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sealing technology manual for the process industry

1. ced professionals from prestigious companies in the pharmaceutical industry It provides a forum for experts from industry and government independent consultants and students VDMA Verband Deutscher Maschinen und Anlagenbau German Engineering Association The VDMA is one of the leading service providers offering the largest industry network of the capital goods industry in Europe The VDMA represents about 3 100 mainly medium sized member companies making it one of the leading industrial associations in Europe with one of the largest memberships The VDMA covers the entire process chain everything from components to entire plants from system suppliers and system integrators to service providers The VDMA thus facilitates both industry specific and inter sectoral cooperation INTRODUCTION THE PROCESS INDUSTRY AND ITS REQUIREMENTS FOOD INDUSTRY THE DIVERSITY OF THE FOOD INDUSTRY REQUIRES SEPARATE CONSIDERATION OF THE DIFFERENT AREAS SINCE THE RESPECTIVE REQUIREMENTS ARE AS VARIED AS THEY ARE NUMEROUS 2 08 Chocolate Chocolate production and processing is a particular challenge for seals The ingredients themselves are challen ging because it is a medium containing fat which may also contain additives such as nuts raisins or crisps causing severe abrasion This is further increased when crystallization of the sugar occurs during the manufacturing process Additives containing flavoring agents
2. low temperature ADI free ADI free High temperature ADI free Chemical application Chemical application 33 ELASTOMERIC MATERIALS EPDM EPDM ETHYLENE PROPYLENE DIENE RUBBER IS PARTICULARLY SUITABLE FOR USE IN POLAR MEDIA THE EXCELLENT RESISTANCE TO WATER AND AQUEOUS SYSTEMS MAKES EPDM THE MOST WIDELY USED MATERIAL IN FOOD PRODUCTION AND PROCESSING WITH A SHARE OF ABOUT 70 General properties M Very good resistance to aging ozone and light m High heat and cold resistance approx 50 C to 150 C 58 F to 302 F m Good tensile elongation and strength Very high abrasion resistance m Very good resistance to water and to polar and oxidative media m Excellent elastic behavior 70 EPDM 291 black and 70 EPDM 253815 white Application profile EPDM seals exhibit good chemical resistance in hot water steam acids and alkaline solutions They are very well suited for use in all polar media and therefore also in CIP SIP media CIP media are diluted acids or alkaline solutions with cleaning additives In SIP media disinfectants steam or oxidizing media e g peracetic acid or polar organic solvents e g acetic acid are used EPDM is of limited use in products containing fats or oils While it can be used well at low temperatures in dairy products with a fat content up to 70 the use in pure fats and oils as well as in non polar solvents is not possible EPDM contains no plasticizers
3. FG 360 1 021508 1 5 mm thick 3 0 mm thick T FA A O ENSO IOO 109 ype DIN 28091 2 DIN 28091 3 DIN 28091 3 DIN 28091 3 Graphite aramid fibers Material bound with NB Silica filled PTFE Expanded PTFE Expanded PTFE Color Blue White White White EC Reg 1935 2004 d EC Reg 1935 2004 FDA 21 CFR 1771550 FDA 21 CFR 1771550 Asse KTW FDA 21 CFR 1771550 USP Class VI 121 C USP Class VI 121 C PP ni TA Luft 250 F 250 F W 270 DVGW TA Luft TA Luft Density g cm A 2 10 0 85 0 85 Tensile strength longitudinal 180 170 140 180 N mm Compression 6 0 9 69 0 66 2 Recovery 60 0 45 0 76 11 6 Temperature range 00 C 164 3007 leans ais S72 F 200 C ta 207 poze 710 2077 206 os 450 F to 599 F 208 Glo 4315 450 F to 599 F 75 Y NN INTRO ENTALS PRODUCT PORTFOLIO DIAPHRAGMS DIAPHRAGMS FORM A RELIABLE BUT FLEXIBLE SEPARATING WALL BETWEEN TWO COMPONENT SPACES THE VOLUME CHANGES OF THE SEPARATED MEDIA CAN BE CONVERTED INTO FORCE Diaphragms are especially interesting sealing components for the food and beverage industry where they can perform a number of different functions They can be used to actuate valves to control and switch devices fo pump and compress liquids or gases but also to separate or store media or pressures Available in all basic elastomer variants or with application specitic modifications such as fabric reintorce ments metal inserts or foil la
4. Function m Elastomer core provides elastic contact pressure m FEP or PFA encapsulation effectively protects the seal against aggressive media Dimensions m All metric and inch cross sections are available all standard dimensions are in stock m FEP PFA O rings are available in all internal diameters with no additional tooling costs the smallest possible internal diameter of 1 6 mm is limited by the cord thickness m Pure PTFE O rings are available in all dimensions as they are manufactured by machining Types Very good compression set and permitted temperature range from 20 C to 200 C 4 F to 392 F FKM core FEP encapsulation VMQ core FEP encapsulation For low temperatures from 60 C to 200 C 70 F 1 392 F For high abrasion resistance and temperatures from 20 C to 200 C 4 F to 392 F FKM core PFA encapsulation For high abrasion resistance and extreme temperature ranges from 60 C to 260 C 6 F to 500 F VMQ core PFA encapsulation For applications in delicate devices and requiring little contact pressure the use of a VMQ hollow core is possible For protiles with oval rectangular or semicircular cross sections all with rounded edges please contact Freudenberg Design notes Cross sections from 1 6 to 25 4 mm Dimensions Internal diameters from 10 to 600 mm Special dimensions available on request Coarseness No more than 50 ym on conta
5. HNBR I a seal is intended to be mainly resistant to non polar media HNBR can be taken into consideration Seals made of HNBR can cover a broader range of appli cations however their durability in aggressive CIP SIP cleaning agents is lower than EPDM HNBR should not be used in concentrated acids Operational temperatures in air and in water reach up to 150 C 302 F VMQ It the seal does not necessarily have to be sterilized with hot steam silicone VMQ can also be used apart from HNBR VMQ is resistant to non polar and polar media but in steam it can only be used in temperatures up to 120 C 248 F Its temperature range in air is trom 50 C to 200 C 58 F to 4392 F RESISTANCE OF FKM FLUOROPRENE XP AND FFKM Nitric acid 2 80 C 176 F Phosphoric acid 4 70 C 158 F Sodium Active chlorine 3 60 C 140 F Active oxygen lt 1 35 C 95 F BIFKM Mi Fluoroprene XP E FFKM hydroxide 5 80 C 176 F Active chlorine 3 60 C 140 F FKM It a seal is required that can be used in non polar media such as fat and oil up to 180 C 356 F and that is also resistant to CIP SIP media and steam FKM should be used FKM is also well suited for use with citrus juices and aromatic oils Its temperature range in air is from 15 C to 200 C 5 F to 392 F If alkaline cleaners are in operation FKM is not the optimal solution I
6. TFDA 2AIL RR I7 2600 FDA 21 CFR 177 2600 FDA 21 CFR 1772600 FDA 21 CFR 1772600 3 A Sanitary Standards Class EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR 177 2000 3 A Sanitary Standards Class EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR 1772600 3 A Sanitary Standards Class EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR I7 2000 gt EC Reg 1935 7 2004 and 2023 7 2006 FDA 21 CFR 1772600 3 A Sanitary Standards Class EC Reg 1935 2004 and 2023 2006 FDA 21 CHR 1772000 EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CR 1772000 EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR 1772600 EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F W 270 NSF 61 gt W 270 ACS KIWA NORM B 50141 NSF 6 KTW W 270 WRAS uS ACS ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free ADI free
7. TTE E SEALING TECHNOLOGY MANUAL FOR THE PROCESS INDUSTRY Freudenberg alin Technologies TABLE OF CONTENTS COMPANY 2 MARKET SPECIFIC SERVICES Freudenberg Xpress machining technology Product marking technology Test facility Damage analysis Washing and individual packaging Collaboration with associations 3 THE PROCESS INDUSTRY AND ITS REQUIREMENTS Food industry Pharmaceutical industry Chemical industry 4 TECHNICAL FUNDAMENTALS Basic materials testing Storage conditions Approvals examinations compliances Hygienic design Material requirements Friction optimization 5 ELASTOMERIC MATERIALS Overview of elastomeric materials EPDM Fluoroprene XP FKM Simriz NBR HNBR VMQ ODODO NO 0 ook 20 20 24 25 28 29 30 32 7 94 38 42 AA 46 48 50 ENGINEERING PLASTICS PTFE EPTFE PEEK POM PA PU MATERIALS RESISTANCE AND PURITY Temperature resistance Fat resistance Flavoring agents Cleaning process Extractables Hygienic design Storage tests PRODUCT PORTFOLIO O rings Encapsulated O rings Seals for pipe connections Diaphragms Hygienic Usit rings Rotary shatt seals V Seal set packings Stuffing box packings Molded parts Butterfly valve seals Extruded seals Guide strips PTFE bellows PTFE U packings APPENDIX List of abbreviations General installation and assembly instructions legal notices 52 33 29 56 58 59 59 6O 63 64 66 07
8. 0 5 hydrogen peroxide SIP 2 peracetic acid cleaner CIP 4 phosphoric acid CIP 2 nitric acid cleaner cleaner at 80 C 176 F at 60 C 140 F cleaner at 70 C 158 F at 80 C 176 F after 1 week after 1 week after 1 week after 1 week Bl volume in Bl elonaationQbreak in Bi tensile strength in g g PRODUCT PORTFOLIO pn Facio ENGINEERING PLASTICS ELASTOMERIC MATERIALS en INICAL alla CIP 5 sodium hydroxide cleaner at 80 C 176 F after 1 week A NO INTRODUCTION VMQ VMQ SILICONE RUBBERS ARE HIGHLY POLYMERIC VINYLMETHYLPOLYSILOXANES SILICONE IS QUITE WIDESPREAD AS A MATERIAL IN BUTTERFLY VALVE SEALS DUE TO ITS LOW VOLUMETRIC EXPANSION UNDER THE INFLUENCE OF MEDIA AND ITS HIGH ELASTICITY THE BUTTERFLY VALVE SWITCHES RELIABLY UNTIL THE END OF ITS SERVICE LIFE Another argument for VMQ in contact with food and pharmaceuticals is its purity clearly visible in the trans parency of the material even if the mechanical strength and chemical resistance are not optimal especially during intense cleaning operations General properties m Excellent thermal and heat resistance Best low temperature flexibility m little temperature dependency of the technological properties Excellent weathering aging and ozone resistance High gas permeability Very good physiological properties Very good dielectric properties glycols fire resistant hydraulic fluids an
9. 495 for aroma containing media and thus safeguards the 497 and 506 85 Simriz 496 production process flawlessly m Molded parts made of 70 Simriz 491 80 Simriz 492 75 Simriz 494 497 and 506 Simriz in the chemical and pharmaceutical industries m Diaphragms made of 70 Simriz 491 75 Simriz 494 Simriz can be used in almost all chemicals Exceptions Butterfly valve seals made of 75 Simriz 506 are the compounds of the alkali metals Download Rules and standards 75 Simriz 494 75 Simriz 506 mE Data sheet 75 Simriz 494 FDA compliant CFR 21 Part 177 2600 4 EC Reg 1935 2004 as well as 4 d EC Reg 2023 2006 4 4 USP Ch 87 in vitro E E USP Ch 88 in vivo Class VI 121 C m Download 250 F Data sheet 75 Simriz 506 IMMERSION RESULTS OF SIMRIZ IN DIFFERENT MEDIA 20 sodium hydroxide Methanol Ethyl acetate Acetonitrile 20 nitric acid solution 20 acetic acid at 64 C 147 F after 72 h at 70 C 158 F after 72h at 70 C 4158 F after 72 h 20 Simriz 494 Simriz 506 Simriz 494 Simriz 506 Simriz 494 Simriz 506 at 98 C 208 F after 72h at 98 C 208 F after 72h at 98 C 208 F after 72 h Simriz 494 Simriz 506 Simriz 494 Simriz 506 Simriz 494 Simriz 506 Bi volume in Bl elongationQbreak in B tensile strength in Js Cn INTRODUCTION PRODUCT PORTFOLIO
10. BOTH REGARDING THE BASE RUBBER AND ALSO AS A RESULT OF SUITABLE MIXING ADDITIVES The aging process depends largely on the following factors Five rules for the storage of elastomer products can be temperature thermal radiation solar radiation humidity relative air humidity 6576 ozone and ionizing radiation and stress condition of the component derived from this l The storage temperature must be below 25 C 77 F 2 There must be no direct heat sources in the storage area 3 The seals must not be exposed to direct sunlight 4 Exposure to ozone and ionizing radiation must strictly be excluded 5 The seals must be stored without stress as far as possible 24 To meet these requirements all container cover and packaging materials must be tree of substances that have a degradation effect on elastomers Therefore primarily PE coated kraft paper aluminum foil or opaque poly ethylene film minimum thickness 0 075 mm are used Storage Extension Group period in period in years years NBR AU EU SBR 5 2 NBR HNBR XNBR ACM AEM ECO CIIR CR IIR FKM FFKM VMQ 3 PVMQ FVMQ EPDM 10 3 Fluoroprene XP CSM The storage and the recording of the time in storage of vulcanized rubber products are described in ISO 2230 In this standard the elastomer products are divided into three groups to which different storage times are assigned THE REQUIREMENTS OF THE PROCESS INDUSTRY
11. The FDA compliant material ZO EPDM 471 is ideal for use under aggressive sterilization and cleaning conditions Thanks to its high abrasion resistance long service lives can be achieved During the cleaning process the gasket is inflated resulting in high contact stress preventing leakage Atter cleaning the seal is relaxed again and the door opens without damaging the seal Seal in the inflated state Inflatable seal in the evacuated state under pressure Freudenberg offers inflatable seals on request even with a specitic valve matched to the seal that controls the supply of compressed air Instead of a threaded coupling this valve works by means of a click mechanism making it easier to install Intlatable seals trom Freudenberg have a special sealing lip geometry that causes a locally high contact stress and prevents creeping leakage When for instance a door must be opened the seal is depressurized It now retreats to the starting position so that the door can be opened easily without suction sticking and damaging the seal The advantages at a glance m Seals reliably against external influences m Easy opening and closing of doors for example no sucking tight by the seal on the frame Long service life Very good chemical and thermal resistance Seal and valve are perfectly matched Automatic pressure supply Individual dimensions by means of butt joint vulcanization m Industry specitic certification of t
12. 3 A9 Sanitary Standards Class USP Ch 87 in vitro E USP Ch 88 in vivo Class i VI 121 C 250 F Download Data sheet ZO VMQ 117055 Download Data sheet 78 VMQ 166898 Download Data sheet 76 VMQ 176643 INTRODUCTION PRODUCT PORTFOLIO pan rae ENGINEERING PLASTICS ELASTOMERIC MATERIALS Lis RAE ENGINEERING PLASTICS ENGINEERING PLASTICS HAVE PROPERTIES THAT MAKE THEM IDEAL FOR A VARIETY OF APPLICATIONS IN THE PROCESS INDUSTRY THE COMBINATION OF THEIR FUNDAMENTAL PROPERTY WITH OTHER SUBSTANCES SUCH AS REINFORCING FIBERS LUBRICANTS OR OTHER POLYMERS CAN SIGNIFICANTLY EXPAND THE RANGE OF POSSIBLE APPLICATIONS It should be noted that thermoplastics depending on their sophistication have very different performance limits with respect to temperature pressure resistance and chemical resistance which should be taken into account when it comes to their application Properties of thermoplastics m ow density Chemical resistance m High resistance to wear m Excellent electrical properties m High energy input capacity m Very good processing properties Temperature resistance Pressure resistance Chemical resistance mPA POM MPEEK W PIFE 2 PIFE THANKS TO ITS COMPOSITION PTFE POLY TETRAFLUOROETHYLENE HAS A NUMBER OF EXCELLENT PROPERTIES FOR THE FOOD CHEMICAL AND PHARMACEUTICAL INDUSTRIES THE CHEMICAL RESISTANCE EXCEEDS THAT OF ALL ELASIOMER MATERIALS AND THERMOPLASTICS THU
13. 68 68 O 2 6 8 80 82 84 86 88 90 92 93 94 96 96 98 98 COMPANY THE FREUDENBERG GROUP OF COMPANIES WAS FOUNDED IN 1849 AND IS STILL FAMILY OVVNED THE RESULTING FINANCIAL STABILITY AND SOCIAL AVVARENESS ARE KEY SUCCESS FACTORS THAT CREATE TRUST Today Freudenberg is a global broadly diversitied group While Freudenberg amp Co KG represents the strategic lead company Freudenberg SE as the operational holding company reflects the global nature of the Group of companies Freudenberg is divided into business groups which operate in different industries From household products of the Vileda brand to technically complex sealing solutions the company is always considered an innovation and techno logy leader Thus for example the famous Simmerring is a Freudenberg invention dating back to 1929 which is still being used in many industries and a wide variety of appli cations today The pronounced segmentation of the Group has only one goal to be close to the customer and to meet the require ments of a market specialist Numerous research and development facilities ensure the longterm success of the company and allow a rapid response to market and customerspecitic transformations Freudenberg Sealing Technologies is the largest business group of the Freudenberg Group and belongs to the business area Seals and Vibration Control Technology Together with the partners of NOK Corporation the company form
14. CLEANING IN PLACE STERILIZATION IN PLACE PROCESS CIP SIP and superheated steam processes are an integral part of production in the process industry Cleaning agents and heat put significant stress on the seals which is a critical factor for smooth workflows if the seal was badly configured here with respect to material and design Freudenberg s test plant allows meaningful seal tests in all standard CIP SIP media as well as in steam and hot water under real conditions From the O ring to the butterfly valve seal verified statements on the functionality of the seal used can thus be derived even prior to serial use A proactive development partnership which significantly increases the reliability and thus the cost effectiveness of valves and customerspecific systems Tap water Disinfectant Demineralized Deionized water Acid gt gt Base solution N Media Product pump Steam generator Heat exchanger The system design The test plant is designed as a multitank CIP system and thus offers the possibility to demonstrate different cleaning processes with acids alkaline solutions and disinfectants The core of the system is formed by three test tracks in which three valves are tested in parallel or in series The operating parameters such as temperature pressure and tlow rate are recorded digitally For intentional conta mination of the valves a container can be filled with the medium used in the application In order
15. Flange seals 69 PRODUCT PORTFOLIO ENCAPSULATED O RINGS ENCAPSULATED O RINGS ARE A COMBINATION OF AN ELASTOMERIC O RING AND A CLOSED ENCAPSULATION OF MODIFIED PTFE WHICH COMBINE HIGH CHEMICAL RESISTANCE AND ELASTICITY IN AN EXCELLENT SEALING FUNCTION They consist of an elastomer core that provides elastic contact pressure as well as a jacket for reliable sealing in aggressive media The core material used is either FKM or VMQ depending on the required temperature resistance The sheath is made of FEP fluorinated ethylene propylene or PFA perfluoroalkoxy copolymer Encapsulated O rings are used exclusively for static applications since move ments or abrasive media would destroy them Encapsulated O rings are basically available in all desired dimensions internal diameters and cord thicknesses in metric and inch sizes Since they are only slightly expand able and compressible the installation spaces should be designed accordingly especially for seals with small diameters FEP PFA jackets as well as the VMQ core are FDA compliant as a standard If desired a FDA compliant FKM core can also be used The different material types affect both the sealing properties and the price level Thus PTFE encapsulated O rings are less expensive but must be protected against ingress of media at the seam in terms of their constructional design Solid PTFE O rings in contrast are extremely resistant to media but lack elasticity 79
16. For all types of seals it is imperative that both the installation space and the seal itself are clean Metallic processing residues such as The sealing surfaces must at least have the surface roughness indicated in the catalogs Check for scratches gouges and cavities If seals have to be stretched and pushed over sharp edges or threaded surfaces during installation these should be rounded off or covered Storage Prior to installation ensure that the seal was properly stored If the seal is individually wrapped do not remove it from its package until you It is always important to ensure that mounting tools and other aids do not damage the seal or the installation space Installation sleeves conditions are ready to install it see page 24 Assembly aids tool Lubricants Positioning LEGAL NOTICES Freudenberg Process Seals GmbH amp Co KG has care fully prepared the contents of this handbook The information is based on our decades of research into the develop ment and manufacture of sealing solutions as part of the Freudenberg Group and reflects our current state of knowledge However as seal performance is not only dependent on the seal itself but also on various other parameters connected to the individual application which are beyond our control Freudenberg Process Seals GmbH amp Co KG does not assume any liability for the statements made in this document 98 expansion mandrels chamfers on pistons and cylinders an
17. High version Applications Seals for dairy couplings cover a broad range of applications for the sealing of pipe connections m Suitable for use in a wide variety of pipe connections in the food beverage and pharmaceutical industries m ideal for flange connections that need to be opened on a regular basis m Used in non critical media The advantages at a glance Standardized sealing element m High density of use Especially fast and easy assembly regardless of the direction of installation Can be removed quickly m Available in numerous approved material variants Conventional clamp seal Clamp seals Clamp seals were developed for a quick and secure pipe connection for continuously operating systems The main advantage of clamp connections is their simple installation since the flanges are designed symmetrically and thus the seals do not need to be installed with a particular orientation The dimensions are standardized in accordance with ISO 2852 inch dimensions and DIN 32676 metric dimensions the standardized seals are therefore particularly economical and ovailable from stock Since the clamp connection does not have a metallic stop there is the danger that leakage can occur if the seal is overly compressed or not seated properly on installation 2 3 1 Clamp connection with nominal diameter DN 6 to DN OD 34 Series A DIN to DN 6 Series B DN OD 10 2 to DN OD IZZ Series C DN OD W to D
