new 2015 brochure
TRANSCRIPT
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PHARMA
Company ProfileUnternehmen
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Introduction
Ultrapharma BV was founded in 2002 in the
Netherlands, starting as European Master Distributor
for Rubberfab Technologies Group, a leading
company in the development of Sanitary Seals
for the pharmaceutical industry. Well passed our
12,5 year anniversary Ultrapharma BV has become
a recognized partner for many companies that
are involved with daily processing challenges in
this industry in Europe. Innovation is our drive for
success, smart solutions that will help resolve many
in-field problems.
In house engineering has lead to manufacturing
of DIN & ISO gaskets for the European market,
with carefully selected compounds we create new
products. A well balanced inventory is a security
for fast shipments with an emphasis on the full
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 Tuf-
Steel®, Tuf-Flex®, Steam-Flon®, Tri-Bond® and
standard elastomers such as Platinum Silicone,
Peroxide Silicone, FKM, EPDM and many more.
Popular material such as PTFE or TFM are standard
among the many validated materials we offer. We
have capabilities to develop specific compounds with
unique properties.
Ultrapharma BV has developed gasket manufacturing
capabilities for European pipe standards such as
DIN32676, ISO1127, DIN11864, SMS3017, BS4825
and DIN11851.
Ultrapharma BV is ISO-9001 certified (September 2015)
Ultrapharma BV
Heemskerk
The Netherlands
2 www.ultrapharma.com
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Chapters
Certification 4 Compounds 5
Standard Gaskets 6
Dimensions 7
Screens 8
Orifice Plates 10
Smart Gaskets 11
Tuf-Flex & Tri-Bond 12
Tuf-Steel & Steam-Flon 13 Pressure Gauge 14
Snap On Gaskets with Color Identification 15
Torque Knob 16 Removable Steam-Flon® 17
DIN11864 18
Special Gaskets 19
Smart Clamps & Lock-Out 20
Clamps 21
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Certification
USP-NFThe United States Pharmacopoeia and the National
Formulary are the official compendia of standards
for drug, excipients dietary supplements, and
other therapeutic products for the United States
and several other countries. It is an independent
organization under one cover. The USP contains
legally recognized standards of identity, strength,
quality, purity, packaging, and labeling for more than
3400 drug substances, preparations and products.
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.
Most important test protocols for elastomer and
perfluorocarbon products (seals) are:
USP Class VI testing Part 88, Biological reactivity
test Part 87, in vivo. It is designed to determine
the biological response of animals to elastomerics,
plastics and other polymeric material with
direct or indirect patient contact, or by the injection
of specific extracts prepared from the material
under test.
USP testing Part 87, Cytotoxicity test, Biological
reactivity test, in vitro. It is designed to determine
the biological reactivity of mammalian cell cultures
following contact with the elastomeric plastics
and other polymeric materials with direct or indirect
patient contact or of specific extracts prepared
from the material under test.
USP testing Part 661, is a Physico-Chemical Test
which determines the Physico-Chemical properties
of certain material. This test measures defined
properties of impurities in plastics. The material is
for example PTFE or TFM.
USP testing Part 381, is a Physico-Chemical Test
which determines the Physico-Chemical properties
of certain material and impurities extracted from
elastomeric closures. The material is for example
EPDM and FKM. Not Silicone.
European Pharmacopoeia testing Part 3.1.9 is a
Physico-Chemical Test which determines the Physico-
Chemical properties of Silicone material. The material
is either Peroxide Silicone or Platinum Silicone.
FDA
Food and Drugs Administration is a US government
agency within the Department of Health and Human
Services. FDA is the federal agency responsible
for ensuring that foods are safe, wholesome and
sanitary; human and veterinary drugs, biological
products, and medical devices are safe and effective;
cosmetics are safe; and electronic products that
emit radiation are safe. FDA has written codes
(CFR’s) to ensure that seals that we make conform
to certain standards when in contact with food or
pharmaceutical processing systems.
Examples:
FDA CFR 177.1550 Perfluorocarbon resins. A detailed
description of methods of processing and substances
that can be safely used.
FDA CFR 177.2600 Rubber articles intended for
repeated us may be safely used in producing,
manufacturing, packaging, processing, preparing,
treating, transporting or holding food, subject to the
provisions of this section. It also describes a test for
impurities from elastomeric closures. The purpose of
the study is to analyze total extractables.
