatures
Takes longer to process titan
mineral acid systems
Meets or cxcceds ASTM A967
10% citric acid
Chclant system.s
Should be proccssed at
elevatéd 1.emperatures
Takes Jonger to process 1.han
mineral acid systems
Removes iron oxides i n
addition to free iron
Meets or exceeds ASTM A967
3% to 10% cltrlc acld witl1
varlous c.helants, buffers,
and surfactánts
305
ASME BPE-2022
Table E-3.2-2
Passivation Processes (Cont'd)
Process Type
Process Description
(Notes (1). (2))
Comments (Note (3)]
Conditions of Process
[Notes (4), (S)J
Cbemistry (Note (6))
Passivation (Cont'd}
Passivatjon
Electropolishing
processes
(Cont'd)
This proces.s is generaJly
limited to components
rather than installed
Exposure time shall be
calculated to ensure 5 µm to
1O Jtm material removal
systems
Process should be performed
from ali surfaccs requiring
according t(I a qualified
pn>cedure
This proces.s removes metal
Rinsing shall indude a step to
ensure removal (1( residual
from the surface
Electropolishing should be
Phosphoric acid-based
electrolyte
passivatlon
film that may adversely
affe-ct the appearance or
performance of the produce
pcriormcd In such a way as
to mect or excecd ASTM
8912
Oxldat:Jon
Oxidatíon processes Hydrogen peroxide
Hydrogen peroxide with
peracetic acid blends
Oxidiie.s metal s urface and
sanitizes
Oxidiies metal surface and
sanitizes
30 mín t() 2 hr at ambient to 3% to 10% hydrogen
l04• F (4-0'C)
peroxjde
1% to 2% blend
NOTES:
(1) Application methods include flu id circulation. gelled applications for welds or surfaces, and spraying methods for vessels and equipment.
(2) Special atténtfon should be directed t:C) removal ()f metal shavings and constructi()n debris from locatíons such as sprayballs. diaphragm
valve.s, heat e.xcha ngers, etc.
(3) Thcsc passlvation proccsses may produce hazardous wastcs bascd on the met:als content, and local a nd statc rcgulatlons.
(4) The time and rorrelating temperatures in the Table are in direct relation to the percent by weight of the base reactant(s). A change in a
formulation may change those corresponding requirements.
(5) /1. deionized water rinse shall immediately follow each of the chemkal treatments.
(6) Chemical percentages are based on weight percent.
tation generated during the process (listed in E-4.2)
s ho uld prov ide assurance t ha t t he components or
system has received the specified treatmen t. As a
guide to owner/use rs a nd others, to help determine
w hether an acceptable surface has been achieved
following a particular cleaníng or chemical passivation
procedure, Table E-5-1 has bee n developed.
E-4.2 Certificate of Passivation Conformance
The passivation provider shall supply a Certificate of
Conformance for each system or set (type) of component(s) that shall include, but not be limited to
(a) customer's name
(b) description of system or component(s)
(e) vendor company name
(d) qualified passivation method used
(e) documentation of passivation process, as follows:
(1) written qualified procedure
(2) docume ntation of process control of essential
variables
(3) instrument calibration records
(4) certificates of analysis for ali chemicals used
(5) process testing and verification
{f) postpassivation verifica tion method(s) used
E-5.l Acceptance Criteria for Cleaned and
Passivated Process Contact Surfaces (See
Table SF-2.6-1)
Table E·S-1 may be used as a guide for accep tance
criteria for cleaned and passivated components or
systems. Th is matrix is a simplified compi la tion of
testing methodologies that an owner/user may want to
use in selecting a test oras a mea ns to interpret a proposal
from a testing company.
The matrix is divided into groups offour types oftesting
methods
(a) gross inspection of cleaned and passivated parts
per ASTM A380/A967 (Pass/Fail)
(b) precision inspection of cleaned and passivated
parts under ASTM A380/A967 (Pass/Fail)
(e) electrochemical field and bench tests
E-5 EVALUATION OF CLEANED AND PASSIVATED
SURFACES
There are no universally accepted tests to ensure that a
componen t or system has been passivated or is in a
passive condition. lf the system/component has received
the proper chemical passivation treatment. the documen306
( 22)
ASME BPE-2022
Table E-5-1
Test Matrix for Evaluation of Cleaned and Passivated Surfaces
Type of Test
Test Descrlptlon
Pros
(22)
Cons
Group 1. Cross lnspectlon oí Cleaned and Passlvated Parts per A380/ ASTM A967 (Pass/Fall)
Visual examinat.ion [CT (test Bench or field test Visual
Can be performed with minímal
for deanliness). RT (test
examination is the direct or
preparation a nd equipment
for the presence of
remote visual examination of, i n Good general appearance review
this case, a passivated met.lllic
rouge)]
surfacc.
Wlpe test ASTM A380 (CT,
RT)
Bench or field test This test consists Useful for tcstlng suríaces that
of rubbi ng a test surface with a
cannot be readily accessed for
de.an, lint-free, white ootton
direct visual examination
doth. commercial paper prodttct. Removable surface contamination
or filter paper moistened with
high·purity solvent
can be easily identifted and
rompared
Not quantitative
Subjective interpretation of
findings
Not quantltatlvc
Di fficult to i nspect hard-to-reach
areas of large tube diameters
There is al so a risk of leaving errant
fibers behind from the 1Nipe or
plug
can be detrimental to
clcctropolished surfaccs
Residual pattcrn test ASTM Bench or tlcld test Aft:er flnlsh•
A simple test with rapid r esults
A380 (CT)
d~ning, dry the deaned surface
per ASTM A380. The presence of
stains or water spots indicates
the presence of contaminants.
Not quantltatlve
Not very sensitive
Water-break test ASTM F22 The water-break test is performed General deanliness of surface is
by w ithdrawing the surfare to be
easily determined
tested, in a vertical posltlon, from Useful i n detecting hydrophobic
a C()ntáiner overílowing with
C()ntámínation
water. The i nterpr etátlon of the
test is based on the pattern of
wetting.
Not quantitative
This test identifies the presence of
r etained olls and greases
The test Is not applicable on ali
surfaces i ndudi ng, but not
limited to, electropolished
surfaces
ASTM A380 water-wetting Bench or fiel d test. lmmersed in,or Staini ng is evidente of free i ron,
Not quantitative
and drying; ASTM A967
flushed with distilled water then
w hich is detected through visual
alr dried. A modifled vcrsion of
water i mmcrsion practice
examination
A (PT (tost for
this test rcqulr esa solution of3% ldcntifies possible pitting corrosion
passivatíon))
to7%saltwater, w ith a final ri nse
Sites or embedded iron
prior to inspection, using 0 1·
quality water or better.
High-humidity test ASTM
A380 and ASTM A967
Practice 8 (Pl1
Bench test. Sample coupon is
Staini ng is evidente of free i ron,
immersed or swabbed with
which is detected through visual
acetone or methyl alcohol then
examination
dried in an lnert atmosphere. Thc
coupon is then subjcctcd to 97%
humidity át tOOºF for 24 hr or
mor e.
Not quantitative
Not used for installed tubi ng
Sample coupons can be used, but
docs not prove complete
coverage
l,engthy test
Containment cabi net req_ui red
Salt spray test ASTM A967
Practice C ( f'T)
Bench or field test. This test is
Rust or staining attributable to the Not quantitative
tondutted i n atcordance wi d,
presence of free iron partides
Longer·tenn testing is required to
A~'TM B117 subjecting the test
embedded in the surface will
test for passive film quality or
become noticeable on visual
corrosion resistance
area to a 5% salt solution for a
mlnlmum of 2 hr.
examination ofthc metal sul'face J-lowever, exposul'es over about 24
hr may show light staíni ng
resulting from di fferences in
micro ftnish texture
Group 2. Precision lnspection of Cleaned and Passivated Parts Under A380/ASTM A967 (Pass/Fail)
Solvent ring test ASTM A380 Bench test. Place a single drop of Good test for organit
Not quantitative
(CT)
high-purity solvent on the
contami nation on the test surface
surface to be eval uated, stir
brieny, then transfor to a dean
quartz microscopc slidc and
allow the drop to evaporate. l f
foreign material has been
dissolved by the solvent, a
distinct ring1A'ill be fo1med on the
outer e<lge of the drop as it
evaporates.
307
ASM.E BPE-2022
Table E-5-1
Test Matrix for Evaluation of Cleaned and Passivated Surfaces (Cont'd)
Type or Test
Test Descrlptlon
Pros
Cons
Group 2. Preclslon lnspectlon oí Cleaned and Passlvated Parts Under A380/ ASTM A967 (Pass/Fall) (Cont"d)
Black light inspection ASTM Bench test. This test requires the
A380 (CT)
absence of white light and a
flood-type ultraviolet light.
Suitable for detecting certain oil
Not quantitative
films and other transparent fil ms Not practica) when testing for
that are not detectable under
passivation
white light
Good test for organlc
contamination on surface
Atomiier test ASTM A380
(CT)
Bench test This test Is conducted in Test for pr esente of hydrophobic
accordancewithASTM F21 using
films
Not quantltative
Requires direct visual examination
01-quality water or better. A
This test is more sensitive than the
variation of the water-break tes t,
water-break tes t
this test uses an atomized spray,
rather t11an a simple spray or dip
to wet the suríace.
Ferroxyl tc-st ror free iron
Bench or field test. Apply a fres hly ldentlflcatlon of free iron
ASTM A380/potasslum
pr epared solution of 0 1-quality
fe rricyanide-nitric acid
ASTM A967 Practice E
water or better, nitric acid, and Very sensitive test
potas.sium fe rricyan ide to the
coupon using an atomizer having
no iron or st eel parts. After 15 sec
a blue stain is evidc-nce or s urface
iron. Remove solution from the
(PT)
contamination on surface
sur face as so-0n as possible after
testing, per ASTM A380 or ASTM
Not quantitative
Thls test will only identify free in>n
on the s urface and will not
directly measure the
improvements of the passive
oxide layer
This is a very scnsltlvc test and shall
be pcrformed by personnel
familiar wíth it.S li mi tati ons
Either a sacrificial coupon is used
A967. Test nonsystem coupons
only.
fo r this test, or the test area is
deaned as described in the
respective ASTM practice or
spccitlcation
Safoty and disposal issues cxi.stwith
the test chemical
Easy to get a false·positive result
Copper sul fate test ASTM
A380/ASTM A967
Practice D (Pl1
Bench test. Prepare a 250-cm1
ldentification of free iron
Not quantitative
solution consisting of 1 cm3 of
contamination on die test surface Embedded iron is detected, but
sulfuric acid (s.g. 1.84), 4 g
Is effective in detecting smeared
difficult to detect small discrete
copper s ulfate, and the balance in
iron depos its
iron particles
D1-quallty water or bcttcr. Apply
thls to a sacrlflcial coupon uslng a
swab. Keep t he surface to be
tested wet for a period of 6 min
with additional applications as
needed.
Group 3. Electr ochem ical Field and Be nch Tests
Cyclic polarization
measurements
This technique uses cyd ic
polarization mcasurc-ments
This test method provides a direct The medtod requires a potentiostat
measuremcnt of the corroslon
and corroslon software package
Similar to the ASTM G6I test
r esistance of a stainless steel
to make the measurements
method to measure the critical
surface.
To ensure reliable results,
pitti ng potentlal (CPP). The more The measured CPP provides a
operator s should be trained in
noble (more positive) the CPP.
quantitative measurement of the
electroc.hemical tes t techniques
the more passive the s tainless
leve) of passivation
steel s urfuce. Similar results may The test equipment is relatively
be obtai ned witll tl1c ASTM G! SO
lnexpensive
test that measures critica) pittlng
temperature (CPT).
308
ASME BPE-2022
Table E-5-1
Test Matrix for Evaluation of Cleaned and Passivated Surfaces (Cont'd)
Type of Test
Pros
Test Descrlptlon
Cons
Group 3. Electrochernlcal Fleld and Bench Tests (Cont'd)
Electrochemical pen
(ec-pen) ( PT)
The result is based on preset values. Easy to handle, short sample
This test does not quantify the
The s ize and shape of a writing
preparation time, real-time
passive layer, but instead
instrument, the ec-pen makes
results, a nd the possibility to run
provides a pass-fail indication of
electrolytic contact when placed
experimcnts on virtually any size
passivi ty
on thc test suríace. Capillary
objcct with various suríace
The local test area nccds to be
action causes electrolyte to now
geometries
from the reservoi r to the surface The ec-pen is a portable instrument
through a porous polymer body
while preventing the electrolyte
from leaking out of the pen. There
is a stable electrode inside the
pen mechanism. By slmply
positioni ng the ec-pen on the
s.ample surface, electrolytic
deaned a nd repassivated after
testing
for the measurement of
corrosion potential suitable for
field use
contact is established and
electrochemical characteriz.ation
is possible. The measured area is
typically 1.5 mm 2•
Koslow test kit 2026/3036 Similar to the ec-pen., in that i t
Mcasul'CScon·osion potentlal at the User sensltive
measures thc corros ion potencial
suríace
(PTJ
of the metal surface. 1.he Koslow
2026/3036 consists oí a meter, a
probe, and an interconnecting
cable. An electrical charge is firs t
applied to the test pie-ce, after
which a moist µad is placed on the
surtacc or the same test plccc.
The probe is pressed into the
moist pad to complete the circuit.
Within a couple of seconds the
cell voltage result appears on t he
digital meter.
Group 4. Surface Chemical Analysis Tests
Auger electron
spectroscopy (AES) (PT.
RTJ
Secondary and auger electrons, in
the targetcd arca of the test
coupon, are bombardcd with a
Provides quantitative analysis
Using a scannlng prlmary beam.,
secondary clcctron hnagcs yicld
The spedmen chamber s haH be
malntaincd at ultra•high vacuum
(UliV)
primary electron beam, which is
lnformation related to surface
The spedmen shall be electrically
used as an excitation source.
topography
conductive
Photoelectrons are s ubsequently Augerelectrons, when analyzed asa lnstrument is not readily available
ejected from the outer orbital of
fu nction of energy, are used to Expertise is needed for data
atoms in the target material. The
identify the elements present
interpretation
cjected photoelectrons are then
detected by means of electron
spectroscopy. Th• method by
which the ejected photoelectrons
are detected and analyzed is AES.
This test is useful for surfuce
analysis from Z A to a depth
Elemental compositlon or thc
surfaco to a depth of 2 A to 20 A is
determíned and can be used in
depth pr()filing appliCátiOnS
greater tlian 100 A.
309
ASME BPE-2022
Table E-5-1
Test Matrix for Evaluation of Cleaned and Passivated Surfaces (Cont'd)
Ty¡,e or Test
Test Descrlptlon
Pros
Cons
Croup 4. Surface Chemlcal Analysls Tests (Cont'd)
Electron spectrosoopy for
chemical analysis (ESCA)
also known as X-ray
photoelectron
spccn-oscopy (XPS) (PT,
RT)
Using X-rayas an excitation source, Provides quantitative analysis in
The specimen chamber shall be
photoelectrons are ejected from
measuring the following:
maintained at ultra·high vac-uum
the inner-shell orbital of an atom
(a) Elemental composition ofthe
(UHV)
from the target material. The
surface ( 10 Á to 100 Á usually)
lnstrument is not re;:idily available
ejcctcd photoclcctrons are thcn
(b) Empirlcal formula of pur c Thc specimen shall be
detected by means or XPS. The materiaIs
electroníC"dlly conductive
method by which the ejected
(e) Elements that tOntaminate a Expertise is ne-eded for dáta
photoelectrons are then detected surface
interpretation
and analyzed is ESCA (or XPS).
{d) Chemical or electronic state
Useful for surface analysis to a of each element in the surface
depth of 10 Á to 100 Á.
(e) Uniformity of elemental
composldon across thc top or the
surface (also known as: liné
profUing or mapping)
{fl Uniformity of elemental
composition as a function of ion
beam etching (also known asdepth
profiling)
GD·OES (glow discharge-
optlcal cmission
specn-oscopy) ( PT, RT)
GD·OES unifonnly sputters
The GD-OES method is particularly Relatively expensive
material from thc sample surface
useful for rapid, quantltatlvc
lnstrument not widely avallable
by applying a controlled volrage,
depth profiling of t.hki<• and thin•
current, and argon pressure.
film structures and coatings
Photomultiplier tube detectors
are used to identify the spe-cific
concentrations of various
elcmcnts based on thc
wavclcngth and intcnslty of thc
light emitted by the exclted
elettrons in each element when
they return to the ground state.
those used for postpassivation testing of installed piping
systems and passivated welded s urfaces.
Passivation is capable of dra matically increasing the
chromium-to-iron (Cr/Fe) ratio on the surface of 3161,type stainless steel when properly applied. One measurement of the degree of enhancement of the )ayer following a
chemical passivation treatmentis theCr/ Fe ratio as determined by AES, GD-OES, or ESCA. The procedure is not
readily a dapted to field use but may be useful in developing the passivation procedure.
A Cr /Fe acceptance ra tio, regardless of test method,
should be 1.0 or greater (see Table E-3.2-1}; because
of variab ility in accuracy, identica l res ults obtained
with the different test methods are not expected. The
s urface chem ical analysis tests in Group 4 in Table
E-5-1 include methods for evaluation of the th ickness
and chemica l state of the passive ]aye r on stai nless
stee l. Cycl ic pola rization measurements (Group 3 in
Table E-5-1) may also be used to provide a quantitative
evaluation ofthe level of passivation. Cyclic polarization as
well as the methodologies in Group 4 in Table E-5-1 might
be applied to sacrificial coupons placed in systems subject
to the complete passivation process.