18. Place Cleaning method in the process industry with disassembly Deutsches Institut f r Normung German Institute for Standardization Dachmanschette Rod seal set consisting of roofshaped seals and supporting rings Nominal diameter e g for pipes Deutscher Verein des Gas und Wasserfaches German Technical and Scientific Association for Gas and Water Compression set a mechanical performance parameter for elastomers The compression set describes the ability of a material to generate a sufficient restoring force on the sealing surfaces and thus ensure the tightness even after a certain contact time with the media in question Druckverformungsrest Ethylene diamine tetra acetic acid European Hygienic Engineering amp Design Croup Consortium of plant engineers and operators in the food and pharmaceuticals industries Ethylene Propylene Diene Rubber Expanded PTFE European Technical Approvals Denmark Verordnung der europ ischen Union A base elastomer In a special process the molecular chains of ultra thin PTFE layers are stretched these layers are stacked multi directionally and loosely pressed As a result the cold flow is optimized the seals are very adaptable and meet after pressing on site the highest leak tightness requirements e g according to TA Luft Danish organization for issues concerning drinking water EC Reg Regulation of the European Union a regulation is a legally binding act directive
19. a variety of media such as logy is the hardness The nominal hardness is specified for liquids and gases which intluence the elastomer materials all Freudenberg materials in the materials designation in different ways before the base elastomer e g ZO EPDM 291 and determined using various standardized procedures In the A distinction is made between the chemical and physical process the parameter which is measured is always how effects of media If an elastomeric compound is chemically far a given test specimen that penetrates into the material affected the properties are irreversibly changed The under a defined force splitting of the cross linking points between the molecular chains leads to a softening and loss of elasticity of the Shore A pursuant to DIN 53 505 material concerned The formation of additional cross The method according to DIN 53 505 was developed by linking points entails hardening leading to embrittlement of Albert F Shore in the 1920s and is the most commonly used the material Certain media can also attack the molecular method for measuring hardness in elastomers The surfaces chains of the elastomer and destroy them Physical proces of the test specimen must be flat and coplanar The value is ses can be roughly divided into two groups read after a holding time of three seconds The test according to Shore A is used mainly in materials development and in a absorption of the medium by the elastomer and the clear
20. and have good chemical resistance and workability The properties of the polyamides are largely dominated by the amide groups which interact with each other via hydrogen bonds Polyamides have a high wear resistance and good sliding properties The mechanical properties can be further improved by means of fiber composites with glass or carbon fibers so that for example strength and impact resistance can be adjusted to suit the application Suitable areas of application PA is distinguished by its high strength values as a particu larly suitable material for use in mechanical elements such as gears friction bearings or guide rails In the sealing area PA rings are often used as backup rings for a wide variety of sealing elements PA is characterized in particular by high wear resistance good damping power good dry running characteristics low tendency to creep and low water absorption PA 2 5 3 5 and PAT2 0 2 0 5 Typical products m Backup rings m Guide rings PU Polyurethane Polyurethane PU or PUR is a plastic that can be proces sed with almost all methods of plastics technology Poly urethanes are linear or crosslinked high polymers that are formed by the reaction of di or polyisocyanates and hydroxyl carriers such as polyols chain extenders and crosslinkers and potentially other components Common to all of them is the urethane bond created by this reaction which gives the name to this material g
21. and other potential extract able ingredients and therefore displayed negligible amounts of extract in the extractables study see page 64 f Thus the materials EPDM 291 and EPDM 253815 can be recommended for use in the manufacture of medical products 34 Suitable areas of application m Hot water and steam on a sustained basis up to 180 C 356 F briefly up to 210 C 410 F m Acids hydrochloric acid nitric acid and phosphoric acid m Alkaline solutions sodium hydroxide solution potas sium hydroxide solution m Polar organic solvents m CIP SIP media for continuous operation plants in the food beverage and pharmaceutical industries 70 EPDM 70 EPDM Rules and standards 253815 FDA compliant CFR 21 Part 177 2600 4 EC Reg 1935 2004 as well as EC Reg E 2023 2009 3 A Sanitary Standards Class Note Class Il due to poor grease resistance sterilization up to 121 C 250 F cleaning up to 82 C 180 F possible USP Ch 87 in vitro i a USP Ch 88 lin vivo Class V 121 C 250 F Drinking water DVGW W 270 and 534 KTW WRe NSF NSF 61 OVGW ACS WQC NSF 5I fe M 4 EPDM in the dairy industry EPDM cannot be used in every product containing fat which limits but does not completely exclude the use in the dairy industry According to DIN 11483 dealing with dairy plants the use of EPDM is only recommended for products with a fat content of up to 15 This i
22. be designed in such a way that no overstretching and no excessive stress peaks can occur The diaphragm s mountings must in some cases be able to withstand considerable forces and should be designed accordingly It is advisable to utilize FEM calculations here too The elastomer base material as well as any applicable fabric metal or plastic inserts must be resistant to all media involved in een operation Freudenberg s materials experts will be glad to advise you For applications in particularly aggressive media it is advisable to add a layer of PTFE to the diaphragm Installation and assembly The advantages at a glance Good media resistance Please refer to page 98 for general assembly and installation instructions Broad range of functions and applications Economical and maintenance tree Applications Highly dependable Since diaphragms can be very closely tailored to specitic Various approvals and clearances applications in terms of their shape and materials compo sition they can be used in a very broad spectrum of app lications In the food and beverage industry they are generally used in the following areas Actuators Fittings VVater reservoirs Pumps Compressors Valves and controllers PR PRODUCT PORTFOLIO HYGIENIC USIT RINGS FREUDENBERG S HYGIENIC USIT IS A PRODUCT DEVELOPED SPECIFICALLY FOR THE REQUIREMENTS OF THE PROCESS INDUSTRY WHICH SETS STANDARDS IN PURITY Since it was in the past not po
23. chamfers Surface roughness Hardness 20 standard Sealing surfaces in accordance with the diagram Lead in chamfers 1 6 ym Groove flanks 2 5 ym Optimal running surface hardness 20 HRC 65 HRC Penetration depth min 300 pm Installation and assembly Installation preferably without stretching or compressing of the rings If stretching or compression is unavoidable please consult Freudenberg Lightly oil the rings prior to installation Please refer to page 98 for general installation and assembly instructions Applications Ball valves Hanges and lids Swivel joints Distribution manifolds Hot water and steam valves Fittings Piston pumps Bearings RECOMMENDATIONS FOR SEALING SURFACES Mean roughness value R of the sealing surface Hydrogen SAE 10 to 50 Motor oils Water steam Air Water Grease On 14 a o The advantages at a glance Universal media resistance and broad temperature range Highly dependable Resistant to aging No stickslip effect Special variants for higher pressures Special hygienic variants with minimal dead space Bitumen Dust Powder 0 5 LL O l gaseous liquid solid E static Bi dynamic Aggregate state of the medium 95 INTRODUCTION PRODUCT PORTFOLIO Haeo rae ENGINEERING PLASTICS ELASTOMERIC MATERIALS een alae APPENDIX LIST OF ABBREVIATIONS Abbreviation ACN ACS ADI free API ASME AWQC BfR CIP CNC CO
24. data sheets of the Freudenberg elastomers They describe the behavior of the respective material to tensile stress Resistance to tear propagation The tear propagation resistance is a measure of the sensitivity of elastomers in case of cutting and tearing damage The most common test to determine tear propagation resistance is the strip test according to DIN ISO 34 1 DIN 53 507 In this case a longitudinal cut is made in the material to be tested the two haltstrips are clamped in a pulling machine and pulled apart The force subtended by the test specimen to the tear propagation is measured in relation to the sample thickness A further testing method is the angle test specimen accor ding to DIN ISO 34 1 DIN 53 515 Here an incision is made in an angled bent sample manufactured in a form and the sample is similarly pulled apart using a pulling machine The measured values do not need to correlate with the stress values determined in the tensile lest Since the results of the tear propagation resistance test strongly depend on the specific test conditions and particularly on the shape of the sample it is crucial that the test method and the sample shape are always indicated when the results are stated 23 TECHNICAL FUNDAMENTALS STORAGE CONDITIONS ARTICLES MADE OF RUBBER ARE SUBJECT TO AGING MODERN ELASTOMER MATERIALS ARE MORE STABLE AND HAVE LONGER SERVICE LIVES THAN THEIR PREDECESSORS FROM EARLIER GENERATIONS
25. determined G weight in air G weight in fluid p density of the fluid in case of water approx 1 g cm Tensile test Tensile tests are used to determine the tear strength tensile strength elongation at break and the stress values of elastomeric materials The test specimens used for this purpose are usually tensile bars or standardized rings with rectangular cross sections These are stretched at a constant speed to break In the tensile test according to DIN 53504 as many points as possible of the force length change curve tensile force with corresponding change in length of the sample are recorded The following values can be calculated from the experiment l The tear strength is the quotient of the force achieved at the moment of rupture and the initial cross section of the specimen 2 The tensile strength is the quotient of the measured maximum force and the initial cross section of the specimen Tear strength and tensile strength are generally the same in elastomers if the measurement is performed at room temperature or above 3 The elongation at break is the ratio of the length change achieved at the moment of rupture to the initial length 4 The stress value is defined as the quotient of the tensile force existing when a certain elongation is achieved and the initial cross section The three characteristics tear strength 100 stress value and elongation at break are indicated on the material
26. fine and specialty chemicals seals with an especially high thermal and chemical resistance are required In addition to the use of harsh and sometimes toxic media temperatures from 300 C 572 F down to the low temperature range are not uncommon in crystalli zation processes The material and the seal made from it must be able to cope with this Production of detergents and personal care products The production of detergents and personal care products whose requirements are similar to those of the pharma ceutical industry makes especially high demands in terms of the purity and hygiene of all process media used In addition to the lack of dead space of the sealing point the sealing materials must have the prevalent approvals and clearances of the pharmaceutical industry and be able to withstand the sophisticated CIP SIP cleaning media and processes INTRODUCTION PRODUCT PORTFOLIO por rae ENGINEERING PLASTICS ELASTOMERIC MATERIALS Ku RAO TECHNICAL FUNDAMENTALS BASIC MATERIALS TESTING HARDNESS COMPRESSION SET DVR OR THE VOLUME CHANGE OF A MATERIAL IN USE ARE IMPORTANT PARAMETERS VVHICH AFFECT THE SEALING FUNCTION BUT ALSO THE LIFE OF THE SEAL PRECISE STATEMENTS ABOUT THE BEHAVIOR OF THE MATERIAL ARE THEREFORE ESSENTIAL FREUDENBERG USES A VARIETY OF TESTING PROCEDURES AND METHODS FOR THIS Hardness tests Volume change measurement One of the most important parameters in rubber techno Seals come into contact with
27. food and pharmaceutical industries m Oxidizing media e g hypochlorite or polar organic solvents e g acetic acid Concentrated acids e g nitric acid formic acid m Concentrated oxidizing media e g peracetic acid Rules and standards 75 Fluoroprene XP 40 75 Fluoroprene XP 41 85 Fluoroprene XP 43 75 Fluoroprene XP 44 FDA compliant CFR 21 Part 177 2600 EC Reg 1935 2004 as well as EC Reg 2023 2006 3 A Sanitary Standards Class USP Ch 87 in vitro USP Ch 88 in vivo Class VI 121 C 250 F 38 Volume swelling in 76 Fluoroprene XP in the dairy industry A wide variety of material versions has been used in the dairy industry until now The EPDM material widely used in the food industry shows indeed the best performance in CIP processes here but is not usable in every product containing fat While FKM and VMQ materials are indeed resistant to fatcontaining media they have only limited resistance in the cleaning media customarily available on the market Fluoroprene XP was designed specifically for the high demands of the food industry and thus also the dairy industry It is a 3 A Sanitary Standards Class material and can therefore also be used in pure olive oil and in butter with a fat content of 82 In addition the material is recommended not only for use in diluted but also in concentrated CIP SIP media Fluoroprene XP in the beverage industry W
28. material Ice cream The threat to the sealing material in the manufacture of ice cream consists firstly of the high fat content of the ice cream mixture and secondly of additives such as pieces of fruit which may press themselves into the seal and cause leakage Large temperature ranges e g from O C 32 F during the transportation of a cold product up to 140 C 284 F during steam sterilization must be mastered reliably by the seal Aside trom that resistance to CIP SIP media should also be given of course INTRODUCTION m N v A L TECHNICAL FUNDAMEI r YU LASTOMERIC MATERIAL L CE amp PURITY ENGINEERING PLASTICS MATERIALS RESISTA T PORTFOLIO PRODUC THE PURITY REQUIREMENTS VVITH RESPECT TO PROCESSES AND PRODUCTS IN THE PHARMACEUTICAL INDUSTRY REQUIRE SEALING SOLUTIONS THAT RELIABLY PREVENT PROCESS CONTAMINATION BEYOND THEIR RESPECTIVE MEDIA RESISTANCE Freudenberg has developed special materials and seals such as white EPDM and Simriz FFKM which compre hensively satisty both the demanding operating conditions and simultaneously support the hygienic processes In the pharmaceutical industry the synthesis of pharmaceu tical products takes place from basic chemicals The basic and reactive chemicals need to be extra pure so that no unwanted by products are generated in the synthesis In general production is done in batches in order to ensure trace
29. the synthesis of many active ingre dients polar solvents such as ethanol or isopropanol are used EPDM is the most suitable material for this The exceptions are non polar solvents and aliphatic products such as waterin oil emulsions V O emulsions In this case a fluorinated elastomer should be used EPDM in the chemical industry In the chemical industry EPDM is recommended where polar solvents aqueous salt solutions as well as diluted acids and alkaline solutions are used Products and materials m O rings made of ZO EPDM 291 85 EPDM 292 and O EPDM 253815 m Molded parts made of 7O EPDM 291 85 EPDM 292 and 70 EPDM 253815 Butterfly valve seals made of 75 EPDM 253356 and O EPDM 253815 Clamp seals made of 70 EPDM 291 and 70 EPDM 253815 Diaphragms made of 70 EPDM 291 and 60 EPDM 290 Elastomer bead of the Hygienic Usit made of O EPDM 29 Profiles and cords made of ZO EPDM 39 Download Data sheet 7O EPDM 29 Download Data sheet ZO EPDM 253815 37 ELASTOMERIC MATERIALS FLUOROPRENE XP FLUOROPRENE XP IS A VERY HIGHLY FLUORINATED MATERIAL HAVING A SPECIFIC MONOMER COMPOSITION AS A RESULT OF THIS THE PERFORMANCE ALMOST ACHIEVES THE CAPABILITY OF A PERFLUOROELASTOMER General properties m Excellent temperature resistance up to 200 C 392 F m Very good resistance to ozone weathering aging and oxygen Excellent resistance in mineral oils and fats low gas permeability Very go
30. which increase the diversity of flavors are also an exclusion criterion for some materials Then the temperatures must be taken into account some of which are very high in chocolate production in order to make the ingredients capable of being processed The sealing material must meet all of these requirements Jam In the manufacture of jams and preserves pieces of fruit and crystallization of sugar lead to increased wear Fruit particles can be pressed into the seal and cause leakage in extreme cases The sealing material used here must be resistant fo the fat and flavorcontaining additives and to the partly aggressive cleaning agents Convenience foods Different cleaning media for closed and open processes greatly stress seals in the production of ready made meals such as frozen pizza The production of powders pastes liquids etc makes individual demands on the sealing materials For some convenience foods excellent low temperature flexibility is also required which cannot be met by every seal material in combination with the resistance requirements Dairy products In the dairy industry influences such as a high fat content of the product media must be taken into account in the selection of materials An EPDM material which has a very good resistance to CIP SIP media for example has only limited resistance to fatty media Here cleaning with alkaline solution is also carried out very intensively i e at high concentrations
31. 12 F special blends remain flexible at low temperatures down to 55 C 67 F 46 70 NBR 150 und 88 NBR 156 As a standard solution Freudenberg offers within its NBR family the material ZO NBR 150 In addition the compound 88 NBR 156 is also available as a harder version for special applications Application profile NBR has very good properties in applications with mechanical stress and in oils fats and waxes Its temperature resistance in hot water is up to 100 C 212 F NBR cannot be used in concentrated acids e g nitric acid formic acid concentrated oxidizing media e g peracetic acid and in aromatic and chlorinated hydrocarbons Rules and standards 70 NBR 150 88 NBR 156 FDA compliant CFR 21 Part 177 2600 EC Reg 1935 2004 as well as EC Reg 2023 2006 NSF 61 Products and materials O rings made of ZO NBR 150 and 88 NBR 156 Molded parts made of 7O NBR 150 and 88 NBR 156 Diaphragms made of 62 NBR 152 and 52 NBR 153 Clamp seals made of 7O NBR 150 Download Data Sheet ZO NBR 150 Download Data sheet 88 NBR 156 4 7 ELASTOMERIC MATERIALS HINDR HNBR HYDROGENATED ACRYLONITRILEBUTADIENE RUBBER IS A MATERIAL THAT IS GENERATED BY FULL OR PARTIAL HYDROGENATION OF THE DOUBLE BOND CONTAINING BUTADIENE PORTIONS OF NORMAL NBR POLYMERS THUS HNBR OFFERS A SIMILAR CHEMICAL RESISTANCE TO NBk BUT HAS BETTER HEAT AND OXIDATION STABILITY FURTHERMORE THE MATERIAL IS CHARAC
32. 8 Class VI 121 C 250 F and NSF 51 8 Dimensions of the washer m MA compatible with M3 and MA screws and cap nuts a M5 a M m M8 a MIO m MI2 m MIO MH TAL P _ mu P m m NovoNox cap nut Material 1 4404 in A4 7O quality Highly polished with up to max R O O4 um Freudenberg washer Material Elastomer made of ZO EPDM 291 shim of 1 4404 NovoNox hexagon head screw with collar Material 1 4404 in A4 7O quality Highly polished with up to max R O O4 um Applications m n closed process steps for areas in contact with the product m Outside the area in contact with the product i e in open processes to ensure the complete exterior cleaning and steam sterilization of the plant The advantages at a glance EHEDG certified Optimally matched screw cap nutUsit composite Prevention of contamination due to dead space tree design Replaces inflexible welding solutions Premium elastomer with numerous approvals Cleaning with CIP SIP and WIP COP OPC and WOP process possible 79 PRODUCT PORTFOLIO ROTARY SHAFT SEALS ONLY FREUDENBERG OFFERS THE ORIGINAL SIMMERRING AS A ROTARY SHAFT SEAL FOR THE SEALING OF ROTARY SHAFTS AND SPINDLES AND THE PROTECTION OF BEARINGS THIS SEALING SYSTEM IS PRIMARILY INTENDED FOR USE IN APPLICATIONS INVOLVING ROTARY MOTION Simmerring Radiamatic HTS Il rotary shaft seals are a custom de
33. ATERIALS OVERVIEVV OF ELASTOMERIC MATERIALS me em ANN FREUDENBERG AVAILS OF WORLD 60 EPDM 290 black peroxidic 65 5 RENOVVNED MATERIALS EXPERTISE l 70 EPDM 391 black peroxidic 70 amp 5 Q a 85 EPDM 292 black peroxidic 85 5 85 EPDM 302 black peroxidic 85 5 75 EPDM 253356 black peroxidic 5 5 ZO EPDM 253815 white peroidic 70 5 8 VMQ 166898 light blue peroxidic 78 5 Oo 6 VMQ 176643 red peroxidic 76 5 gt 70 VMQ 117055 transparent peroxidic 70 5 Er ZO NBR 150 black peroxidic 70 5 co z 88 NBR 156 black peroxidic 8825 O HNBR 254067 green peroxidic 70 5 5 HNBR 231142 black peroxdic 75 x5 Co mINBR Zes green peroxidic 85 45 75 Fluoroprene XP AO blue peroxdic 75 x5 a x e 2 75 Fluoroprene XP Al blue Beroxidie 75 5 D 5 Q S 85 Fluoroprene XP 43 blue peroxidic 8545 75 Fluoroprene XP AA blue peroxdic 75 x5 5 FKM 180497 black bisohenolic 75 5 re 70 FKM 37508 red bisohenolic 75 5 70 Simriz 49 black peroxidic 70 5 75 Simriz 494 black peroxide ea 775 5 a 75 Simriz 495 black peroxidic 75 E Zr m 197 black peroxidic 75 5 s 75 Simriz 506 white peroxidic 72 5 80 Simriz 492 black peroxidic 80 5 85 Simriz 496 black peroxidic 8545 32 Temperature range in air EE Food Pharmaceutical Drinking water Nu 0 Cio 150 7 40 Fie 4302 FT 40 C to 150 C 40 F to 302 F 0 Cio 50 7 ct Fie 4302 ds 40 C to 150 C 40 F
34. CIP SIP media Concentration range Residence time min Acidic cleaning agents 30 C to 80 C e g on the basis of HNO oo ies ir 86 F to 176 F Alkaline cleaning agents 30 C to 80 C e g on the basis of NaOH in 29e 129 H86 F io 176 F Disinfectants 25 C e g on the basis of H O Sern alee 77 F Acidic disinfectants 25 C e g on the basis of H O and HNO el 20 EH F Alkaline disinfectants Bere 30 80 C e g on the basis of H O and NaOH NaOH 1 0 to 2 0 176 F 120 C io 140 C Sterilization with steam 100 0 2046 45 4248 F to 284 F INTRODUCTION DAMAGE ANALYSIS SEALS MAY BE DAMAGED IN SEVERAL WAYS DAMAGE IS OFTEN CAUSED BY CHANGES OF THE PROCESS MEDIA AND THE FACT THAT THEIR EFFECTS ON THE SEAL MATERIALS WERE NOT TAKEN INTO ACCOUNT IN ADVANCE After an incident it is essential to find out the cause in order to prevent subsequent damage and to find the right seal for the individual application Freudenberg s applica lion support creates meaningful damage analyses and helps you fix the problem When a case of damage occurs the following documentation has to be carried out How should seal damage be documented m Take photographs of the installed seals using the maximum resolution possible m Indicate seltintlicted damage e g by using a screwdriver during the removal m Give the exact installation location valve number component eic m Observe mating surfaces and grooves co