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TSE
TSE also known as BSE (Bovine Spongiform
Encephalopathy) has been addressed by FDA and the
European Union. The use of animal derived ingredients
in the production of medicine and other related
products has in the past lead to the transmit of TSE
disease. TSE disease is a central nervous disease.
The European Union has written a journal
(EMEA/410/01) in which they give guidance on
minimizing the risk of transmitting animal spongiform
encephalopathy agents via human and veterinary
medical products.
Whereas many of our products are used in human or
veterinary medicine production plants, it is important
to know if any of our products have been in contact
or are produced with animal derived ingredients.
The only product (compound) that is made
manufactured with animal derived ingredients is
NBR (buna). All other products such as EPDM, FKM,
PTFE and Silicone are Animal Derived Ingredient free.
(ADIF).
CompoundsToday the need for traceability in the pharmaceutical
industry is eminent. We need to know what we are
getting and we need to know if the supply chain
is consistent time after time. One way to secure
consistency is to introduce compound numbers. If
compound numbers are linked to product numbers
ore creates the condition that the supplier cannot
change from one compound to another. Once a
gasket is validated and known by its compound there
is no possibility to change things. This is what we are
seeking for in today´s industry. Most pharmaceutical
companies require a written notification for any
change in the manufacturing process including
compound changes. The impact of compound
changes can be severe, is expensive and time
consuming, in which no one is eager to get involved
with. This is why Ultrapharma BV is introducing fixed
compound numbers for all products.
Compound Data Sheets will tell exactly what the
compound is all about including all its credentials
such as FDA-CFR listing, USP Class VI and other
relevant test criteria. All clients of Ultrapharma BV
have access to these Compound Data Sheets (CMD),
they can advice pharmaceutical end-users of the
existence and determine which compound to use for
their applications. The compound number that has
been chosen can be referred to at any point in time
when ordering new gaskets.
The Certificates of Conformance that we generate
for all products are now made automatically. The
Compound Data are stored in our SAP system, all
information about lot numbers is stored as well. In
the final stage all information is gathered and printed
on the Certificate of Conformance. All is based on
the one specific compound.
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Standard GasketsPharmaceutical Grade
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
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.
1 = Excellent 2 = Good 3 = Acceptable 4 = Marginal 5 = Poor x = do not use
Gasket typeContinuous
SteamIntermittant
SteamPure 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
*recommended
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Dim
ensio
ns
1 = Excellent 2 = Good 3 = Acceptable 4 = Marginal 5 = Poor x = do not use
Gasket typeContinuous
SteamIntermittant
SteamPure 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
*recommended
DIN32676 ISO 1127 ASME-BPE SMS 3017 BS 4825 E C4PTFE
C4ELASTOMER C2
DIN 32676Reihe A
DIN 32676Reihe B
DIN 32676Reihe C ISO 2852
DN06 22 4 4,2 20,21/4” 22 4,7 5,1 20,2
DN08 22 6 6,2 20,2DN10 * 3/8” 22 8 8,2 20,2
