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