35. DM assumed as 100 Ester 100 Ketone 3 Ester 2 Ester 4 Ketone Ester 3 E precleaned EPDM E water 80 C EPDM Il precleaned XP 40 Ml water 80 C XP 40 63 MATERIALS RESISTANCE amp PURITY EXIRAC TABLES PARTICULARLY HIGH PURITY REQUIREMENTS APPLY TO ELASTOMERS IN THE PHARMACEUTICAL INDUSTRY INCLUDING THE DESIRE FOR DISCLOSURE OF THE INGREDIENTS OF THE COMPOUNDS THIS DOES NOT PROVIDE THE DESIRED INFORMATION ABOUT THE INTERACTIONS THAT CAN TAKE PLACE DURING THE PRODUCTION PROCESS That is why manufacturers in the pharmaceutical industry want to examine materials for a possible interaction with the pharmaceutical preparation For example they want to know how an O ring for the sealing of an inhalation spray head behaves in contact with the drug It is also of interest to minimize the influence of the seals from production on the product In addition to studies at ambient temperatures with respect to the completeness of the packaging the storage conditions and test substances leachables study tests are slated in the worstcase scenario with more stringent conditions such as elevated temperatures and solvent strengths extractables study Apart from the quantification the identitication of the migrated substances is particularly important for a subsequent toxicological evaluation Compared to storage a multiple of the volume tlows by the seal in the production process The ratio of surface area to volu
36. ELIABLE CLEANING OF SEALS AFTER PRODUCTION SO THAT EVEN THE SMALLEST IMPURITIES OR PARTICLES ARE REMOVED IN ORDER TO PROTECT THE PURITY WE RECOMMEND SUBSEQUENT INDIVIDUAL PACKAGING Especially when seals are not immediately installed but put into storage contamination can occur which may then be introduced into the process Freudenberg ofters the possibility to create custom packaging For example we provide the bags with logo article and batch numbers and other individual information Thus the individual package not only fulfills the purpose of protection against soiling and contamination but also helps to track compo nents up to the seal and thus comply with the prescribed documentation requirements Furthermore Freudenberg provides the option to apply a removable label with customerspecitic information on the package which can be pasted into the service manual This allows for comprehensive and continuous documen tation For an OEM Original Equipment Manufacturer the individual packaging has another important advantage When seals are resold to MRO customers Maintenance Repair and Operations they do not need to be repacka ged Depending on the order quantity the individually packaged seals can be combined in one shipment The advantages at a glance m Washing service for hygienically demanding appli cations m Secure traceability to the point of the individual seal thanks to single unit packaging m Rapid id
37. ERFLY AND DISC VALVES IN THE FOOD AND BEVERAGE INDUSTRY THEY ARE USED VVHEREVER A SHUT OFF VALVE IS SUFFICIENT AND A MORE EXTENSIVE FLOW REGULATION IS NOT NECESSARY Shut off butterflies butterfly or disc valves are normally four part units composed of a two part housing with a threaded connector weld on ends or a clamp connector a valve disc and a butterfly valve seal It is only the last component that guarantees the integrity of the entire unit making it indispensable in preventing all three types of potential leakage at the pipe seal the flange and the actuator Despite the simplicity of their basic design seals for butterfly valves are expected to master extremely demanding operating conditions when the valve is open the gasket should only minimally reduce the pipe diameter and should be nearly free of dead space The valve should be easy to close but at the same time should exhibit high compression when closed to provide a perfect seal Optimal materials torque reducing geometries and highly realistic testing are needed in order to combine all of the desired qualities The requirements are further intensified by the high flow speed when the valve is closing This flow creates a major pressure differential and pressure fluctuations both of which can blow the seal out of its seat into the pipe In order to optimally tailor the seal design to prevent this Freudenberg utilizes efficient and highly eftective compu tation
38. Filled PTFE Reinforcement with glass fibers or carbon tibers of those parts of the bellows under the most stress Applications of bellows as compensators e g where the bellows are mounted on a pump head Compensation for expansion and vibration Compensating for axle offset misalignments and Function displacements in pipes m Protection of piston rods linkages and other machine m Fluid circulation in chemical food and beverage industries parts involving axial and in some cases radial motion m Rod protection in chemical food and beverage industries Compensation of movements and displacements m Protection from dust and contamination e g for between two connecting components weighing equipment in filling plants m Circulation and pumping of gases and liquids using volume changes Applications of valve and pump bellows m n feed pumps and metering pumps Dimensions m For control and shut off valves in chemical m Smallest standardized internal diameter 10 mm smaller pharmaceutical and food and beverage industries diameters available on request Largest external diameter theoretically unlimited The advantages at a glance Highly ressiont o nearly al chemicals FBA 9000 rer Dependable sealing to prevent media contamination m High cost effectiveness thanks to production by machining FBC 9002 Compensators for moderate pressures m Special variants made to order and small batches are FV series Individual solutions for pump and valve bellows p
39. IAL RESISTANCE VERY DIFFERENTLY ESPECIALLY PEACH AND TROPICAL FRUIT FLAVORS AS WELL AS ORANGE OIL CAN RESULT IN PROBLEMS WITH REGARD TO MATERIAL RESISTANCE Flavoring agents consist of various chemical ingredients therefore a classification based on their elastomer destroying potential is difficult even more difficult than for CIP cleaning agents for example In addition the ingre dients which are dangerous for elastomers may potentiate their eftect or conversely may greatly attenuate each other It is very difficult to gain systematic knowledge here Traditionally FKM is used in these media because FKM has excellent resistances to aliphatic and aromatic hydro carbons as well as oils and fats FKM can also be used in media such as essential oils and citrus flavorings whereas EPDM swells a lot due to its high proportion of non polar ingredients Since most flavoring agents in addition con tain aldehydes ketones and carboxylic acids which are known to be harmful to elastomers there is sometimes no other alternative but to resort to FDA compliant perfluoro elastomers Fluoroprene XP with its significantly better chemical resistance compared to an FKM can be an interesting alternative to this solution At any rate what is important in terms of reliable material recommendations are well grounded resistance tests In order to be able to make a reliable assessment of the suitability of an elastomer not only the physical intluenc
40. IGO Ps ZO ROS Lap ILO 7 UR ISO Rol IR Ol PRG62 URZ8 PR32 UR28 PRS59 UR6 8 PRATZ URAS PRIA S PRS PR 11 9 PR 13 1 PR 16 8 PR 19 6 PR 16 8 PR 19 1 le FIDE 02 SOO 0 30 0 68 0 37 0 47 9 8 8 2 INS 8 8 EPTFE c r Pudar n dar EPTFE IS AN EXPANDED PTFE MATERIAL WITH IMPROVED ra FA s MECHANICAL PROPERTIES AS A RESULT OF THE MULTI ena y DIRECTIONAL AUGNMENT OF THE POLYMER CHAINS Freudenberg s FG 360 has a denser form and therefore otters better stability and even less creep relaxation and cold flow than existing expanded PTFE products This eliminates the need for a reinforcing effect by means of tillers and binding agents FG 360 is thus a 100 pure ePTFE without additives Because of its purity the material can be used in the biotechnology and pharmaceutical industry without concerns Damaged or worn flange surfaces are easily offset by this material It is a soft extremely compressible and at the same time very strong material that has excellent sealing properties even at low surface pressures and tightening torques Due to the impermeability effect at low surface pressures it is ideally suited for plastic and glasslined flanges Its low friction coefficient of O 2 similar to wet ice allows easy installation and dismantling FG 360 has an unlimited shelf lite because it does not embrittle or age or deteriorate in any other way This material is resistant to UV radiation ozone and almost all chemicals It is ve
41. K202 G216 Extrusion length in mm E 80 C W 120 C 92 PTFE BELLOVVS BELIOWS ARE COMPONENTS WHICH ARE PRIMARILY USED TO PROTECT MOVING MACHINE PARTS FROM EXTERNAL INFLUENCES ted from environmental influences or aggressive media Berner Standard bellows as well as metal reinforced special bellows serve as reliable sealing components They can variants possible also be Used lo compensate for movements expansions as Valve and Design guidelines based on individual experience in pump bellows development and testing well as axle offset misalignments and vibrations When used The flange contact surfaces must be smooth and clean in combination with check valves they can also be used to PTFE bellows should not be overexpanded circulate or pump gases and liquids utilizing volume changes Special l o Se in the bellows provided the installation space allows it ns t may be advisable to use soft packings between flange i oe and flange thickness listed for types FBA Application range of bellows 9000 and FBC 9002 are smaller than those indicated in m Virgin PTFE Broad application range throughout the LEN chemical industry Modified PTFE Low porosity variant for the food Installation and assembly beverage and pharmaceutical industries Please refer to page 98 for general installation and m Conductive PTFE Designed to prevent static electrical buildup assembly instructions m
42. MPERATURE THE FASTER AGING PROCEEDS No single elastomer can be used universally The requirements with respect to media resistance and the lower and upper temperature limits must be taken into account and then be used together with the specific application to select the most suitable material ELASTOMERIC MATERIALS During contact with the media there are always two different mo 32 gt S processes impacting the elastomer material which may affect its sealing performance physical swelling and chemical HERES reaction In contrast to pure swelling the chemical processes A are irreversible In general the chemical principle is like v dissolves like This means that polar elastomers swell in polar media and non polar elastomers are only conditionally stable E NBR A p in non polar media 100 Polar media Resistance to Non polar media AGING AND VISCOUS FLOVV Diagram Elastic behavior Elastic modulus Rubbery elastic plateau E Application range M Threshold range Temperature po TEMPERATURE RESISTANCE The temperature significantly affects the physical properties of rubbery elastic materials If the modulus of elasticity E modulus elastic modulus is considered in relation to the temperature a constant E modulus at a high level and at a low temperature is visible which identifies the glassy state As the temperature rises the area of the glass transition is entered where the el
43. N OD 34 Clamp connection with nominal diameter DN 10 to DN OD 6 Series A DN 10 to DIN 200 Series B DN OD 21 3 to DN OD 219 1 Series C DIN 7 OD F to DN 7 OD 6 3 A version with truncated lip pursuant to ISO 2852 is also available Freudenberg offers a portfolio of four materials that can be processed into clamp seals from a single tool m O EPDM 291 black m 70 EPDM 253815 white 75 Fluoroprene XP 41 blue 70 VMQ 117055 transparent Applications Clamp seals cover a broad range of applications for the sealing of pipe connections Suitable for use in a wide variety of pipe connections in the food beverage and pharmaceutical industries Ideal for flange connections that need to be opened on a regular basis m Used in non critical media Dimensions m According to ISO 2852 Nominal dimensions from DN 12 to DN 2191 m According to DIN 32676 Nominal dimensions from DIN 6 to DN 200 The advantages at a glance Standardized sealing element m High density of use Especially fast and easy assembly regardless of the direction of installation Can be removed quickly m Available in numerous approved materials variants 3 PRODUCT PORTFOLIO O rings for aseptic clamp connections In order to ensure that Hygienic Design requirements are met clamp seals with aseptic O rings compliant with DIN 11864 were developed They optimally combine the advantages of easy installation and a sealing area fre
44. OC level Migration tests Material composition Examination of the components Toxicity tests Microbiological examination Material composition Manutacture Toxicity test Migration test BR 21 recommendation cat 4 ADI free Determination of OML and SML values in different media and temperatures BIR positive list Migration tests subdivided into categories depending on the contact time BIR positive list Migration tests subdivided into categories depending on the contact time FDA positive list Migration tests FDA positive list Migration tests FDA positive list Resistance tests in defined media and classification according to specified limits Testing of the formulation for animal derived ingredients Testing of the compatibility on living organisms in vitro Testing of the compatibility on living organisms in vivo 27 TECHNICAL FUNDAMENTALS HYGIENIC DESIGN THE SELECTION OF MATERIALS ACCORDING TO THE OPERATING CONDITIONS TAKING INTO ACCOUNT THE REQUIRED PURITY WITH THE CORRESPONDING CONFORMITIES IS ONLY THE FIRST STEP TOVVARDS FULFILLING THE HYGIENE REQUIREMENTS The most important duty of every plant operator is to know and to obey all legal requirements and procedures to ensure a proper product quality Every food pharmaceu tical and cosmetic product must be clean and must not endanger the health of the consumer in any way A plant c
45. P DIN DM DN DVGW DVR EDTA EHEDG EPDM ePTFE ETA DK EC Reg FB FDA FEM FEP FFKM FKM GC GMB GMBM HNBR HRC HTS Il 96 Full name Description A The higher the ACN content of an NBR or HNBR elastomer the better the Acrylnitril resistance against non polar media The smaller the ACN content the better the low temperature flexibility The ACN content ranges between 18 and 50 Attestation de Conformit Sanitaire French drinking water approval Animal Derived Ingredient free Assurance that no products derived from animals are used in manufacture Active Pharmaceutical Ingredients The pharmaceutically active ingredients in a medicinal product American Society of Mechanical Engineers United States platform for engineers and students Australian Water Quality Centre Australian organization for drinking water standards German Federal Office for Risk Assessment BfR focusses on the assessment of risks in the field of consumer health protection and food and feed safety e g BER Recommendation 15 for silicones BfR Recommendation 21 Recommendation for articles of daily use based on natural and synthetic rubber material for silicone material rubber in food use Bundesinstitut f r Risikobewertung C Cleaning In Place Cleaning processes in closed plants of the process industry without disassembly Computerized Numerical Control Method in machining technology Cleaning Out of
46. Q HNBR 24 h 96h 20 Change in NES Bi volume in Bl elongation break in B tensile strength in In the strongly aldehyde containing flavor mixture Peach base both EPDM and VMQ show the best resistance values The loss of tensile strength of HNBR and FKM is clearly too high INTRODUCTION Flavor carry over Flavor transfer or flavor carry over is a well known problem in beverage bottling The seals absorb the ingredients of the tlavoring mixture during the bottling of a flavored drink and gradually release them again during the next bottling process for another product This may well go unnoticed it the products bottled successively are both flavored and one of the products merely has a slightly stronger raspberry taste for example It is different when after a slightly flavored water so called nearwater products the thus far tlavorless mineral water is bottled and the subsequent batch has unintentionally absorbed a peach or cherry tlavor for example In order to find the most suitable material for this application different materials were analyzed by Freudenberg with respect to their flavor absorption and release capacity 62 Studies by Freudenberg related to the flavor carry over of different materials such as EPDM FKM and Fluoro prene XP have shown that EPDM materials absorb and release flavor the most The remigration rate of an EPDM material is 100 times greater than the uptake and release capac
47. S A BROAD PORTFOLIO OF APPLICATIONS IN ALMOST ALL MEDIA IS POSSIBLE The extremely large thermal application range of this material allows it to even be used in contact with liquid gases It should be kept in mind that the material is not elastic as such it cannot simply be used to replace elastomer materials The excellent chemical resistance of PTFE is based on the strong bond between the carbon and fluorine atoms which is due to the strong electronegativity of fluorine In order to break these bonds the contacting materials need to use more energy which is not possible in most food and pharmaceutical applications PTFE is extremely resistant to all acids bases alcohols ketones benzines oil and other substances The materia is only non resistant to very strong reducing agents such solutions of alkali metals e g sodium in liquid ammonia as Or very strong oxidizing agents such as elemental fluorine ot high temperatures PTFE has a very low coefficient of friction This means that it glides similarly well on PTFE as wet ice over wet ice In addition the static friction is equal to the dynamic friction so that the transition from standstill to movement takes place without jerking The stickslip effect is thereby prevented There are almost no materials that adhere to PTFE since its surface tension is extremely low The surface may be prepared for bonding by targeted etching General prope
48. START WITH THE SPECIFICATIONS IN TERMS OF THE MATERIAL THE FOLLOWING TABLE PROVIDES AN OVERVIEVV OF THE MOST IMPORTANT RULES AND STANDARDS 25 Pharmaceutical NO du Drinking Water Industry Food and Beverrage Industry Industry W 270 KTW materials in drinking water AS WRAS NORM KIWA ETA DK Danish Board of European Technical Approvals NSF l AS NZS 4020 2005 EC Reg 1935 2004 EC Reg 10 2011 BfR 21 recommendation for rubbers BfR 15 recommendation for silicone materials FDA INS 3 A Sanitary Standards ADI free USP Chapter 87 USP Chapter 88 WSP lacs IEEE SO SIR DVGW Deutscher Verein des Gas und Wasserfaches German Association of Gas and Water BtR Bundesinstitut f r Risikobewertung Institute for Risk Assessment ACS Attestation de Conformite Sanitaire French association for sanitary affairs WRAS Water Regulations Advisory Scheme OVGW Osterreichische Vereinigung f r das Gas und Wasserfach Austrian Association of Gas and Water Ministerial Expert Committee Toxicity Subcommittee DEPA and DIC National Sanitation Foundation AWQC Australian Water Quality Centre European Parliament European Parliament BtR Bundesinstitut f r Risikobewertung Institute for Risk Assessment BfR Bundesinstitut f r Risikobewertung Institute for Risk Assessment Food and Drug Administration National Sanitati
49. TERIZED BY HIGH MECHANICAL STRENGTH AND IMPROVED ABRASION RESISTANCE HNBR is often used in dairies cheese making facilities and other milkprocessing plants where the fat content of the product to be processed is so high that EPDM is no longer deployable General properties Partly higher chemical resistance than NBR Better heat and oxidation stability than NBR High mechanical strength Improved abrasion resistance Can be used well in water steam and ultrapure water Temperature resistant from 30 C to 150 C 22 F to 302 F 75 HNBR 231142 70 HNBR 254067 and 85 HNBR 216553 Application profile HINBR is very well suited for use under mechanical stress as well as in oils and waxes animal and vegetable fats Moreover the material is suitable for use in CIP SIP media with continuously operating plants in the food and pharmaceutical industries In these processes diluted acids and alkaline solutions with cleaning additives as well as disinfectants steam or slightly oxidizing media or polar and organic solvents such as acetic acid are used HNBR however cannot be used in concentrated acids e g nitric acid formic acid and concentrated oxidizing media e g peracetic acid 48 HNBR in the beverage industry Since HNBR has good fat and oil resistance it is at any rate an interesting alternative material for the beverage industry The use of essential oils in particular such as those contained in hops can b
50. ability trom the raw material supplier to the patient in the case of quality problems Seals are a not to be underestimated part in this process because they partly have direct contact with the media And with the appro priate sealing technology the risk of contamination and thus of costly and time consuming retracing can be reduced A particular challenge for this industry lies in the versatility of its processes where many different demands are made on the components To illustrate this three areas and their peculiarities are presented in this context Production of finished medicinal products During the production of chemically produced drugs API Active Pharmaceutical Ingredients or in vivo diagnostics contrast agents biomarkers chemicals and toxic substances are used which can attack conventional sealing materials During organic synthesis high temperatures and high pressures occur whereas cooling takes place during the precipitation of the product The temperature range is correspondingly quite large To ensure the hygiene and purity of a batch special attention must be paid to the documentation of the processes Thus the ingredients of the sealing materials must be known too or appropriate certificates such as the FDA test and confirmation of biocompatibility according to USP Chapter 88 Class VI must be available In galenics pharmaceutical technology the medicinal product receives its form Thus in this