1/2” 1/2” 22 9,6 10,8 20,2DN12 * DN12 * 22 10 10,2 20,2DN14 * 22 12 12,2 20,2DN16 * 22 14 14,2 20,2DN18 * 3/4” DN18 * 3/4” 22 16 16,2 20,2DN08 * 34 8 - 27,5DN10 34 10 10,2 27,5
DN08 34 10,3 10,5 27,5DN10 34 14 14,2 27,5
DN15 34 16 16,2 27,5DN15 34 18,1 18,2 27,5
DN20 34 20 20,2 27,5DN10 * 50,5 10 10,3 43,5
DN08 * 50,5 10,3 10,5 43,5DN10 * 50,5 14 14,2 43,5
DN15 * 50,5 16 16,2 43,5DN20 * 50,5 20 20,2 43,5
DN15 * 50,5 18,1 18,4 43,51 “ 50,5 22,1 22,5 43,5
DN25 50,5 22,8 23 43,5DN20 50,5 23,7 23,9 43,5
DN25 50,5 26 26,2 43,5DN25 50,5 29,7 29,9 43,5
DN33,7 50,5 31,5 31,7 43,5DN32 50,5 32 32,2 43,5
1.5” 1.5” 50,5 35,1 35,3 43,5DN38 50,5 35,8 36 43,5
DN40 50,5 38 38,2 43,5DN32 50,5 38,4 38,6 43,5
1” * 64 - 22,5 56,5DN32 64 38,4 38,6 56,5DN40 64 44,3 44,5 56,5
DN51 64 48,8 49 56,52” 2” 64 47,4 47,8 56,5
DN50 64 50 50,2 56,5DN50 77,5 56,3 56,5 70,5
DN63,5 77,5 60,5 60,7 70,52.5” 2.5” 77,5 60,5 61 70,5
DN65 91 66 66,2 83,5DN65 91 72,1 72,3 83,5
DN76,1 91 73,1 73,3 83,53” 3” 91 73,3 73,5 83,5
DN80 106 81 81,2 97DN80 106 84,3 85,1 97
DN88,9 106 85,1 85,3 974” 4” 119 97,5 98,2 110
DN101,6 119 97,8 98 110DN100 119 100 100,2 110DN115 * DN100 4.5” * 4.5” 130 110,3 110,5 122
DN114,3 130 110,5 110,7 1225” * 5” * 144 125 125,4 134,5
DN125 155 125 125,4 146DN125 155 134,5 134,7 146
5.5” * 5.5” 155 - 135,9 146DN139,7 155 135,9 136,1 146
6” 167 146,9 147,2 156,5DN150 183 150 150,4 174
DN150 6,6” 183 163,2 163,4 174DN168,3 183 163,3 163,5 174
8” * 217,4 197,8 198 207DN200 233,5 200 200,2 225
DN200 8,6” 233,5 213,9 214,3 225DN219,1 233,5 214,1 214,3 225
DN250 * 10” * 268 250 250,2 257DN250 286 267,8 268 276
10,6” * 286 268 268,2 276DN300 * 12” * 319 300 300,2 309
DN300 338 318,7 318,9 32812,6” * 338 319 319,2 328
Note: sizes indicates with (*) is not a norm strandard
A
A
B A E* E C4 C2
SECTION A-ATYPE I
A
A
B A E* E C4 C2
SECTION A-ATYPE II
1967 DB HeemskerkThe Netherlands
T: +31-(0)251-207050F: +31-(0)251-207055
Type I & II3RD ANGLE PROJECTION
GASKET TYPES
A3
DESCRIPTION:
SHEETSIZEUNITS:The information contained in this drawing is the soleproperty of Ultrapharma BV. Any reproduction in part or as a whole without written permission of
Ultrapharma BV is prohibited.
CONFIGURATION
SCALE:
2:1mm
Tri-Clamp Type 2 Gasket
A
A
B A E* E C4 C2
SECTION A-ATYPE I
A
A
B A E* E C4 C2
SECTION A-ATYPE II
1967 DB HeemskerkThe Netherlands
T: +31-(0)251-207050F: +31-(0)251-207055
Type I & II3RD ANGLE PROJECTION
GASKET TYPES
A3
DESCRIPTION:
SHEETSIZEUNITS:The information contained in this drawing is the soleproperty of Ultrapharma BV. Any reproduction in part or as a whole without written permission of
Ultrapharma BV is prohibited.
CONFIGURATION
SCALE:
2:1mm
A
A
B A E* E C4 C2
SECTION A-ATYPE I
A
A
B A E* E C4 C2
SECTION A-ATYPE II
1967 DB HeemskerkThe Netherlands
T: +31-(0)251-207050F: +31-(0)251-207055
Type I & II3RD ANGLE PROJECTION
GASKET TYPES
A3
DESCRIPTION:
SHEETSIZEUNITS:The information contained in this drawing is the soleproperty of Ultrapharma BV. Any reproduction in part or as a whole without written permission of
Ultrapharma BV is prohibited.
CONFIGURATION
SCALE:
2:1mm
Tri-Clamp Type 1 Gasket
A
A
B A E* E C4 C2
SECTION A-ATYPE I
A
A
B A E* E C4 C2
SECTION A-ATYPE II
1967 DB HeemskerkThe Netherlands
T: +31-(0)251-207050F: +31-(0)251-207055
Type I & II3RD ANGLE PROJECTION
GASKET TYPES
A3
DESCRIPTION:
SHEETSIZEUNITS:The information contained in this drawing is the soleproperty of Ultrapharma BV. Any reproduction in part or as a whole without written permission of
Ultrapharma BV is prohibited.