(d) s urface chemical a na lysis tests
Groups 1 and 2 ofTable E-5-1 reflect the two main divisions in ASTM A380 and ASTM A967. The most obvious
type of examination of these methods is visual. The examine r s hall look for a clean s urface free of oxides,scale, weld
discoloration/heat tint, stains, dirt, oil, grease, or any
deposits that could prevent the chemical passivation solution from reaching the metal surface.
The test results from ASTMA967, which a re excl usively
for passivation, are ali based on visual detection of staining
or discoloration indicative of the presence of free iron.
These test results are subjective and nonquantifiable.
However, for sorne applications this may be a li that is
re qui red. The visual acceptance criteria in ASTM A380
a nd ASTM A967 apply.
Groups 3 a nd 4 of Table E-5-1 reílect t wo d istinct
meth ods of quant itative testing. These tests are not
contained in either of the ASTM standards. These tests
a re designed to provide a more qua ntifíable analysis of
a pass ivated s u rface. The electroche mica l field and
bench tests in Group 3 in Table E-5-1, with the exception
of cyclic polarization, are s uitable for field tests such as
310
ASME BPE-2022
NONMANDATORY APPENDIX F
CORROSION TESTING
Odier methods used to screen for more specific meta llurgical problems such as the presence of sigma phase,
chromium carbi des, or imprnper heat treatment a r·e
described in Table F-1-1.
F-1 GENERAL
Corrosion testing may be used to determine whether
the material manufacturer has used the appropriate
processing variables during the fabrication of the raw
product form. These variables include those primarily
related to thermomechanical processing and heat treatment. The material can be evaluated based on weight loss
or e lectrochemical response, or it can be measured by
des tructive testi ng tech niq ues such as to ughness
testing. The sta ndard ASTM tests that are common ly
used are shown in Table F-1-1. However, there is no guarantee that a tested alloy will be appropriate for a specific
e nviro nment even if it performs well in an industryaccepted test.
lt is often appropriate to test a number of candidate
alloys in a specífic environment. ldeally the test selected
should reflect the corrosion mode a nticipated in production. These corrosion modes include general corrosion,
crevice corrosion, pitting corrosion, a nd stress corrosion
cracking.
F-3 PITTING RESISTANCE EQUIVALENT (PRE)
NUMBER
F-2 CORROSION TESTS
For genera l corrosion, the most commonly used test
method is ASTM G31, Standard Practíce for Laboratory
lmmersion Corrosion Testing of Metals.
To rank materia Is based on their resistance to localized
corrosion, s uch as p ittíng corrosion, the two most
commo nly used electrochem ical methods are ASTM
G61. Standard Test Method for Conducting Cyclic Potentiodynamic Polarizatio n Measurements for Localízed
Corrosion, and ASTM Gl50, Standard Test Method for
Electrochemical Critica! Pitting Temperature Testing of
Stain less Steels.
311
Where testing is not possible or desired, owner/users
may use the PRE nu mber as a guide to ra nk a material's
corrosion resistance. Relative PRE number values for
sorne wrought stainless stee l and nickel alloys a re
shown in Table F-3-1. Notice thatalthough different equations are used to calculate the PRE number for the two
different alloy systems [see Table F-3-1. Notes (1) and
(2)], the numbers may still be used to compa re a lloys
for ra nking purposes.
Since the PRE numbers are calculated based on composition, the lísted va lues in Tab le F-3-1 are based on
nominal composition only and are not representative
of the ranges of PRE numbers that could result from
t he compositional ranges permitted by the applicable
material specification. The values listed in Table F-3-1
are not representa tive of values that may be obta ined
by composi ti ons specified by t he ow ner / user. The
owner/user is cautioned that PRE numbers should be
developed from the specific composi tion o f t he heat
intended for use in order to accurately rank or estímate
the alloy's resistance to pitting. Consideration should be
given to other factors that might reduce the corrosion
resistance s uch as
(a) improper heat treatment
(b) s urface finish and quality
(c) deleterious second pilases
(d) welding
(22)
ASM.E BPE-2022
Table f-1-1
ASTM Corrosion Tests
(22)
ASTM Standard
ASTM A262
Practice A (oxalic a cid
test)
Practice B (ferric
sulfate-sulfuric aci d
test)
ASTM A923
Purpose or Test
Data Obtalned
Qualitative test to deter mine susceptibílity Comparative, visual
to intergra nular attack as.sociated with
examination oí
chromium car bide precipitates, Tests
the effectiveness oí ñnal heat treatment.
Uscd to sc-recn spcdmcns i ntcndcd for
léStl ng i n Practíces 8, C, and F,:
microstnicture after
testing only
Quantitative test measuring weight loss
due to intergranular corrosion
Typlcal Alloys Tested
Austenitic stainless
steels
Report weight loss only Austenitic stainl ess
steels
associated with c,h romium carbide
precipitates, Also tests for sigma pitase
i n 321-typc alloys. Tests the
effectiveness or final hcat treatment
Practice C (nitric acid
test)
Quantítative t~t mea.suring weight loss Report weight loss only Austenitic stainless
due to i ntergranular corrosion
steels
associated with c,h romi um c.arbide
precipitates, Also tests for sigma pitase
i n 316·, 3 16L•, 321·, and 347-typealloys.
Tests the effectiveness of fi nal heat
treatment
Practice E (coppercopper sulfatesulfuric acid test)
Qualitative test to determine susceptibility Pass or fail
to intergranular attack associated w ith
chromium car bide precipitates, Tests
thc effectivencss or final hcat trcannent
Austenitic stai nless
steels
Method A (sodi um
hydroxide etch léSt)
Detcction of tite presencc or detrimental
int.er metallic phases. Used to screen
speci mens lntended for testing In
Method 8 and Method C
Duplcx stah\less stecls
Method B (Charpy
lmpact test)
Used to test toughness characteristics that l mpact toughness
may result from processing
energy
irregulárities
Visual examinatlon.
Pretest for
subsequent methods
Duplex stainless steels
Method C (ferric chloride Detects a loss of corrosion resistance
Report weight loss only Duplex stainless steels
test)
associated with a local depletion of Cr,
Mo, or both, as a result of the
precipitation of chromium-rich and
possibly molybdenum•rlch phases
ASTM G48
ASTM G28
Methods A and B ( lcrric Rcslstance to plttlng or crevice con·osion Rcport weight loss
chloride test)
Stalnless stecls, Ni-based
alloys, and Cr -bearíng
alloys
Methods C and O ( fe1TiC Resistance to pitting or cr evice corr osion. Report critical
chloride test)
Define the minimum temperature at
temperatu re
w hlch pi ttlng or c-revice corroslon
initiates. Test thc effects or aHoying
elements, final heat treatment, and
surface finish of final product.
Ni-based and Cr-bearing
alloys
Methods E and F (ferric Resistance to pitting or crevice corr osion, Report critic.al
chloride test)
Define the minimum temperature at
temperatu re
w hid l pi ttlng or c-revice corroslon
i nitiates. Test thc effects or aHoying
elements, final heat treatment, and
surface finish of final product.
Stainless steels
Method A
Tests the susceptibility to l ntergranular Report weight loss only Nl -based alloys
attack associ ated with composition and
pr ocessing
Method B
Tests thc susceptlbility to i ntcrgranular Rcport weight loss only Ni-based alloys
attack associated wi th composition and
pr ocessl ng.. specifically subsequent heat
treatments
312
ASME BPE-2022
Tabl e f -3-1
PRE Numbers for Stainless Steels per Table MM-2.1-1
Table f-3-1
(22) PRE Numbers for Stainless Steels per Table MM-2.1- 1
and for Nickel Alloys per Table MM-2.1-2
UNS
Number
EN
Des1gnatlon
and for Nickel Alloys per Table MM-2.1-2 (Cont 'd)
PRE Number
(Note (1)]
JIS
Deslgnatlon
NOTES:
(1) Cakulation of PRE numbers is based 0 11 typical analyses for the
Austenlt1c Stalnl ess Steels (Note (2))
S30400
respective alloys.
(2) For stainless steels, PRE number =%Cr + 3.3[%Mo + 0.5(%W)] +
16(%NJ.
(3) For nickcl alloys, PRE number = % C1' + 1.5(%Mo + %W + % Nb).
20
1.4301
19
SUS304
S30403
20
20
l.4307
19
1.4306
20
SUS304L
S31600
20
23
1.4401
23
SUS316
531603
23
23
1.4404
23
1.4435
26
SU316L
23
Superaustenitic Stainless Steels [Note (2)]
N08904
35
1.4539
36
N08367
43
S31254
42
1.4547
42
42
N08926
1.4529
42
Duplex Stainless Steel s ( Note (2)1
S32101
24
1.4162
24
S32205
35
1.4462
31
Ni ckel-Based Alloys [Note (3))
41
N06625
2.4856
41
NCF625
41
45
N10276
45
2.48 19
NW0276
N06022
45
46
2.4602
46
NW6022
46
GENERAL NOTES:
(a) Alloys listed between horizontal lines are not equivalent. but
comparable.
(b) The below are industry-accepted formulas. Other formulas may
be used at the owner/user's discretion.
313
ASME BPE-2022
NONMANDATORY APPENDIX G
FERRITE
(e.g., solution a nnealing of welded tubing) reduces the
a mount of ferrite in the weld.
lt should be recognized that many a ustenitic stainless
steels with high nickel content and nickel alloys do not
contain a ny ferrite in as-solidified welds.
Measuring of ferrite in production welds shall be in
accordance with AWS A4.2M:2006 (ISO 8249:2006MOD).
G·l GENERAL
Ferrite is a phase that may precipitate during solid ification of austenitic stainless steels depending on the ratios
of the alloying elements. The ferritic phase consists of
crystals wi th a body-centered cubic (bcc) lattice in
contrast to the face-centered cubic (fcc) lattice of the a ustenitic matrix. The presence of ferrite in auste nitic stainless steel welds may reduce the corrosion resistance in
some corros ive envi ronments. However, a min imu m
ferrite leve! may be required to maintain specific properties o f particu lar prod uct forms (e.g., castings) or is
dee med necessa ry to prevent hot cracking of heavy
wall weldments (e.g.. vessels made from plate).
The ferrite leve! of auste nitic sta inless steel base metal
strongly depends on heat a nalysis, prima rily the chromium to nickel ratio, product form. and final heat treatment. Whereas wrought 316L-type s tainless steel
materia ls in the solution annealed condition typically
show very low ferrite levels of O vol.%- 3 vol.%, CF8M
and CP3M s t ai nl ess stee l castings may co ntai n
10 vol. %- 20 vol.% of ferritic phase in the a ustenitic
matrix.
As·solidified austenitic stainless steel welds typically
have higher ferrite levels tha n the base metal. This is
caused by rapid cooling that prevents the ferrite to auste·
nite transformation from proceeding to the rmodynamic
equ ilibrium. The ferrite leve! of as-solid ified austenític
sta inless steel welds can be determined from the WRC·
1992 Constitution Diagram fo r Sta inless Steel Weld
Metals 1 using a ch romium equivale nt Cr (eq) = %Cr +
% Mo + 0.7%Nb a nda nickel equ ivale nt Ni (eq) = % Ni
+ 35%C + 20%N + 0.25%Cu. Postweld heat treatment
G-2 INFLUENCE OF FERRITE IN
BIOPHARMACEUTICAL SERVICE
Ferrite in the base metal and welds can havea beneficia!
or a negative effect depend ing on the particular service,
but generally offers little concern for biopharmaceutical
services. Laboratorycorrosion tests in severe biopharmaceutica l service have shown that increased amounts of
weld metal ferr ite somewhat lowers corros ion resistance.2 However, in high-purity water systems, there
have been no reported system failures related to delta
ferrite content in welds.
G-3 CONTROL OF FERRITE CONTENTIN WELDS OF
AUSTENITIC STAINLESS STEELS
Ferrite in welds of a ustenitic stainless steels can be
controlled by one or more of the following methods:
(a) postweld solution annealing
(b) use of weld filler with increased nickel content
(e) increaseof nickel equivalentby addition ofapproximately 1 vol.%-3 vol.% nitrogen to shielding gas
{d) selection of heats of materials with high nickel to
chromium ratios. such as the European steel grade 1.4435
(see Table MM-2.1·1) with a restricted Cr(eq) to Ni(eq)
ratio 3 as per BN2 4
2
R. Morach ánd P. Gintcr, "lnílucncc of Low 6-Fcrritc Contcnt on thé
Con·osion Behaviour ofSta inless Steels," SUJinless Steel World, September
1997.
3 C,·(eq) 1
0.91 Nl(eq) s 7.70, with
(a) Cr(eq) = %Cr + !.$%Si+ %Mo + 2%Ti, and
0. 1. Kotecki and •r. A. Siewert, ...W~C-1 992 Constitution Oiagram fo r
Srainlcss Stctl Wcld Metals: A Modification of thc WRC-1988 Diagram;"
IVeldi'\9 Joumal 71(5), p. 171-s, 1992.
(b} Ni(eq) = % Ni + 0.5%Mn + 30%C + 30(%N-0.02)
• Bosler Norm BNZ (N '11.265), Nichtrostender Stohl noch BN2, 1997.
314
ASM E BPE-2022
NONMANDATORY APPENDIX H
ELECTROPOLISHING PROCEDURE QUALIFICATION
(a) prepolish inspection process
(b) precleaning process
(e) specific gravity a t operating tempera ture of electrolyte bath (mínimum a nd maximum)
(d) bath analysis data (last date analyzed, iron/water
concentrations of e lectrolyte, adjusted specific gravity
value)
(e) resistivity of final deionized rinse water (mínimum
and maximum)
Qualification will be supported by interna! documenta•
tion for each method. The actual values of the essential
variables listed above s hall be documented, mainta ined,
and available for customer review.
H-1 SCOPE
This Appendix defines a method for qualifying the electropolishing process used for electropolis hing component
(s) surfaces that will be exposed to the process tluids in
bioprocessing and pharmaceutical systems a nd ancillary
equipment.
H-2 PURPOSE
This Appendix is inte nded to provide general guidelines
for q ua lification of the e lectropolish methods used to
achieve required s urface improvements. Electropolishing
is used to impart a s urface that
(a) shall be free of oxide contamination a nd undesirable metallurgical conditions
(b) ta kes advantage of a material's s urface che mical
characteristics minus any damage or degradation from
the component(s) manufacturing process
(c) exhibits a surface that is free of the surface irregula ri ties that result from prior machin ing a nd formi ng
processes
( d} optimizes corrosion resistance
H-3.2 Essential Variables
The electropolis h vendor shall develop a n electropolis hing procedure for each method used. The procedure
will be developed to ensure t hat essential variables
used to produce the qualification samples can be reprod uced. The electropolishing procedure, as a mínimum,
shall include the following essential var iables:
(a) amperage/time (mínimum a nd maximum)
(b) t e mperatu r e ra nge of ba th du r ing process
(mínimum and maximum)
(e) electropolish process
(d) fina l rinsing/cleaning process
(e) fina l inspectio n requirements
H-3 ELECTROPOLISH PROCEDURE
QUALIFICATION
H-3.1 Method Procedure
This Appendix is inte nded to provide general guidelines
for qualifying the electropolish process used to provide
the surface improvements of component(s) required.
The electropolis h vendor s hall produce sample compo•
nent(s) or coupons from each electropolish method used
(e.g., subme rsion, spot, in situ) for the purpose of demonstrat ing that t he method is capa ble of p roviding t he
required s urface characteristics.
The electropolis h vendor should also demonstrate the
abili ty to reproduce the method used on the qualification
component(s) or coupons on the production componen!
(s) a nd/or equipment for which the method is being qual·
ified.
The electropolis h vendor shall have a written quality
control program that shall describe, as a mínimum, the
following:
H-3.3 Vendor Documentatlon
The electropolish vendor, as a mínim um, shall generate
and maintain the following additiona l information:
(a) scanning electron microscope (SEM) records for
each process qua lification sample produced.
(b) XPS (ESCA} records for each process qualification
sample produced. These results must meet the criteria of
Table H-3.3-1.
(e) actual sample(s) used to qualify th e process.
(d) process control records.
(e) the e lectropolish procedure used.
(fJ final R. (if required).
(g) copies of Certificate of Conformance (C of C) for
each job.
315
ASME BPE-2022
Table H-3.3-1
Mínimum Surface Requirements for Process Qualification Samples
Surface Photo
Material
UNS S31600
Cr/Fe Ratio
1 to 1 or greater
UNS S31603
NOTES:
( 1) Test method: X-ray photoelectron spectroscopy (XPS/ESCAJ analysis.
(2) Scanning electron microscopy (SEMJ.
H-3.4 Certificate of Conformance
The electropolish vendor. if requested by the customer.
shall provide a Certificate ofConformance with each type
of component(s) that shall include but is not limited to
(a) vendor's company
(b} customer's name
(e) description of component(s)
(d} identification of the electropolish procedure used
(e) final surface finish report (Ra if required by the
customer)
316
Oepth ( Note (1))
(Note (2))
15 A minimum
!SOX
ASME BPE-2022
NONMANDATORY APPENDIX J
VENDOR DOCUMENTATION REQUIREMENTS FOR NEW
INSTRUMENTS
J-1 OVERVIEW
J-2 INSTRUCTIONS FOR USE
J-1.l Section 1: VDR Definitions
Together, these two sections are intended to be used by
end-users, design and procurement agents, and vendors,
to identify the documents required to support comm issioning/qualification, installation, operation, and mainte·
nance of instrumentation for the biopha rmaceutical
industry.
These documentation requirements may be modified,
as necessary, to retlectthe actual documents required for a
particular instrume nt, based on t he instru ment's
complexity, application, end-user's specific requirements,
etc.