51. acid and surfactants Paps VAGOS ee 68 F to 176 F Sn rn m EE x cd d RH utor I i o JET Phosphoric acid based foam cleaners Acifoam VF 10 40 100 io ES d vue Not specified rr damni os os so EEE apache Dog 7 05 5000 MOC ASOT Na pct Alkali gel cleaners Powergel VG 1 20 100 e ee Not specitied Chlorinated alkali CIP or circulation cleaners Divo CIP VC 94 0 3 3 0 i y ue Not specitied Hypochlorite based disinfectants Divosan Hypochlorite VT 3 O25 10 Room temperature Not specified es boosters containing surfactants DTE 02 05 E po Noel gereffise Disinfectants containing peracetic acid Divosan forte VT 6 0 04 2 0 en E k P E Not specitied Amphoteric surfactant based disinfectants 2600 0000 4B O25 10 Room temperature gt 20 66 STORAGE TESTS FREUDENBERG HAS CARRIED OUT EXTENSIVE EXPOSURE TESTING THE DATABASE FOR THE CIP SIP CLEANING AGENTS CONSISTS OF OVER 200 COMPOSITIONS AND 5 100 MEASUREMENTS THE TESTS WERE CONDUCTED USING THE HIGHEST RECOMMENDED OPERATIONAL CONCENTRATIONS AND TEMPERATURES EPDM EPDM is highly resistant to acids alkaline solutions oxidizing media cleaning agents and sterilization including steam But at higher temperatures and concentrations EPDM swells in media containing fat and cannot therefore be used every where The operational temperatures range between 40 C to 150 C 40 F to 302 F in air and up to 180 C 356 F in steam briefly up to 210 C 410 F
52. al models such as FEM Function m Shutting off pipes Dimensions m Dimensions fit standard DIN and ISO pipe dimensions Standard metric DN 15 to DN 250 Standard inch 1 to 6 Individual dimensions available on request 88 Types Customerspecitic types available on request thanks to FEM calculations m Special models with additional treatment e g RFN Installation and assembly m When stretching the gasket over the valve avoid ledges sharp edges and threaded surfaces on the shafts m Please refer to page 98 for general installation and assembly instructions 1 Optimal compression on the butterfly valve or valve disc ensures that the sealing location is reliably sealed Here the goal is an ideal compromise between the integrity of the closed valve and the torque involved in actuating it 2 The quasi static sealing location is also worth examining If the compression is oriented correctly the leakage of production and cleaning media is reliably prevented 3 The axle lead through represents a particularly difficult sealing location The optimal design dependably prevents leaks Applications Information on the minimum and maximum dimensions of the flanges and valves are necessary for gasket design Dimensions Minimum necessary and maximum permissible actuating O Beverage industry forces should be included in design considerations Use of a patented Freudenberg design to reduce torque Use o
53. al rotary shaft seals are very difficult to clean the HTS Il 9539 with no dead space and with its protruding lip seal made of PTFE is barely subject to contamination and very easy to clean Standardized connections HTS Il 9539 VL Version with no dead space and Aseptic O ring screw connection protruding sealing lip for applications Metallic stop according to hygienic design leaktree DIN 11864 European Hygienic Engineering and Design Group The EHEDG is an interest group for operators and suppliers of equipment for the production of food pharma ceuticals and cosmetics as well as for test institutes and maintenance companies Freudenberg is a member of the EHEDG and is very involved in advancing the interests of hygienic design including through active participation in the development of recommended practice Heat exposure of O rings 20 C gt gt 100 C 20 C Expansion of elastomers 15 times greater than stainless steel MATERIAL REQUIREMENTS IN THE PROCESS INDUSTRY THE DEMANDS PLACED ON SEALS INCREASE FOR MANY REASONS IN ORDER TO SHORTEN THE CLEANING TIME OF THE EQUIPMENT CONDITIONS ARE EXACERBATED BY INCREASING THE CONCEN TRATIONS OF THE ACIDS AND BASES USED AND OF THE TEMPERATURES Suitable for contact with foodstuffs Resistant to CIP media Resistant to SIP media Universal resistance While foods were treated with preservatives in the past today the shelt lite is optimized
54. ance of mixture batches It can only be used on b extraction of soluble components of the mixture from molded parts if they have a sufficient thickness and flat the elastomer supporting surfaces for the measurement Shore A is suitable for hardnesses between 10 and 90 Above 90 Shore Shore D measurements must be made which however are not applied in case of elastomers IRHD pursuant to DIN ISO 48 For hardness tests on seals the IRHD International Rubber Hardness Degree pursuant to DIN ISO 48 is applied Four procedures are described in this standard m N for hardnesses between 30 and 95 IRHD m H for high hardnesses between 85 and 100 IRHD m for the range from 10 to 35 IRHD and m M micro hardness for the testing of small or thin walled samples In sealing technology the N and M processes are mainly used The micro hardness measurements on seals are not directly comparable to the IRHD values procedure IN and the Shore A values on test plates i 20 Both changes can take place separately but also in parallel These processes are detected by measuring the change in volume occurring thereby If an increase in volume is measured the absorption of medium takes precedence while a decrease in volume means a predominant loss of mixture components Swelling processes are usually rever sible which means that the absorbed medium can also leave the elastomer again when switching to another product The size
55. and temperatures in order to eliminate the fat and protein residues from the pipes Steam sterilization methods are also to some extent used much more inten sively in dairies than for instance in breweries The seals must be designed accordingly for this Beer Hygiene and cleanliness of the production facilities as well as a variety of other challenging factors require a precisely matched sealing technology in the production of beer In addition to the sometimes aggressive cleaning processes the sealing materials must withstand salt deposits beer scale and tolerate a high CO content The preferred cleaning method here uses acid with a concentration of up to 3 at 80 C 176 F in order to remove the salt depo sits from the pipe system During production and cleaning steam sterilization high temperatures prevail which present a major thermal load for seals Ultimately the wort also promotes a high degree of wear of the seals For this reason the sealing material for this application should be carefully selected Non alcoholic beverages While alcoholic and carbonated drinks stabilize themselves due to their ingredients still waters are highly sensitive products whose production process requires great attention with respect to hygiene and cleanliness Because of the use of strong cleaning media in the production of fruit juice and because of flavorcontaining additives it is not possible to use just any elastomer or plastic
56. ane Phosphate buffer pH 2 5 and Phosphate buffer pH 9 5 In addition to a gravimetric evaluation the extractable contents were analyzed by means of gas chromatography mass spectrometry GC MS For this purpose the evaporated extracts were absorbed in the respective extracting agent and the extracts of the buffer solutions in methanol and injected into the gas stream The chromatograms were olotted with the same scale size for evaluation The sum of the detected substances was assessed by an evaluation of the entire surface and by the determination of the main compounds found Extract values in 96 TOC in ppm EXTRACT VALUES AFTER 24 HOURS REFLUX BOILING IN HEXANE AND ETHANOL ETHANOL N HEXANE EPDM EPDM EPDM XP 41 XP 43 Simriz Simriz EPDM EPDM EPDM XP 41 XP 43 Simriz Simriz 291 292 253815 494 506 291 292 253815 494 506 In addition Total Organic Carbon TOC studies were amount found in the liquid sample was again quantitatively performed on the extract solutions of the phosphate buffers assessed in comparable proportion to the elastomer sample as a measure of the organic contamination The TOC TOC VALUES PHOSPHATE BUFFER PH 2 5 PHOSPHATE BUFFER PH 9 5 EPDM EPDM EPDM Simriz Simriz EPDM EPDM EPDM Simriz Simriz 291 292 253815 XPA XP43 494 506 291 202 253815 XPA XP43 494 506 The present extractables study offers two main advantages and can be incorporated into one s own leachables study F
57. ange ensure smooth operational processes but also in equal connections that are frequently used in the chemical measure robust features to withstand the sometimes industry as well as universally applicable secondary seals extremely high pressures tor the mechanical seals used in pumps For this Freudenberg offers highly resistant sealing solutions made from perfluoroelastomers Simriz but also from The versatility of the processes in the manufacture and synthetic materials such as PIFE as well as a wide range processing of chemicals requires separate examination of of high quality elastomeric materials such as EPDM or FKM individual areas A summary of the main applications is when elastomeric flexibility is required in less aggressive presented below production environments FR m u um Y 7 E T ii u ihe s Ha i Y Mi ic oo 7 ERN Processing inorganic basic chemicals In the field of inorganic chemistry numerous completely different applications occur In addition to manufacturing processing separation and many other process steps particularly extreme parameters always prevail when handling inorganic basic chemicals In addition to aggres sive to some extent also toxic media high pressures are prevalent The seals used here must have a broad ope rating temperature range Corresponding to the multitaceted applications high quality robust and chemically resistant materials are required To meet the high
58. antages such as a change of the cleaning cycle higher costs and additional storage overheads In the past EPDM was not used oat all in the dairy industry Today s technologically advanced EPDM materials demonstrate a significantly better performance and are quite usable in many applications despite fatty products If EPDM seals are to be used there are different upper temperature limits for various kinds of products contai ning fat m Milk with 3 5 fat content can be processed up to a temperature of 80 C 176 F m For cream with 30 fat content the temperature limit is already reached at 35 C 95 F m Butter with 82 fat content can only be processed up to a maximum of 8 C 46 F The diagram on page 35 illustrates the use of EPDM as a function of fat content and temperature EPDM is appli cable below the line above it Fluoroprene XP should be used if there are no restrictions regarding the cleaning special purpose types process Diagram 2 gt Es Fo cc u 1 5 l 100 50 O 50 100 150 200 250 E Application range W Threshold range Temperature in C FFKM VMQ FKM HNBR NBR EPDM 300 59 MATERIALS RESISTANCE amp PURITY FLAVORING AGENTS IN ADDITION TO THE DEMANDING CLEANING PROCESSES FLAVORING AGENTS IN THE FOOD INDUSTRY REQUIRE AN EQUALLY CAREFUL SELECTION OF THE RIGHT MATERIAL THE VARIOUS FLAVORS AFFECT THE MATER
59. astic modulus drops sharply A constant level follows subsequently The rubbery elastic plateau where the material displays elastic behavior represents its application range as a sealing material If the temperature rises further the modulus of elasticity drops indicating aging or viscous flow of the material diagram 1 The transition from the rubbery elastic state to the glassy state is particularly important because in many cases it represents the lower limit of the possible operating tempe rature Depending on the stress the actual operating limit for the specific application is slightly higher at the beginning of the glass transition range or slightly lower at the beginning of the glassy state Simply stated this means that in static applications elastomers can be used at lower temperatures than in dynamic applications Diagram 2 shows an overview of the thermal application ranges of various types of elastomers The orange areas indicate temperature application ranges to which standard types may only be exposed briefly or which are covered by FAT RESISTANCE Although fat causes problems for many sealing materials it is in the traditional sense not an aggressive medium In processing plants for the food industry about 70 of the seals used are made of EPDM Only if EPDM cannot be used as is the case with products with a high fot content an alternative must be found The use of other materials may have disadv
60. ations prevail in the production of vaccines enzymes or proteins which also apply to all other process components such as seals With respect to separation of the active ingredients purity has top priority which requires seals without dead space that provide no basis for germs and external influences As in any hygienic area cleaning is carried out with aggressive media using the CIP SIP method in order to clean the plant free of residues When mixing the ingredients cooling is required which involves cold resistant sealing materials It is also important to protect the pharmaceutical product against external influences during filling in order to prevent process contamination INTRODUCTION PRODUCT PORTFOLIO MATERIALS RESISTANCE amp PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIALS TECHNICAL FUNDAMENTALS THE CHEMICAL INDUSTRY IS CONCERNED WITH BOTH THE PRODUCTION OF BASIC CHEMICALS SUCH AS AMMONIA ACIDS ALKALIS AND SIMPLE HYDRO CARBONS AND WITH THE FURTHER PROCESSING OF THESE MATERIALS INTO HIGH QUALITY PRODUCTS THUS AMMONIA IS OBTAINED FROM NITROGEN IN ORDER TO PRODUCE A FERTILIZER FROM THE FORMER FOR EXAMPLE CRUDE OIL IS USED TO PRODUCE SIMPLE HYDROCARBONS FROM WHICH HIGH GRADE PLASTICS ARE THEN SYNTHESIZED Most of these media require excellent and comprehensive A wide range of thermally and chemically resistant flat resistance characteristics of the seals used in order to gaskets is available especially for the pipes and tl
61. can be manufactured by machining from semifinished products in a particularly accom economical manner without the use of tools Special pressures up to 300 bar DM 9406 relatively rigid lip profile for dynamic sealing and pressures up to 200 bar Nomex fabric require tools but are also better suited for DM 9409 flexible lip profile for dynamic sealing and pressures up to 50 bar as well as vacuum purpose V Seal set packings made of PTFE impregnated PTFE higher pressures as they are less susceptible to cold flow Freudenberg has a broad range of suitable tools in its Packing rings made of PTFE impregnated fabric or for certain inventory for this PTFE fabric applications packing ring combination of PTFE impregnated form pressed fabric and virgin PTFE PTFE compound for pressures up to 700 bar with low friction Further materials such as polyethylene PEEK and Univerdit a compound of PTFE and graphite are also available on request as are specialized profiles should none of the Design notes three standard options be compatible with the individual Due to their lack of elasticity and high degree of thermal application expansion V Seal set packings must be preloaded using a spring device The spring force should be tailored to the seal s design Function Virgin PTFE dimensions and operating conditions The higher the m Multi oart sealing set consisting of a compression ring PTFE spring force the less leakage The pa
62. credited testing laboratory Every accredited testing laboratory Every accredited testing laboratory Every accredited testing laboratory NSF certified laboratories Every accredited testing laboratory Each individual material supplier Licensed laboratories Licensed laboratories Material Material and product Material and product Material and product Material and product Material and product Material and product Material and product Material and product Material Material Material Material Material Material and or product Material Material Material Material 5 years 5 years 5 years 5 years 5 years 5 years 5 years 5 years with annual audit 5 years unlimited unlimited unlimited unlimited unlimited 5 years with annual audit unlimited unlimited unlimited unlimited Microbiological examination BIR positive list i e BIR 15 recommendation cat A Chlorine loss TOC total organic carbon level Migration tests Positive list Material composition Cytotoxicity TOC level Material composition Manufacture Cytotoxicity Migration tests Positive list Material composition Chlorine loss TOC level Migration tests Material composition Manufacture Toxicity test Migration test Microbiological examination Positive list Material composition Manufacture T
63. ct surfaces Lead in chamfers Chamfer angle of 30 to 40 length must be min 50 of the cord thickness Any parts that come into contact with the seal during assembly or in operation must be clean and tree of flash All edges must be rounded Preparation Given the reduced elasticity and compressibility of the ring the installation space should be axially accessible Otherwise extra care should be given to using clean smooth and flash free pins or mounting sleeves Atter insertion in the groove the ring should return to its normal dimensions Installation and assembly Inside sealing grooves in housings Seal must be deformed to fit in the housing To facilitate assembly soak the ring in hot water for 10 minutes and then immediately fit it into the groove To do so push the ring s leading edge past the groove Carefully position the ring s trailing edge in the groove and pull back on the leading edge until the ring snaps into the groove rod should be inserted while the ring is still warm and pliable m Use installation aids it necessary Outside sealing grooves on shafts m Use an assembly aid for installation m Soak the ring in hot water for 1O minutes then slide over the installation aid quickly and smoothly until the ring snaps into the groove m f necessary compress the ring to its original form by means of a second ring by applying pressure Applications FEP PFA encapsulated O rings are primaril
64. ction of components different compounds depending on the desired properties can be used to produce semi finished products pipes rods and plates which are further processed into finished products in a subsequent processing step Products Rotary shaft seals Bellows U packings Slide bearings V Seal set packings O rings MATERIAL Properties Test standard Mri ing virgin Filler content of weight Density ASTM D 92 g cm 2 15 Ball indentation hardness DIN 2039 1 N mm 2770 Tensile strength DIN 120862 MPa Elongation at break DIN 120862 Tensile modulus of In house standard elasticity T 40 C 104 F Deformation under load at 23 C 73 F 24h Sale fex 2 PR 13 8 UR 16 4 D62 15 N mm Irreversible deformation rn LM PR ZO UR 8 3 Tensile yield point 1 ASTM D695 MPa PR 11 0 Tensile yield point 5 ASTM D695 MPa PR 15 7 Surface resistance ASTM D257 Q gt 107 Thermal conductivity ASTM 1461 W mK O 24 Coefficient of linear expansion at 50 C to DING S67 52 10 K4 1915 100 C 122 F to 212 F PR Pressing direction UR Circumferential direction 54 PR 29 UR 33 PROSA UR S67 MPa PR 446 UR 383 Bee PTFE carbon BE PTFE bronze 250 DSO 10 0 40 0 222 2 10 2 03 She 34 0 87 0 3510 41 0 PR 14 UR 17 PR 12 UR 16 PR 18 UR 19 PR 24 UR 25 ER 390 7 Us So PR 20 ZUR 1710 PR 3927 7 UIROS RU PRO 47 UR 752 PROZ5 UR 959 PRO 37 URG 0 PR O07 UR 771 Feiho UR
65. d rounded brass pins are well suited A screwdriver is not a suitable assembly If the use of lubricants is required for assembly or installation it must be verified whether the seal material is resistant to the lubricant For many seals e g U packings and radial shaft seals it is important to install them with the correct positioning in the correct direction As such the information contained in this handbook can provide only general and non binding guidelines We recommend that you discuss specific individual appli cations with our technical consultants as a matter of principle All rights in particular to texts images and other work protected by copyright and published in the handbook are reserved by Freudenberg Any reproduction distribu tion transmission and other utilization of the contents without written permission is expressly prohibited Freudenberg Process Seals GmbH amp Co KG Lorscher Stra e 13 69469 Weinheim Germany Phone 49 0 6201 80 8919 00 Fax 49 0 6201 88 8919 69 E mail fpsQfst com www tst com
66. d to identify N NBR A base elastomer NSE DO LE nn in the food industry INSF 61 and O OEM OML ba MET from a sealing material under certain test OPC A cleaning method used in the process industry VGW Austrian Gas and Water Union p PA A thermoplastic PE A thermoplastic PEEK A thermoplastic PFA A thermoplastic POM A thermoplastic PTFE A thermoplastic PU A thermoplastic R RFN A patented Freudenberg method for reducing friction in elastomer seals RWDR Rotary shaft seal S safe A product marking technology ensuring reliable identification SIP A sterilization method used in the process industry SML Migration value of a single substance in tests according to EC Reg 10 2011 see also OML T TOC Sum parameter for the carbon content in water and wastewater analysis U USP Collection of recognized pharmaceutical rules originating in the USA M VDMA German Engineering Federation a German industrial association VMQ A base elastomer silicone W A part of KTW testing W 270 is concerned with the propagation of W 270 microorganisms on materials used in drinking water applications testing and assessment WIP A cleaning method used in the process industries WOP A cleaning method used in the process industries WRAS LE ET a for the approval of machinery used 97 GENERAL INSTALLATION AND ASSEMBIY INSTRUCTIONS Cleanliness particles and cuttings are particularly dangerous Sealing surfaces Surrounding area with protective sleeves
67. d various solvents Not resistant in low molecular esters and ethers aliphatic and aromatic hydrocarbons Temperature resistant trom 60 C to 200 C 6 F to 392 F o0 Good resistance to synthetic animal and vegetable oils 70 VMQ 117055 76 VMQ 176643 and 78 VMQ 166898 Application profile VMQ as a silicone rubber has very good applicability in animal and vegetable fats oils and waxes and essential oils Moreover the material also allows application in high temperature ranges VMQ also has good properties in the application of CIP SIP media for continuous operation plants in the food and pharmaceutical industries with the exception of steam sterilization VMQ should not be used in concentrated acids e g nitric acid formic acid concentrated oxidizing media e g peracetic acid or in water and steam above 100 C 212 F esters and ethers and aromatic hydrocarbons Furthermore it should be noted that VMQ does not swell but loses hardness and tensile strength under the influence of the wrong media Products and materials m O rings made of ZO VMQ 117055 and 8 VMQ 166898 m Molded parts made of ZO VMQ 117055 and 78 VMQ 166898 m Diaphragms made of 60 VMQ 117117 Butterfly valve seals made of 76 VMQ 176643 Clamp seals made of ZO VMQ 117055 Rules and standards 70 VMQ 76 VMQ 78 VMQ 117055 176643 166898 FDA compliant CFR 21 Part 177 2600 j EC Reg 1935 2004 as well as EC Reg 2023 2006
