ASME BPE-2022: Bioprocessing Equipment Standard

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 . ASME issues written replies to inquiries concerning interpretations of technical aspects of this Standard. Periodically, certain actions of t he ASME BPE Committee may be published as cases. Cases and interpretations are published on t he ASME website under the Committee Pages at http://cstools.asme.org/ as t hey are issued. 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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 (22) 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 (22) 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'ication 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 (22) 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 (22) 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. (22) 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 (22) (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. (22) 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 (22) 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. (22) (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 (22) 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 performance 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 material-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 examination 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 (22) 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 (22) 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 (22) 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 November 2018 ) 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 □ NE D Contractors O Consultants Page_of _ 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 327 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- 350 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

ASME BPE-2022: Bioprocessing Equipment Standard

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