This section identifies the vendor documentation requirements (VDR) n umber, document title, and definitions for the documentation (see Table )·1.1· 1).
J-1.2 Section 2: lnstrument Types and Required
Documents
Th is section identifies the major instrument types and
t he requi red documentation, by VDR n umber (see
Table )·1.2-1).
317
ASME BPE-2022
Table J-1.1-1
Vendor Documentation Requirements for New lnstruments: Section 1, VDR Definitions
(22)
VDR #
Docu mentatlon
Oeflnitlons
Certífied Ar rangements/
Assembly Dr awings
Provide Cert:ified Arrangements/Assembly Drawi ngs for the tagged component (or tagged
packaged equipment (skid)] speci fied on the P.O. A "Certified Arrangement" or
"Assembly Drawing" means that a statement, signed and dated by an autho1ized
company representative, is i ncluded on (or with) die drawing. certifyi ng the component
(or slddJ has been manufacrurcd i n accordance with statcd applicablc ícderal and
state or i nternationally rccognized regulatory requircmcnts and the designatcd
component (or skid), by tag number, conforms to the established índuSlry standards and
product specifications.
2
Catalog information, cut
sheets, product bulleti ns
This information shall include the suppl ier's literature for the component being
purchased. Tite literature shall indude dimensions, materials of construction. and
layout conslderations such as oricntation, typical utility requiremcnts, power, and
instrumcnt alr.
3
Oetailed parts list/bill of
material
Provide a complete listing of all subassemblies, parts, and raw materials that compose
tite final {finished) component (or sk.id). lnclude the quantity of each item.
4
lnstallatlon, operatlon.
maintcnancc, and
lubrication
manual(s)
Provide manuals for thc components (or skid) bclng purchascd. Manuals should lnclude
installadon guidclines, detaHed operating i nstructions wlth operatlng ranges, settings,
etc. Also, lnclude Stép•by•step startup, OJ>éráting, and shutdown procedures and
malntenance procedures for ali required mai ntenance/repairs and l ubñcation schedule.
5
Recommended spare parts
for 1 yr normal
maintcnancc
$pare parts list w iU include the vendors' recommended listing of spare parts required
for 1 yr, assuming tltat the system is cycled once a week (SO times/yr); the l ist is to
includc the tag numbcr (lf appUcable), a description of cach part sufflcient for
ordering. and the vcndor's part numbcr.
6
Certified l:,erformance
Report
Provide a Certified Perfor mance Report that states that the i nstrumentation by tag
number and serial number conforms to the stated proces.s ranges established in the
stated specification. The Certified Perfonnance Repo11 must be signed and dated by
an authorized person from the manufacturer or subsupplier who performed tite test
Typkally this testing is a destructlvc test. and thc instrumcntatlon being purchascd
was produced by the samc manufacturlng process w ith thc samc material supplicr(s).
7
Wiring schematics
Provide drawings that show the following:
(a) terminal strip/V\'lr ing numbe1ing
(b) starter, overloads, protective devires
(e} ALL clcctrlcal componcnts
(d) lnstrumcntatlon (electlical connections)
8
lnstrument calibration
n,ports
Calibration certificates or rep<>rts must be traceable t() NIST or other i nternationally
r eoognized and agreed-on calibr ation standards. 'fhey must also include the
procedure used, calibration data/results, the calibration date, the person who pe1f ormed the
calibration, along with the serial number(s) of the standards or e-quipment used in
tite calibration process. Ali calibr ation certific.ates or repor ts must contain the instrument serial
numbcr.
9
Siiing calculations
Given tw(> or three of the followlng parameters, provide the sizing calculations,
designated by tag m1mber, for the design tlow:
(a) <ype of liquid ond viscosi<y
(b) piping size
(e) Row
For relief devlces, thc c.alculadon to show thc rcllcving flow, set prcssurc, back
pressure, vacuum, speclfic gravlty, viscosity, coeftidcnt of dischargc, back prcssurc
coefficient, viscosity (or other applicable) coeíflcient, cakulated ré-quired ar ea In
squar e inches; summary to show the manufacturer, model number, and the
selected area.
10
Mater ial Test Rcport for
metallic matcr lals
The Material Test Report for process contact mctallic materials shaJI conform to thc
r cquircmcnts Usted i n Pal't GR. REQUIRED ONLY FOR HYGIENIC APPLICATIONS
11
Certificate of Conformance
for elastomers
The Certificate of Conformance for process contact elastomer materials shall confonn to
the r equirements listed in Part GR. REQUIREO ONLY FOR flYGIENIC APPLICATIONS
12
Certificare of Confonnance
for surface Hnish
The Ce11i ficate of Conformance for surfare finish must be uniquely identified by tag
numbcr, serial number. and/or model numbcr; state the associated surface tlnish valuc
in R" or BPE designadon pcr Part SF; and whethcr any pollshing comp,ounds wcre used
to meet the stated speci fkati()n. l f polishing compo1mds are used they shall be
inorganíc and animal source material-free as stated on the CertífiCáté of Confor mance.
The Certificate of Conformance must be signed and dated by an authorized person from
the manufocturer. REQUIRED ONLY FOR HYGIENIC APPLICATIONS
318
ASME BPE-2022
Table J-1.1-1
Vendor Documentation Requirements for New lnstruments: Section 1, VDR Definitions (Cont'd)
VDR #
Documentadon
13
Certificate C)f Coníormance
for polymer·based
Definltlons
The Certificate of Conformance íor pn>cess contact polymer•based materials shall coníonn
to the requirements listed in Part GR. REQUI RED ONLY FOR HYGIENIC APPLICATIONS
materiaIs
Table J-1.2-1
Vendor Documentatlon Requirements for New lnstruments: Section 2, lnstrument Types and Requlred Documents
lnstrument Types
Required Oocuments (VOR Number)
Conservatlon vent valve
2. 3, 4, 5. 7, 10, 11. 12. 13
l . 2, 3, 4, 5, 6. 9, 10, 11, 12. 13
Control damper: Aow/hurnidity/pressure/temperature
Control valve: analytical/ílow/humidity/ level/ pres.sure/temperature
Controllcrs, lndlcating controlle1's
2, 4
1, 2, 3, 4, 5, 7. 9, JO, 11, 12. 13
2, 3, 4, 5, 7
0/P trans míuer: Row/level/pressure
Oamper actuator
2, 4, 7, 8, 10, 12
2, 4, 7, 9
2, 4, 7
Analytical element: condition/density/pH/resistivity
Elcctrlcal components
Flow element
Flow orifice
1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13
2, 4, JO, 11, 12, 13
2, 3, 4, 5, 7, 10
Flow switch: thermal
Flow valve, automated valve assembly
lndicator: flow/level
lndicator: humidity/pressure/temperature
1, 2, 3, 4, 5, 7. 10, ll, 12, 13
2. 3, 4, 5, 10, 11. 12, 13
2. 4, 8, 10. 12
2, 3, 4, 5, 7, 10, 11. 12, 13
Lcvcl element
Leve! transmitter: microwave
2, 4, 7, 10, 11, 1 2, 13
2. 4, s, 7. 1 0. 12
2, 4, 7
Lighting
MisccUaneous lnstrumcnts: alarm/elemcnt/switch/transmitter
Positioner/transducer 1/P: pressure/speed/temperature
Pressure element, pressure safety element
2, 4, 7
2. 4, 6, 10. 1'1. 12, 13
2, 4
Pressure port
Pressure safety (reliel) valve
Recorder, indicating reoorder
Rcgulator valvc: tcmpcrature/pressurc
1, 2, 3, 4, 5, 6, 9, 10, 11, 12, 13
2. 4, s, 7
l . 2, 3, 4, 5, to, 11. 12, 13
Sight glass
Smoke detector, motion detector
2. 3,4,5, 10, 11.12, 13
2. 3, 4, 5
Solcnold valvc
Switch: current/limit
Switch: analytical/flow/level/pres.sure/vibration
2. 4, 7
2, 4, 7
2, 3, 4, 7, 10, 11. 12, 13
2, 4, 7, 8, 10
s.
Tcmpcran.1 re elemcnt: RTD
Temperdture switch
·rhermowell
Transmitter: a nalytical/flow/humidity/ level/pressure/temperature/weight
Weíght elernent
319
2, 4, 7, 10, 12
2, 10. 1 2
2. 3, 4, 5. 7
2, 3, 4, 5, 7, 8
ASME BPE-2022
NONMANDATORY APPENDIX K
STANDARD PROCESS TEST CONDITIONS (SPTC)
FOR SEAL PERFORMANCE EVALUATION
(•e) valve type
(·d) valve size
(·e) valve model number
(b) Test samples shall be representative of a certain
model or product range of sea ls and shall be chosen
randomly from those fabricated with the standard manu•
facturing process. Any modifications that may impact
performance sha ll be included in the test report, e.g.,
travel stops. Knowledge of factors that impact material
performance may help determin e the mínimum selection
crite ri a of samples. Appropria te study des ig n or
supporting data a re required to support ali conclusions.
Any differences or factors that impact material performance across the commercial product range shall be
addressed. This includes, but is not limited to, sea! materia Is of construction, size, shape, a nd manufacturing
process.
K-1 SEALING COMPONENT PERFORMANCE
EVALUATION
(22)
K-1.1 Material and Component Testing
Standard process test conditions are presented here in
order to assess sealing components (hygienic union sea!
materia Is and diaphragm valve componentseals). Asimulated steam -i n-place (SIP) tes t cycle is p resented in
K-1.2.l. Other process cons iderations are presented in
K-1 .2.2 . Any s peci fic process conditions tha t fall
outside the design of this standard test should be evalua ted separately.
The specific ma terial composition(s) used in the test
article shall be evaluated against the process conditions
to which it may be exposed, including routine sterilization
and cleaning. For diaphragm valve testing, the test article
should reflect the specific valve configuration to be used in
the anticipated application. Other conditions or process
parameters/ch emica ls, such as allowable extreme
process upse t condit ions and nonroutine treatments
(e.g., passivation, derouging), should also be considered.
Form S-1, Application Data Sheet, defines a number of
operational condi tions (e.g., che mistry, temperature,
pressure) to consider when developi ng nonstandard
performance tests.
Before testing
(a) verify that t he mate rial/component's service
tempera ture a nd pressure rating meet the desired
process conditions, including sterilization and cleaning.
(b) verify that the materialfcomponent is compatible
with the intended process and cleaning chemicals a t the
routine concentrations used, including consideration for
extreme allowable process conditions, per Part PM .
K-1.2 Exposure Testing
Section K-1.2.1 presents a simulated SIP test describing
a typical steam sanitization cycle thatcan be performed on
test articles. Actuation requirements in K-1.2.1 a pply to
valve testing only.
K-1.2.l Simulated Steam-in-Place Testing. Expose
the material to multiple SIP cycles to esta blish a life expecta ncy for the application and configuration. The testing
cycles should occur without inte rve ntion (e.g .. retorquing
of clamps or fasteners ). beyond initial installation procedures. Ali deviations identified during the test program
sho uld be documented and ana lyzed, íncluding their
impact on the test results and conclusions.
The cycle will consist of the following:
(a) Jnitial lnstallation and Preparation. This typically
includes assembly, cleaning, performance ve rification
(routinely includes a thermal exposure cycle to allow
the sea ls to set), seating of seals, and retorqu ing of
valve clamps and fasteners, etc., per the manufacturer's
procedures.
(b) Jnitial Performance Evaluation. Verify the initia l
performance of the sealing component per K-1.2.3.
(e) Steam-in-Place. Expose the system to a simulated
SIP with saturated USP pure steam or eq uivalent (e.g.,
stea m generated from DI/RO water or equivalent) .
K-1.1.l Test Article Requirements
(a) The following information, ata mínimum, shall be
included in test reports:
(1) seal type
(2) sea! size
(3) sample size
(4) maximum rated pressure of valve or sea!
(5) for valves only
(•a) actuator model number and spring pressure
(·b) air pressure supplied to actuator
320
(22)
ASME BPE-2022
{1} System Temperacure/Pressure. Mínimum
temp eratu re of 266•1' (130ºC) representing 24 psig
(1.65 barg) under saturated steam conditions (refer to
SD-2.3.1.1)
(2) System Stabilization Time. Mínimum of 5 min
(3) Test Exposure Time. Mínimum of 30 min at
greate r tha n 266ºF (130ºC)
( 4) Actuations. Mínimum of 30 actuations (cycle time
to allow for valve to move from fully open to fully closed
and back) per cycle (at SJ P temperature)
(d) Cooldown. Cool the system with a combination of
ambient clean dry a ir and deionized, or better qua lity,
water.
(1) Aír Cooldown
(-a) System Pressure. Atmosphe ric press ure or
above
(·b) Cooldown Tar9et. Until the system reaches
122ºF ± 9ºF (50ºC ± 5•ci
(2) Water Cooldown
(·a) System Pressure. Atmospheric press ure or
above.
(·b) System Flow Tar9et. Flow velocity target 2: 5~/
sec (1.52 m/s) for line size up to 2 in. (50.8 mm). Record
velocity used.
(-e) Cooldown Tar9et. Until th e system temperature is less than 86ºF (30•C).
(-d) Actuatíons. Mínimu m of 15 actuations (cycle
time to allow for valve to move from fully open to fully
closed and back) at ambient temperature under tlow conditions.
(e) Performance Evaluatíon. Assess the performance of
the seal ing component at appropriate intervals (e.g.,
initial, 1O cycles, 100 cycles, 500 cycles, and final) per
K-1.2.3.
(f) Repeat Steps. Repeat steps in (e) a nd (d).
(9) Final Performance Evaluation. Assess the performance of the sealing component at the completion of
testing per K-1.2.3.
K·l.2.2 Other Process Testing Considerations
K-1.2.2.1 Vacuum. The ability of th e system to hold
vacuum s hould be considered for routine process equipment, where applicable. Specific applications that require
vacuum, s uch as a utoclaves and lyophilizers, shall require
the addition of a vacuum hold test requirement.
(b) For valve sealing components, use test procedure
and acceptance requirementsof seat tightness, Test P12 of
EN-12266-1 with maximum allowable seat leakage rate A.
(e) For a li sealing components postexposure, complete
and docu ment a test for entrapment. The test s hould
enable assessment of process media migration beyond
the primary sealing point of the sealing componen! post•
expos ure. Tes ting s hou ld be performed at a mb ie nt
temperature for 1 hr oras required a t 90 psig (6.21
barg) (shell) or at the component design pressure, whichever is less, using a suitable soiling media (e.g., color dye,
UV fluorescing solution). The assessment is to be made
and photographically reco rded on dismantling of the
components.
K-1.3 Test Acceptance Criteria
K-1.3.l Hyglenlc Flttlngs. The sea! will be classified as
a Leve! 10, 100, or 500 sea!, if a li of the following acceptance criteria are met after the corresponding number (1O,
100, 0 1· 500) of SIP exposure/cooldown cycles:
(a) Pressure hold test shall be passed after the 10th,
100th, and/or 500th SJP exposure cycle.
(b) Confonnance to MC-4.2 s ha ll be established after
the 10th, 100th, a nd/or 500th SJP exposure cycle (lntrusion Category I or 11) for gaskets.
(c) The condition of the sea! shall be examined after the
10th, 100th. and/or 500th SI P exposure cycle. and any
direct visible changes (e.g., surface defects. compression
marks, discoloration, or erosion) shall be recorded.
Cracks, tears, or holes will be considered failures.
(d) lnspection at O (initial), 10 (through outlet), 100
(through outlet), an d 500 (through disassem bly of
fittings) cycles.
K-1.3.2 Valve Dlaphragms. The purpose of this section
is to establish recommendations for evalua ting diaphragm
service life under specified process conditions in order to
(a) provide accepta nce criteria for hygie nic performance of diaphragms when conducting the performance
evaluation test per this Appendix.
(b) provide ad ditional observations t hat may be
recorded after pe rforming the test or when evaluating
valve diaphragms that a re in service.
K-1.3.2.1 General Requlrements for Performance
Evaluation Test for Valve Diaphragms, per This Appendix.
Prior to testing, ensure that
(a) the manufacturer·s installation and operational
procedures are followed.
(b) a new diaphragm and new backing (if applicable)
are used.
(e) the valve mating s u rfaces are dry and free of
scratches a nd any residual material.
(d) the manual bonnet or actuator compressor is undamaged.
Figures K-1 .3.2.1-1 through K-1.3.2.1 -5 provide visual
reference to the term inology used in this section.
K- 1.2.3 Performance Testing and Acceptance
Criteria. Test the sealing components to evaluate their
ability to ma intain the component's integrity before,
during, and after exposure (e.g.. ini tial, 10 cycles, 100
cycles, 500 cycles, a nd fina l), using the test procedures
a nd accepta nce requ irements of EN-12266-1 andas
outlined below.
(a) For ali sealing components, use test procedure and
acce ptance requirements for s hell tightness, Test Pll of
EN-12266-1.
321
i\SME BPE·Z02Z
Figure K-1.3.2.1-1
Weir-Style Diaphragm
Stud
(al Bayonet Style
Stud
(bl Threaded Style
322
ASM E BPE-2022
Figure K-1.3.2.1-tcont'd)
Weir-Style Diaphragm
(e) Button Style
--------Id) Exa mple of Diaphragm Marking
323
ASM.E BPE-2022
Figure K- 1.3 .2.1- 1
Weir-Style Diaphragm (Cont'd)
Reinforcement fabric
(if present)
(el
Diaphragm center bead (if present)
Diaphragm sealing bead (if presentl
lfl
Soft diaphragm backing
PTFE diaphragm
(g )
324
ASM E BPE-2022
Figure K-1.3.2.1-2
Weir-Style Body
Valve body sealing bead
(if present)
Figure K-1.3.2.1-3
Radial-Style Body
Valve seat
Valve cavity
325
ASME BPE-2022
(5) Reinforcement fabric, if present, does not penetrate into product contact surface.