68. dismantling and cleaning of the plant by hand OPC Open Plant Cleaning is the external cleaning of a plant without disassembly Typical cleaning procedure l Pre rinsing to roughly remove product residues with cold or warm water depending on the product Cleaning with an alkaline cleaner sodium or potassium hydroxide plus various additives surfactants complex ing agents antidoaming agents etc Hushing out the alkaline detergent with water Acidic cleaning to remove e g limescale phosphoric acid or nitric acid as well as additives Flushing out the acid with water Disinfection for elimination of microorganisms peracetic acid and or hydrogen peroxide mixtures alternatively using steam Final rinsing with water of drinking water quality or higher depending on the application Ketone 2 Among the most important requirements when designing a seal is not only the resistance of the sealing material to the product itself in which the seal is used but also the compatibility with various cleaning agents and steam temperatures of up to 140 C 240 F The aggressive cleaning media on the basis of acid alkali and peroxides pose fo some extent even greater challenges for the sealing materials than the product medium itself In addition the high cleaning temperatures exacerbate the effects of the media on the material WASHING OUT TEST EPDM FLUOROPRENE XP First rinse cycle EP
69. e easily Promises of guarantee are sateguarded and unjustitied warranty claims are averted With regard to the marking process Freudenberg has consistently taken the requirements for contamination ree components into account FDA compliant and hygienic With the laser marking Freudenberg abstains from the admixture of marker substances or components and thus avoids interfering with contormities like FDA or USP Class VI of the sealing material used Also unproblematic for hygienic applications is the coding depth of the laser marking For this Freudenberg has carried out extensive testing of marked seals in accordance with EHEDG guidelines European Hygienic Engineering and Design The code structures affect neither the cleanability nor the risk of microbial contamination for example in the case of a bottling plant The advantages at a glance m Unique laser marking system for easy and economical identitication and traceability m Forgery proof technology to protect against product piracy m Traceability of article batch and serial numbers date of manufacture materials dimensions and design details m High readout reliability even with damaged codes m Protection against product mix ups m Sateguarding of guarantee promises and protection against warranty claims m FDA compliant INTRODUCTION TEST FACILITY THE FREUDENBERG TEST FACILITY OFFERS NEW VALIDATION OPTIONS FOR THE PERFECT ADJUSTMENT OF SEALS TO THE RESPECTIVE CIP SIP
70. e of dead space Aseptic O rings are available in stock in specialized high performance materials with various approvals ET I 2 Aseptic clamp seal Dimensions m Design A Nominal dimensions from DN 10 to DN 100 m Design B Nominal dimensions from DN 13 5 to DN 114 3 ZA Flat gaskets Another option to seal a pipe joint is a flat gasket It is inserted between two flat tlanges which are connected to each other by screws With the help of such flanges different system elements such as valves fittings pipelines pumps etc are added together The sealing material should offset and seal the macro unevenness of the flanges well on the one hand and be resistant to the media flowing in the pipes on the other An almost inert material is needed both in the food e g detergent concentrates as well as in the pharmaceutical and chemical industries aggressive solvents and chemicals Freudenberg offers a range of flot gasket materials with excellent chemical resistance to suit any application Flat gaskets primarily provide the static sealing of two sealing surfaces A flat gasket on which a compacting pressure greater than the internal pressure is applied is used to create a secure seal Freudenberg flat gasket portfolio covers all these requirements and also enjoys marketspecific approvals There is a choice of gaskets of the following three material classes according to DIN 28091 FG 120 FG 120 is a fiber
71. e reliably ensured here by HINBR HNBR in cleaning processes Not every sealing material used in the food industry is also automatically suitable for the different cleaning processes and media Due to the enormous development leap of CIP SIP processes in recent years it has become essential to adapt the development of materials accordingly Among other things a DIN standard has already been developed in 1984 for the harmonization of cleaning media and sealing materials Moreover Freudenberg has also conducted a comprehensive compatibility project with leading producers of CIP SIP media which allows reliable statements about the material behavior with respect to temperatures and concentrations of cleaning agents HNBR is sensitive to the use of detergents and disinfectants containing nitric acid formic acid or peracetic acid In cases of doubt our materials advisory service should be consulted Rules and standards 75 HNBR 70 HNBR 85 HNBR 231142 254067 216553 Ar d ES FDA compliant Download CFR 21 Part 177 2600 Data sheet 75 HNBR 231142 Products and materials Oxings made of 75 HNBR 231142 Download m Molded parts made of ZO HNBR 254067 and Data sheet 85 FINBR 216553 85 HNBR 216553 Butterfly valve seals made of ZO HNBR 254067 m Diaphragms made of 75 HNBR 181070 and 85 HNBR 181071 Download Data sheet 85 HNBR 181071 IMMERSION RESULTS OF HNBR IN DIFFERENT CIP SIP CLEANING MEDIA 50 40 30 F 20 Change in SIP
72. ecialized types of grooves should be utilized Degree of groove fill Max 6 in constant use Elongation Max 25 of the elongation at break cited in the data sheet when assembled In the case of greater elongations corresponding elastic recovery time should be taken into account Compression strain Max 3 atter installation otherwise risk of deformation and shearing during installation The acceptable gap widths and surface qualities depend on the material s hardness rating and the operational parameters Standard values can be found in the relevant standards e g DIN 3771 and DIN ISO 3601 1 Gap widths and surfaces Attention In dynamic applications involving plastic housings the friction heat can result in localized overheating In dynamic applications or those involving pulsating pressures no plastics reinforced with glass fibers should be used since otherwise extensive wear will occur Applications O rings are utilized in numerous applications and in nearly The advantages at a glance all industries An overview of the primary applications is m Can be used universally given below m Available in all dimensions m Available in all types of elastomer m Static cover seals axial sealing m Easy to install and assemble m Static piston or rod seals radial sealing Good price performance ratio m Dynamic seals involving translatory movement hydraulic m Small installation space or pneumatic m Dynamic seals involving rotation m Valve seals m
73. entification of individually wrapped seals m Removable labels for easy transfer of the information into the service manual to ensure comprehensive traceability COLLABORATION WITH ASSOCIATIONS FREUDENBERG S COMMITMENT TO COOPERATION WITH ASSOCIATIONS IS AN ESSENTIAL BASIS OF ITS MARKET SPECIALIZATION IN ORDER TO BE ABLE TO TURN TRENDS AND DEVELOPMENTS INTO INDUSTRY SPECIFIC SOLUTIONS AT AN EARLY STAGE FREUDENBERG SEALING TECHNOLOGIES IS AN ACTIVE MEMBER IN THE FOLLOWING ASSOCIATIONS AMONGST OTHERS ASME American Society of Mechanical Engineers ASME is an American non profit organization that has set itself the goal of being a platform for engineers The ASME has about 130 000 members in 158 countries worldwide and invests heavily in education among other things which is why a large proportion of members are students ASME is divided into many specific groups such as Manufacturing amp Processing Automotive and Bioengi neering thus enabling exchanges between professionals DIN Deutsches Institut f r Normung German Institute lor Standardization DIN develops standards as a service to industry govern ment and society It is a private enterprise institution with the legal status of a non profit organization The main task of DIN is the development of consensus based standards together with the representatives of interested stakeholders in line with the times and with the market About 26 000 experts contribute their
74. erial impregnated with PTFE which is wound and compressed into rings Pressures play an important role in the sealing function When there is no pressure on the packing a good compression set is necessary to maintain a good seal using resilience Stuffing box packings are selFamplitying under pressure their maximum pressure load is influenced by the gap width To improve their gliding ability and therefore the cross section impermeability stuffing box packings are also impregnated with lubricants Function m Sealing in pressuretree environments by means of restoring force Sel amplitying sealing function under pressure the higher the pressure the better the sealing Double Triple Quadruple Concentric Dimensions and types m Double triple and quadruple diagonally braided with quadratic cross section trom 3 mm to 25 mm available by the meter m ube braided packings also available as double layer bands m Braided packings as pre cut components or pressed in ring form Graphite versions as pre pressed rings and bushings m PTFE impregnated packings Valtec as rings or bushings m Combination of different packing rings to a set e g with anti extrusion versions on the outside and low friction rings on the inside m Use of lantern rings for lubrication shutoff or cooling M Versions with internal or external springs for plunger pumps m Gratitlex as cover seals in internal pressure supported Systems For cent
75. eriod 30 minutes after removal the thickness is measured again Please note Compression set values are only comparable if the parameters are identical m deformation default 25 m duration of the deformation default 24 or 72 hours m temperature during the deformation m storage medium standard air and m form ot the test specimen 22 Density measurement The density of vulcanized rubber is a specific characteristic Through a simple expeditious measurement of this para meter first conclusions regarding the compound used can be drawn In tne preparation of a mixture the density value serves as an indication whether all components of the mixture were added properly Similarly the density measurement precedes all other tests in the analysis of unknown mixtures in order to limit the number of possible materials In general the density is measured using the buoyancy tlotation method According to the Archimedean principle a body experiences a buoyancy force when immersed in a liquid This is calculated trom the difference of the weight in air and the weight in liquid Since the buoyancy force is equal to the weight of the fluid volume displaced by the body the volume of the test specimen regardless of its geometric shape can be derived The specific density can be calculated on the basis of the volume determined in this way and the weight in air p IG G GJ x p Explanation p density to be
76. es through the usual tests of mass and volume changes should be used here but also the no less hazardous chemical effects of the media on the mechanical properties of the material These can be determined through comparative measurements of elongation at break 10076 modulus and tensile strength Because even in dilutions as low as one tenth of one percent tlavoring agents may lead to partly fatal changes in the tensile strength of elastomers IMMERSION RESULTS OF EPDM FKM FLUOROPRENE XP HNBR AND VMG IN ORANGE OIL EPDM FKM 24h 96h 24h 96 h 96 h 150 Change in Bi volume in Bi elongation break in B tensile strength in 6O FLUOROPRENE XP HNBR VMQ 336 h 672h 24h 96h 24h 96h Silicones and EPDM materials clearly swell far too much in orange oil Even the swelling behavior of HNBR exceeds the tolerable limit Fluororubbers on the other hand are very resistant A Ata PRODUCT PORTFOLIO PIONIERE ALTO ENGINEERING PLASTICS FLASTOMERIC MATERIALS tuin BOCH IMMERSION RESULTS OF EPDM FKM VAAQ AND HNBR IN FANTASY FRUIT FLAVOR 0 1 Fantasy Fruit flavor solution rm J FKM VMQ HNBR 24h 96h 96h Cn O E volume in Melongation break in Bi tensile strength in Due to the poor strength properties in Fantasy Fruit flavor HNBR material should not be used there IMMERSION RESULIS OF EPDM FKM VMQ AND HNBR IN PEACH FLAVOR 0 1 Peach flavor solution lt A VM
77. f EPDM materials Thermal resistance in steam and sterilization to 140 C 4284 op far briel periods up to 4160 C 320 oF Tolerances Lowest possible tolerances with regard to the seal and installation space Suitable for aqueous media and cleaning processes For applications involving nitric or formic acid high RITU EM ee nn temperatures and media concentrations EPDM repre The sealing butterfly should be polished on the sealing Surfaces surface R 2 5 ym R 0 05 0 3 pm sents the most economical solution in comparison to Js uet deuote th essen rei 25 other materials In extreme cases however EPDM is not pm R 0 05 0 3 pm optimal either and alternatives may have to be used m Dairy industry EPDM FKM VMQ or HNBR materials are used The advantages at a glance depending on the fat content and temperature m Patented torque reducing design allows high trequency In certain cleaning media HNBR FKM and VMQ operating cycles with low actuating forces and minimal cannot match the service life of EPDM however abrasion unlike EPDM they are resistant to fats thus making m Extremely easy to assemble them well suited for use at high temperatures and m leaktree and dead space tree variants available concentrations m owfriction coatings available m A broad range of material versions for high media and m Pharmaceutical and chemical industry temperature resistance FKM is resistant to certain oils and some aromatic oils but s
78. fluences and process media or to cleaning agents and steam sterilization Freudenberg offers extruded profiles and rings in the following premium materials m O EPDM 391 resistant to water steam acid and alkali solution O EPDM 471 resistant to disinfectants and CIP SIP media 75 Fluoroprene XP 41 resistant to steam fat and CIP SIP media 80 NBR 217383 good low temperature flexibility and abrasion resistance The advantages a glance m implementation of sophisticated geometries m Innovative vulcanization process m Industry specific approvals m Chemical and thermal resistance Inflatable seals Inflatable seals are often used in the food and pharma ceutical industries Wherever the containers and doors of systems must be protected against germs and dirt the gap bridgings are sealed with inflatable profiles In laboratories and research institutes the standard silicone material often creates problems due to insufficient stability Also the profiles of conventional inflatable seals often stick to the door frame and make it difficult to open the door which in turn damages the seal and makes it incapable of performing its sealing function To produce a seal that is fully closed around the entire door frame the two ends of the profile are butt jointvulcanized The molecules cross link at the joint to the same material as the protile Consequently the protile at the joint seals as reliably as at all other points
79. for this reason alkaline cleaning Data sheet ZO FKM 37508 process should be evaluated on a case by case basis Due to the variety of possible applications and application parameters a comprehensive technical clarification by our Download Data sheet 75 FKM 180497 application advisory service is recommended IMMERSION RESULTS OF FKM IN DIFFERENT CIP SIP CLEANING MEDIA SIP 0 5 hydrogen pero SIP 2 peracetic acid CIP 4 phosphoric acid CIP 2 nitric acid CIP 10 sodium hypo CIP 5 sodium hydro xide cleaner at 80 C cleaner at 60 C cleaner at 70 C cleaner at 80 C chlorite cleaner at 40 C xide cleaner at 80 C 60 AO 20 Change in 20 80 Bl volume in Bl elongationQbreak in Bi tensile strength in A3 176 F after 1 week 140 F after 1 week 158 F after 1 week 176 F after 1 week 104 F after 1 week 176 F after 1 week ELASTOMERIC MATERIALS SIMRIZS SIMRIZ9 PERFLUOROELASTOMERS FFKM ARE PRODUCED USING SPECIAL PERFLUORI NATED COMPLETELY HYDROGEN FREE MONOMERS VVITH APPROPRIATE COMPOUNDING AND PROCESSING TECHNIQUES THEY REPRESENT THE HIGH END SOLUTION IN MATERIALS TECHNOLOGY Simriz is characterized by a broad chemical resistance similar to that of PTFE combined with the rubber elastic properties of an elastomer With Simriz Freudenberg offers a complete range of high quality FFKM materials In addition to the Simriz compounds for standa
80. h at least r O 1 mm I O rings must be stretched over sharp corners or threaded parts due to the design of the application these surfaces should be covered with bushings casings where possible In radial sealing applications there should be lead in chamfers on the pistons rods and or on the housing When installing in pistons avoid twisting If necessary use a compatible lubricant for easier assembly For applications in the food and beverage industry the use of coated O rings is recommended e g PTFE lacquer RFN treatment When O rings are installed in housings the O ring is compressed Here it must be ensured that the O ring does not warp form a loop General installation and assembly instructions see page 98 The design of O ring sealing systems groove sealing surface is described in the relevant standards e g DIN 3771 General and DIN ISO 3601 1 Depending on the application the following benchmarks apply for standard cases compression in of the cross section diameter Static seals 15 30 Dynamic seals hydraulic at least 6 Dynamic seals pneumatic 2 676 Compression In standard applications there is the rule that the O ring volume is 70 90 of the groove volume It should be kept in mind that the elastomer is more susceptible to thermal expansion than the metal housing Applications in the food and beverage industry must be leaktree The degree of groove fill can be more than 100 sp
81. he sealing material N N FC M INTRODUC E Y NICAL FUNDAMENTALS W im LX ur ENGINEERING PLASTICS amp amp LS RESISTANCE LE R A PRODUCT PORTFOLIO GUIDE STRIPS GUIDE STRIPS ARE USED IN VARIOUS MACHINES FOR THE FOOD AND BEVERAGE INDUSTRY TO COMPENSATE FOR THE LATERAL FORCES AND DEFLECTIONS OCCURRING This requires a high pressure resistance of the material At Guide strips made of PTFE YOOS ensure low wear and a the same time the material used must have sufficient flexibility much longer durability thanks to minimized extrusion propen to prevent it trom being damaged during assembly In food sity PTFE YOOS is a special compound and consists of a and beverage applications where guide strips have direct virgin high grade pure PTFE and a filler contact with the medium the materials used must comply with the legal framework The advantages at a glance Comparable combinations of approved materials demon High compressive strength with simultaneous flexibility strated in a benchmark that they do not withstand the high Resistant to CIP SIP cleaning media forces e g in homogenizers and have a propensity to Low extrusion propensity gap extrusion This leads to increased wear and thus to a Low wear ensures a long service life significantly reduced service life Different sizes up to 200 mm available at short notice Food grade materials EXTRUSION LENGTH PTFE MATERIAL Y005
82. hile FKM materials swell significantly even at room temperature in aroma concentrates such as Raspberry and Fantasy Fruit Fluoroprene XP provides a good compatibility here However there are flavoring agents such as Peach where even Fluoroprene XP reaches its limits too Only a perfluoroelastomer can be used here as a stable solution In the application of the material in concentrations that are common for beverages Fluoro prene XP offers a significant advantage given the limited absorption capacity of flavoring substances see page 60 f VOLUME CHANGE OF FKM AND FLUOROPRENE XP IN DIFFERENT FLAVOR CONCENTRATES 100 FANTASY FRUIT FLAVOR FKM Fluoroprene XP FKM 96 hours 180 160 140 120 100 80 60 40 20 100 RASPBERRY FLAVOR 96 hours 100 PEACH FLAVOR Fluoroprene XP FKM Fluoroprene XP 96 hours 39 ELASTOMERIC MATERIALS Fluoroprene XP in the pharmaceutical industry The Fluoroprene XP material offers an unbeatable advan tage in terms of its excellent resistance to non polar and oil based product media compared to EPDM both in the dairy industry and in the pharmaceutical industry For instance in the production and packaging of pharmaceutical products such as ointments The special resistance of Fluoroprene XP to flavors is also soughtatter in ointments containing euca lyptus oil Fluoroprene XP is the right choice for a wide variety of oil containing preparations such as emulsio
83. hows limited resistance to alkaline cleaning media It is also more prone to swelling in acids making it necessary to select compatible cleaning media when using FKM EPDM FKM VMQ or HNBR materials are used depending on the production media and solvents Certain applications in the production of flavorings in the pharmaceutical and chemical industries exceed the resistance properties of EPDM VMQ and HNBR In such cases Freudenberg recommends the use of Fuoroprene XP materials 89 PRODUCT PORTFOLIO EXTRUDED SEALS LARGE AREAS ARE DIFFICULT TO SEAL WITH COMMONLY PRODUCED PRODUCTS BECAUSE TOOLS ARE TOO EXPENSIVE OR UNFEASIBLE TO REALIZE WITH THE HELP OF EXTRUDED SEALS IT IS POSSIBLE TO SEAL THESE DIFFICULT POINTS Profiles and cords Typical examples are oven door seals For the standard program there is a variety of different tools for different materials available By switching from mold based to extruded parts tool costs can be saved when developing customized individual applications 90 Freudenberg has developed a special vulcanization process in which the cord and the joint are made of the same material Thus a uniform quality of the seal is achieved In conventional extruded gaskets of other manufacturers the joint is often connected by means of an adhesive resulting in a significant difference in quality In contrast to the seals made by Freudenberg the joint here is not reliably resistant to thermal in
84. ication is valid for the following areas m sale of sealing products m technical advice for sealing products and m provision of services involving seals in particular the optimization of the supply system Certification is intended to give our customers confi dence Because quality can only be guaranteed if the internal processes are performed in a standardized and structured manner and can be replicated From the preparation of a quote to the packaging of individual O rings we have established streamlined processes and constantly strive for further improvement Our zero detect policy motivates all employees to excellence and top achievements Moreover our quality management and application support are readily avail able in case of technical problems BROCHURES AND FLYERS ofso obs MATERIAL 73 DATA SHEETS WEBSITE DEI n CONTACT INTRODUCTION CHNICAL FUNDAMENTALS N TE r YU LANCE amp PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIAL MATERIALS RESIS PRODUCT PORTFOLIO MARKET SPECIFIC SERVICES FREUDENBERG XPRESS MACHINING TECHNOLOGY THE FREUDENBERG XPRESS SERVICE CAN PROVIDE SEALS IN ORIGINAL QUALITY WITHIN A FEW HOURS USING THE LATEST CNC TECHNOLOGY FREUDENBERG XPRESS IS THE BEST CHOICE NOT ONLY FOR THE QUICK DELIVERY OF NEEDED REPLACEMENT PARTS BUT ALSO FOR THE ECONOMIC PRODUCTION OF SMALL SERIES Thanks to state oHhe art manufacturing facilities a
