New 2015 Brochure

advertisement
Company Profile
Unternehmen
PHARMA
Introduction
Ultrapharma BV was founded in 2002 in the
Popular material such as PTFE or TFM are standard
Netherlands, starting as European Master Distributor
among the many validated materials we offer. We
for Rubberfab Technologies Group, a leading
have capabilities to develop specific compounds with
company in the development of Sanitary Seals
unique properties.
for the pharmaceutical industry. Well passed our
12,5 year anniversary Ultrapharma BV has become
Ultrapharma BV has developed gasket manufacturing
a recognized partner for many companies that
capabilities for European pipe standards such as
are involved with daily processing challenges in
DIN32676, ISO1127, DIN11864, SMS3017, BS4825
this industry in Europe. Innovation is our drive for
and DIN11851.
success, smart solutions that will help resolve many
in-field problems.
Ultrapharma BV is ISO-9001 certified (September 2015)
In house engineering has lead to manufacturing
of DIN & ISO gaskets for the European market,
with carefully selected compounds we create new
Ultrapharma BV
products. A well balanced inventory is a security
Heemskerk
for fast shipments with an emphasis on the full
The Netherlands
product range.
Ultrapharma BV offers a very wide spectrum
of products for fluid handling systems for the
pharmaceutical industry as well as the Food &
Beverage. Unique sealing materials such as TufSteel®, Tuf-Flex®, Steam-Flon®, Tri-Bond® and
standard elastomers such as Platinum Silicone,
Peroxide Silicone, FKM, EPDM and many more.
2
www.ultrapharma.com
Chapters
Certification4
Compounds5
Standard Gaskets 6
Dimensions 7
Screens 8
Orifice Plates
10
Smart Gaskets
11
Tuf-Flex & Tri-Bond
12
Tuf-Steel & Steam-Flon
Pressure Gauge
13
Snap On Gaskets with Color Identification 15
Torque Knob
Removable Steam-Flon® 16
DIN11864 18
Special Gaskets
19
Smart Clamps & Lock-Out
20
14
17
Clamps21
Certification
USP-NF
USP testing Part 381, is a Physico-Chemical Test
The United States Pharmacopoeia and the National
which determines the Physico-Chemical properties
Formulary are the official compendia of standards
of certain material and impurities extracted from
for drug, excipients dietary supplements, and
elastomeric closures. The material is for example
other therapeutic products for the United States
EPDM and FKM. Not Silicone.
and several other countries. It is an independent
organization under one cover. The USP contains
European Pharmacopoeia testing Part 3.1.9 is a
legally recognized standards of identity, strength,
Physico-Chemical Test which determines the Physico-
quality, purity, packaging, and labeling for more than
Chemical properties of Silicone material. The material
3400 drug substances, preparations and products.
is either Peroxide Silicone or Platinum Silicone.
When a standard is published in the USP-NF, federal
and state government agencies, such as FDA have
the authority to enforce them and to ensure that
products comply.
FDA
Most important test protocols for elastomer and
perfluorocarbon products (seals) are:
Food and Drugs Administration is a US government
agency within the Department of Health and Human
USP Class VI testing Part 88, Biological reactivity
Services. FDA is the federal agency responsible
test Part 87, in vivo. It is designed to determine
for ensuring that foods are safe, wholesome and
the biological response of animals to elastomerics,
sanitary; human and veterinary drugs, biological
plastics and other polymeric material with
products, and medical devices are safe and effective;
direct or indirect patient contact, or by the injection
cosmetics are safe; and electronic products that
of specific extracts prepared from the material
emit radiation are safe. FDA has written codes
under test.
(CFR’s) to ensure that seals that we make conform
to certain standards when in contact with food or
USP testing Part 87, Cytotoxicity test, Biological
pharmaceutical processing systems.
reactivity test, in vitro. It is designed to determine
the biological reactivity of mammalian cell cultures
Examples:
following contact with the elastomeric plastics
FDA CFR 177.1550 Perfluorocarbon resins. A detailed
and other polymeric materials with direct or indirect
description of methods of processing and substances
patient contact or of specific extracts prepared
that can be safely used.
from the material under test.
FDA CFR 177.2600 Rubber articles intended for
USP testing Part 661, is a Physico-Chemical Test
repeated us may be safely used in producing,
which determines the Physico-Chemical properties
manufacturing, packaging, processing, preparing,
of certain material. This test measures defined
treating, transporting or holding food, subject to the
properties of impurities in plastics. The material is
provisions of this section. It also describes a test for
for example PTFE or TFM.
impurities from elastomeric closures. The purpose of
the study is to analyze total extractables.