(6) No visually apparent adherence of diaph ragm
material to valve seat.
(b) The following checks can aiso be recorded as observations after performing the test, where applicable. These
arealso useful whe n evaluating valve diaphragms that are
in service.
(1) Check t hat the marking o n t he d iap hragm.
according to MC-3.3.2.3(b)(4). is present a nd legible.
(2) Check that the diaphragm stud is firmly attached,
not rotated, a nd undamaged. The bayonet pin should be
cente red to the stud.
(3) Check for creases or ma rks that traverse the
sealing bead. Sorne tlattening of the bead is a normal
occurrence from compression during assembly and/or
operation. Uneven compression indicates improper
assembly.
(4) Check that deformation into valve cavities aligns
with the center bead a nd is not excessive.
(5) Check that compressor deformation marks on
the backing align with the center bead and are not exces·
sive. Extreme deformation is an indication of overciosure.
(6) Check that the backing is free of splits and cracks.
(7) Check that bolt holes are round and not elongated. Elongated bolt holes indicate overclosure and/or
improper assembly or excess ive service li fe.
(8) Check for any diaphragm discoloration. Discoloration of diaphragms may be unrelated to diaphragm
performa nce (e.g., rouging) oran indication that the
diaphragm is not suitable for the application (e.g., unsuitable d iaphragm material selection).
(9) Check that there is no evidence of adherence of
dia phragm material to the body/bonnet tlange.
Figure K-1.3.2.1-4
Manual Bonnet
Bonnet fla nge
Compres.sor
Figure K- 1.3.2.1-5
Pneumatic
K-2 MECHANICAL SEAL PERFORMANCE
EVALUATION
K-2.1 Mechanical Seal Performance Evaluation
MC -4.3.2 of t his Standa rd enumerates t he various
poinrs, from manufacture to owner/user, that seal performance may be tested. This Standa rd recommends that the
performa nce test of the supp li e r/ ma n ufactu rer be
accepted at each point. Th e reason for this is twofold,
as follows:
(a) A mechanical seal is a complex piece ofequi pment,
a nd seal designs have proven to be very reliable directly
from the supplie r/manufacturer.
{b) A performance test conducted in a n environment
other than the process operating conditions a nd the specific piece of equipment provides little more than generalized results.
K-1.3.2.2 Test Acceptance Criteria - Required
Criteria for Hygienic Performance of Diaphragms
(a) After conducting performance evaluation testi ng
per this Appendix, the following criteria will determine
if the diaphragm has passed or failed the test:
{ 1) Valve passes pressure test cr ite ria per th is
Appendix.
(2) Diaphragm sn,d is a ttached.
(3) Produce contact surface is free of surface splits,
tears, cracks, or blisters.
(4) Diaphragm tlexes a nd inverts without dispiaying
a ny cracks or tears to product contact surface.
K-2.1.1 Factors Affecting Seal Performance. Seai
performance may vary significantly depending on the en·
vironment in which the seal will operate. Mechanical seai
326
ASME BPE-2022
designers shall take into account many factors, including
the following:
(a) shaft speed (revolutions per time)
(b) shaft size
(e) process pressure
(d) process temperature
(e) tribological characteristics of the lubricating fluid
(f) weepage expectation
(g) equipment on which the sea] operares
(h) start-stop operation
(i) barrier or buffer fluid availability
GJ multiprocess characteristics Jike CJP and SI P
(e) improper selection of materials
(d) insufficient cooling
(e) dynamic secondary seal hang-up
K-2.2.3 Equipment-Based Failures. Examples of
equipment-based faílures are
(a) excessive run-out/detlection
(b) bolting d istortion/equipment mounting tlange tlatness
(e) equi pment alignment
{d} pipe strain a nd pipe support issues
(e) vibration
(n bearing failure
K-2.1.2 Design Parameters. Once ali process information is understood, the sea] designer shall determine the
following:
(a) seal face material(s)
(b) secondary sea] material(s)
(e) type of lubrication such as boundary Jubrication or
full fluid film lubrication
(d) sea] balance
(e) color of wearing materials
(f) flush (piping) plan
Ali ofthese factors affect operating life and weepage of
the mechanical sea!.
Sea! performance is dictated by many factors. A properly designed, installed, and operated sea! can exceed
operational expecta tio ns. Ma ny mechani cal seals do
not meet thei r operational Jife because of a variety of
errors. Exceptions to normal sea l wear t hat lead to
failure are listed, in part, in K-2.2.
K-2.2 Exceptions to Normal Seal Peñormance
K-2.3 Mechanical Seal lntegrity Tests
Performance oí mechanical seals may be tested severa!
different ways. Test methods may vary between compa·
nies, andsometimes within acompany. K-2.3.1 and K-2.3.2
provide a framework from which a test procedure may be
d rawn followed by a reasonable assessment of the test
results. Unless otherwise specified, the test fluid is
water for the liquid seals and oil-free compressed ai r
o r nitrogen for the gas sea ls. These tests will o nly
ve rify t he integrity of the sea! faces and secondary
seals. These tests do not re vea! a ny information about
the validity of the sea! selection, expected sea] li fe, or
dynamic sea! performance. The tests describe examples
of effective methods to verify sea! integrity. The owner/
user may mod ify the test or pass/fail criteria.
K-2.3.1 Single Mechanical Seals: Liquid Lubricated by
Process
(a) Wet Test. A single-cartridge sea! or noncartridge
sea! shall be installed in equipment for a performance
test A líquid sea! is tested dynamically with liquid lubricat ion. Visible leakage is a typical quantifier to verify integ·
rity of a seal.
(1) Dynamic Wet Test for liquid-Lubricated Single
Mechanical Sea/
Step J. Follow ali safe ty rules a nd regu lations
during assembly and testing of the sea!.
Step 2. After the sea! has been installed, ílood the
equipment with the test líquid, paying special attention
that the sea! chambe r has been completely tlooded.
Step 3. Confirm that the equipment is capable of
withsta nding the test pressure.
Step 4. Operate and pressurize the equipment.
Ste¡, 5. Observe the sea!. lf the test criteria have
been met, the sea! passes the test
Step 6. lf the sea! fails the test criteria initially,
consider operating the equipment longer to see if the
sea! wears in a nd passes the test.
Step 7. Document the results.
Step 8. lf the sea! does not pass the test, follow the
procedure for resolution.
lt is rare tha t e nd face mechanical seals "wear out." For a
seal to be "worn out" implies that one or both of the
primary sea! faces have worn away d ue to normal
rubbing friction. Three groups of examples to the exceptions to normal sea! performance a re listed in K-2.2.1
through K-2.2.3.
K-2.2.1 Event-Based Operational Failures. Examples
of event-based operational failu res are
(a) pressure reversals
(b) dead-heading pump
(e) process upset conditions
(d) tampering with sea! support syste m or support
system upset
(e) lubricating fluid becomes contaminated
(f) dry sea! runs wet or liquid sea! runs dry
(g) faces glue together during shut-off
(h) shock-induced failure - shaft
K-2.2.2 Design- and Applícation-Based Failures.
Examples of design· and applícation-based failures are
(a) runningseal dry when a líquid sea! was designed or
running seal wet when a dry sea! was designed
(b) operation outside of sea! design parameters
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ASM.E BPE-2022
(2) Static Wet Test for Liquid-lubricated Single
Mechanical Sea/
Step 1. Follow ali safety rules and regu lations
dur ing assembly and testing of the seal.
Step 2. After the sea) has been installed, flood the
equipment with the test liquid, paying special attention
that the sea) chamber has been completely flooded.
Step 3. Confirm tha t the equipment is capable of
withstanding the test pressure.
Step 4. Pressurize the equipment.
Step 5. Observe the sea l. lf the test criteria are met,
the seal passes the test.
5tep 6. lf the sea) fails the test criteria initially,
consider rotating the shaft manually a few turns.
5tep 7. Document the results.
5tep 8. lf the sea) does not pass the test, follow the
procedure for resolution.
(b) Dry Test. A single-cartridge liquid mechanical sea)
ornoncartridge liquid mechanical sea) shall be installed in
equipment for a performance test. A liquid sea) tested dry
with gas pressure, typically air or nitrogen, is tested stati·
cally. Gas flow across the sea) is the typical quantifier to
test the integrity of the seal. lf the flow rate of gas across
the sea) is greate r than 1 std. ft3 / hr/in. (1.1 L/hr/mm)
shaftdia meter a t 30 psi (2 bar) the seal may be considered
failed. Other pass/fail crite ria may be applied if required.
{1) Static Dry Test for liquid-lubricated Single
Mechanical Sea/
5tep 1. Follow ali safety rules and regulations
du ring assembly a nd testing of the sea l.
Step 2. Confirm that the equipment is capable of
safely withstanding the test pressure.
Step3. lnstallan appropriately sized flowmeter and
pressure regulator to the equipment.
Step 4. Sea) ali other openings in the equipment.
Step 5. Pressurize the equipment to 30 psi (2 bar).
Do not block off the source of pressure. Hold the pressure
constant.
Step 6. Let the pressure stabilize in the equipment
and read the flowmeter.
Step 7. lf the flowmeter reads less than 1 std.ft3 /
hr/ in. (1.1 L/ hr/ mm) of shaft diameter, the seal passes the
test.
Step 8. lf the sea) does not meet the test criteria,
consider turning the shaft slowly by hand to see if the flow
rate is reduced.
Step 9. Document the results.
Step 1O. 1f the sea) does not pass the test, follow
procedures for resolution.
(2) Static Dry Test for liquid-lubricated Single
Mechanical Sea/
Step l. Follow ali safety rules and regulations
during assem bly and testing of the seal.
Step 2. Confirm that the equipment is capable of
safely withstanding the test pressure.
328
Step 3. Attach a pressure source and a pressure
regulator to the equipment.
Step 4. Sea) ali other openings in the equipment.
Step 5. Pressurize the equipment to 30 psi (2 bar).
Step 6. Note time, pressure, volume, and te mperature of the equipment.
Step 7. Block off the source of pressure.
Step 8. Wait for a designated time.
Step 9. Note the ending time, pressure, volume, and
te mperature of the equipment.
Step 10. Use the ideal gas law and the measured
time to calcula te the volume flow of gas over the sea)
per hour.
Step 11. lf the calculations revea) less than 1 std.
fr / hr/in. (1.1 L/ hr/mm) ofshaftdiameter, theseal passes
the test.
Step 12. lf the sea) does not meet the test criteria,
consider turning the shaftslowly by hand to see ifthe tlow
rate is reduced.
Step 13. Document the results.
Step 14. lf the seal does not pass the test, follow
standa rd procedures for resolu tion.
K-2.3.2 Dual Mechanlcal Seals: Liquld Lubrlcated by
Barrler Fluid (Dual Pressurlzed) or by Processand Buffer
Auld (Dual Unpressurlzed)
(a) Wet Test. Dynamic and static barrier and buffer
!luid tests may be used to check the integrity of a dual
mechanical sea). A dual·cartridge mechanical sea ) may
be capable of bei ng bench tested. A dual·com ponent
seal shall be installed in equipment for a performance
test. However, it is not poss ible to view the inboard
seal, and in many cases it is not possible to view the
outboa rd sea l. This means that a static or dynam ic
liquid test will only revea) if secondary seals a re installed
properly and if proper face contact is occurri ng.
(1) Static Wet Bench Testfor liquid-lubricated DualCartridge Mechanical Seals
Step 1. Follow ali safety rules and regulations
during assembly and testing of the seals.
Step 2. Confirm t hat the eq uipment and sea l
cartridge are capable of safely handling the test pressure.
Step 3. Find and plug appropriate ports in the seal
cartridge.
Step 4. Connect the pressure line to the appropriate
port in the seal cartridge.
Step S. lmportant: Double check that belting in the
seal cartridge is adequate to hold the test pressure.
Step 6. fill the seal cavity with test liquid, usually
water, taking special care to purge the cavity of ali air.
Step 7. Pressurize the sea) to 30 psi (2 bar).
Step 8. Observe both ends of the sea)cartridge. lf no
visible leakage occurs, the seal passes the test
Step 9. Document the results.
Step 10. Jfthe sea) does not pass the test, follow the
procedure for resolution.
ASM E BPE-2022
(2) Static and Dynamic Wet Test for Dual Liquid
Mechanical Sea/ lnstalled in Equipment. In this test it is
(e) Dry Testfor Gas Mechanica/ Sea/ Designed, Static, or
Dynamic Test. This is a bench test of a dual -cartridge
not possible to view the inboard sea) of the dua l seal.
Therefore t he inboard sea) wi ll not be observed for
visible leakage. lt might be possible to view the outboard
sea). Therefore these tests will on ly revea) if inboard
secondary seals have been installed properly and are unda maged and if the inboard sea l faces are in proper
rubbing contact.
Step 1. Pollow ali safety rules and regulations
during assembly and testing of the seals.
Step 2. Confirm that the equipment and sea) are
capable of safely handling the test pressure.
Step 3. for the dynamic test, confirm that the pressure, temperature, and flow rate of the barrier fluid or the
buffer fluid are appropriate for the test.
Step 4. Con nect the pressure li ne and pressure
gauge to the a ppropriate port in the sea) cavity.
Step 5. Fill the sea) cavity with test liquid, usually
water, taking special care to purge the cavity of ali air.
Step 6. Pressurize the sea) to 30 psi (2 bar).
Step 7. Shut "IN" and ·ouT" valves to the seal to
isolate the pressure for no mo re than S sec to avoid
sea) damage.
Step 8. Observe the pressure drop. lf the pressure
does not immed iately drop, the seal parts a re in place and
operating and pass the test.
Step 9. Document the results.
Step 10. lf the seal does not pass the test, follow the
procedure for resolution.
mechanical seal or a n installed-in-equipment test for a
cartridge or component mechanical seal.
Step 1. Follow all safety rules a nd regulations during
assembly and testing of the seal.
Step 2. Confirm tha t the equipment is capable of safely
withstanding the test pressure.
Step 3. Attach a source of gas pressure, a pressure
regulator, and a flowmeter to the seal.
Step 4. Plug ali other openings in the equipment.
Step S. Pressurize the sea) to 30 psi (2 bar) [for lift-off
seals SO psi to 60 psi (4 bar)].
Step 6. Let the pressure equalize.
Step 7. lf it is a dynamic test, and it is safe to do so,
operate the equipment.
Step 8. Note the gas flow rate on the flowmeter.
Step 9. If the flowmeter reveals less than 1 std. ft3 /hr/
in. (1.1 L/hr/mm) (for líft-off seals 2 std. ft3 /hr/in.) of
shaft diameter, the sea) passes the test.
Step 10. lfthe test is performed statically and does not
meet the test criteria and is installed in the equipment,
consider turning the shaft slowly by hand to see if the
tlow rate is reduced.
Step 11 . Document the results.
Step 12. lf the seal does not pass the test, follow stan dard procedures for resolu tion.
K-2.4 Mechanical Seal Testing Notes
(a) Safety Precaution. lf testing dual -cartridge mecha nical seals that are not installed in the equipment, it is nec·
essary to review the seal design. The sea)cartridge shall be
capable of containing the pressure injected into the seal
chambe r. Using comp ress ible flu ids ca n be a very
dangerous method for bench testing dual seals.
(b) When gas is used as a test fluid, the volume of gas
passing across the mecha nical seal determines the seal
in tegrity. Deter mi ni ng t he vo lume of gas passing
across seal faces is the preferred method when using a
compressible fluid as a test fluid.
(e) Pressure d rop of compressible flu id tests are acceptable when used consistently and checked aga inst
operational sea ling success. Equipment manufacturers
and assemblers use pressure drop tests that have been
proven repeatable in the field. Experience of the OEM
and assembler allows for accurate and repeatable inte rpretation of the results.
(d) Volume flow across a sea) may be calculated using
the ideal gas law if ali the following information is known
in the test system:
(1) initial pressure a nd final pres su re
(2) initial temperature a nd final temperature
(3) volume of the system; consta nt and known
(4) the system is dry
(b) Dry Testfor líquid Mechanical Sea/, Static TestOnly.
This is a bench test of a dual-cartridge seal oran installedin-equipment test for a cartridge or component sea).
Step 1. Follow ali safety rules a nd regulations during
assembly and testing of the seal.
Step 2. Confirm that the equipment is capable of safely
withstanding the test pressure.
Step 3. Attach a source of gas pressure, a pressure
regula tor, and a flowmeter to the seal.
Step 4. Plug ali other openings in the equipment.
Step S. Pressurize the sea) to 30 psig (2 bar).
Step 6. Let the pressure eq ualize.
Step 7. Note the gas flow rate on the flowmeter.
Step 8. lfthe flowmeter reveals less than 1 std. ft3 /hr/
in. (1.1 L/hr/mm) of shaft dia meter, the seal passes the
test.
Step 9. lf the sea) does not meet the test criteria a nd is
installed in the equipment, consider turning the shaft
slowly by ha nd to see if the flow rate is reduced.
Step 10. Document the results.
Step 11. lf the seal does not pass the test, follow standard procedures for resolution.
329
ASME BPE-2022
NONMANDATORY APPENDIX L
STANDARD TEST METHODS FOR POLYMERS
ASTM D2240 or ISO 48, Standard Test Method for Rubber
Property - lnternationa l Hardness or Durometer
Hardness
Publisher: American Society of Tes ting and Materials
(ASTM ln ternational), 100 Barr Harbor Orive, P.O.