85. irstly Freudenberg customers can request the extract values Furthermore in the case of batch contamination it is possible and the evaluation of the leached chemicals and use them fo use the Freudenberg database results for risk assessment for their own leachables studies This saves time and money and for decision making on the batch as the leachable chemicals have already been identified OS INTRODUCTION PRODUCT PORTFOLIO AaS TAE SERIE ENGINEERING PLASTICS ELASTOMERIC MATERIALS cA aena HYGIENIC DESIGN IN STERILE TECHNOLOGY THERE IS A RULE THAT A SEAL MUST BE INSTALLED FREE OF DEAD SPACE AND LEAKS THE GROOVE MUST BE 90 FILLED AND THE MATERIAL MUST NOT HAVE ANY SWELLING GREATER THAN 5 OTHERWISE GAP EXTRUSION WILL ALLOVV SEALING MATERIAL PARTICLES TO CONTAMINATE THE PROCESS MEDIUM The resistance of the sealing materials taking into account production or in cleaning and sterilization cycles and the the production CIP and SIP parameters and the require subsequent possibility of a deterioration of the product ments of Hygienic Design must be ensured The elastomer quality as a result of foreign matter stripped or dissolved trom materials that come into contact with the actual product must the interior of the plant be sufficiently resistant to preclude their breakdown in Class detail Product Operating concentration Exposure time min CIP or circulation cleaners containing nitric 20 C to 80 C
86. ity of Fluoroprene XP In addition the fluorinated material does not absorb all components of the flavor mixture in equal measure After the investigation it turned out that the esters present in the flavor mixture could not be detected i e that they had been absorbed by Fluoroprene XP at a small undetectable rate However the ketones migrated into the elastomer matrix and decrea sed by half after the cleaning step In bottling establish ments where multiple products of different flavor intensity are bottled on the same bottling line it must be ensured that the quality of the product made remains constant after each production cycle and is not contaminated by the flavoring agents from the batch that was bottled last Due to the negligible absorption of flavoring substances the Fluoroprene XP materials portfolio qualifies as especially suitable for such applications CLEANING PROCESS The cleaning methods at a glance CIP Cleaning In Place is the fully automatic cleaning without disassembly of the equipment COP Cleaning Out of Place or Cleaning Open Plant refers to cleaning after disassembly opening of the plant etc SIP Sterilization In Place is the sterilization either with peracetic acid hydrogen peroxide cold sterilization or with hot steam WIP Washing In Place requires partly manual work brushing scrubbing etc in some places WOP Washing Out of Place means the complete
87. know how to the work of creating generally accepted standards Due to a contract with the Federal Republic of Germany DIN is recognized as a national organization in European and international standards organizations Today about 90 of the work of DIN has an international outlook and orientation EHEDG European Hygienic Engineering and Design Group The EHEDG is an interest group for operators and suppliers of equipment for the production of foodstuffs as well as for lesting institutes and maintenance companies More than 300 member companies participate in the EHEDG This gives rise to wide support and sound instructions for all aspects of hygienic design and manufacture of machi nery and equipment for the production of safe food and pharmaceuticals ISBT International Society for Beverage Technologists The ISBT is an American organization which consists of about 1 000 members worldwide The focus of its activity is the beverage industry and it offers this industry a highly specialized platform which concerns itself with flavor transter packaging ingredients and other current trends ISPE International Society for Pharmaceutical Engineering The ISPE is the world s largest non profit organization for the advancement of the pharmaceutical industry and the continuing education of its employees Founded in 1980 it now has more than 25 000 members in 90 countries The ISPE is an independent organization led by experien
88. lavors and their mixtures cannot be made because this is an extraordinarily diverse and complex media group But it is worthwhile to discuss the individual applications with Freudenberg s materials tech nology experts since FKM is in many cases the more economical alternative to other material solutions FKM in cleaning processes An FKM material cannot keep up with the rapid develop ment of cleaning agents and the increasingly critical cleaning conditions FKM reacts very sensitively when used with highly oxidizing cleaning agents and disinfectants con taining nitric acid formic acid or peracetic acid In any prolonged use in alkaline solutions FKM also loses its stability However for short cleaning cycles this material is still suitable In cases of doubt our materials advisory service can assist in finding an optimal materials solution for the individual requirements FKM in the pharmaceutical industry Products and materials In the pharmaceutical industry FKM is employed when m O rings made of ZO FKM 37508 and 75 FKM 180497 non polar solvents aliphatic compounds fats and oils are m Molded parts made of 75 FKM 37508 and used Amines and ketones however preclude the choice 75 FKM 180497 of FKM materials m Diaphragms made of 75 FKM 180497 FKM in the chemical industry FKM has in many cases sufficient resistance to common organic solvents Especially in contact with alkaline solutions Download the material is sensitive
89. limitation is the flavor transfer between the produced drinks batches This occurs especially in highly aggressive and complex assembled aromatic blends like in energy drinks EPDM in cleaning processes In modern process technology processes cleaning media significantly affect the selection of the sealing material The DIN 11483 standard Part 2 a set of rules for the use of cleaning media and materials which was already developed in 1984 shows how important the interaction is The rapid further development of cleaning media and sealing materials has prompted Freudenberg to launch a comprehensive compatibility project with leading produ cers of CIP SIP media In this project elastomers were tested in a variety of presentday cleaning media under the maximum recommended operating conditions in terms 36 of temperature and concentration EPDM has achieved outstanding results in this test The possibility of adverse effects exists only in contact with media containing formic acid or nitric acid and also at high temperatures and concentrations EPDM in the pharmaceutical industry In addition to the cleaning media EPDM materials are also suitable tor aqueous pharmaceutical products Thus for example EPDM materials are preferably used in the sterilizable biochemical reactor for the fermentation Furthermore EPDM is also used in autoclaves for steam pressure sterilization of culture media for biotechnological production methods For
90. luable production media The advantages at a glance Variable and reliable use in the food and beverage industry m Highly resistant to media and temperatures m Dead space tree variants available for hygienic applications Minimal abrasion Available in all dimensions m Economical to use as they make secondary seals unnecessary PRODUCT PORTFOLIO V SEAL SET PACKINGS V SEAL SET PACKINGS ARE MULTI PART SEALING SETS PRIMARILY USED IN APPLICATIONS INVOLVING TRANSLATORY MOTION AS THEY OFFER LOWER FRICTION AND REQUIRE LESS PRE TENSIONING FORCES THEY REPRESENT A WORTHVVAILE ALTERNATIVE TO U PACKINGS V Seal set packings normally consist of a compression ring Dimensions several V shaped packing rings and a backup ring provi Virgin PTFE and PTFE compounds ding reliable sealing for spindles on regulating and shut off m Available in all inventory standard dimensions valves rods on plunger pumps hydraulic cylinders as well m Special customerspecitic dimensions are possible as swivel joints and mixers Predominantly used with trans without difficulty latory motion but also with slow rotation they generate less friction and require considerably less initial axial pre PTFE fabric tensioning force than stuffing box packings for instance M Extensive inventory of tools available m Special customerspecific dimensions available upon request As the standard materials for V Seal set packings are PTFE and PTFE carbon compounds they
91. ly the rotary shaft seal can be lightly oiled if desired a f possible disassemble the sealing ring from the inside using a shaft sleeve alternatively a bearing remover can be used provided there is sufficient room If the seal is damaged replace the sealing ring m Please refer to page 98 for general installation and assembly instructions Applications Due to their variable designs the HTS Il rotary shaft seals offer an enormous application range for production processes involving the sealing of media the separation of lubricants and media and the secure sealing of cleaning processes HTS ll rotary shaft seals must be installed as a unit consisting of a PTFE sealing ring and a stainless steel retaining ring The retaining ring is deformed during installation and General cannot therefore be reused The installation space must be axially accessible lead in chamfers on both the shaft and housing should be included to prevent ring damage Peakto valley heights R R Housing 1 8 ym lt 10 pm Surfaces Shaft twisHree um OS 1 9 un Hardness of 45 65 HRC running surface Suitable for use in m beverage filling facilities m food and beverage production machinery M process equipment used in pharmaceutical and cosmetics manutacturing mixers and separators machines with a high rotational speed cleaning and sterilization processes and the reliable sealing of dangerous substances and highly va
92. materials In a dynamic application the seals should be lubricated only shortly before assembly because this will achieve good long term lubrication ASSESSMENT OF THE RESISTANCE TO WEAR OF RFN H 12 1 0 Untreated 0 8 0 6 0 4 RFN 02 O 200 400 600 800 1000 1200 Glide path m Coating with PTFE varnishes PTFE coatings adhering firmly to the surtace of elastomers provide a high degree of friction reduction However the relatively soft PTFE layer is lightly abraded in dynamic continuous operation Despite abrasion of the coating a certain amount of friction reduction is maintained since the PTFE burrows into the valleys of the roughness profile of the mating surface and fills them The slide active PTFE layer is not as elastic as the base material however Thus the PTFE layer forms cracks in the event of greater elongation which may lead to leaks or cause the layer to flake off Halogenation In this method the surface is hardened in the micro range and thus does not get pressed as strongly into the roughness profile of the mating surface The result is a better gliding property However the layer is abraded in the event of high dynamic stress so that the seals lose their gliding property The method is very well suited for the automated assembly of O rings since the rings are dry and powdertree The devices remain clean and free of abrasion over a very long period of time TECHNICAL FUNDAMENTALS FLASTOMERIC M
93. me and hence the concentration of possibly leached compounds is therefore much smaller Neverthe less an interaction between the sealing material or the soluble components of the elastomeric compound and the active pharmaceutical ingredient can occur This interaction might alter the pharmaceutical product and in the worst case adversely affect its efficacy It the interactions between the seals in valves and other system components and the products therein are known to the pharmaceutical manufacturers possible contamination can already be evaluated during the production process This safeguards the processes ensures the necessary purity of the products and is in the interest of public health 64 Freudenberg Extractables Study Freudenberg conducted an extractables study on O rings with different media at high temperatures EPDM 291 Black 70 EPDM 292 Black 85 BDI 259 5 White 7O Fluoroprene XP 41 Grey blue 73 Fluoroprene XP 43 Grey blue co Simriz 494 Black 75 Simmnize 30 8 White 748 The tested O rings were extracted without prior cleaning steps in a low ratio of elastomer to extract medium for 24 hours under reflux to achieve the most stringent conditions possible for evaluation To ensure the comparability of results of different O rings the ratio between surface and media volume was kept constant In line with the recom mendations of the FDA the BfR and other relevant sources four media were used m Ethanol N hex
94. n Excellent resistance in mineral oils and fats low gas permeability Shows a very good resistance in non polar media Tends toward increased swelling in polar solvents ketones and amines Temperature stability from 20 C to 200 C 4 F to 392 F special types from 35 C to 200 C 31 F to 392 F 70 FKM 37508 and 75 FKM 180497 Application profile Fluororubbers with a special composition of the mixture provide excellent resistance in hot water steam and alcohols FKM is very well suited for use in animal and vegetable tats oils and waxes aliphatic and aromatic hydrocarbons essential oils and at high temperatures The material also has good properties in CIP SIP media for continuous operation plants in the food and pharmaceutical industries In cleaning processes however it must be taken into account that the use of alkaline solutions acids and oxidizing media such as peracetic acid is restricted 42 Rules and standards 70 FKM 37508 75 FKM 180497 FDA compliant CFR 21 Part 177 2600 EC Reg 1935 2004 as well as EC Reg 2023 2006 E 5 3 A Sanitary Standards Class USP Ch 87 in vitro E USP Ch 88 in vivo Class VI 121 C 250 F FKM in the beverage and dairy industry FKM is recommended for both the processing or handling of pure citrus juices and for applications with concentrated essential oils and dairy products However a blanket recom mendation for use in all f
95. n this case Fluoroprene XP is the better material Fluoroprene XP Seals made of Fluoroprene XP can also be used if EPDM is inteasible because the fat concentration is too high This material not only shows excellent resistance to acid alkaline solutions and steam but also to fats and most flavo ring agents It can be used at temperatures of 10 C to 200 C 14 F to 392 F Simriz It the requirements are so high that none of the previously mentioned sealing materials is suitable seals made of FFKM are used Simriz otfers comprehensive media resis tance in a temperature range of up to 260 C 500 F RESISTANCE OF EPDM HNBR AND VMQ Nitric acid 2 80 C 176 F 100 Steam 140 C 7 284 F Phosphoric acid 4 70 C 158 F Sodium hydroxide 5 80 C 176 F Fat gt 40 RT a Ah Active oxygen 176 35 C 95 F MEPDM B HNBR BVMQ MATERIALS RESISTANCE amp PURITY PRODUCT PORTFOLIO O RINGS AS A UNIVERSAL SEALING ELEMENT THE O RING IS A SEALING COMPONENT USED IN ALL INDUSTRIAL SECTORS THAT IS CHARACTERIZED BY ITS EXCELLENT PRICE PERFORMANCE RATIO AND BROAD RANGE OF APPLICATIONS O rings can be manufactured in nearly all conventional elastomer materials as a standard part in large quantities or in smaller quantities for customerspecific applications In comparison to other sealing systems the required installation space is e
96. nd in house machining tools development Freudenberg has achieved a unique surface quality with a mean roughness index of max R 2 38 pm roughness depth R 13 7 pm This value is approximately equal to that of a conventionally injection molded or pressed seal All rotationally symmetric products can be produced by machining such as rotary shaft seals with an outside diameter of up to 250 mm Machined seals made from EPDM and INBR can even be realized with an outside diameter of up to 1 000 mm You can find an overview of materials suitable for machining technology on page 32 f The lip edge is created by cutting which is a complex process and therefore rarely applied in the market The machined seals of Freudenberg achieve an exceptionally long service life Delivery of replacement parts in record time When a seal fails during the production process and a replacement part is not in stock every hour counts in order to prevent costly machine downtime Freudenberg Xpress can normally tind a remedy within 24 hours On the basis of a drawing or a sample the seal can be machined and sent without detours directly to the location where it is required Rapid prototyping The term rapid prototyping i e the rapid production of tunctional models is in actual fact not applicable to elastomer technology Nevertheless the specialists at Freudenberg make exactly this possible Thanks to produc tion of prototypes without standard tools
97. ndition roughness deposits etc and document changes Which media have contact with the seal m Products Ingredients Pressures Temperatures Concentrations It possible obtain the safety data sheets m Flavoring agents f samples are allowed to be taken they should be tilled into glass bottles m Cleaning media Media sequence Pressures Temperatures Concentrations of the cleaning agents and trequency of cleaning It possible obtain the safety data sheets Typical cases of O ring damage Gap extrusion Provided that the design is consistent the factors which can push the O ring into a gap and lead to a shearing off include varying pressures dynamic stress and media expansion Depending on the individual case there are very diverse manifestations as shown in the sample illus trations above With dynamically stressed seals one colloquially refers to mouse nibbling in case of damage Image left Gap extrusion in static application Image right Gap extrusion in dynamic application Twisting during installation large O rings with a small cross section are not very dimensionally stable and can be twisted when mounted After removal a circumferential track in the elastomer is visible in case of heavy strain and wear If one puts the O ring on a flat surface a permanent deformation can be noticed as a twist The use of an assembly grease suitable for the material and great care during the in
98. ns or sprays e g nasal sprays with essential oils Both in the synthesis of active ingredients and in their packaging it is important to keep in mind that the sealing materials release as few substances as possible from their matrix into the product In order to ensure the purity of the product analyses of extractables are necessary Freudenberg examined the range of materials for the pharmaceutical industry in an extractables study In addition to the EPDM materials Fluoroprene XP compounds were also analyzed see page 64 f FLUOROPRENE XP IN CIP SIP MEDIA Steam Alkaline CIP NaOH 200 C 392 F 72 h 30 20 20 Acidic CIP HNO 5 80 C 176 F 168h 2 80 C 4176 F 168 h Fluoroprene XP in the chemical industry It the resistance of FKM should not be sufficient and the use of pertluoroelastomers is assessed as not economical then the material Fluoroprene XP can be an interesting alternative provided that the process media used are not foo aggressive Due to the variety of possible applications and para meters a comprehensive technical clarification is suggested We recommend that you consult our appli cation advisory service Products and materials m O rings made of 75 Fluoroprene XP 40 m Molded parts made of 75 Fluoroprene XP Al 75 Fluoroprene XP 44 and 85 Fluoroprene XP 43 m Diaphragms made of 75 Fluoroprene XP AA m Profiles made of 75 Fluoroprene XP 41 Clamp seal
99. nts in the food and pharma ceutical industries Simriz appears at first glance to be overengineered However its cost effectiveness comes to the fore in the holistic view of maintenance and downtime costs which may occur especially in satety related appli cations Here Simriz provides reliability which pays oft Suitable areas of application Water and water vapor Concentrated acids e g nitric acid 60 Amines e g ethylenediamine Organic acids e g acetic acid Ketones e g methyl ethyl ketone Alkaline solutions e g sodium hydroxide potassium hydroxide m Organic solvents e g methanol M Aroma concentrates Simriz replaces elastomers such as EPDM or FKM when their temperature and media resistance no longer copes with the demands of the application area but rubber elastic behavior is imperative For example hygienic design requirements in terms of absence of dead space and good cleanability only leave a minimal margin to the sealing element Thermal expansion and media swelling must be as small as possible here Under these stricter requirements with regard to purity and extreme media resistance even in CIP SIP processes and at temperatures above 150 C 302 F Simriz delivers a high performance that is widely acknowledged in the market Simriz in the beverage industry Products and materials Simriz provides highly reliable performance especially m O rings made of 70 Simriz 491 75 Simriz 494
100. o SOOO DO ENGINEERING PLASTICS PEEK POM PA PU PEEK PEEK polyether ether ketone has a similar chemical resis tance as PTFE but with improved mechanical properties This material is renowned for its almost universal chemical resistance and high temperature resistance 260 C 500 F continuous operating temperature and is therefore growing in popularity While only of limited use in seals due to its lack of elasticity PEEK is increasingly tinding application opportunities as a backup ring for O rings under high pressure or in V Seal set packings as backup rings or compression rings Untilled PEEK is FDA compliant but there are also options here to modity the mechanical properties by means of fillers such as glass fiber and carbon fiber or PTFE In contrast to PTFE PEEK can also be processed by injection molding Typical products m Backup rings for O rings m Backup rings in V Seal set packings m Compression rings in V Seal set packings 56 POM Polyoxymethylene abbreviation POM also called polyacetal is a semi crystalline thermoplastic POM has been on the market since 1956 and is used especially for precision parts because of its high rigidity low friction coefficients and excellent dimensional stability POM is characterized by high stability hardness and rigidity over a wide temperature range It retains its high strength even at low temperatures down to 40 C 40 F Its natural color is opaq