4
www.ultrapharma.com
TSE
TSE also known as BSE (Bovine Spongiform
Whereas many of our products are used in human or
Encephalopathy) has been addressed by FDA and the
veterinary medicine production plants, it is important
European Union. The use of animal derived ingredients
to know if any of our products have been in contact
in the production of medicine and other related
or are produced with animal derived ingredients.
products has in the past lead to the transmit of TSE
disease. TSE disease is a central nervous disease.
The only product (compound) that is made
manufactured with animal derived ingredients is
The European Union has written a journal
NBR (buna). All other products such as EPDM, FKM,
(EMEA/410/01) in which they give guidance on
PTFE and Silicone are Animal Derived Ingredient free.
minimizing the risk of transmitting animal spongiform
(ADIF).
encephalopathy agents via human and veterinary
medical products.
Compounds
Today the need for traceability in the pharmaceutical
Compound Data Sheets will tell exactly what the
industry is eminent. We need to know what we are
compound is all about including all its credentials
getting and we need to know if the supply chain
such as FDA-CFR listing, USP Class VI and other
is consistent time after time. One way to secure
relevant test criteria. All clients of Ultrapharma BV
consistency is to introduce compound numbers. If
have access to these Compound Data Sheets (CMD),
compound numbers are linked to product numbers
they can advice pharmaceutical end-users of the
ore creates the condition that the supplier cannot
existence and determine which compound to use for
change from one compound to another. Once a
their applications. The compound number that has
gasket is validated and known by its compound there
been chosen can be referred to at any point in time
is no possibility to change things. This is what we are
when ordering new gaskets.
seeking for in today´s industry. Most pharmaceutical
companies require a written notification for any
The Certificates of Conformance that we generate
change in the manufacturing process including
for all products are now made automatically. The
compound changes. The impact of compound
Compound Data are stored in our SAP system, all
changes can be severe, is expensive and time
information about lot numbers is stored as well. In
consuming, in which no one is eager to get involved
the final stage all information is gathered and printed
with. This is why Ultrapharma BV is introducing fixed
on the Certificate of Conformance. All is based on
compound numbers for all products.
the one specific compound.
Standard Gaskets
Pharmaceutical Grade
Our standard process gaskets are Tri-Clamp versions in several standards; OD tube also known as ASME BPE,
DIN32676, SMS 3017, ISO1127 and BS4825. The Tri-Clamp gasket is made in several types of elastomers.
EPDM Ethylene Propylene Diene Monomer FKM (Viton®) Fluoroelastomer
Silicone (Peroxide)
Silicone Rubber
Silicone (Platinum)
Silicone Rubber
BUNA Acrylo Nitrile Butadiene Rubber
High performance plastics are:
PTFE PolyTetraFluoroEthylene
TFM Modified PolyTetraFluoroEthylene
Tuf-Steel® Blend of non pigmented PTFE and 316L powder
Tuf-Flex® Bonded PTFE with EPDM substrate
Tri-Bond® Bonded PTFE with FKM or EPDM substrate, DIN & ISO only
Steam-Flon®
Blend of non pigmented TFM and 316L powder, only for DIN & ISO