Box C700, West Conshohocken, PA 19428 -29 59
(www.astm.org)
L-1 STANDARD TEST METHODS FOR
THERMOPLASTIC POLYMERS
ASTM Cl 77, Standard Test Method for Steady-State Heat
Flux Measurements and Thermal Transmission Properties by Means of the Guarded-Hot-Plate Apparan,s
ASTM D256, Standard Test Methods for Determ ining the
lzod Pendulum lmpact Resistance of Plastics
ASTM D543, Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
ASTM D570, Standard Test Method for Water Absorption
of Plastics
ASTM D638, Standard Test Method for Tensile Properties
of Plastics
ASTM D648, St andard Test Method for Deflect ion
Temperature of Plastics Under Flexura) Load in the
Edgewise Posit ion
ASTM D785, Standard Test Method for Rockwell Hardness
of Plastics and Electric lnsulating Materials
ASTM D789, Standard Test Methods for Determination of
Solution Viscosities of Polyamide (PA)
ASTM D790, Standard TestMethod for Flexura) Properties
of Unreinforced and Reinforced Plastics and Electric
lnsulating Materials
ASTM D2240 or ISO 48, Standard Test Method for Rubber
Property- lnternational Hardness or Durometer Hard-
L-3 THERMOSET POL YMER TEST PROPERTIES
Refer to Table L-3-1.
L-4 INTERPRETATION OFTHERMOSET MATERIAL
PROPERTY CHANGES
Refer to Tab le L-4-1.
L-5 TESTING PROTOCOLS FOR THERMOSET
POLYMERS
L-5. 1 Samples
Sample partsshall be prepared according to ASTMD412
(ISO 37). Samples tested per this specification shall be
from the same formulation as finished parts.
L-5.2 lmmersion Fluids
ness
ASTM D3418, Standard Test Method for Tra nsit ion
Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
Publisher: America n Society of Testi ng a nd Materials
(ASTM lnternational), 100 Ba rr Ha rbor Orive, P.O.
Box C700, West Conshohocken, PA 19428-2959
(www.astm.org)
Test fluids and test temperatures for fluid immersions
are as follows:
(a) sodium hydroxide - (O.S N, O.SM, 2% w/w) at
l 76ºF (80ºC)
(b) phosphoric acid - (0.36N, 0.12M, 1.2% w/w) at
176ºF (80ºC)
(e) sodium hypochlorite - (0.67N, 0.67M, 0.5% w/w)
a t 176º F (80ºC)
{d) saturated clean steam at 266º F (l30ºC)
Rinse samples with water to a neutral p H, or mínimum
conductivity, a nd dry before testing.
Add itional test fluids and conditions may be s pecified.
L-2 STANDARD TEST METHODS FOR THERMOSET
POLYMERS
ASTM D395 or ISO 8 15,Standard Test Methods for Rubber
Property - Compression Set
ASTM D412 or ISO 37 - Standard Test Methods for Vulca·
nized Rubber and Thermoplastic Elastomers - Tension
ASTM D471 or ISO 1817,Standard Test Method for Rubber
Property - Effect of Liquids
ASTM D624, ISO 34, or ISO 816, Tear Strength
L-5.3 Qualification Testing
Qualification testing s hould be performed on samples
from each product formulation. Product properties shall
be tested in accordance with the specifications listed in
L-2, as applicable.
330
ASME BPE-2022
Table L-3-1
Thermoset Polymer Test Properties
Property Chango
(f rom Original Value)
Descr1ptlon and Appllcation
(Reference Table ~-4-1)
Test Oesignation
Fluid immersion (70 hr, 166 hr, and 502 hr
at specified temperature) [Note (1)]
Comprcssion set
ASTM D3958 or ISO 8 15
Mcasurc of recovery af\."er deforrnation
Volume and/or weight
ASTM D471 or ISO 18 17
Absorption of solvent or extracrion of
soluble constituents from elastomer
Hardness, IRHO, or Shore
ASTM D1415, D2240, or ISO 48
Changes related to solvent and/or
temperatur c; hlghcr nurnbcrs lndicatc
hardcr material
100% modulus
ASTM D4 J2 or ISO 37
Measure of force requíred to extend
sample by 100%
Ten.sile strength at break
ASTM D412 or ISO 37
Force needed to stretch pa11 to breaking
Elongatlon at break
ASTM D4 J2 or ISO 37
Percent elongation at br eak
Tear strength
ASTM 0624 or ISO 34
Elastomer resistance to tear
point
NOTE: (1) Test duídtion tlme.s ar e 0/+2 hr.
tance a nd provide a guide regarding property cha nges
with exposure time.
L-5 .4 Elastomer Testing: Property Retention
Elastomer material testing requirements are listed in
Table L-3-1. The test dura tions are 70 hr, 166 hr, a nd
502 hr. These tests indicate a minimum standard of accep•
331
ASM.E BPE-2022
Table L-4-1
lnterpretation of Thermoset Material Property Changes
Measurement
Test Result lnterpretatlon
Hardn~s
Property Change
Shore A, shore D scale, shore M
scale (0-rings), or IRHD
hardness. UsuaHy measured
in units of points
May indicate Ruid absorption
(incr ease) or e>..t raction of
ingredients (decrease) ; however,
both absorption and extraction
may occur simultaneously.
A signltlcant change in hardncss
may also indícate attáck on t he
polymer backbone.
100% modulus
This is the stress required to
reach 100% elongation.
Change may be caused by heat aging Requires specfalized equipment
for measurement.
(increase) and/or chemical attack
EvaJuatcs the cla.stomcr
(dccrcase). Chcmical absorption
(dccrcase) or i ngrcdient extraction
on the micro leve!.
(increase) can also affect modulus.
Elastomer modulus
Excessive increase in modulus may
should not be confttsed
be a sign of polyme1ic
with modulus
embrittlement. Related to
measurements for metals.
tcnsilc strength and lnversely
rclated to clongation
Tensile strength at
break
Ultimate tensile strength
May lndicate exposure to excessive
recorded at material breakage
heat (incr ease) and/or chemical
attack ( decrease)
Re,¡uires specialized e<¡uipment
for measur ement.
Evaluates the elastomer
on a micro leve!
Elongation at break
Ultimate clongation or sample
measured at material
br eakage
Rcquires spcd alizcd
equi pment íor measurement.
Evaluates the elastomer
on a micr o leve!. Especi ally
important for flexing
applications such as
diaphragms
Compresslon set
Measures the ability of an
Compressi on set Is an lndicatíon of Relatively easy test to ru n.
elastomer to r ecover
whether an elastomer Is able to
Preíer red to r un at
dimensionally after being
maintain sealing force. In general,
application temperature.
subjected to compressive load,
the lower the compression set
Most important for
at a temper-ature, over time
value, the better, especially
applications involving O·
if the application will involvc
rings or gaskets
tcmpcran1rc cycling. In
this case, the elastomer has
to maintain sealing thr ough
thermal expansion cycles.
Volume/weight
Measure weight gai n/l oss or
volume increase/decre.ase
Volume sweU and weight gai n
Weight and volume change
typically track together. Fluid
are relatively easy to measure
cxposurc can result in Huid
and may be thc bcst
absorption (i ncr ease) or extráC1:ion
indicators of performance.
of elastomer i ngredíents
An i ncrease due to
(decr ease). Absorption of pr ocess
absorption can result in
tluid may or may not be a
product fuilure due to
reversible process.
nibbling and extrusion. A
dccreasc can r csult in
leakage around thc scal.
Tear strength
The ease at which a tear can be
initiated and propagated
May indicate Ruid absorption
(decr ease) or extraction of
ingredients (increase) .
r roperty is typic.ally related
to changc in elongatlon
May indicatc cxposure to exccsslvc
heat (decr ease) and/or chemical
attack (increase). Elongation
(macro) and localized is
important for sealing to avoid
elastomer splits and cracks.
332
Addltlon.al Comments
Relatively easy test to ru n.
A significant decrease in
hardness may result i n
i ncreased abrasion. This
is a macro mcasurcment
Requires specialized e<¡uipment
for measurement. May
be useful data for applications
i nvolving diaph1--agms
ASM E BPE-2022
NONMANDATORY APPENDIX M
SPRAY DEVICE COVERAGE TESTING
M-1 SCOPE
This Append ix defines an acceptable method for
performing spray device coverage testing for bioprocessing equipment.
(d) The quality ofwater used for the formulation ofthe
riboflavin solution a nd forcoverage testingshall beagreed
to by the owner/user and ma nufacturer. The mínimum
acceptable water qua lity is noncom pendial pu rifi ed
water (e.g., reverse osmosis or deionized) .
M-2 PURPOSE
M-4 PROCEDURE
The purpose of a spray device coverage test is to document fluid coverage of the process contact surfaces of
bioprocessing equipment. The test provides information
about fluid coverage and the conditions necessary to
achieve this coverage as a prerequisite for cleaning of
the process equipment. The coverage test is not intended
to demonstrate cleanability, but rather the ability to
deliver cleaning solutions to the target surfaces. Cleanability is verified using a full CIP protocol during cleaning
validation.
M-4.1 Equipment Preparation
(a) AII interna! appurtenances should be installed (e.g.,
agitators, level pro bes, a nd dip tubes) during the spray
device coverage testing. lf conducting the test with all
interior appurtenances in place is not practica!, alterna·
tive means to simulate shadowing should be agreed on
with the owner/user (e.g., du mmy shafts a nd dip tubes
may be used). lf the agitator is installed, it should be
rotated at the same rateas planned for CIP.
(b) AII intern a! surfaces a nd appurtena nces shall be
clean prior to the coverage test. Conta mi nated surfaces
(e.g .. with grease or oil) may produce inconcl usive results.
(e) Veri fy tha t the spray device(s) are installed in the
designed location a nd orientation (where applicable).
M-3 MATERIALS
(a) A concentration of 0.08 g/L to 0.22 g/ L riboílavin
(vita mi n 82) aqueous solution provides visible fluorescence under ultraviolet light. The riboflavin should be
free of animal -derived ingred ients (AD I). Riboflavin is
water soluble, noncorrosive, a nd nonreactive on ma terials
commonly used to manufacture bioprocessing equipment
(e.g.. stainless steel, polymers, and ceramics). Riboílavin
fluoresces with exposure to long-wavelength ultraviolet
(UV) light with peak intensity at 365 nm. Note that if other
fluorescent materials are used, the UV wavelength for
optimum visibility may be different.
(b) UV lamps are available with different wavelengths
and intensities. A lamp with a peak wavelength of 365 nm
and an intensity of 4 000 µW/cm2 a t a dista nce of approximately 15 in. (38 cm) is optima! to observe riboflavin
fluo rescen ce. Ultraviolet lam p intensity is inve rsely
p roportio nal to the sq uar e o f t he distance from t he
source. Ultraviolet lamps of this intensity may present
a safety hazard to the eyes and skin. Personal protective
equipme nt (PPE} is recommended. UV lamps of other
wavelengths can be used, but stronger concentra tions
of riboflavin may be required for detection.
(c) An extension mirror or borescope camera may be
useful for visual inspection of hard·to· reach areas.
M-4.2 Application of Fluorescent Solution
(a) The test shall be performed by spraying the tluorescent solution as a mist on all targeted surfaces of the
bioprocess eq uip ment includ ing walls, nonles, bafíles,
and other app u rte nances. The sol ut io n application
shoul d minim ize dro plet fo rmation and ru noff. Care
shou ld be taken to avo id apply ing the fluo resce nt
agent to areas that are outside of the process boundary
(e.g .. the side of the manway gasket tha t is not exposed to
the process). Note that the inside of dip tubes or similar
hollow members not ta rgeted by the spray device may
require a separate rinse path during the test.
(b) Usingan ultraviole t light permitsvisual verification
that the targeted surfaces have been wetted with the tluorescent solution. Fluorescentagents such as riboflavin typi cally tluoresce only when they a re wet.
(e) The riboflavin application inspection methods shall
be consistent with the postrinse inspection methods.
333
ASME BPE-2022
(b) A typical acceptance criterion is removal, to the
limit of visual detection, of the ribotlavin solution from
ali targeted areas or as otherwise agreed on with the
owner/ user.
(e) lf areas of residual riboflavin are presen t, they
sho uld be d ocumen ted, and a corrective action pla n
should be established with the owner/ user.
M-4 .3 Execute Rinse
(a) The rinse s hould be performed with ambient (or
colder) temperature water to allow forimmediate inspection of wet surfaces. The use ofothertemperatures shall be
agreed on with the owner/user.
(b) The rinse s hould be performed befo re the riboflavin
solution has dried, as the test is designed to confinn
coverage a nd not cleaning.
(e) The rinse shall be performed in a once-through
mode.
(d) Conditions s uch as flow ra te, pressure, a nd time
shall be recorded during the coverage test as described
in M-6.
M-6 RECOMMENDED DOCUMENTATION
{a) Test co nfiguration sketch (reference t he OEM
drawing) and description (with, e.g., line size, instrument
locations, elevation)
(b) Spray Device Data
(1) Model, make, serial numbe r, and tag number.
{2} Verify correct installation, orie nta tion, down
pipe, and down pipe length.
(3) Recommended press ure a nd tlow cond itions
(data sheet).
(e) lnscrument Daca
(1) Data sheets (instrument ranges)
{2} Calibration certificates for instruments
(d) Riboflavin Solucion Daca
{1} Riboílavin cata log number and lot number
(2) Expiration date
(3) Amount of riboflavin
(4) Amount of wate r and quality
(5) Time a nd date of preparation
(6) Time and date of applica tion and preinspection
(7) Time a nd date of rinse and postinspection
(e) UV lamp Data. Model number and da ta sheet
(f) Temperature of Rinse Water
(g) For initial ílow path and each subsequent transition
to a different flow path. document
(1) Flow rate
(2) Time (burst/delay sequence, if a pplicable)
(3) Pressure (measured as close to the spray device
as practica!)
(4) For dual-axis dynamic spray devices, time, ílow,
and pressure to complete a pattern
(h) Test Results
(1) Pass/fail
(2) lf applicable, residual riboflavin location(s) and
descriptions
(3) lf a pplicable, corrective actions taken
M-4 .4 lnspection
(a) lnspection s hould be performed before the surfaces
dry. Surfaces must be wet to detect riboflavin fluorescence.
(b) lf surfaces are d ry at the time of inspection, the
surfaces shall be gently rewetted from bottom and up
with a mbient or cold wate r to observe any residual riboflavin fluorescence. Rewet ti ng a nd inspecting lowe r
s urfaces first and higher s urfaces next will reduce the likelihood of misidentification of the location of residual ribo·
flavin.
{e) Ambient light s hould be minimized to improve the
visibility of riboflavin tluorescence.
{d} The postrinse inspection me thods s hall be consis·
tent with the ribotlavin application inspettion methods.
{e) For large e nclosures (e.g., vessels with manways)
confined space entry may be necessary to conducta thor·
ough inspection.
(fJ The inspection sequence should be designed to
avoid false results due to transfer of residua l ribotlavin
from interna! or externa ! sources.
M-5 ACCEPTANCE CRITERIA
(a) Acceptancecriteria and coverage test protocol s ha ll
be agreed on with the owner/user before the coverage
test.
334
ASM E BPE-2022
NONMANDATORY APPENDIX N
COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE
DISCOLORATION ACCEPTANCE CRITERIA
(a) The acceptance criteria for discoloration on weld
heat-affected zones were developed by making a utogenous squa re groove welds on 2 -in. -diamete r UNS
S31603 sta inless steel tube -to-tube butt joints whose
inside diameters were purged with a rgon conta ini ng
controlied amounts of oxygen. The oxygen levels reported
were measured on the downstream side of the welds. For
t he sample nu mbe rs listed in Figures MJ -8.4-2 and
MJ-8.4-3, the oxygen contents were as foliows:
(1) # l a a nd #lb - 10 parts per million (ppm)
{2} #2 - 25 ppm
(3) #3 - 35 ppm
(4) #4 - SO ppm
(5) #5 - 80 ppm
(b) Ali welds were made with the gas-tungsten are
we ldi ng (GTAW) process us ing 95% a rgo n - 5%
hydrogen shielding gas.
(e) The electropolished tubing used for the test welds
had a n SF4 surface finish (15 µi n. R. max.) a nd t he
mechanically polished tubing had an SFl surface finish
(20 ¡Lin. R., max.).
(d) Thephotos shown in Figures MJ-8.4-2 and MJ-8.4-3
were taken using a camera having direct visual access to
the weld surfaces.
(e) The corrosion resistance of the welded samples was
detennined by both ASTM GlS0. Critica! Pitting Temperature Test, a nd the modified ASTM G61, Potentiodynamic
Pola rization Corrosion Test.
(j) ASTM GlS0 dete rmines the voltage-inde pendent
critica! pitting temperature (CPT) by way of a potentiostatic technique that determines the te mperature a bove
which pitting corrosion proceeds on its own under standardized test conditions. Higher CPTs indicate increased
resistance to pitting corrosion.
The modifiedASTM G61 determines the voltage (potential) at which the anodic current increases rapidly during a
standardized cydic polarization testatroom temperature.
The vol tage determ ined, referred to as the Ep,.r, is a
measure of resistance to pitti ng co rrosion. Higher, or
more noble, va lues of Ep1T indicate increased resistance
to pitting corrosion.
Neithe r the CPT nor the E,,,.,. values determined are
material properties per se; rather, they are the result
of standardized tests designed to rank differe nt materials
or different surface finishes of the same material in their
resistance to the stable propagation of pits in a standard
test e nvironment.