101. od resistance in non polar media such as hexane Tends to increased swelling in polar solvents e g ethylenediamine and ketones e g methyl ethyl ketone Application profile Seals made of Fluoroprene XP are characterized by an excellent and broad resistance The blue Fluoroprene XP material thus allows the replacement of EPDM VMQ and FKM in applications with foodstuffs and pharmaceuticals as it combines the excellent properties of EPDM materials in polar media water acid alkaline solution with the excellent performance characteristics of FKM and VMQ types in all non polar media fats oils and hydrocarbons lts outstanding resistance in steam hot water alkaline solu tions and acids as well as in non polar solvents makes it the preferred elastomer for applications with extreme CIP SIP cleaning media high temperatures and fat concen trations Thanks to Fluoroprene XP the multiplicity of materials can thus be reduced significantly which minimizes the complexity and cost of storage and maintenance of plants and equipment on a lasting basis The Fluoroprene XP family consists of four materials m 75 Fluoroprene XP 40 75 Fluoroprene XP 41 85 Fluoroprene XP 43 75 Fluoroprene XP 44 Suitable applications for Fluoroprene XP m Animal and vegetable fats oils and waxes Aliphatic and aromatic hydrocarbons Essential oils and flavorings High temperature ranges CIP SIP media for continuous operation plants in the
102. of the volume change depends on five factors type of medium composition of the elastomeric compound interaction parameters temperature time geometric form thickness of the seal and OY RR ON stress condition of the seal in the case of stretched parts the impact is greater in the case of compressed parts lower Due to the crosslinked structure of the elastomers swelling is limited i e it no longer changes alter reaching a limit value Every volume change whether swelling or shrinkage is associated with changes in the physical properties such as hardness elasticity tensile strength and elongation at break Therefore the determination of the volume change alter a defined storage period time and temperature is a parameter in order to measure and evaluate the stability of elastomeric compounds in the media used Note In the food industry not only the production media e g beer mineral water dairy products etc must be tested for their compatibility with the sealing material but also the cleaning and sterilization media used in the processes Sequence of the tests according to DIN ISO 1817 l The volume of the test specimen the seal or a portion thereof is determined 2 The test specimen is stored in the medium according to the standard or to customer specitications 3 At the end of the storage period and after cooling down the volume of the specimen is measured again 4 The resul
103. on Foundation 3 A United States Pharmacopeia United States Pharmacopeia Recommendation German Food and Feed Code LFGB 8 2 para 6 sentence no 1 AFNOR XO P41 250 part 1 3 Association francaise de normalisation BSI 6920 and BS 2494 NORM B5014 Part 1 Directive Doc 94 0 NKB rules DS EN standards NSF Standard 61 AS NZS 4020 2005 EC Reg 1935 2004 EC Reg 10 2011 LFGB German Food and Feed Code LFGB German Food and Feed Code FDA 21 CFR 177 2600 Elastomers FDA 21 CFR 1772400 Perfluoroelastomers FDA 21 CFR 1771500 Plastics FDA 21 CFR 1772600 Elastomers FDA 21 CFR 1772400 Perfluoroelastomers FDA 21 CER 1771500 Plastics FDA 21 CFR 177 2600 Elastomers EMEA 410 01 rev2 USP 29 USP 29 Germany Germany France Great Britain Austria also accepts the KTW test Netherlands Denmark also accepts the KTW test USA Australia Furope Europe Germany Germany USA also accepted in Europe USA USA also accepted in Europe Worldwide USA also accepted in Europe USA also accepted in Europe DVGW certified laboratories DVGW certified laboratories CRECEP Paris LHRSP Nancy IP Lille WRAS certified laboratories OVGW certified laboratories KIWA Gertified laboratories NSF certified laboratories AW QC certified laboratories Every accredited testing laboratory Every ac
104. onstructed according to hygienic design is characterized by good cleanability so that contamination by microorganisms cannot occur The more the use of the automated CIP and SIP Cleaning In Place Sterilization In Place processes spreads the less equipment needs to be disassembled This eliminates the possibility of visual control It must therefore be possible to trust automated cleaning to achieve a good result and it must be certain that there are no dead spaces in which product residues can collect initially and microorganisms can settle later This means that rectangular grooves with a degree of tilling of about 80 are not permitted Hygienically designed grooves are narrower and the evasion spaces for sealing materials are correspondingly limited Flastomers and steel behave differently with respect to production and temperature Elastomers have significantly greater manufacturing tolerances so that in the case of an incorrect design an overtilling of the groove may in extreme cases already exist during installation Elastomers are incompressible and need an allowance for expansion The thermal expansion of elastomers exceeds that of steel by a factor of 15 and must be taken into account As a result of overly narrow gaps extreme stresses can arise during cooling resulting in shearing of the material 28 Attention must also be paid to the absence of any dead space in the case of dynamic seals such as rotary shaft seals While norm
105. order to determine potential strains on and deformations of the molded seal taking into account the temperature and swelling Installation and assembly Please refer to page 98 for general installation and assembly instructions Applications Generally speaking molded seals are used when standard seal types cannot suitably meet the needs of a specific application Typical applications include m filing head seals and valve seats for beverage systems molded seals for double seat valves and sterile valves profile gaskets for separators frame gaskets for filters and joining technology fittings Recommendation Innovative simulation and analysis processes The advantages at a glance Global leader in sealing expertise Focused industry specific and application specific know how Extensive materials and manufacturing expertise Reliable quality management Extensive testing facilities for dependable prognoses Innovative simulation and analysis methods IDEAL DEVELOPMENT PROCESS Freudenberg Functional description specifications drawing technical description Feasibility testing If necessary revision of the specifications Construction of sample mold prototypes NN le Testing If necessary correction phase Manufacture of mass production molds Approval First sampling inspection ep pung mee 87 PRODUCT PORTFOLIO BUTTERFLY VALVE SEALS SEALS FOR BUTTERFLY VALVES ENSURE THE RELIABLE FUNCTION OF BUTT
106. ossible FBAX 9001 Variant of FBA 9000 available on request as well as an x Compensator bellows in nominal widths of DN 10 to extensive range of customerspecific variants DN 500 available in stock 93 PRODUCT PORTFOLIO PIFE U PACKINGS U PACKINGS ARE UNIDIRECTIONAL SEALING ELEMENTS WITH A U SHAPED CROSS SECTION AND A REINFORCING METAL SPRING WHICH ARE USED FOR SEALING APPLICATIONS INVOLVING ROTARY OR TRANSLATORY MOTION PTFE U packings are sealing components that enjoy a wide range of uses in the food and beverage industry trom ball valves to piston pumps They are ideal for the sealing of pressures as the system pressure amplities their sealing function as well as for aggressive media thanks to PTFE s excellent media resistance PTFE U packings contain a metal spring which compen sates for the loss of initial load caused by PTFE s tendency to creep The contact pressure can be tailored to the parameters of the individual application scenario by means of u v or o shaped springs open or crimped PTFE U packings are available as axial or radial sealing models for sealing applications involving translatory or rotary motion Radial sealing models are available in inside and outside sealing versions Function m Sealing of rotary and translatory motions m Sealing of aggressive media and pressures Dimensions m Manufactured by machining therefore available in nearly all dimensions m Springs to match the dimensions are manufac
107. ous statutory requirements with respect to sealing components characterize the process industry And only quality products designed for this meet the expectations in terms of smooth production workflows Freudenberg product marking technology gives plant operators the certainty of using original quality according to individual stipulations of preventing the use of unverifi able knockoffs and of ensuring complete traceability of the component used Unmistakable seals The safe technology identifies seal components by means of a patented laser marking among other things in a forgery prool manner with a 24 digit encrypted code This code contains information about article batch and serial numbers date of manufacture and individually definable customerspecitic application and approval information The readout is simple and reliable with the help of a readout device our security software and a commercially available notebook computer The unique aspect here is this The product markings can still be decrypted thanks to the high redundancy of the code even when up to 60 of the identification marking is destroyed In addition the product markings are also outstandingly protected by their topography against mechanical and chemical influences sate otters the significant added value that the risk of process disruptions caused by seals is minimized Mix ups of materials can be excluded and documentation require ments can be satistied much mor
108. pn i ENGINEERING PLASTICS ELASTOMERIC MATERIALS Ku BONN NBR NBR ACRYLONITRILE BUTADIENE RUBBER IS A POLYMER OF BUTADIENE AND ACRYLO NITRILE ACN THE PROPORTION OF ACRYLONITRILE CAN BE BETVVEEN 18 AND 5076 AND SIGNIFICANTLY AFFECTS THE PROPERTIES OF THE POLYMER THUS AN NBR WITH A LOW ACRYLONITRILE CONTENT IS CHARACTERIZED BY A VERY GOOD LOVV TEMPERATURE FLEXIBILITY AND GOOD ELASTIC PROPERTIES THE HIGHER THE ACN CONTENT THE BETTER THE RESISTANCE AGAINST POLAR MEDIA The gas permeability and flexibility at low temperature decrease in this context NBR is only used sporadically in the food industry The remaining applications are usually characterized by high mechanical forces where a large energy input into the seal takes place NBR resists this quite well if no high demands in terms of temperature are placed on it and if a particularly cost effective solution is sought General properties m Very good abrasion resistance The acrylonitrile content must be selected for each application in such a way that the material shows the optimal combination of chemical resistance and low temperature flexibility Good mineral oil and fuel resistance and outstanding resistance to vegetable and animal oils silicones as well as to diluted acids and alkaline solutions at room temperature NBR tends to swell in aromatic and chlorinated hydrocarbons as well as in polar solvents Temperature resistant from 30 C to 100 C 22 F to 2
109. rameters can be l l l compound requested from Freudenberg V packing rings and a backup ring V Seal set When using a spring device for installation on the side Predominantly eed with translatory motion or packings turned away from the pressure set the spring force to maximum pressure occasionally with slower axial motion For information on permissible installation space tolerances and the characteristics of their surfaces please consult Freudenberg Can usually be installed without spring pre load Abs Installation space must be adjustable see diagram V Seal set E Dackings Tolerances and surface characteristics match those of the virgin PTFE PTFE compound variant In the standard version V Seal set packings consist of a compression ring a backup ring and three V packing rings General In case of deviations from this standard for design reasons or due to higher sealing requirements please consult Freudenberg Special In order to avoid damaging the seal during installation the installation installation space and rods and or shafts should include notes lead in chamfers 82 Installation and assembly Please refer to page 98 for general installation and The advantages at a glance assembly instructions m Highly variable to cover a broad range of applications m High pressure resistance virgin PTFE and PTFE Primary applications compounds up to 30 MPa tabric reintorced V packing m Regulation and shut off valves rings
110. rd and high temperature applications there is an FDA and USP Class Vl compliant variant which is ideally suited for use in the food and pharmaceutical industries General properties Thanks to FFKM utmost temperature and media resistance is not reserved only to PTFE materials with a degree of tluorination of 76 The operating conditions are limited when using PTFE due to its tendency to cold flow and lack of elasticity At high pressures and many changes in tem perature pure PTFE seals prove to be unsuitable Simriz on the other hand combines an almost equally universal resistance like PTFE with the elastic advantages of elastomers Therefore with Simriz many sealing problems can be solved better and easier Simriz also shows very reliable properties in static and dynamic applications as well as in frequent temperature changes and aggressive media In addition Simriz as FFKM offers the highest degree of fluorination among elastomers The high bond energy between carbon and fluorine atoms enables excellent resistance to a variety of chemicals with different reactive functional groups and the use in polar and non polar media even at high concentration and temperature In addition the temperature stability with approximately 10 C to 325 C 14 F to 617 F is extraordinarily comprehensive for an elastomer AA 75 Simriz 494 black and 75 Simriz 506 white Application profile For the prevalent requireme
111. reinforced graphite seal with an unmistakable royal blue color This flat gasket is reinforced with aramid fibers bound with NBR and thus withstands a wide variety of chemical and thermal stresses FG 180 FG 180 is a silicatilled flat gasket made of modified PTFE lts very good mechanical characteristics thermal resistance and white color make it a particular favorite of the pharmaceutical industry i Bita Freud Bink i a Te Frei 4 Fro c roudan erg F ucerni Da Fr Liege var Pe Suche F T reu anbara E roe Lipi LITT ial Senken FG 360 The unique flexibility of FG 360 is due to the fact that it consists of 10076 expanded PTFE ePTFE Gaskets made trom expanded PTFE stand out for their high temperature cycle resistance They also resist cold flow and are considered especially pure In addition to the conventional flat gasket form made of FG 360 Freudenberg also offers a sealing band joint sealant This sealing band delivered in rolls can be individually cut and is seltadhesive on one side That means it can seal joints covers or frames quickly and reliably without tooling costs The FG 360 joint sealant is 25 m long and is available in a variety of widths All three material qualities are available as panels in the following sizes and thicknesses NENNEN Panel format in mm Thickness in mm 05 FG 120 L 1 500 08 2 000 x 1 500 FG 180 1220271208 1 0 1 500 x 1 500
112. rifugal pumps plunger pumps and mixers s 1 4 x d d shaft diameter in mm For valves s 1 2 x V d d spindle diameter in mm Packing cross sections Surface roughness for shafts spindles and valves Surfaces Re 025m Surface roughness for housings R lt 0 25 ym vedi Min 40 HRe for heavier loads 60 HRc Amount of guide play in less than 1 1 000 of the spindle diameter the spindle Max permissible gap between spindle and gland packings housing bore 2 100 of the packing width Copan For larger widths use packings with high strength aramid yarns ee Max 0 001 x the shaft diameter Recommended number of rings for valves Media pressure bar Recommended number of rings lt 10 3 10 30 4 30 60 5 60 100 100 250 K 250 500 8 Recommended number of rings for centrifugal pumps and mixers Media pressure bar Recommended number of rings lt 5 3 5 10 A 10 20 2 20 30 6 gt 30 7 Recommended number of rings for plungers Recommended number of rings Media pressure bar ee TA With spring preloading 10 3 i 16 Gee zer 25 4 diis 40 do 64 gt 100 9 VS 160 250 027 d 400 7 lis 630 2 det 1 000 8 i Installation and assembly Installation space must be axially accessible m Ensure that the gland packing goes far enough into the stuffing box and check the reset path Use a cutting gauge when cutting the material Form pressed rings should be opened axiall
113. roup Thanks to the highly polar urethane group common to all polyurethanes this plastic is characterized particularly by m high tensile strengths tar in excess of 60 MPa high elongations at break in some cases more than 1 000 elasticity abrasion resistance oil resistance and ozone resistance Using special raw materials it is possible to achieve good hydrolysis acid and alkali resistances as well Polyurethanes cannot be used in contact with amines glycols and chlorinated solvents Since the urethane group is non toxic and biologically very compatible polyurethanes are especially well suited for drinking water and food applications in compliance with KTW and FDA standards A high quality sub group of the polyurethanes are the thermoplastic polyurethanes These offen expensive granulates can be processed into extremely high quality components e g by means of injection molding or extrusion processes with reasonable processing costs Typical products m U packings m VVipers 37 ENGINEERING PLASTICS MATERIALS RESISTANCE AND PURITY SEALS ARE USED IN A BROAD VARIETY OF MEDIA RESULTING IN VERY SPECIFIC OPERATIONAL CONDITIONS DEPENDING ON THE DURATION AND NATURE OF THEIR EXPOSURE TO THESE MEDIA AGING PROCESSES IN THE ELASTOMER TRIGGER CHANGES THAT COULD LEAD TO HARDENING OR SOFTENING THIS IS REFLECTED FOR EXAMPLE BY SVVELLING CRACKING AND BRITTLENESS OR DISCOLORATION OF THE MATERIAL THE HIGHER THE TE
114. rties m Density 2 10 to 2 30 g cm m Hardness 55 to 60 Shore D m The thermally reliable application range of PTFE is between 200 C and 250 C 328 F and 482 F At temperatures above 400 C 752 F highly toxic pyrolysis products such as fluorophosgene COF are released m Special types of PTFE can be welded m To a certain degree PTFE has an innate memory effect which means that it seeks to go back to its original shape This is based on the extremely long chains of molecules that build up PTFE 53 ENGINEERING PLASTICS Optimization possibilities of PTFE Unfilled PTFE as a base material has some disadvanta geous properties such as poor cold flow behavior relatively low wear resistance low resistance to high energy radiation and poor adhesion behavior All of these can be eliminated by the addition of various additives Reasons for admixing fillers in PTFE m he wear resistance is increased many times over m The resistance to creep or deformation under load is increased to a multiple of the original value m Depending on the filler the thermal conductivity can be increased significantly The thermal expansion is reduced m f necessary the electrical properties of PTFE can be changed by appropriate filler selection m The choice of filler also influences the wear behavior of the opposing surface PTFE Processing of PTFE PTFE cannot be processed by injection molding For the produ
115. ry easy to cut or punch by hand General properties a Wellsuited for applications in the temperature range from 200 C to 300 C 328 F to 572 F Usable in the pressure range trom vacuum to 200 bar Chemically inert over the pH range from O to 14 FDA compliant USP Class VI 121 C 250 F certified Products FG 360 Joint Sealant is a sealant tape with adhesive strips on the back for ease of installation It is an excellent product for heat exchangers irregular flanges fuel caps manholes and hand holes FG 360 Seal Plates are produced in 1 5 mm 2 mm and 3 mm plate thickness The panel size is 1 500 mm x 1 500 mm Other thicknesses are also available on request FG 360 Packing Cord is a round cord pack that does not harden in use It can be used in almost all conceiv able applications The low friction coefficients ensure the valve function even after a long period of inactivity Packing cords are available as standard sizes with a diameter of 2 mm to 25 mm DNA oo Type TF O O TF O O yP DIN 28091 3 DIN 28091 3 Color White White FDA 21 CFR 1771550 FDA 21 CFR 1771550 USP Ch 88 USP Ch 88 ridi s in vivo Class VI in vivo Class VI euer 121 C 250 F 121 C 250 F TA Luft TA Luft Density g cm 0 85 0 85 Tensile strength 14 18 longitudinally N mm Compression 69 66 2 Resilience 7 6 11 6 zo Cor C7 A50 F to 599 F 288 iotslo C7 Temperature range DAO SIE i
116. s Diaphragms Molded parts O rings O rings Molded parts Molded parts O rings Molded parts O rings Molded parts O rings CONC machined Molded parts O rings Ee machined z SITE machined Diaphragms on request O Tings O7ings FDA 21 CFR 177 2600 SGECGIRESNIDOSPAP DONO 202377 2006 FDA 21 CFR 1772600 3 A Sanitary Standards Class Il EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F NSF 51 DASA Rus 1772000 EG Req 192577 2004 andl 20237 2006 eo C 87 FDA 21 CFR 1772600 3 A Sanitary Standards Class Il EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR 1772600 EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR 177 2600 EC Reg 1935 2004 and 2023 2006 FDA 21 CFR 1772600 3 A Sanitary Standards Class II EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F FDA 21 CFR 177 2600 EC Reg 1935 2004 and 2023 2006 FDA 270 72 2000 EC Reg 1935 2004 and 2023 2006 FDA 21 CFR 1772600 3 A Sanitary Standards Class EC Reg 1935 2004 and 2023 2006 USP Ch 87 and Ch 88 Class VI 121 C 250 F D AEC FR 17726000 TEC Regn 1925 7 2004 and 2003772905 FDA 21 CFR 177 2600 EC Reg 1935 2004 and 2023 2006
117. s a network with the aim of offering local products of uniform quality worldwide This concept is supported by global manufacturing innovation occupa tional health and safety and quality management strategies Freudenberg Sealing Technologies is organizationally divided into independently operating market segments This ensures that the respective industry sectors are mana ged by specialized know how carriers From the standard seal to the tailormade molded part Freudenberg Sealing Technologies offers a unique product range in all segments The basis of its success are the highly developed proprie tary materials and products Products specially developed for the process industry in accordance with hygienic design and materials with industry specitic approvals such as FDA or USP Class VI as well as a comprehensive resistance database make Freudenberg the technology leader in the industry As a technology leader we want to provide our customers with exceptional quality at all times and to develop the sealing solutions of tomorrow together with them We invest in innovation and partnership and thus ensure our long term SUCCESS Quality management We not only enhance our products continuously we also work on the continuous improvement of our internal processes with only one goal to provide our customers with consistent quality Therefore Freudenberg Process Seals GmbH amp Co KG is certified according to ISO 9001 The certif