Typical Gasket Guidelines
1 = Excellent
2 = Good
3 = Acceptable
4 = Marginal
5 = Poor
x = do not use
Continuous
Steam
Intermittant
Steam
Pure Water
Ambient
Pure Water
Hot
Process
Fluids
Ambient
Proces Fluids
Hot
Proces Fluids
Variabe T
Temperature
Range*
Torque Value
in Nm*
Tuf-Flex®
1
1
1
1
1
1
1
-20°C to 150°C
2,0
Tri-Bond®
1
1
1
1
1
1
1
-30°C to 175°C
2,0
Tuf-Steel®
1
1
1
1
1
1
1
-212°C to 288°C
4,0
Steam-Flon®
1
1
1
1
1
1
1
-212°C to 288°C
4,0
PTFE Solid
1
1
1
1
1
3
3
-74°C to 260°C
3,0
PTFE Envelope
(EPDM)
2
2
1
1
1
3
3
-30°C to 150°C
3,0
PTFE Envelope
(FKM)
2
1
1
1
1
3
3
-30°C to 170°C
3,0
Silicone Platinum
cured
2
2
2
2
2
2
1
-40°C to 230°C
1,5
FKM
Fluoroelastomer
2
2
2
2
2
2
2
-30°C to 205°C
1,5
EPDM peroxide
cured
3
3
3
3
3
3
3
-20°C to 150°C
1,5
Gasket type
*recommended
6
www.ultrapharma.com
Dimensions
A
DIN32676
ISO 1127
ASME-BPE
SMS 3017
DIN 32676
Reihe A
DIN 32676
Reihe B
DIN 32676
Reihe C
ISO 2852
BS 4825
DN06
1/4”
DN08
DN10 *
3/8”
1/2”
DN12 *
DN14 *
DN16 *
DN18 *
DN08 *
DN10
1/2”
DN12 *
3/4”
DN18 *
3/4”
DN08
DN10
DN15
DN15
DN20
DN10 *
DN08 *
DN10 *
DN15 *
DN20 *
DN15 *
1“
DN25
DN20
DN25
DN25
DN33,7
DN32
1.5”
1.5”
DN38
DN40
DN32
1” *
DN32
DN40
DN51
2”
2”
DN50
DN50
DN63,5
2.5”
2.5”
DN65
DN65
DN76,1
3”
3”
DN80
DN80
DN88,9
4”
4”
DN101,6
DN100
DN115 *
DN100
4.5” *
4.5”
DN114,3
5” *
5” *
5.5” *
5.5”
DN125
DN125
DN139,7
6”
DN150
DN150
6,6”
DN168,3
8” *
DN200
DN200
8,6”
DN219,1
DN250 *
10” *
DN250
C2
10,6” *
DN300 *
12” *
DN300
12,6” *
E
22
22
22
22
22
22
22
22
22
34
34
34
34
34
34
34
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
50,5
64
64
64
64
64
64
77,5
77,5
77,5
91
91
91
91
106
106
106
119
119
119
130
130
144
155
155
155
155
167
183
183
183
217,4
233,5
233,5
233,5
268
C4
286
286
319
338
338
C4
PTFE
4
4,7
6
8
9,6
10
12
14
16
8
10
10,3
14
16
18,1
20
10
10,3
14
16
20
18,1
22,1
22,8
23,7
26
29,7
31,5
32
35,1
35,8
38
38,4
38,4
44,3
48,8
47,4
50
56,3
60,5
60,5
66
72,1
73,1
73,3
81
84,3
85,1
97,5
97,8
100
110,3
110,5
125
125
134,5
135,9
146,9
150
163,2
163,3
197,8
200
213,9
214,1
250
E
267,8
268
300
318,7
319
C4
ELASTOMER
4,2
5,1
6,2
8,2
10,8
10,2
12,2
14,2
16,2
10,2
10,5
14,2
16,2
18,2
20,2
10,3
10,5
14,2
16,2
20,2
18,4
22,5
23
23,9
26,2
29,9
31,7
32,2
35,3
36
38,2
38,6
22,5
38,6
44,5
49
47,8
50,2
56,5
60,7
61
66,2
72,3
73,3
73,5
81,2
85,1
85,3
98,2
98
100,2
110,5
110,7
A
125,4
125,4
134,7
135,9
136,1
147,2
150,4
163,4
A
163,5
198
200,2
214,3
214,3
250,2
268
268,2
300,2
318,9
319,2
SECTION A-A
TYPE I
20,2
20,2
20,2
20,2
20,2
20,2
20,2
20,2
20,2
27,5
27,5
27,5
27,5
27,5
27,5
27,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
43,5
56,5
56,5
56,5
56,5
56,5
56,5
70,5
70,5
70,5
83,5
83,5
83,5
83,5
97
97
97
110
110
110
122
122
134,5
146
146
146
146
156,5
174
174
174
207
225
225
225
257
276
276
309
328
328
info@ultrapharma.com
www.ultrapharma.com
info@ultrapharma.com
www.ultrapharma.com
B A E*
A
C2
A
A
C2 C4
E
B A E*
C2 C4
E
B A E*
Tri-Clamp Mini
Gasket
SECTION
A-A
TYPE MINI
SECTION A-A
TYPE MINI
1967 DB Heemskerk
The Netherlands
1967 DB Heemskerk
The Netherlands
T: +31-(0)251-207050
F: +31-(0)251-207055
T: +31-(0)251-207050
F: +31-(0)251-207055
CONFIGURATION
DESCRIPTION:
Default
DIN 32676 FERRULE REIHE A DN6-DN/OD ¾
The information contained in this drawing is the sole
property of Ultrapharma BV. Any reproduction in
part or as a whole without written permission of
Ultrapharma BV is prohibited.