(9) The acceptable levels of discoloration identified in
Figures MJ-8.4-2 a nd MJ-8.4-3 are based on corrosion
resistance, not on the oxygen leve ls of t he interna!
purge gas used d uring weld ing. As a result, the photographs in Figu res MJ -8 .4-2 a nd MJ-8 .4-3 sho uld be
used to identify the degree of d iscoloration by number,
but not to specify the amount of oxygen in the backing gas.
(/J) Ali welds were tested in the as-welded condition,
with no postweld conditioning.
(i) For the electropolished tubing in Figure MJ-8.4-2,
accep table levels o f heat-affected zone discolora tion
were those that exhibited corrosion resistance similar
to unwelded, electropolished UNS S31603 base metal
in the ASTM GlS0 test.
(j) Fo r t he mechan ically polis hed tu bin g in
Figure MJ-8.4-3, acceptable levels of heat-affected zone
discoloration were those that exhibited corrosion resistance similar to that of a cold-rolied, mill-finished, UNS
S31603 base metal.
(k) lt is generally accep ted t hat as-welded heataffected zones on mecha nicaliy polished tubing having
t he same leve! o f d iscoloratio n as weld heat-affected
zones on electropolished tubing will exhibit lower resistance to pitting than the heat -affected zone on electropolished tubing.
(/) The user is cautioned that the amount of d iscoloration and its appearance can be intluenced by factors other
than oxygen, as listed below:
(1) High levels of moisture in the backing gas can
increase the degree of discoloration.
(2) Other con tam inants, such as hyd rocarbons,
moisture, an d sorne types of partic ul a tes on the
surface prior to welding. can ali affect discoloration levels.
(3) Hydrogen in the argon backing gas can significantly reduce the amount of discoloration.
(4) The meta l's surface finish ca n also affect the
appearance of the discoloration.
335
ASME BPE-2022
NONMANDATORY APPENDIX O
GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC
MATERIALS
0-1 GENERAL
0-2 PARTICULATES
Polymer mate rials can be divided int o t wo general
classes: thermoplastics and thermosets. The composition,
form, and construction ofthese materials determine their
suitability for use in their various applications, and the
systems designer shou ld be aware of their st rengt hs
and limitations.
Polymer materials may be manufactured from a single
monomer (homopolymer) or multiple monomers (copo·
lymers). They may be filled or unfilled. They may be elas·
tomeric or rigid. They may exist in an amo rp hous,
crystall ine, or semicrystalline state. They may consist
of either single or multiple microphases, be manufactured
as composites, and include adhesive materials.
Nonmetallic materials may be rigid or flexible, amorphous or crystall ine, exist in single or multiple microphases, a nd formed in to complex mixtu r es and
composites. These ma te r ials ca n offer a range oí
un ique properties (e.g., extreme hardness, chemical inertness, selí-lubrication, or tra nsparency). The system
designer and owner/ use r s hould be aware of t he
broad range of phys ica l and chemica l properties oí
these materials.
0-2.1 Characterization
Particulates are characte rized by severa) attributes
incl uding, but not limited to, size, morphology/shape,
hardness, and chemical composition. These attributes
may affect the ability to detect, measure, capture, identify,
and control the particulates.
(a) Physical Form. Particu lates may be of varying
shapes. Sorne may be long and thin while others may
be shortand round. A majority ofthe particulates are irregular shapes with complex geometries.
(b) Material Makeup. lntrinsic particulates are native to
the single-use syste m and include materials of construction or ingredients in the process formulation. Extrinsic
part iculates are foreign to the single-use system and come
from the manufacturing e nvironment or process personnel.
(e) Hardness. Particulates may be rigid or soft.
( d) Chemical Composition
0 -2.2 Levels of Acceptance
Acceptable levels ofpart:iculate quantity and size distri·
bution in single-use components and assemblies should be
dete rmined by their intended use. Owner/use rs should
use established industry standards for the end product
to quantiíy acceptable particulate criteria. Sorne of the
industry standards a vailable as acceptance crite ria for
dr ug products include USP <1>, USP <787>, USP
<788>, USP <790>, EP 2.9.19, El' 2.9.20, JP 6.06, a nd JP
6.07.
0 -1.1 Gamma lrradiation
Gamma irradia t ion oí po lymers may cha nge t he
physical properties oí t he po lymeric material (see
SU-9). OthereffectS may includediscoloration andgeneration oflow-molecular-weight compounds. Antioxidants or
stabilizers may have been added to the polymeric material
to minimize changes in physical properties.
336
ASME BPE-2022
NONMANDATORY APPENDIX P
GENERAL BACKGROUND/USEFUL INFORMATION FOR
EXTRACTABLES AND LEACHABLES
P-1 REFERENCES
"Toward lndustry Standardization ofExtractables Testing
for Single-Use Systems: A Collective BPSA Perspet"tive"
Publisher: BioProcess lnternational, 2 lnternational Place,
Boston, MA 02110-2601 (www.bioprocessintl.com)
21 CFR 211.94, Code of Federal Regulations, Part 211,
Current Good Manufacn,ring Practice for Finished Pharmaceuticals
Guidance for lndustry-Container Closure Syste ms for
Packaging Human Drugs and Biologics, FDA/CDER/
CBER
ICH Q3A, Guidance for lndustry, FDA, "lmpurities in New
Drug Substances·
ICH Q9, Guidance for lndustry, FDA. "Quality Risk Manage•
ment"
Publisher: U.S. Food and Drug Administration (FDA),
10903 New Hampshire Aven ue, Silver Spring, MD
20993 (www.fda.gov)
ISO 10993-18: 2005(E), "Biological Evaluation of Medica!
Devices;' Part 5: ''Tests for In Vitro Cytotoxicity"; Part
13: "ldentification and Quantification of Degradation
Products From Polymeric Medica! Devices·; Part 16:
"Toxicokinetic Study Design for Degradation Products
and Leachables"; Part l7: "Establishment of Allowable
Limits for Leachable Subs tances"; Part 18: "Chemical
Characterization of Materials"
Publisher: lnternational Organization for Standardization
(ISO), Central Secretariat, Chemin de Blandonnet 8, Case
Pos ta le 401, 1214 Vern ier, Geneva, Switzerland
(w,,vw.iso.org)
"Accumulatio n of Orga nic Compounds Leached From
Plastic Materials Used in Biopharmaceutical Process
Containers"
Publisher: Parenteral Drug Association (PDA), Bethesda
Towers, 4350 East West Highway, Suite 600, Bethesda,
MD 20814 (www.pda.org)
Je nke, D., Compatibility of Pharmaceutical Solutions and
Contat"t Materials Safety Assessments of Extractables
and Leachables for Pharmaceutical Products
Publisher: John Wiley & Sons, 111 River Street, Hoboken,
NJ 07030-5774 (http://www.wiley.com)
"BPSA Recomme ndations for Testing and Evaluation of
Extractables From Single-Use Process Equ ipment,"
Bio-Process Systems Alliance, 2010
Publisher: Bio-Process Systems Alliance (BPSA). 1400
Crys ta l Orive, Suite 630, Ar lingto n, VA 22202
(www.bpsalliance.org)
PQRI - Safety Thresholds and Best Practices for Extraetables and Leachables in OIN DP
Publish er: Product Qual ity Resea rch lnstitute (PQRI),
1500 K Street, N.W., 4th Floor, Wash ington, DC
20005-1209 (www.pqri.org)
"Standardization of Single Use Components' Extractable
Studies for lndustry"
"Sta ndardized Extractables Testing Protocol for SingleUse Systems in Biomanufacturing"
Publisher: lnte rnational Society for Pharmaceutical Engi neering (ISPE), 3109W. Dr. Martín Luther King, Jr. Blvd.,
Tampa, FL 33607 (www.ispe.org)
EP 3.1.5, Polyethylene With Additives for Containers for
Parenteral Preparations and for Ophthalmic Prepara·
tions
EP 3.1.9, Silicone Elastomers for Closures and Tubing
EP 3.1.13, Plastic Additives
Publis her: European Directorate for the Quality of Medí·
cines & Healthcare (EDQM Council of Europe), 7 allee
Kastner, CS 30026, F-67081 Strasbo u rg, Fra nce
(www.edqm.eu)
USP <88>, Biological Reat"tivity Tests, In Vivo
USP <232>, Elemental lmpurities Limits
USP <661.1>, Plastic Materials of Cons truction
Publisher: U.S. Pharmacopeial Convention (USP), 12601
Twi n brook Parkway, Rockville, MD 20852 -1790
(www.usp.org/usp -nf)
"Extractables and Leachables: Challenges and Strategies in
Biopharmaceutical Development"
"Recommendations for Extractab les and Leachables
Testing. Part 1: lntroduction, Regulatory lss ues, and
Risk Assessment"; Part 2: "Executing a Program"
337
ASME BPE-2022
P-2 RECOMMENDED CONDITIONS FOR A
POLYMERIC MATERIAL-SPECIFIC
EXTRACTION
P-3 RECOMMENDED CONDITIONS FOR AN
EXTRACTION STUDY IN BIOPROCESS MODEL
SOLUTIONS
(a) Surface Preparation. Materials of construction with
a high likelihood for contact.
(b) Sample Size. 60 cm2 /20 mL of extra et fluid or 0.2 g/1
m L of extraet fluid.
(e) TestTemperature. When a soxhlet extractor is used,
fluid temperature is controlled by the condenser. near
room temperature. For other methods of solvent extraction, the temperature may be elevated compared with the
a nticipated actual use conditions.
(d) Test So/vencs. Use of one compatible polar solvent
(e.g., ethanol, DI water) and one nonpolar solvent (e.g.,
hexane or toluene) to maximize extraction.
(e) Test Time. 24 hr.
(a) Su,face Preparation. Fi nal art icle a nd co ntact
surface s hould be used.
(b) SampleSize. 60 cm 2 /20 mL ofíl uid or 0.2 g/1 mL of
fluid.
(e) Test Temperature. 4-0ºC.
{d) Test Fluids. 20% ethanol (v/v). 0.1 M phosphoric
acid (H 3 P0 4 ). 0.1 M sodium hydroxide (NaOH). 5.0 M
salt solution (NaCI), and/or purified water (meets USP
requirements, at a mínimum).
(e) Test Time. 30 days, unagitated.
P-4 OVERVIEW OF BIOPROCESSING EQUIPMENT/
COMPONENT EVALUATION RELATED TO
EXTRACTABLES AND LEACHABLES
CHARACTERIZATION
See Figure P-4-1.
338
ASME BPE-2022
Figure P-4-1
Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables
Characterization
Start
Evaluate new
equipment/
compo nent
Obtain polymeric material•
specific extractab1es profile in
appropr iate solvenHs>OR
extractables profile in
bioprocess mod0I solution{s)
~----- ves
Sufficient
NO- +
YES -+
Conduct in-process
Sludy 10 iden1ify
potential leachables
NO
lmplement
equipment/component
~
NO
YE
Conduct stability
study
YES
YES - -
Evaluate new
equipment/component
or reformulate
339
Conduct leachables
study
ASME BPE-202 2
NONMANDATORY APPENDIX Q
TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
Q-1 GENERAL
Q-3 .2 Wiring and Cabling
Th is Append ix prese nts additio nal info n nation not
a ddressed in Pl-7 on te mpera ture sensors a nd various
influences on sensor performance.
Sensor wiri ng configu ration a nd wire length will influence the measurement accuracy due to resistance variation between lead wires a nd the lead wire compensation
technique used.
(a) For RTDs, accuracy is influenced by lead wire compensation, s pecifically when long cable lengths are used.
Four-wire designs provide the most effective compensation. Three-wi re designs are e ffective for shorter cable
lengths. Two-wire designs are generally not recommended by sensor manufacturers unless a closely moun ted
transmitter is incorporated into the instrument assembly.
(b) RTDs with long cable runs typically use shielded
cab le t o minim ize t he in fl ue nce o f e lectrical n oise
a long the cable run.
(e) For commonly used the rmocouples, it is best to
match the extension wire type with the the rmocouple
type. For thermoco uple types R, S. a nd B (p latinu m
based), alterna te extensio n wire is com mon ly used.
The manufacturer can provide guidance regarding extension wire choices, including when to use s hielded wire.
Q-1.1 General Considerations
Platin um- based resistance te mperatu re detectors
(RTDs) are the most co m mon ly used tempe ratu re·
sensing technology. Alternative temperature measure·
ment technologies a re available that may be selected
based on syste m design and owner /user preference.
Manufacture rs of the tempera tu re sensors ca n confirm
that the selected instrument meets the specified performance requirements in the environmental conditions at
the installation location.
Q-2 EXTERNAL SUPPORT COMPONENTS
Temperature sensor assemblies may include compone nts externa! to the se nsor tha t will infl ue nce the
meas ureme nt acc uracy. Assemb lies typ ically may
include e nclosures, wire a nd cables, a nd transmitters.
The instrume nt manufacturer can provide guida nce on
appropriate externa! components need ed to meet the
required measurement accuracy of the system.
Q-3.3 Electronics
The accuracy and sta bility of electronic devices a nd
control systems should be included in the assessme nt
of the tota l measurement accuracy.
Matching electronics to sensor calibration data is a n
effective way to improve measurement accuracy and is
preferred fo r p rocess measu re ments where process
system accuracy better than ±3ºF (1.SºC) is required.
Electronics have an input resistance limit.ation that
limits sensor cable lengths. Input resistance should not
exceed the capability of the electronics. Re fer to the mam1facturer's specifications.
Q-3 MEASUREMENT ACCURACV
Total measure ment accuracy includes, but is not limited
to, sensor accuracy, installation e ffects on accuracy, wiring
and cabling influences,electronicsaccuracy, process influences, and ambient intluences.
Q-3.1 Sensor Accuracy
The sensor ma nufacturer's sta ted accuracy represents
the sensor performance as verified by the manu facturer's
calibration laboratory. The sensor can be expected to meet
the interchangeability criteria based on the toleran ce class
stated by the ma nufacturer and defined by the industry
standards per Pl -7.4.1,
Amultipoint calibration can be performed to define the
actual resistance vs. temperature relationship of the specific RTD. This calibration data can be used to improve the
measureme nt accuracy.
Q-3 .4 Process lnfluences
Stagna nt flow, heating/cooling sources, valves, tubing
construction, and o ther instru ments near t he flu id
temperatu re measurement location can a lso influence
the measurement accuracy.
Q-3.5 Ambient lnfluences
(a) Environmental lnj1uences. Moisture and other environmental conditions near the measurement location ca n
influence the measure me nt and/or damage the sensor.
340
ASME BPE-2022
Se nso r installatio n sho uld incorpora te wire/ca ble
connector a nd/or an enclosure (connection head). The
e nclos ure rating shou ld meet or exceed the NEMA
rating ( or international equivalent) for the installation
location as define d by the owner/user. Selection of a n
appropriate enclosure should be based on ambie nt conditions during system operation and cleaning/sterilization cycles.
(b) Ambient Temperature E!Jects. For sensor assemblies with an interna) transmitter, the maximum operating
temperature of the transmitter should b e considered
when insulating the assembly to minimize the iníluence
of the a mbient temperature (see Pl-7.4.4).
Q-5 MAINTENANCE
Sensor maintenance should include calibration verification and general sensor in spection.
Q-5.1 Sensor Calibration Verification
(a) Methods. Specific cali bration verification
approaches should be accord ing to the manufacture r's
recommendations a nd specific process system performance req uiremenrs.
Senso r/tra nsm itter comb in ed calibratio n s houl d be
verified as a system. Th e association between sensor/
tra nsmitter system componentS s hould be ma intained
through tagging a nd/or serialization.
When verifying sensor or sensor/ tra ns mitter system
accuracy, the typical verification t em peratu re is the
m idpoint of the process operati ng temperature. At a
mínimum, sensors should be verified at 32°1' (OºC).
Bimetallic sensors should be calibrated in the orientation of final use.
(b) Frequency. Sensor cali bration s hould be verified
annually. Alternate verification frequency may be specified based on criticality of the measurement and historical
sensor verification data.
Q-4 SELECTION
Q-4.1 Sensor Selection
(a) Consider t he cab le/wire le ngth necessary to
s upport removal for calibration or other ma intenance
activities.
(b) RTD-based sensors will generally provide the most
accurate tempera ture measurement.
(e) A d1ermocouple-based sensor may be an effective
choice where the accuracy requirements can be achieved
and the control system accepts a millivolt (mV) input
(d) Bimetal lic, mechanical temperature sensors are
typically used o n ly for loca l ind icatio n due to the
limited measurement range and accuracy.
(e) Liquid-in-glass (LiG) temperature sensors are not
an effective choice dueto various performance, capabilíty,
and environmental concerns.
Q-5.2 Sensor lnspection
An insulation resistance test (sensor lead wi re to sensor
body) on ali RTDs a nd ungrounded thermocouples should
be performed d uring periodic verification. ln sulation
resistance s hould be tested p er the manufacnirer's specification.
Physical inspection s hould be performed at each periodie verifica tion event per the manufacturer's specification for the specific sensor, including an examina tion of
overall condition a nd cleanliness of the sensor. The manufacturer's recommendations should be followed regarding
cleaning, repair, or replacement if die sensor or thermowell exhibits indications of wear, damage, or other conditions that may affect performance or the usefu l life of the
instnunent.
Q-4.2 Transmitter Selection
When a transmitter is required, a sensor/transmitter
comb ined calibration is preferred to achieve the bestaccuracy.
341
ASME BPE-2022
NONMANDATORY APPENDIX R
INSTRUMENT RECEIVING, HANDLING, AND STORAGE
R-1 INTRODUCTION
R-3.1 lnstrument Assembly Segregatlon
This Appendix is a s upplement to Pl-3.