CONFIGURATION
SCALE:
2:1mm
A
A
B A E* E C4 C2
SECTION A-ATYPE MINI
1967 DB HeemskerkThe Netherlands
T: +31-(0)251-207050F: +31-(0)251-207055
Default3RD ANGLE PROJECTION
DIN 32676 FERRULE REIHE A DN6-DN/OD ¾"
A4
DESCRIPTION:
SHEETSIZEUNITS:The information contained in this drawing is the soleproperty of Ultrapharma BV. Any reproduction in part or as a whole without written permission of
Ultrapharma BV is prohibited.
CONFIGURATION
SCALE:
2:1mm
Tri-Clamp Mini Gasket
A
A
B A E* E C4 C2
SECTION A-ATYPE MINI
1967 DB HeemskerkThe Netherlands
T: +31-(0)251-207050F: +31-(0)251-207055
Default3RD ANGLE PROJECTION
DIN 32676 FERRULE REIHE A DN6-DN/OD ¾"
A4
DESCRIPTION:
SHEETSIZEUNITS:The information contained in this drawing is the soleproperty of Ultrapharma BV. Any reproduction in part or as a whole without written permission of
Ultrapharma BV is prohibited.
CONFIGURATION
SCALE:
2:1mm
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ScreensOur 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 GraphCalculated with pipe id 35,1 mm (1,5” Tri-clamp Gasket) 100 Mesh screen strainer (open area 30,3% / 0,152 mm)
Volume Flow [m3/h]
Pres
sure
Dro
p [m
bar]
0,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0 8,0 9,0 10,0
300
250
200
150
100
50
0
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Approx. Retention in
Microns
Opening in mm
Mesh (wire/inch)
Open Area % Filter Cloth Filter Cloth Thickness
in mm
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
96 - - 20x200 0,838
80 0,076 180x180 34,3
74 0,051 200x200 33,6
70 - 120x180 0,254
65 - 120x200 0,229
61 0,051 250x250 36
50 - 120x330 0,254
43 0,025 325x325 - -
40 - - 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 Tabbed Screen Standard Screen
Scre
en R
efer
ence
Cha
rt
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.
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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
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.
Self draining PTFE orifice plate with tab.
Tabbed Orifice plate with self draining hole
Clamp for Tabbed Screens or Orifice plates
Self-draining vertical plates
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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)
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
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.
1, 2, 3 or 4 ports configuration
4 port clamp
2 ports in 34 mm DIN32676
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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 Envelope PTFE Tuf-Flex® Tri-Bond®Solid PTFE Envelope PTFE Tuf-Flex® Tri-Bond®
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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
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
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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)
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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
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.
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
• FKM CMD-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
with double slit.
Snap-On gaskets
Recommended Torque 1,5Nm
(30 Bar test pressure @20°C)
White silicone
EPDM
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Torque Knob
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
on the gasket material you can chose the specific
Torque in Nm. Turn until it starts clicking.
Available in: for elastomers in 1,5 Nm – 2 Nm - 2,5 Nm
for PTFE in 3 Nm - 4 Nm.
Material Rec. Torque Nm Pressure 20°C SIP @ 135°C Pressure after SIP 20°C CyclesEPDM 1,5 Nm 30 Bar 2,2 Bar (2h) 30 Bar 1SILICONE 1,5 Nm 30 Bar 2,2 Bar (2h) 30 Bar 1FKM 1,5 Nm 30 Bar 2,2 Bar (2h) 30 Bar 1TUF-FLEX 2 Nm 30 Bar 2,2 Bar (2h) 20 Bar 1TRI-BOND 2 Nm 30 Bar 2,2 Bar (2h) 20 Bar 1PTFE ENVELOPE 3 Nm 25 Bar 2,2 Bar (2h) 6 Bar 1PTFE SOLID 3 Nm 30 Bar 2,2 Bar (2h) 10 Bar 1STEAM-FLON 4 Nm 8 Bar 2,2 Bar (2h) 8 Bar 1TUF-STEEL 4 Nm 15 Bar 2,2 Bar (2h) 15 Bar 1
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
All is true. We tested several rubbers and PTFE
gaskets and learned that many of them can be
sealed with a much lower torque than expected.
Below a table of results.
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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 Steam-
Flon® seal.