3RD ANGLE PROJECTION
UNITS:
SCALE:
mm
2:1
SHEE
A
CONFIGURATION
DESCRIPTION:
Default
DIN 32676 FERRULE REIHE A DN6-DN/OD ¾
The information contained in this drawing is the sole
property of Ultrapharma BV. Any reproduction in
part or as a whole without written permission of
Ultrapharma BV is prohibited.
3RD ANGLE PROJECTION
UNITS:
SCALE:
mm
2:1
SHEE
A
A
A
A
A
C2 C4
E
B A E*
C2 C4
E
B A E*
Tri-Clamp Type
1 Gasket
SECTION A-A
TYPE I
SECTION A-A
A
TYPE I
A
in
w
in
w
A
A
C2 C4
C2 C4
E
B A E*
E
B A E*
Tri-Clamp Type
2 Gasket
SECTION A-A
TYPE II
SECTION A-A
TYPE I
Note: sizes indicates with (*) is not a norm strandard
CONFIGURATION
DESCRIPTION:
Type I & II GASKET TYPES
info@ultrapharma.com
www.ultrapharma.com
1967 DB Heemskerk
The Netherlands
T: +31-(0)251-207050
F: +31-(0)251-207055
The information contained in this drawing is the sole
property of Ultrapharma BV. Any reproduction in
part or as a whole without written permission of
Ultrapharma BV is prohibited.
3RD ANGLE PROJECTION
UNITS:
SCALE:
mm
2:1
S
in
w
Screens
Our screens are not used the same way as conventional filters, although it can be considered a filter.
Conventional filters are build differently and have many layers to prevent particles to pass through,
these can reach efficiencies of almost 100%. Our screens are only one layer and therefore they cannot
be considered the same.
Screens are designated in mesh sizes. Mesh 20, 40, 100 etc. 20 mesh means 20 wires per inch,
in both directions, the hole is therefore square. The higher the mesh number the smaller the hole size.
The smallest size has a 10 µm retention, 200 x 1150 wires. It is important to take into account the shape of
the particles anticipated in your system when choosing your mesh sizes. It is surely not an exact science.
Typical application for a screen is a pump protection. Think about what can be pumped through a new
build piping system in a startup! Some pumps might not survive this first run. Another application is a
fine filter in front of filling needles in the final stage of a pharmaceutical line. Just to prevent any lose
particle to end up in a vial.
Screens can also be used at the point of use in WFI systems, it is fascinating to know that the pressure
drop over a 1,5” screen with 100 mesh is only 100 mbar at 6m3/h. Frequent cleaning is required,
because the captured particles will create a higher pressure drop.
Pressure Drop Graph
Calculated with pipe id 35,1 mm (1,5” Tri-clamp Gasket) 100 Mesh screen strainer (open area 30,3% / 0,152 mm)
Pressure Drop [mbar]
300
250
200
150
100
50
0
0,0
1,0
2,0
3,0
4,0
5,0
6,0
Volume Flow [m3/h]
8
www.ultrapharma.com
7,0
8,0
9,0
10,0
Screen Reference Chart
Approx.
Retention in
Microns
Filter Cloth
Filter Cloth
Thickness
in mm
20x200
0,838
-
120x180
0,254
-
120x200
0,229
120x330
0,254
Opening
in mm
Mesh
(wire/inch)
Open Area %
5156
5,156
4x4
65,9
3340
3,340
6x6
62,4
2464
2,464
8x8
60,2
1905
1,905
10x10
56,3
1532
1,532
12x12
52,4
1306
1,306
14x14
51,8
1130
1,143
16x16
50,7
979
0,991
18x18
48,2
864
0,864
20x20
46,2
703
0,711
24x24
44,1
516
0,508
30x30
37,2
381
0,381
40x40
36
318
0,330
50x50
30,3
233
0,229
60x60
30,3
160
0,178
80x80
31,4
140
0,152
100x100
30,3
118
0,127
120x120
30,9
103
0,102
150x150
37,2
-
-
80
0,076
180x180
34,3
74
0,051
200x200
33,6
96
70
65
61
0,051
250x250
36
50
-
43
0,025
-
-
40
-
325x325
-
120x400
0,229
35
-
-
120x500
0,229
30
-
120x600
0,229
25
-
200x600
0,152
21
-
200x830
0,152
10
-
200x1150
0,152
Sock screens offer up to 300% more open area and more soil collection capabilities than conventional flat
screens. Available from 1,5” through 4” TC connections. Also available with a Steam-Flon reusable gasket.
