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PHARMA Company Profile Unternehmen

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Page 1: New 2015 Brochure

PHARMA

Company ProfileUnternehmen

Page 2: New 2015 Brochure

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

Page 3: New 2015 Brochure

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

Page 4: New 2015 Brochure

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.

4 www.ultrapharma.com

Page 5: New 2015 Brochure

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.

Page 6: New 2015 Brochure

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

6 www.ultrapharma.com

Page 7: New 2015 Brochure

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

[email protected]

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

[email protected]

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

[email protected]

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

[email protected]

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

[email protected]

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

[email protected]

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

Page 8: New 2015 Brochure

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

8 www.ultrapharma.com

Page 9: New 2015 Brochure

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.

Page 10: New 2015 Brochure

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

10 www.ultrapharma.com

Page 11: New 2015 Brochure

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

Page 12: New 2015 Brochure

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®

12 www.ultrapharma.com

Page 13: New 2015 Brochure

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

Page 14: New 2015 Brochure

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

Page 15: New 2015 Brochure

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

Page 16: New 2015 Brochure

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.

16 www.ultrapharma.com

Page 17: New 2015 Brochure

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

Page 18: New 2015 Brochure

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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18 www.ultrapharma.com

Page 19: New 2015 Brochure

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

Page 20: New 2015 Brochure

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

Page 21: New 2015 Brochure

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

Page 22: New 2015 Brochure

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

22 www.ultrapharma.com

Page 23: New 2015 Brochure

316SS clamps in 13LAH execution

Notes

KF vacuum clamps 304SS

Page 24: New 2015 Brochure

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