Material Rec. Torque Nm Pressure 20°C SIP @ 135°C Pressure after SIP 20°C CyclesEPDM 1,5 Nm 30 Bar 2,2 Bar (2h) 30 Bar 1SILICONE 1,5 Nm 30 Bar 2,2 Bar (2h) 30 Bar 1FKM 1,5 Nm 30 Bar 2,2 Bar (2h) 30 Bar 1TUF-FLEX 2 Nm 30 Bar 2,2 Bar (2h) 20 Bar 1TRI-BOND 2 Nm 30 Bar 2,2 Bar (2h) 20 Bar 1PTFE ENVELOPE 3 Nm 25 Bar 2,2 Bar (2h) 6 Bar 1PTFE SOLID 3 Nm 30 Bar 2,2 Bar (2h) 10 Bar 1STEAM-FLON 4 Nm 8 Bar 2,2 Bar (2h) 8 Bar 1TUF-STEEL 4 Nm 15 Bar 2,2 Bar (2h) 15 Bar 1
Removable Perforated disc 1,5”
DN20 Screen mesh 20
¾” Orifice plate Ø3,0 mm
Sock screen 1,5” mesh 200
Rupture disc 1,5” Steam-Flon® seal
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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
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
EPDM CMD-1004
Platinum silicone CMD-1012
FKM CMD-1010
Peroxide silicone CMD-1015
FEP/FKM CMD-1029
Screens
DIN11864 DIN11850 ISO1127 BPE
ID X S ID X S ID X S
DN08 12 x 3,5 DN1/2" 12 x 3,5 12 x 3,5
DN10 12 x 3,5 16 x 3,5 DN3/4" 18 x 3,5 18 x 3,5
DN15 18 x 3,5 24 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
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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.
Removable Elastomers Gaskets (Slit Gasket), Simple to install or and to replace.
Ball Valve Seat in Steam-Flon® Two Part PTFE DIN2633 PN16 Screen
¾” Sock screen Steam-Flon® washers
Laser Engraving
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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.
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Clamps
304 (1.4301) Inch Flanch OD Ø A mm Part NO.
DN/NW1/2” 25 31,75 13MHHM-050\075
20-32 1 1/2” 50,5 53,59 13MHHM-15040 2” 64 66,90 13MHHM-20050 2 1/2” 77,5 80,59 13MHHM-25065 3” 91 93,98 13MHHM-30080 3 1/2” 105 108,28 13MHHM-350100 4” 119 122 13MHHM-400115 4 1/2” 130 133,68 13MHHM-450
5” 144,7 148,23 13MHHM-5006” 167,1 170 13MHHM-600
200 8” 218,00 220,85 13MHHM-800250 10” 267,20 272,80 13MHHM-1000300 12” 319,00 322,45 13MHHM-1200
Inch Flange OD Ø A mm PART NO. 316 (1.4401)KF VACUMM 304 SS
DN/NW PART NO. PART NO.
8-20 DIN34 34 37,7 13LAH-0341/2” 25 31,75 13LAH-050\075 13LAH-050\075-316SS 13KF-16
20-40 1-1/2” 50,5 53,59 13LAH-150 13LAH-150-316SS 13KF-2540 2” 64 66,90 13LAH-200 13LAH-200-316SS 13KF-4050 2-1/2” 77,5 80,59 13LAH-250 13LAH-250-316SS 13KF-5065 3” 91 93,98 13LAH-300 13LAH-300-316SS80 3-1/2” 106 110 13LAH-350100 4” 119 122 13LAH-400 13LAH-400-316SS115 4-1/2” 130 134 13LAH-450
5” 144,7 148 13LAH-500125 5-525” 155 158 13LAH-550
6” 167 170 13LAH-600150 6-5/8” 183 187 13LAH-6625200 8-5/6” 233,5 238 13LAH-8625250 10” 268 273 13LAH-1000300 12” 319 322,45 13LAH-1200
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Clamp versions
13LAH + 13LAH-316SS
13MHHS
13MHHM
13MHP
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
Ribbed
Wing Nut
Butterfly
Wing Nut
Closed
Wing Nut
Hex Nut
Non Metallic Clamp ½” – 8” TC
316SS clamps in 13LAH execution
KF vacuum clamps 304SS
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316SS clamps in 13LAH execution
Notes
KF vacuum clamps 304SS
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De Trompet 1510NL-1967 DB, HeemskerkThe NetherlandsT. +31 251 20 70 50F. +31 251 20 70 [email protected]
www.ultrapharma.comGet more information about other Sanitary Solutions on our website
ASME BPE