Screens can be supplied with 3.1B certificates.
Sock Screens
Tabbed Screen
Standard Screen
Orifice plates
Ultrapharma offers a very wide range of Orifice
Plates, used to alter flow patterns in critical systems.
Orifice plates are made in 316L stainless steel and
can be electro polished as an option. Standard plates
are delivered without hole. We offer custom drilled
holes either eccentric (self-draining) or concentric.
A new innovation are the conical plates used in
vertical pipelines. A flat plate in a vertical pipeline
Self-draining vertical plates
placed horizontally is not self-draining, a conical
plate pointing down is self draining.
Available from ½ ” through 6”
Sealing material:
EPDM, FKM, Silicone, PTFE,
Tuf-Steel®/Steam-Flon® removable.
Tabs are a helpful feature to visualize the presence
of an orifice plate “in line” easy to recognize from
the outside. Text can be laser engraved on the tab
indicating hole size for example.
Tabbed Orifice plate with self draining hole
Clamp for Tabbed Screens or Orifice plates
Self draining PTFE orifice plate with tab.
10
www.ultrapharma.com
Smart Gaskets
The Rubberfab Smart Gaskets® have become a
standard tool for Validation Engineers. Thermal
mapping is an easy task with the Smart Gasket®,
a reliable tool for a temperature probe.
A standard sanitary flange utilizing the Smart
Thermocouple Gasket obtains the critical thermal
mapping information needed during the validation
process without interference due to incorrect
installation.
Available in ASME BPE 1/2” - 4” incl 2,5” NEW
DIN32676 DN20 (34 mm flange)
ISO1127 DN50 (77,5 mm flange)
2 ports in 34 mm DIN32676
Materials:
EPDM
Platinum Silicone
FKM Fluoroelastomer
PTFE or Tuf-Flex is not possible in a Smart Gasket
The Smart Gasket® is twice as thick as a standard
1, 2, 3 or 4 ports configuration
gasket and therefore it requires a special stainless
steel clamp. The clamp is available with the same
amount of slots/ports as the gasket itself.
4 port clamp
Tuf-flex®
Tuf-Flex® the ultimate pharmaceutical gasket, is setting new standards for purity, performance, flexibility and
is the world’s first unitized gasket. A Tuf-Flex® gasket’s contact surface is PTFE unitized to an EPDM rubber
inner core. This totally bonded construction provides the inert, non-stick benefits of PTFE with the memory of
an elastomeric gasket without fear or risk of pigmentation or spalling. Designed to meet critical requirements in
biopharmaceutical, ultra-pure water, WFI and difficult aseptic processing applications. Tuf-Flex® extended service
life increases up-time by outperforming other gaskets by eliminating costly process interruptions.
Available sizes: 1/2” through 6”
Material: PTFE/EPDM
Compound CPO-Tuf-Flex
Temperature range -20°C to 150°C
Meets: USP Class VI-121°C
Meets: FDA CFR 177.1550
Ultrapharma has developed Tri-Bond® an identical
product as Tuf-Flex® but for DIN32676 and ISO1127,
raw materials used are different from the Rubberfab
version. The contact surface is PTFE and the core
is FKM. It also has the lip feature build in for easier
installation.
Available sizes: DN10 through DN100
DIN32676 & ISO1127
Material: PTFE/FKM
Temperature range -30°C to 175°C
Meets: USP Class VI-121°C
Meets: FDA CFR 177.1550
Solid PTFE
Solid
PTFE
12
www.ultrapharma.com
Envelope PTFE
Envelope
PTFE
Tuf-Flex ®
Tuf-Flex
®
Tri-Bond ®
Tri-Bond
®
Tuf-Steel®
Tuf-Steel® a Rubberfab innovation, is composed of a unique proprietary blend of non-pigmented PTFE and
316L passivated and atomized stainless steel. Testing and many years of documented application usage has
demonstrated that Tuf-Steel is the choice for perfect surface performance, outstanding durability, extended
service life, and increased up-time in both SIP and WFI applications. Tuf-Steel® is ideal for sanitary steam and
extreme temperature processes. Especially when large temperature fluctuations are present Tuf-Steel® will
eliminate the need for re-torque clamps. The gasket will move with the temperature and will maintain sealing
capabilities, no more leaks. The superior strength of Tuf-Steel® minimizes creep and cold flow providing a
leak-free seal.