When d isassembling an instru ment, each instrument
assembly s hall be segregated or kitted from other instrument assemblies to avoid mixing of components.
R-2 INSTRUMENT RECEIVING
The instrument(s) shall be verified against the packing
slip prior to items leaving quarantine for release to inspection and/or storage.
R-3.2 Component Labels
Each componen! should, when possible, have a printed,
individual, waterproof componen! label that includes
information s uch as the inst rume nt name, componen!
part description, serial nu mber, P & ID location, o r
barcode. Each component should have a unique pa rt
number. The preferred method for doing this is to use
the serial number followed by (A) - first compon ent;
(B) - second component; etc.
R-2.1 Warnlngs and Documentation
Refer to the product manua l for any wa rnings and/or
notices (e.g., ANS I Z535.6) regarding the instrument a nd
comply accordingly. Documentation, such as calibration
reports, material traceab ility, etc., should be kept with
the instrument or handled per the owner/user's document control procedures.
R-4 STORAGE
R-2.2 lncoming lnspection
After receiving and inspections, instruments shall be
packaged for storage to protect them from environmental
conditions and contamination. The outside of the packaging shall be labeled to clearly identify the stored instrument.
lncoming inspection shall be performed to check for
man u factu ring defects per Parts DT and SF and/or
other standards and interna! quality criteria.
R-3 INSTRUMENT HANDLING
Many instruments are assemblies of componentS. lf it is
necessary to disassemble the instrument to compone n!
leve!, compone n! control is required.
342
ASME BPE-2022
NONMANDATORY APPENDIX S
APPLICATION DATA SHEET
See Form S-1 beginning on the next page.
343
Form S-1 Application Data Sheet
Client: _ _ _ _ _ _ _ _ __
Project: _ _ _ _ _ _ _ _ __
ldentification # _ _ _ _ _ _ _ _ __
Tag# _ _ _ _ _ _ _ _ __
Location: - - - - - - - - - Data: _ _ _ _ _ _ _ _ __
P&ID#
Serviee
Nonn•I
()pen1tlng
Slze
AppUcatlon/
Operation
AppUcatfon Detalls
Ruptu.r e Disk
Set Pre$'$.ure
Pressure
Operating
l.ow
IHigh)
o-
T«npen,ti,Q, Temperat.,.._ Tempe,M\n,.
"fo,"C
-.=or "C
•for "C
psi (bar)
tNote 011
Shut off
O,olgn
Prff$tl,-
Pr•S\We,
Pr$$&ur._
10"/l OO'li),
......
...
(Note (21)
Service DesCl"ipt ion.s
(H igh)
Nonn•I
()pei-a,tlng
...
psigor
.,, °""""
Our•tl,oo,
hrl d•v
d8yf'Vtltf,/'yr
(Not.e C311
Coocentration, %
Proeess Fluid
Steam
Contfluou, O YC'e$ O No
ll'IUl!Mitten1
º'"
O No
Puriíie-d Water/WPI
o v.,
□ No
Other
o v.,
□ No
Sodium hyd roxid te
O Yes □ No
Phosphoric add
CIP
~
O Yes □ No
3:
.,"'..,
Sodium hypot:hloritte
......
w
O Yes □ No
Other
~
a Yes a N o
SIP
o v.,
□ No
A utoclave
C Ye&
□ No
N
0
N
N
Check one:
Citric add
Passlvadon
O Yes □ No
Cooce-ntration, % _ _
Nitrlcacid
CI Vos □ No
Cooce-1\lration, % _ _
Pho&phOrlc ecid
Sofids
O Yes □ No
Concentretk>n, %
0 thcr C Ye& C No
Concc,nv;:ition, %
O Yes
□ No
Concentration. % _ _
Val ve Op,erat ion
Manual O Yes O No
M ode of Operat ion:
Val ves
AV1Qmt1ted
O Yes O No
Minimv,11,,;,p -.,,t _
OlbiU
Oiaph tagm ma1e11a1 cutrenLIV usi~? (pleMe siete h'I Lt\espace below►
p,;
()• ~ ·
M111(11rn11m 11ir pr-11ro _
l'I~
ASM E BPE-2022
NONMANDATORY APPENDIX T
GUIDANCE ON POLYMER APPLICATIONS:
CHROMATOGRAPHY COLUMNS AND FILTRATION
T-1 CHROMATOGRAPHY COLUMNS
T-1.4 Sanitization
T-1.l General
Chemical sanitization processes are used to reduce
bioburden.
Chromatography col umns are used in processes to
purify products or isolate s ubstances of interest from
other components contained within process solutions.
Typica l examples include large-sca le purification of
biopharmaceuticals and fine chemicals.
T-1.2 Column Construction
A typical chromatography column is comprised of a cylindrical s hell (the "tube") closed at each end. The space
between the ends of the column is filled with a medium
( referred to as the •stationary phase" or "bed") in which
the chromatography separat ion takes place. The liquid
that t rave ls axially through t he column is re fe rred to
as the "mobile phase."
At each end of the column. a "bed s upport" retains the
medium within the tube. This device is a porous disk typically constructed of a rigid, finely woven mesh ora semipermeable material. Behind each bed s upport is a "flow
distributor." The flow distributor ensures uniform distri·
bution of the mobile phase. The distributor is typically
attached to a •rigid support plate;' which is a pressure·
retaining component that includes hygienic connections.
Usually, one end ofthe column is designed in such a way
that it can be inserted into the column tube rather than
fixed to the end (much like a piston in a syri nge), thereby
allowing adjustment of the bed height. This assembly is
referred to as the "adapter." A column is typically installed
with itsaxis oriented vertically and the adapter positioned
at the top.
Chromatography co lu mns may include add itional
mechanical featu res, s uch as th e ab ility to add a nd
remove the mediu m without opening the colu mn and
the ability to mechanically compress the bed.
T-2 FILTRATION
T-2.l General
Liquid or gas filtration is used
(a) to isolate processes
(b) to purify substances of in terest
(e) to concentrate
{d} to exchange buffer/d iafilter
(e) for viral removal
{f) for sterilization/bioburden reduction
T-2.2 Filtration Formats
Typical filtration formats include la rge-scale filtration
and separation of biopharmaceuticals and fine chemicals
usingdirect flowfiltration (DFF) and tangential ílow filtra·
tion (TFF). The filter elements used in both modes may be
hydrophobic or hydrophilic. The principal difference
between DFF and TFF is the direction of flow with
respect to the filter surface. In TFF, the process fluid
flow is tangential to t h e filter media with on ly a
po rtio n of the process fluid passing th rough it. Th is
resultS in one inlet stream and two outlet streams. In
DFF, the process flu id flow is perpe nd icu la r to t he
fil ter med ia with a li of the process fluid pass ing
th rough the filter media. This results in one inlet and
one outlet.
T-2.2.l Direct Flow Filtration. In DFF, the process fluid
passes through the filtration media in a single pass. These
filters are typically used for clarification, gas and vent
filtration, virus reduction, and process fluid sterilization.
This mode of filtration is a lso known as dead·end filtra·
tion, depth filtration, and normal ílow filtration.
T-1.3 Cleaning
T-2.2.l.l Filtration Elements. A typical DFP element
may be one of the following acceptable designs:
(a) Pleated or Wrapped Design. Th is des ign is
comprised of a cylindrical shell, which can have the
media e ither pleated or wrapped. The flow path is typically
from the outside of the cartridge through the wrap or pleat
The purpose of cleaning a chromatography column is to
prevent envi ronmenta l contamination, p roduct·to·
product carryover, or cross·contamination.
345
ASM.E BPE-2022
are usua lly metallic or polyme ric and provide strong
struc tura l support for the membra nes. T ubu la r
membranes flow from the inside out, with turbu lent
flow in t he retentate strea m keeping t he memb rane
surface clean. Permeate flows through the walls of the
tubes and is collected ou tside t he mod ules. Mod ules
are constructed of metallic or polymeric materials, to
accommodate user needs. Solids levels of up to 5% by
weight are commonly handled by tubular membranes.
(c) Plate and Frame. Plat e-and-fram e or flat-sheet
filters are characterized by an envelope-type structure
formed out of two pieces of membrane. In this type of
device, process tluid is passed over the outside of the
envelope and through the membrane into the inside of
the envelope; the remaining material that did not pass
through the membrane is the retentate. In a plate-andframe arrangement, there is usually a rigid or semirigid
frame that supports the membrane so that there is always
a flow path on the inside and outside ofthe envelopes. This
frame may be a rigid metallic or polymeric frame or something as simple as a screen or straps.
{d) Spiral Wound. Spiral-wound membrane devices are
constructed from an envelope of membrane that is wound
aro und a hollow core. The insi de of the envelope is
connected to the hollow core in such a way as to allow
tluid fro m ins ide t he envelope to pass th ro ugh the
center oí the hollow core. The feed material is passed
into one end of the device and over the outside of the
envelope. The permeate passes through the membrane
into the inside of the envelope and eventually outs ide
the hollow core. The retentate passes out the opposite
end of the spiral device from the feed.
(e) Monolirh. A monolith membrane is characterized by
a porous rigid body with long flow paths (lu mens} that
pass through the middle. These lumens are coated on
the in side diameter with a highly cont rolled porous
surface o r membrane. Typically, t hese devices are
made of cera mic materia l, which wi ths ta nds high
temperatures or aggressive chemicals. The process
fluid is fed into one end of the device and the retentate
passes out the other end; the permeate passes through the
membrane surface and porous body and is collected on the
outside of the device.
pack to the core. One end of the cylindrical shell can be
either sealed (capped} or left open (referred to as "double
open end"). Housing connections are typically flat gasket
orvarious 0 -ring configurations. For submicron filtration,
single-open-end designs are preferred with a secured
double 0-ring connection.
(b) lenticular Design. This design is comprised of two
sheets of filtration media cut in a circular design sandw ich ed a nd s upp o rt ed by a flow chann el. These
formats are usually stacked on top of each other. One
end is closed for flow while the other end is connected
either by a tlat gasket seal or by an 0-ring connection.
Sealing between t he stacked formats is accomplished
by either compression or welding.
(e) Hollow Fiber Design. This design is comprised of
small-diameter permeable tubular membranes that are
sealed on opposite ends by "potting." The flow path
can be from either direction (from inside to outside or
vice versa) of the tubes to either end of the potti ng.
One end of the po tti ng is capped or sea led and the
o ther end has si ngle-open-end des igns wi th Code 7
connection being preferred for submicron filtration.
T-2.2.2 Tangentlal Flow Fllt.ratlon. In TFF,also known
as cross-tlow filtration, the bulk of the process tluid tlow is
tangential to the filter media surface and is ty pically
referred to as "feed" or "retentate.· The portion of the
process tluid that tlows through the filter media is typically referred to as "permeate" or "filtrate· and is captured
as a separate tlow stream. TFP filter media are usually
classified as microfiltration, ultrafiltration, or reverse
osmosis based on the fil ter media pore size. TFF is typically
used for clarification, diafiltration (buffer exchange}. and/
or concentration of a substance of interest.
T-2.2.2.l Filtratlon Elements. A typical TFF element
may be one of the following acceptable designs:
(a) Hollow Fiber. This design is comprised of one or
more permeable membrane tubes, which are typically
sea led int o a ho using on both ends by pottin g in a
shell-and-tube design. The ·shell" side of the membranes
and the inside of the tubes are generally the two distinct
different portions of the device as they can communicate
only through the membrane of the tube. Hollow fiber
ele ments are typ ica lly 0.079 in. (2 mm) or less in
inner diameter. The two typical operation arrangements
are inside-out and outside-in. In the inside-out arrangement, the process fluid is pumped into the inside of the
tubes; in this case, the retentate will emerge out the other
end of the tube, and permeate will be collected on the shell
side of the device. In the outside-in arrangement, the
process fluid is pumped into one end of the shell, and
the retentate emerges out the other end; in this case,
permeate is collected from the inside of the tu bes.
(b) Tubular. Atubular membraneis characteriied by its
discrete tubes and large lumen sizes, wh ich are typically
0.5 in. (1 2 mm} or greater inner diameter. These lumens
T-2.3 Houslngs and Encapsulation
Housings are designed with different options, such as
the capacity for handling multiple elements and various
inlet and outlet options. Encapsulated filtration elements
are designed for handling purposes or in place of metallic
housings.
T-2.3.1 Holders. Holders are used to stack or hold in
place the filter elements and to manage or direct the
process flu id. The holders are des igned to ensure
proper sealing between the inlet and outlet connections,
as well as bel:\'Veen the encapsulated elements.
346
ASM E BPE-202 2
allow the permeate flow ra te to rea ch its maximum. Dur ing
the test, the permeate flow ra te (flux) is measured, a long
with the tempera ture of the solution.
The water permeability is calcula ted using the following
equation:
water permeability = permeate flux (l/m 2-h)/TMP (psi or
bar)
The resulting flow rates are normalized to a standard
temperature by applying a temperature correction factor
t hat a ccounts for t he cha nge in density. A baseli ne
meas urement of the me mbrane's permeability s ha ll be
obtained when the membrane is new. For all subseq uent
measurements, the NWP test is performed following the
cleaning of the membrane at operating conditions as el ose
as possible to the original test.
T-2.4 Design for Cleaning
T-2.4.l Cleanlng. The p urp ose of cleaning a DFF
system is to p revent en viro n menta l contam ination,
product-to-product carryover, a nd cross-contamination.
For TFF, flow rates a re a lso a n important design pa rameter for e ffective cleaning.
T-2.5 Normalized Water Permeability (NWP)
Testing
T-2.5.l To conduct an NWP test, the TFF system is
co ntro lle d a t o n e or mo re ope rating poi nt s with
respect to fee d flow a nd t ra nsmem bra ne pressure
(TM P) usi ng py roge n-free pu ri fied water and /or a
buffer or cleaning agent of s uitable quality. The permeate
pressure should be as clase as possible to O psig (atm) to
347
ASM.E BPE-2022
NONMANDATORY APPENDIX U
GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS
Table continued
U-2 GUIDELINES USED TO DEVELOP SI
EQUIVALENTS
Proposed SI
The fo llowing guíd elines were used t o develop SI
equívalents:
(a) SI uníts are placed ín parentheses afte r the U.S.
Customary units in the text.
(b) The table desígnation (e.g., table number) is the
same for both the U.S. Customary and SI tables, wíth
the additíon of suffíx "M" to the designat or for the SI
table, if a separate table is províded. In the text, references
to a table use only the primary table number (i.e., wíthout
the "M"). Fo r most tables, where interpo latíon ís not
requíred, SI un íts are placed in paren theses aft er the
U.S. Customary unít.
(e) Separate SI versíons of graphica l information
(charts) may be provided as necessary, except that if
both axes are dimensíonless, a single figure (chart) ís used.
(d) In most cases, conversíons of units ín text were
done using hard SI (approxímate) conversion practices,
with so rne soft conve rsíons (exact) on a case-by-case
basis, as appropríate. This was ímplemented by rounding
the SI values to the number of significant figu res ofímplied
precis io n in the exísti ng U.S. Customary u níts. For
example, 8 in . has a n implied precision of one significant
figure. Therefore, the conversion to SI units would typically be 200 mm. This ís a dífference ofabout 1.6% from
the "exact" or soft conversion of 203.2 mm. However, the
precisío n of the conversío n was determíned by the
Comm ittee on a case-by-case bas is. More sign ifican t
digits were incl uded ín the SI equívalent íf there was
any question.
(e) Minímum thíckness and radius val ues that are
expressed ín fractions of an inch were generally converted
according to the following table:
Conversion, mm
Difference, %
1/32
0.8
l.2
1.5
- 0.8
%..
1
/ 16
3¡32
¼
%i
3
116
'In
2.5
3
4
5
5.5
Converslon, mm
Olfference, %
1/+
6
8
10
5.5
- 0.8
s/26
%
- 5.0
11
13
14
1.0
- 2.4
16
17
19
-o.a
:r.
22
1
25
1.0
1.6
7/2 6
½
'½6
o/a
11
/16
o/+
2.0
2.6
0.3
(fJ For nominal sizes that are ín even increments of
inches, even mu ltiples of 25 mm were generally used.
lntermediate va lues were ínterpo la ted ra ther t ha n
converted and rounded to the nearest millímeter. See
examples ín the followíng table:
Size, in.
Size, mm
¼
%
½
¾
10
13
19
1
1%
2
21/i
Proposed SI
Fraction, in.
Fracdon, in.
6
25
38
50
3
4
64
75
100
6
150
(g) For ali pressures, the SI units are in kPa (even when
it is 1 000 kPa) . Roundíng was to one significant figure
(two at the most) ín most cases. See examples ín t he
following table. (Note that 14.7 psi co nverts to 101
kPa, whíle 15 psi converts to 100 kPa. While thís may
seem at first glance to be an anomaly, it is co nsistent
with the roundíng ph ilosophy.)
- 0.8
5.5
-5.0
5.5
-0.8
-5.0
1.0
348
ASME BPE-2022
Table contínued
Pressure, psi
Pressure, kPa
0.5
3
2
15
3
20
10
70
14.7
101
15
100
30
200
50
100
350
700
150
1000
200
1500
250
1700
Temperature, ºF
980
1,900
1 040
2,000
1 095
2,050
1120
U-3 CHECKING EQUATIONS
When a single equation is provided, it has been checked
usi ng dimensiona l analysis to ve rify that the results
obtained by using either the U.S. Customary or SI units
provided are equivalent. When constants used in these
equations are not dimensionless, different constants
are provided for each system of units. Otherwise, a U.S.
Customaryand an SI version ofthe equation are provided.
However, in ali cases, the Standard user should check the
equation for dimensional consistency.
{h) In most cases, temperatures (e.g., for PWHTJ were
rounded to the nearest SºC. Depending on the implied
precision of the temperature, sorne were rounded to
the nearest 0.1ºC or lOºC or even 25ºC. Temperatures
co lder tha n OºF (negative values) were gene rally
ro u nded to the nearest O. lºC. The e xamples in the
following table were created by ro un d ing to the
nearest SºC, with one exception.
Temperature, ºF
Temperatun~, ºC
l.800
U-4 SOFT CONVERSION FACTORS
The following table of "soft" convers ion factors is
provided for convenience. Multiply the U.S. Customary
value by the factor given to obtain the SI value; similarly,
divide the SI value by the factor given to obtain the U.S.
Customary value. In most cases, it is appropriate to round
the a nswer to three significant figures.
Temperature, ºC
70
20
100
38
120
50
150
65
U.S. Customary
200
95
in.
250
120
SI
Factor
mm
25.4
ft
m
0.3048
150
in.2
nml
645.16
350
175
ft2
m2
0.09290304
400
205
in.3
mm'
16,387.064
230
ft3
m•
0.02831685
260
U.S. gal
m3
0.003785412
550
290
U.S. gal
L
3.785412
600
315
psi
kPa
6.89475729
345
'F
•e
5/9 x (º F- 32)
300
450
500
650
Notes
...
Not for
temperatu re
di fference
700
370
750
400
800
425
850
455
900
480
925
950
1,000
1,050
1,100
540
565
595
1,200
650
675
5/9 X Of
For
temperature
510
620
•e
ditTercnces
only
495
1.150
1.250
'f
349
lbm
lbf
N
4.448222
psi
p
6 894.75729
kg
0.4535924
µ in.
m
0.0254
gal/min
L/min
3.785
ft/scc
m/s
0.3048
in./in.¡oF
mm/mm¡oc
1.8
ASME BPE-2022
NONMANDATORY APPENDIX W
POSITIVE MATERIAL IDENTIFICATION
dard Guide for Metals ldentification, Grade Verification
and Sorting, or another recognized ind ustry standa rd
me thod. The techniqueshould also conform to this Appendix.
XRF a nalys is may be performed us ing eit he r the
a nalysis mode or the alloy identification (alloy matching)
mode.
In the analysis mode, the PMI instrument will produce
chemical composition data. including an accuracy tolerance, for each alloying ele ment. This will result in a
range o f val ues for each alloying element. For a
reading to be considered acceptable, one of the following
two conditions shall be met:
(a) The nominal values displayed on the PMI instrument, plus the accuracy to lerances disp layed o n the
instrument, shall be within the corresponding chemical
composition ranges in the applicable material specifica·
tion.
(b) The nominal values displayed on the PMI instru·
ment shall fall within the chemical composition ranges
in the applicable material specification as modified by
the product (check) analysis tolerances in the material
specification incorporated by reference.
When used in the alloy identifica tion mode, the instru·
ment will display a specific alloy type, based on a comparison between the chemical composition data obta ined
during testing and the data ranges in the instrument's
interna! library. When usi ng th is mode, the user is
cautioned that any alloy identified by the PM I instrument
is defined by a single material specification in the uni t's
interna! library whose chemical composition ranges may
not coincide with those in the applicable material specification or contraer requirement. As a resu lt, the user of
the PM I instrumentshall take into consideration potential
diffe re nces between the material specification ranges
loaded into the PMI unit's interna! library and thosespecified for the material, component, or surface being tested.
Since che material speci fications loaded into the PMI
unit's interna! library may not coincide with those speci•
fied for the part being analyzed, the recommended mode
of operation is the analysis mode.
W-1 GENERAL
Posit ive material identification (P MI} is a form of
produce (check} ana lysis in which a partial chemical
composition is determined a nd used to verify ma terial
identification.
As discussed in this Standard, the seo pe of PM I is limited
to alloy verification using portable, handheld X-ray fluorescence (XRF} equipment. Typ ically, th is equ ip ment
cannot detect or measure elements havi ng an atomic
number less than 22 (titanium}. For this reason, eleme nts
such as carbon, su lfur, and p hosphorous can not be
detected. This makes it impossible to use this equipment
in lieu of a complete chemical compositional analysis or to
prove that a specific alloy conforms to a mate rial specification. This equipme nt, therefore, is not suitable for
material accepta nce as a stand-alone analysis. Without
the s upport of a r efer ee a nalysis or a Material Tes t
Report (MTR), PMI should not be used to accept materials,
except for forensic situations in which unknown materials
are being analyzed.
PM I results should not be the sole reason for material
rejection either. When PM I results indicate that a material
may be other than that specified, a referee analysis, ac·
ceptable to the owner/user, purchaser (as a ppropriate),
a nd organization pe rforming the PMI sho uld be
performed. unless the owner/user permits rej ection of
material based sole ly on PMI res ults. Rathe r, PMI
should be used in conju nction with MTRs or Certifica tes
of Conformance from the material manufacture r.
W-2 GENERAL REQUIREMENTS
PM I shall be performed in accordance with a written
procedure as described in W-4. The alloying elements
to be tested shall be either those necessary to identify
the alloy in questio n or t hose hav ing a significant
effect on the performance characteristics of the material.
Unless otherwise specified in the contract, the elements to
be a nalyzed shall be a t the discretion of the organization
performing the PMI. The instrume nt employed shall be
capa ble of detecting che alloying elements of interest.
Records of PMI tests shall be documented and provided
to the owner/user on request.
The analytical technique to be used shall be munially
agreed on by the purchaser (as appropriate) and owner/
user and shall be in accordance with ASTM E1476, Stan-
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ASME BPE-2022
W-3 CALIBRATION
Periodic calibrations shall be performed at frequencies
recomme nded by the equipment ma nuíacturer. These
calibration tests shall be documented, a lthough the specific data does not need to be recorded.
In addition, at die beginning oí each shift, or prior to use
on each s hift, the instrument calibration shall be verified
using three consecutive tests against a known standard for
each alloy category to be inspected during the shift, using
the technique to be used during the shift. An acceptable
calibration verification check s hall be valid to the end of
the shift.
In the event of a nonconforming result, the PMI instrument should be again verified against the known standard
and the suspect materia l should be checked again with
three consecutive checks. lf any of the three consecutive
rechecks are found to be nonconforming, refer to W-6 and
W-7.
Ali t hese instru me nt verification checks shall b e
performed under e nvironme ntal conditions similar to
those oí the test locatio n. Ali such standa rds used in
the instrume nt calibration verification s hall be clearly
identified as to no mi na l a lloy composition. A certified
reference material (CRM) that is an Analytical Reference
Materials lnte rna tional (ARMI) or National lnstitute oí
Standards and Technology (N IST) traceable sta ndard is
reco mmended. As an alternati ve, the kn own sample
could be provided with a n MTR anda chemical composition analysis performed by an independent test laborato·
ry.
W-4 PROCEDURE
A written procedure s hall be used, a nd it shall include
the following ele ments:
(a) the instrument to be used
(b) the analytical technique to be used
(e) sampling pla ns for each material, component, or
surface
(d) material, component, or surface to be inspected
(e) documentation requirements
(f) material identification requirements
(g) r eq uirement s for instru me nt ca libration a nd
instrument calibration checks
(h) personnel qualification requirements
(i) control of rejected materials
The procedure may a lso include segregation procedures for the tested material, marking, and small-percentage random sampling.
(a) requirements for surface prepara tion prior to
testing
(b) mínimum exposure times for adequate data collection
(e) proper activation of the analyzer window shutter to
ensure that it opens completely during exposure and data
collection
( d) assurance that the s urface to be analyzed completely covers the a nalyzer window
(e) precautions to take when using th e alloy analyzer
on curved or contoured surfaces
(f) special instructions or ancillary equipment needed
for analyzing welds
(g) demonstration of capabilities. if required by the
owner/user
Record s of t ra ini ng s hall be maintained by t he
employer.
W-6 ACCEPTANCE/ REJECTION
When an MTR is available. material may be accepted
based on PM I results. if the PM I results for the required
elements are acceptable a nd the data for ali other requ ired
elements on the MTR a re acceptable as well.
Gross deviations that are clearly outside the material
specification li mits, as mod ified by the product analysis
tole ra n ce ( e.g., UNS S31603 fo r which PM I testin g
shows 1.50% molybdenum}, s hall be cause for immediate
quarantine of the material. Referee analysis, agreeable to
ali parties, s hould be conducted to verify this unless the
own er/user elects to permit rejection based solely on PM I
results. Whe n the referee ana lysis shows similar gross
deviations, the material s hall be reject ed.
When no MTR is available, acceptance may be based
solely on the resul ts of a lloy ident ifica tio n ana lysis
when permitted by the owner/user.
W-7 PMI REFEREE METHODS
PMI is not meant to replace an MTR. lf PMI testing indicates a nonconforming result, the suspect material shall be
quara ntined, but it s hould not be immediately rejected. A
qua ntitative referee method, acceptable to ali parties,
should be used, unless the owner/user decides otherwise.
Examples ofsuch methods may be found in ASTM El476.
Any remaining disputes shall be resolved by a third party
that is accredited by the American Association for Labo·
ratory Accreditation (A2LA) oran equiva lent, if available.
W-8 PMI SPECIAL CONDITIONS
Generally, PMI ofba re welding filler wire or inserts can
be achieved with proper procedures.
The users of PM I are cautioned that most equipment is
not typically suitable for a nalysis of small a reas or small
volumes of material, such as welds. and is not capable of
accounting for dilu ti on fa cto rs in welds. Special
W-5 PERSONNEL TRAINING AND QUALIFICATION
lndividuals performing PMI s haH be trained and qualified. The t raining shall address t he followi ng as a
m inimum:
351
ASM.E BPE-2022
equipment adaptations, such as reduced -size detection
w in dows, or specia l methods may be required to
perform analysis on small areas. The equipment manufacturer should be consulted for such applications.
Analysis ofwelds, with or without filler metal, for weld
acceptance is not recommended.
Ana lysis of coatings may require special ana lytical
methods and is outside the scope of this Appendix.
352
ASME BPE-2022
NONMANDATORY APPENDIX Y
PROCUREMENT SOURCES
(22)
To procure ASTM specifications, contact ASTM lnternational at www.astm.org.
To procure ASME specifications, contact ASME at www.asme.org.
To procure DIN specifications, contact DIN at wvl\v.din.de.
To procure /IS specifications, contact /IS at www.jsa.or.jp/enf.
EN specifications may be obtained from any of the following member organizations:
Co untry
Coun tr y Standa rds Oevelopmen t Organization
Website
Austria
Austrian Standards lnstitute (ASI)
www..austria n-standards..at
Bclglum
Bl1reau d e Normallsatfon/Bl1reau voor Normalisatie (NBN)
www.nbn.be
Bulgaria
Bulgarian lnstit.ute fo r StandardiU1tion (BOS)
www.bds--bg.org
Croatla
Croatian Standards lt-..stftute (HZN)
www.hzn.hr
Cyp rus
Cyprus Organization fo r Standardisation (CYS)
www.cys.org.cy
Czech Republic
Czech Oftice ror Standards, Metrology and Testing (UNMZ)
www.unmz.cz
Oenmark
Dansk Standard [DS)
www.ds.dk
Es.tonia
Estonian Centre for Standardisation (EVS)
www.evs.ee
Finland
Suomcn Standardlsolmlsllltto r.y. (SFS)
www..sfs.fi
Former Yu.goslav
St.andardiunion lnstitute of the Re public
www.is rm.gov.mk
Republic of Macedonia
of Macedonia (ISRM)
France
Association Fran ~aise de Normalisation ( AFNOR)
www..afnor.org
Germany
Oeutsches lnstitut fü r Normung (DIN)
www.din.de
Greece
Natlonal Quallty lnfrastn1cture Systcm (NQIS/ELOT)
www.elotgr
Hungary
Hungarian Standards lnstitution ( MSZT)
www.msit.hu
lceland
lcclandlc Standards (1ST)
www..stadlar.ls
lreland
National Standards Aut:hority of lrnland (NSAI)
www.nsai.ie
lraly
Ente Nazionale Italiano di Unificazione (UNI)
www.uni.com
Latvia
Latvian Standard, Ltd. ( LVS)
www.lvs.lv
Lithuania
Llthuanian Standards Board (LSD)
www.lsd.lt
L-uxembourg
Organlsrne L-uxembourgeols de Non n allsatlon (ILNAS)
www.portall•qualiteJu
Malta
The Malta Competition and Consumer Affa irs Authority ( MCCAA)
www.mccaa.org.mt
NethcrlMdS
Ncderlands Norrnallsatle-•fnstituut (NEN)
www.nen .nl
Non.vay
Standords Norway (SN)
www.standard.no/
Poland
Polish Committee for Standardization ( PKN)
www.pkn.pt
Portugal
Instituto Portugue'S da Qualidade (IPQ)
www.ipq.p t
Romania
Romanian Standards Association (ASROJ
www.asro.ro
Slovak.ia
Slo\iak Office oí Standar ds Metrology and l'esting ( UNMS)
www.unms.sk
Slove nia
Slovenian lnstitute for Standardiiation (SIST)
www.sist.si
Spa.ln
Asociación Espafíola de Normalizacl6n y Ccrtlflcación (AENOR)
www..ac1~or.cs
Sweden
Swedish Standards lns-titute (SIS)
www.sis.se
Sw1tzertand
Schwel-zerlsche Nonne1~-Verelnlgung (SNV)
www..snv.ch
Turkey
Turkish Standards lnstitution (TSE)
www.tse.org.tr
United Kingdom
British Standards lnstitution (BSIJ
www.bsigroup.com
353
ASME BPE-2022
NONMANDATORY APPENDIX Z
QUALITY MANAGEMENT SYSTEM
Z-1 SCOPE AND PURPOSE
nents will be in conformancewith the ASME BPEStandard.
The manual shall not be a reiteration of the ASME BPE
Standard, but shall, instead, describe or identify what,
when, where, and how processes are conducted.
Th is Appendix identifies the e le ments that s hall be
a ddressed in a Quality Management System (QMS) for
ASME BPE component manufacturers. These elements
identi fy the procedures, d escribe the processes, and
list the reso urces necessary to implement the QMS.
The QMS shall identify and describe t he au thority of
the in dividu als responsib le for e ns uring tha t the
quality activi ti es necessary for t he ma nu facture of
ASME BPE-compliant components is done in a consistent
a nd controlled manner. These activities shall ensure that
the requireme nts of the ASME BPE Standard a re met
through quality planning, quality control, quality assurance. and quality improvement.
A QMS established by a ma nufacturer that intends to
me et t he req u ire ments of the ASME BPE Standard
shall be suitable for the typ es of compone nts being manufactured and the types ofactivities performed in the manufacture of those components.
Z-3.1 Quality Management System
(a) Management personnel sha ll establish objectives
for measuring effective implementation of the QMS a nd
are responsible for obtai ning the desired resu lts. A
policy sta teme nt ind icating ma nageme nt authority a nd
responsibility shall be included.
(b) A description of the components being manufactured in accordance with the ASME BPE Standard sha ll
be provided.
(e) The a uthority and duties of those responsible for
implementing the QMS shall be clearly established. Individua Is performing quality assurance a nd quality control
functions shall not be under the direct supervisio n of
those in charge of areas b ei ng e va luat ed. They s hall
also have sufficien t a nd well-d efin ed respo nsibility.
a uthority. a nd orga nizational freedom to
(1) identify quality-related problems
(2) initiate, recomme nd, and provide solutions to
quality-related problems
(3) verify implementa tion of those solutions
(4) assure that further processing. delivery, or use of
a s uspect material or product is halted until proper dispo·
sition of any potentially nonconform ing. deficient. or un·
satisfactory condition has occurred
(d) Activities req uired to be performed by qualified
personnel s hall be identified. Mínimum qualifications
for such personnel shall be established. Controls s ha ll
be established to ens ure t hat on ly t hose personnel
who have the s pecified qualifications are permitted to
perform those activities.
(e) Auditing activities shall be performed by trained
and qual ified a ud itors. The qualification, experien ce,
a nd training requ irements for a uditors shall be s pecified
in the QMS ma nual. Auditi ng competence includes, ata
mínimum, demonstrated knowledge and understanding
of
(1) the ASME BPE Standard
(2) applicable regulations
(3) the QMS program
(22) Z-2 GENERAL
The manufacturer shall establis h a nd ma intain a QMS
that ensures conformance to ali applicable req uirements
ofthe current ASME BPE Standard. Upon the issuance ofa
revised ASME BPE Standard, the Certiñcate Holder shall
review his QMS a nd, where requ ired, revise it to be in
conforma nce with the revised Standard. lm plementation
of the revised QMS shall be within 6 months of the date of
issue of the revised Standa rd.
Z-3 QUALITY MANAGEMENT SYSTEM MANUAL
The QMS shall be documented in a written QMS manual.
There is no specific formal or particular arrangement
required for the manual, as long as ali a pplicable elements
have been addressed and the various topics are arranged
in a logical and easy-to-interpre t ma nner. The elements
identifi ed in 2-3.1 through 2-3.15, as applicable to the
manu facturer's scope of work, s hall be add ressed in
the ma nual. The manual s hall be ASME's guide for
surveyi ng and a udi ting t he manufacturer's activities
and docum entation for co nform ance to its QMS. The
ma nua l shall be an auditable document that identifies
the controls and processes used to ensure that the activities performed in the manufacture of ASME BPE compo-
354
ASM E BPE-2022
(4) a uditing techniques for examining, questionin