Available sizes: ½” through 12”
Material: PTFE/316SS powder Compound CPO-Tuf-Steel
Temperature range -212°C to 288°C
Meets: USP Class VI-121°C
Meets: FDA CFR 177.1550
Ultrapharma is introducing the Trade Mark ”Steam-Flon®” for their so called ”Tuf-Steel” products in
DIN32676 and ISO1127 and special products. Tuf-Steel® is a registered Trade Name of Rubberfab Inc and is
a well known gasket material with an extremely good reputation. This material is the best choice in a clean
steam environment, no more leaks, no more cold flow, the everlasting seal.
Ultrapharma is manufacturer of the DIN32676 and ISO1127 gaskets and required to develop their own
compound for this material which we call Steam-Flon®. This is the reason why we cannot call the DIN & ISO
gaskets Tuf-Steel®.
The two materials are identical in performance and have similar Biological Compliance.
Available sizes: DN04 through DN300
DIN32676 & ISO1127 (DIN32676 Reihe A, B, C)
Material: PTFE/316SS
Compound CMD-1019
Temperature range -212°C to 288°C
Meets: USP Class VI-121°C
Meets: USP<661>
Meets: FDA CFR 177.1550
Pressure Gauge
A year ago we introduced the 3/4” MINI TC Single
Use PTFE pressure gauge. Right after that we
continued our development with this concept for the
1” Tri-Clamp version. In the meantime we learned
that this pressure gauge is not only suitable for
single use applications but has a much longer life
expectance than initially thought. During testing in
a Steaming In Place (SIP) environment we learned
that the PTFE gauge can withstand this procedure
without any problem. Multiple SIP cycles (40x) have
been conducted @ 135°C ~ 5 hour exposure.
Both the 3/4” and the 1” TC version show no
degradation.
A perfect solution for non metallic systems. The
gauge is liquid filled, we therefore recommend to
use a Gauge Guard Isolator (GGI) to prevent any
liquid to enter your system in case of a breakdown of
the gauge membrane.
Ultrapharma recommends to use non metallic
clamps for our PTFE gauges.
Compound CMD-1028
Meets FDA CFR-177.1550
Meets USP Class VI-121°C<88>
Meets USP Cytotoxicity<87>
Maximum temperature exposure 135°C
Liquid filled (Silicone oil)
Two scales 0-2 Bar and 0-3,5 Bar (accuracy ±10%)
We recommend to use Non Metallic Clamps
(See Page 22)
14
www.ultrapharma.com
Snap-On gaskets
A simple way to identify products is to introduce a
color. There are many reasons why process engineers
like to identify products by color.
• To identify dedicated product lines
• To identify consumable products when
exchanged during maintenance
• To identify a specific size gasket
White silicone
The Snap-On gaskets that we have developed has
several features build in. It has a high temperature
resistant colored plastic ring on the outside. It has
a validated elastomer on the inside. It also has a
compression limiter build in. It has three gaps to
allow easy dismantling. It is designed with three lips
on the side so you can Snap it On easily and doesn´t
fall off the ferrule.
EPDM
Preventing over compression
Over compression is the biggest problem in this
industry. Most commonly used elastomers gaskets
are already broken even before they are being used.
The plastic ring is slightly thinner than the elastomer
inside, resulting in the perfect compression when
clamped between two ferrules. The plastic ring
prevents over compression.
Validated Compounds:
(Some of these compounds may already been
validated in your plant!)
• Peroxide EPDM
CMD-1004
• Platinum Silicone
CMD-1012
• Peroxide White Silicone
CMD-1027
• FKMCMD-1010
Sizes available:
ASME-BPE 1”, 1,5” and 2”, more sizes to come
DIN32676 on request, ISO1127 on request
Slit Clamp
To have a clear view on what color is inside
the connection you made we offer a special clamp
Recommended Torque 1,5Nm
with double slit.
(30 Bar test pressure @20°C)
Torque Knob
Over compression is the biggest problem
experienced in this industry. Most of the elastomers
gaskets are already damaged even before they are
being used. Think about the life expectance of a
gasket that is over compressed.
Each rubber has certain mechanical, thermal and
chemical properties that we can rely on when we
choose to use it. As long as we use the rubber within
its boundaries the rubber will perform as expected.
Once we exceed one of these properties the rubber
will basically fail. High temperature as well as wrong
chemical exposure will destroy a gasket. The same
will happen when we over compress a gasket. The
mechanical structure within the rubber represented
by Tear Strength and Tensile Strength will fail. The
internal structure of the rubber will breakdown,
resulting in lower temperature resistance, weaker
chemical resistance and eventually parts of the
rubber will break out and end up in your system.
Why does man over compress?
• We don´t know!
• People think the gasket will leak, therefore we
turn the wing nut extra
• Users were told to turn the wing nut as far as
they could
• The manufacturer has not provided sufficient
information
The Torque-Knob prevents over compression by
setting a Torque limit. The Torque-Knob is an easy
tool to use. It fits almost all Wing-Nuts depending
All is true. We tested several rubbers and PTFE
on the gasket material you can chose the specific
gaskets and learned that many of them can be
Torque in Nm. Turn until it starts clicking.
sealed with a much lower torque than expected.
Available in: for elastomers in 1,5 Nm – 2 Nm - 2,5 Nm
Below a table of results.
for PTFE in 3 Nm - 4 Nm.
Material
EPDM
SILICONE
FKM
TUF-FLEX
TRI-BOND
PTFE ENVELOPE
PTFE SOLID
STEAM-FLON
TUF-STEEL
16
Rec. Torque Nm
1,5 Nm
1,5 Nm
1,5 Nm
2 Nm
2 Nm
3 Nm
3 Nm
4 Nm
4 Nm
www.ultrapharma.com
Pressure 20°C
30 Bar
30 Bar
30 Bar
30 Bar
30 Bar
25 Bar
30 Bar
8 Bar
15 Bar
SIP @ 135°C
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
2,2 Bar (2h)
Pressure after SIP 20°C
30 Bar
30 Bar
30 Bar
20 Bar
20 Bar
6 Bar
10 Bar
8 Bar
15 Bar
Cycles
1
1
1
1
1
1
1
1
1
Removable Steam-Flon®
The removable Steam-Flon® gaskets are unique and very useful. The mechanical properties of Steam-Flon®
are perfect in combination with this product because of the low Cold Flow. Virgin PTFE will lose its shape as
soon as it is compressed Steam-Flon® does not. The removable gasket can be dismantled and assembled
after cleaning without any problem. Perfect if a screen need to be regenerate. Orifice plates can be
exchanged rapidly. Sock screens that cannot be supplied with PTFE seal can now be supplied with a SteamFlon® seal.
¾” Orifice plate Ø3,0 mm
Removable Perforated disc 1,5”
DN20 Screen mesh 20
Rupture disc 1,5” Steam-Flon® seal
Sock screen 1,5” mesh 200
DIN11864
The DIN11864 fitting is a relatively new sanitary
fitting. The concept of this fitting is based on
controlled compression. It is impossible to over
EPDM CMD-1004
compress the Rubber O-ring inside.
The DIN11864 is available in 3 versions:
DIN11864-1 with treaded Nut - DIN11864-2 with
bolted Flange - DIN11864-3 with Tri-Clamp
DIN11864
DIN11850
ISO1127
ID X S
ID X S
DN08
BPE
FKM CMD-1010
ID X S
12 x 3,5
DN1/2"
12 x 3,5
12 x 3,5
16 x 3,5
DN3/4"
18 x 3,5
18 x 3,5
DN10
12 x 3,5
DN15
18 x 3,5
DN20
22 x 3,5
26 x 3,5
DN 1.5"
37 x 5
37 x 5
DN25
28 x 3,5
32 x 5
DN 2"
50 x 5
50 x 5
DN32
34 x 5
40,5 x 5
DN 2.5"
62 x 5
62 x 5
DDN40
40 x 5
46,5 x 5
DN 3"
75 x 5
75 x 5
DN50
52 x 5
58,5 x 5
DN 4"
100 x 5
100 x 5
DN65
68 x 5
73,5 x 5
DN80
83 x 5
86,5 x 5
DN100
102 x 5
111 x 5
DN125
127 x 5
DN150
152 x 5
24 x 3,5
Peroxide silicone CMD-1015
FEP/FKM CMD-1029
Screens
ID
S
SECTION A-A
www.ultrapharma.com
A
A
18
Platinum silicone CMD-1012
Special Gaskets
We offer the possibility of special gaskets that are custom designed for new applications. Our access to 3D
design in SolidWorks® allows us to quickly respond to any new ideas. Some examples of specials below.
Ball Valve Seat in Steam-Flon®
Two Part PTFE DIN2633 PN16 Screen
Removable Elastomers Gaskets (Slit Gasket), Simple to install or and to replace.
¾” Sock screen
Laser Engraving
Steam-Flon® washers
Smart Clamps
The “HALF-TURN” Sanitary Smart Clamp is a NEW Rubberfab innovation. It allows to assemble and dismantle
a Tri-Clamp connection in only Half a Turn. This dramatically increases production uptime, while reducing hand
& finger strain (RSI). Multiple Torque settings for use with all Sanitary gaskets, eliminating the need for costly
compression control gaskets.
Treadles system prevents soil and bacteria entrapment.
Supports ASME-BPE standards as well as DIN32676, BS4825 and ISO1127, made in 304SS.
Available in ½” (25 mm), DIN32676 (34 mm), 1” (50,5 mm) , 2” (64 mm) , 2.5” (77,5 mm), 3” (91 mm),
DIN32676 (106 mm), 4” (119 mm) and 6” (167 mm).
Lock-Out
The “Lock-Out” tab can be a helpful tool to secure certain piping connections so they are not opened without
breaking the seal. The Lock-Out tag is supplied with a sequential unique number and can be documented in
validation files. It is now easy to register certain points in a process line.
The colored Lock-Out can also be used to identify a dedicated product line, or you may use it to identify for
example a screen with a yellow Lock-out and an Orifice plate with a blue Lock-out.
To take away a Lock-Out tag you need to cut both wires. It is a single use system. Available colors are; Green,
White, Yellow, Blue and Red. 20
www.ultrapharma.com
Clamps
304 (1.4301)
Inch
Flanch OD Ø
A mm
Part NO.
1/2”
1 1/2”
2”
2 1/2”
3”
3 1/2”
4”
4 1/2”
5”
6”
8”
10”
12”
25
50,5
64
77,5
91
105
119
130
144,7
167,1
218,00
267,20
319,00
31,75
53,59
66,90
80,59
93,98
108,28
122
133,68
148,23
170
220,85
272,80
322,45
13MHHM-050\075
13MHHM-150
13MHHM-200
13MHHM-250
13MHHM-300
13MHHM-350
13MHHM-400
13MHHM-450
13MHHM-500
13MHHM-600
13MHHM-800
13MHHM-1000
13MHHM-1200
Inch
Flange OD Ø
A mm
PART NO.
DIN34
1/2”
1-1/2”
2”
2-1/2”
3”
3-1/2”
4”
4-1/2”
5”
5-525”
6”
6-5/8”
8-5/6”
10”
12”
34
25
50,5
64
77,5
91
106
119
130
144,7
155
167
183
233,5
268
319
37,7
31,75
53,59
66,90
80,59
93,98
110
122
134
148
158
170
187
238
273
322,45
13LAH-034
13LAH-050\075
13LAH-150
13LAH-200
13LAH-250
13LAH-300
13LAH-350
13LAH-400
13LAH-450
13LAH-500
13LAH-550
13LAH-600
13LAH-6625
13LAH-8625
13LAH-1000
13LAH-1200
DN/NW
20-32
40
50
65
80
100
115
200
250
300
DN/NW
8-20
20-40
40
50
65
80
100
115
125
150
200
250
300
316 (1.4401)
PART NO.
13LAH-050\075-316SS
13LAH-150-316SS
13LAH-200-316SS
13LAH-250-316SS
13LAH-300-316SS
13LAH-400-316SS
KF VACUMM
304 SS
PART NO.
13KF-16
13KF-25
13KF-40
13KF-50
Clamp versions
13LAH + 13LAH-316SS
13MHHS
13MHHM
316SS clamps in
13LAH execution
13MHP
Non Metallic Clamp ½” – 8” TC
KF vacuum clamps 304SS
Different Wing Nuts are available
Clamps are made in 304SS (1.4301) stainless steel. Only 13LAH series is available in 316SS, from 1/2” through 4”.
Clamps carry Heat numbers. 3.1B certificates available upon request.
Semi Closed
Wing Nut
22
www.ultrapharma.com
Ribbed
Wing Nut
Butterfly
Wing Nut
Closed
Wing Nut
Hex Nut
Notes
ASME BPE
Get more information about other Sanitary Solutions on our website
www.ultrapharma.com
De Trompet 1510
NL-1967 DB, Heemskerk
The Netherlands
T. +31 251 20 70 50
F. +31 251 20 70 55
info@ultrapharma.com
Download