118. s made of 75 Fluoroprene XP 41 CIP Active chlorine 3 60 C 168 h CIP H O 0 5 80 C 176 F 168 h E Vol E Hardness IRHD W Rel tensile strength IBI Modulus W Rel elongation AO Download Data sheet 75 Fluoroprene XP 44 Download Data sheet 85 Fluoroprene XP 43 Download Data sheet 75 Fluoroprene XP 40 Download Data sheet 75 Fluoroprene XP Al INTRODUCTION PRODUCT PORTFOLIO par rae ENGINEERING PLASTICS ELASTOMERIC MATERIALS NUMEN AES FKM FKM FLUORORUBBER IS A HIGH QUALITY MATERIAL WHICH CAN BE ADAPTED TO DIFFERENT APPLICATIONS THANKS TO ITS VARIABLE COMPOSITION By polymerization of vinylidene fluoride VF and optional use of variable proportions of hexafluoropropylene HFP tetratluoroethylene TFE I hydropentafluoropropylene HFPE and perfluoromethylvinylether PMVE it is possible to produce co ter and tetrapolymers with different composition and fluorine contents between 65 and 71 Thus the material can be designed for different requirements in terms of chemical resistance and low temperature flexibility In the food industry FKM is used in applications where temperatures above 140 C 284 F prevail in the process or where media are used which attack other elastomers such as EPDM or HNBR General properties m Excellent temperature resistance m High chemical stability M Very good resistance to ozone weathering aging and oxyge
119. s no longer true today as such The chart gives a rough indication of the usability of EPDM in the interaction between fat content and temperature of the medium If the process parameters are below the curve EPDM can and should be used Only in applications with parameters above the curve a different elastomer must be selected EPDM is also of only limited use according to the 3 A9 Sanitary Standards which have classified EPDM as a Class Il material Nevertheless EPDM is certainly quite suitable for contact with perishable foods at low temperatures and less fatty media In particular its excellent cleaning and sterilization properties which no other elastomer in this price range offers speak for EPDM 100 90 80 7O 60 50 40 30 20 EPDM 20 30 Fluoroprene XP 40 50 60 7O 80 90 39 EPDM in the beverage industry EPDM is recommended for applications in the beverage industry since it shows very good performance in the aqueous media of breweries mineral water and soft drink manufacturers Whether beer mineral water or flavored drinks butterfly valve seals made of EPDM for example are best suited for the application There are limitations in the contact with citrus juices and drinks with orange flavors Because of the same chemical nature of EPDM and limes a terpene the lead compound in orange flavor it quickly leads to swelling of the material in continuous use Another
120. sample parts can be created that can be tested and optimized until the best solution has been found This reduces the development time of new plants while minimizing the financial outlay Economical short runs Machining technology cannot be a production method equivalent to series production From a certain annual quantity the investment in mass production tools becomes worthwhile from an economic point of view However by temporarily switching to machining technology small batches can be processed the manufacturing time of mass production tools can be bridged and market fluctuations with stagnating demand can be responded to The advantages at a glance m Production of prototypes to shorten the development time m Fast remedy in case of defects m Economic production of small batches without series production tools m Machining tool usable as a template for mass produc tion tools m Original Freudenberg materials with approvals such as FDA 3 A Sanitary Standards and USP Class VI m Almost the same mechanical properties as those of mass produced seals m Unique surface quality m long service lives due to cutted sealing edge PRODUCT MARKING TECHNOLOGY FREUDENBERG S PATENTED LASER MARKING TECHNOLOGY SAFE SECURE ADAPTIVE FREUDENBERG ENCRYPTION OFFERS THE HIGHEST APPLICATION SECURITY THROUGH IDENTIFICATION AND TRACEABILITY OF SEALS High material purity reliable media and temperature resistance as well as vari
121. ssible to implement hygienic screw fittings machine manufacturers and operators resorted to welding solutions However welded connections cannot be separated again easily Still other system manufacturers often employ conventional non EHEDG compliant fittings in or on the product space This carries the risk that product residues accumulate under the screw head and become a source of contamination The tightening of the screw already holds numerous sources of error e g damage to the surface of conventional screws by the mounting tool Freudenberg s Hygienic Usit offers the possibility to realize hygienic screw connections Thanks to the cooperation with the company NovoNox the washers can be pur chased with hygienic screws and cap nuts The screws and cap nuts with collar are polished to a high shine and achieve a roughness depth of up to max R 0 04 pm thanks to special manufacturing processes The unique surface finish is free of flash and dimples which would preclude a hygienic design Furthermore NovoNox has patented special sockets with protective plastic inserts that do not damage the screws when tightening The screws and cap nuts are available in the dimensions M3 MA M5 M M8 MIO M12 and M16 with the size of M3 designed for the M4 washers The elastomer bead of the Hygienic Usit is made from the premium compound 70 EPDM 291 and therefore com pliant with EC Reg 1935 2004 FDA 21 CFR 177 2600 USP Chapter 8
122. stallation of O rings with an unfavorable cross section to diameter ratio is recommended Grease swelling EPDM swells in mineral oil and mineral fat and becomes softer The damage is evident in shelHike disruptions with relatively round edges Even individual pieces can break off It is necessary to check whether the correct assembly grease was used Generally EPDM may only be lubri cated with silicone grease In addition the productspecitic information such as fat concentration temperature etc should be recorded in order to verify the possibility of using EPDM Failure due to excessive friction The elastomer scrapes by friction on the opposite surface whereby particles are abraded Depending on the type of surface one can observe different damage patterns To remedy the situation the condition of the opposite surface should be thoroughly investigated and the product and purity parameters should be documented ABB ZEN dl ds ha eec 4 Explosive decompression Cracks in longitudinal directions can be found on the surface The elastomer saturates itself with gas under pressure When rapid depressurization occurs the amount of gas cannot escape fast enough from the matrix of the elastomer and forms gas bubbles similar to diver s paralysis aeroembolism INTRODUCTION WASHING AND INDIVIDUAL PACKAGING FOR PARTICULARLY HYGIENIC APPLICATIONS WE OFFER OUR CUSTOMERS A WASHING SERVICE IT INCLUDES THOROUGH R
123. standards of the statutory emission values for these processes the seal must make a significant contribution to this Handling petrochemicals and derivatives A typical application in the petrochemical industry is so called steam cracking In addition to being resistant to aggressive chemicals seals must withstand high tempe ratures and pressures In a convection capable furnace for heating the bottom product for example there are tempe ratures of up to 600 C 41 112 F with simultaneous pressure and subsequent vaporization During the subsequent cracking of the resulting gas the temperatures increase further to 850 C 41 562 F The real challenge for seals is however in the intense temperature changes that occur during the subsequent cooling of the gas The seal must also withstand the pressure increase during the compression of the cracked gas to about 30 bar The absorption of gases requires the use of chemicals in particular caustic solution Polymer production During the handling of polymers plastics no particularly high demands in terms of pressure and temperature resis tance prevail most of the time Only in some cases for example during the termination of a reaction temperatures as low as 80 C 112 F may occur requiring the use of specially developed sealing solutions In addition the use of solvents can attack conventional sealing materials Fine and specialty chemicals In the handling of
124. step a tablet is pressed for example and coated so that the medication can be taken Before a tablet can be pressed the active ingredients and excipients must be manufactured accor ding to the recipe wet granulated and then dried and ground For seals this means that they have to exist in a dusty environment In addition no components of the seal that could negatively alter the pharmaceutical product in its composition or color must be allowed to migrate into the production process The seal must also protect the pharmaceutical product against external influences in the sterile environment Boiler Pump Pelletizing Drying BN Product formulation by blood fractionation In the separation of blood the various blood constituents are separated by centrifugation For fractionation proteins are separated from blood plasma with the admixture of ethanol at 3 C to 6 C 27 F to 21 F The plasma is cooled to 30 C 22 F very quickly Not every seal withstands this enormous jump in temperature To avoid contamination seals for this area must also be designed tree of dead space and be resistant to CIP and SIP cleaning processes and cleaning media Furthermore defined emission limits must not be exceeded Freudenberg offers special sealing materials for these aseptic high purity processes in the pharmaceutical industry which are resistant to low temperatures and chemicals Biopharmaceuticals Strict hygiene regul
125. t is expressed as a percentage of the initial state INTRODUCTION PRODUCT PORTFOLIO pen saecu ENGINEERING PLASTICS ELASTOMERIC MATERIALS eee dm Compression set measurement elasticity The compression set refers to the ability of a material after a certain time of contact with the medium in question to generate a sufficient restoring force on the sealing surfaces and thus ensure the tightness In a newly manufactured seal the compression set is a measure for assessing the vulcanization and the degree of cross linking The lower the compression set value the better the crosslinking and the longer the expected lite of the mixture It should be noted that the compression set is not an absolute value but must always be considered in comparison with the initial or target values The compression set is determined according to DIN ISO 815 using the following formula DVR h h h h x 100 With hy height of the test specimen h height of the compressed specimen h height of the relieved specimen A number of conditions must be met during the measurement Thus the time between the vulcanization of the test spe cimen and the compression set test should be at least 16 hours The compression is defined and generally amounts to 25 The sample is stored in its apparatus in air or a medium for a predetermined period of time at a specitied temperature and removed trom the apparatus atter expiry of the testing p
126. terial No damage during deflashing No visible inclusions or pores allowed Preferably clamp seals with aseptic O rings in compliance with DIN 11864 Where applicable check pipe inclinations for cracking Ensure proper pipe alignment during assembly Design Preparation Seal for dairy coupling Seals for dairy couplings Seals for dairy couplings can be used to easily connect and seal pipe connections for liquid media The dairy couplings standardized according to DIN 11851 are very common in the food and beverage industry Their essential advantage is the extremely quick and easy installation thanks to their simple separation from the flange so that they can also be frequently disassembled without difficulty Dairy couplings are an economical solution and are particularly suitable tor smaller plants not operating continuously However it should be taken into account that this seal component is best suited for less demanding applications Consequently seals for dairy couplings do 72 not meet Hygienic Design requirements since compression is problematic due to the lack of metallic stops and the formation of gaps into the product area could occur Seals for dairy couplings are available in various materials from NBR EPDM FKM to VMQ and PTFE for a maximum operating pressure of up to 4O bar Dimensions E Standard form with lip and high version Standard dimensions trom DN 15 to DN 100 Standard With lip
127. through sterile processing Thus the seals in the equipment must now also be resistant to sterilizing agents such as peracetic acid or steam Another aspect is the much more versatile use of the facilities Previously production was for the most part limited to one product whereas today all kinds of mixed drinks are in the portfolio Each one has different resistance requirements regarding the seals so that the requirement protile is being shitted more and more toward universal sealing material Sealing material requirement profile FDA compliant compliant with EC Reg 1935 2004 3 A Sanitary Standards dairy industry USP Class VI pharmaceuticals ADHree eg sodium hydroxide solution 5 80 C 176 Flo nine acie 27 FORO 2 zo peracetic acid 1 60 C 140 F steam 140 C 284 F EPDM is suitable for aqueous media and cleaning agents HNBR and FKM are suitable for aliphatic media but less resistant in cleaning media Fluoroprene XP is universally usable in aqueous media and aliphatic media cleaning agents and steam 29 TECHNICAL FUNDAMENTALS FRICTION OPTIMIZATION THE FRICTION OF ELASTIC MATERIALS ON HARD SURFACES DIFFERS SIGNIFICANTLY FROM FRICTION PROCESSES BETVVEEN TVVO METALS The known states m fluid friction the two gliding partners are completely separated from each other by a lubricant film m mixed friction the gliding partners touch each other onl
128. to 302 F 10 Geo 50 0 72070007 30 C to 140 C 22 F to 284 F 10 Cor 50 2720 702027 40 C to 200 C 40 F to 392 F 0 EROON AORO ATF 50 C to 200 C 58 F to 392 F ZI Teac AT 52T 25 C to 100 C 13 F to 212 F 0 Co PAIS v Ped 35 C to 140 C 31 F to 284 F 22 5 io lo eC TT ep trovati cir 15 C to 200 C 5 F to 392 F 15 C to 200 C 5 F to 392 F 15 C to 200 C 5 F to 392 F 15 C to 200 C 5 F to 392 F 25 C to 200 C 13 F to 284 F 15 C to 200 C 5 F to 392 F 20 C to 230 C 4 F to 446 F 5 Cito 230 C 7 45 Fie 446 7 15 C to 230 C 5 F to 446 F 25 Clo 325 C7 45 Fiotol7 TF 10 C to 230 C 14 F to 446 F 10 C to 230 C 14 F to 446 F 10 C to 230 C 14 F to 446 F Diaphragms Clamp seals Diaphragms Hygienic Usit Profiles Cords Molded parts O rings CNC machined Molded parts Molded parts CNC machined Clamp seals Molded parts O rings O rings Molded parts Clamp seals Diaphragms Molded parts O rings Clamp seals Diaphragms Molded parts O rings Molded parts O rings Molded parts O rings Clamp seals Molded parts Molded parts Molded parts O rings Diaphragms Molded parts Oring
129. to create realistic test conditions customizations to the fittings and assem blies can also be carried out easily On this basis meaningful test results can be obtained with respect to service life resistance or necessary design optimi zation of a seal This is valuable information in order to make the right decisions as early as during the conceptual sealing design of the system Tubular heat exchanger Customer specific media Pump for customer specific media Test field Test methods and possibilities m Sealing tests in conjunction with acids alkaline solutions The advantages at a glance and disinfectants m Demonstration of customized CIP SIP processes under m Separate media supply for valve and seal contamination real operating conditions Testing of critical applications with superheated steam a Veritied statements concerning resistances and reliability cooling water and compressed air supply of material and seal design Testing of all types of seals in fittings and equipment a Validation of the seal selection prior to the start of series assemblies such as O rings diaphragms buttertly valve production High operational reliability throughout the product lite cycle seals and gaskets as well as molded parts Testing of measurement instrumentation and pump seals a More efficient production processes Avoidance of time consuming and costintensive field tests m Damage analysis Examples of possible testing cycles
130. tured from endless material m Standard dimensions see Types available in stock 94 Variants with dynamic internal sealing lip for use as a rod seal standard rod diameters from 10 to 200 mm Variants with external sealing lip for use as a piston seal standard piston diameters from 15 to 200 mm Axial sealing Radial sealing Spring types Material variants With inward sealing function for use as a pressure seal dimensions on request With outward sealing function for use as a vacuum seal dimensions on request Vsprings with a great degree of spring travel and soft spring characteristic for reduced friction can be used for dynamic and static sealing and for rotation sealing U spring with a great degree of spring travel and higher spring rate for sealing of higher pressures Round springs for high spring force with a lower degree of spring travel for sealing of extremely high pressures lts special design distributes the spring load over a number of different sealing lips Pure PIFE PTFE with glass fibers PTFE with carbon PTFE with carbon fibers PTFE with glass and or molybdenum PTFE with Econol PTFE with aramid UHMW PE polyethylene LEER Maximum permissible pressure for dynamic applications 45 MPa Maximum permissible pressure for static applications 120 MPa For 25 MPa or more please consult Freudenberg if necessary use backup rings Pressures Lead in
131. ue white due to high crystallinity but the material can also be dyed in all muted colors POM has a density of p 2 1 41 to 1 42 kg m The water absorbtion factor is so low that it is of no importance for its use at standard climatic conditions about 0 2 and at full saturation with water at 23 C 73 F only about 0 8 The physical characteristics of the molded parts thus vary only slightly The good chemical resistance and low water absorption predestine POM for use in contact with food Many types are FDA compliant Due to its high crystallinity POM is more rigid and firmer than other thermoplastics especially in the temperature range of 50 C to 120 C 122 F to 248 F POM has a clearly defined tensile yield point at about 8 elongation at room temperature Below this yield point it demonstrates good resilience even under repeated stress and is therefore particularly well suited for elastic elements The high creep rupture strength and low tendency to creep round off the benefits of POM Suitable areas of application The mechanical properties of POM in conjunction with good friction and wear performance make this material predestined for a wide range of engineering applications Typical products Molded parts m Backup rings m Guide rings PA Polyamide Most commercially important polyamides are partially crystalline thermoplastic polymers They are characterized by high strength stiffness and toughness
132. up to O MPa m Dosing systems m Very good temperature resistance 200 C to 260 C B Mixers 328 F to 619 F M Pivot joints m No tooling costs for virgin PTFE PTFE compound variants Predominantly used to seal Adjustable set heights m spindles of control and regulation valves m Low friction m rods translatory motion possibly in combination with m Universal chemical resistance minor rotation and m ow susceptibility to cold flow and extrusion in PTFE m low speed shafts fabric variant Pure PTFE PIFE impregnated L synthetic fabric Spacers for balancing heights 83 PRODUCT PORTFOLIO STUFFING BOX PACKINGS FROM CENTRIFUGAL AND PISTON PUMPS TO APPLICATIONS ON SPINDLES AND VALVES STUFFING BOX PACKINGS ARE A TYPE OF SEAL BROADLY USED THROUGH OUT THE FOOD AND BEVERAGE INDUSTRY WHERE SEALING IS ACHIEVED BY COMPRESSING THE PACKING The functional principle of a stuffing box packing consists in the axial compression of endless woven cords pressed into rings This process generates a radial compression on the sealing location which must be greater than the internal pressure to ensure reliable sealing Using different types of stranding and packing materials to match the respective chemical and thermal requirements stuffing box packings can be tailored to a variety of application scenarios In addition to the classic woven packings Freudenberg also offers the special Valtec variant made of a non woven mat
133. veloped product made of PTFE and can be used in a broad spectrum of food and beverage industry applica tions The product stands out because of its low triction a result ot PTFEs own low coefficient of friction in conjunction with the low contact pressure exerted on the rotary shaft by the lip The primary advantage of HTS Il rotary shaft seals is their high media resistance since the media to be sealed come into contact exclusively with PTFE PTFE is a material that performs exceptionally well in nearly all media and cleaning agents and makes especially hygienic processes in food and beverage production possible HTS Il rotary shaft seals also offer outstanding sealing performance with minimal contact pressure which is generated by the geometry of the sealing lip joint and the memory effect of the PTFE This concept minimizes abrasion while simultaneously ensuring a reliable sealing performance Special variants are also available for more extreme demands e g higher pressures dead space tree design or dusty operating conditions Lastly the seal s innovative lip design also makes it possible to affordably reduce the number of components needed for individual applications HTS Il 9535 With standard lip for conventional applications SEEN T With additional dust lip for use in dirty and dusty environments that pose a risk of foreign objects getting m HTS II 9536 SL en V MP A under the sealing lip and in applications invol
134. ving alternating pressure vacuum operation HTS II 9538 DL With a double sealing lip for high security standards HTS II 9539 VL Dead space ree version with protruding sealing lip for Hygienic Design applications Extremely compact shaft seal for tight installation spaces WADB 9461 HTS II 9541 with twist HTS II EWS To be used only in combination with a secondary seal made of FKM or virgin PTFE on the surface that will come into contact with media With dynamic return capability for applications with high liquid level or increased demands on impermeability For use at elevated levels of shaft runout With integrated flexible bellows element Application limits up to 1 m s and 3 bar Function m Dynamic sealing for applications involving rotary motion m Sealing pressure is generated by the special lip design and PTFE s memory effect Dimensions Manufactured by machining independent of molds therefore no limits on any dimension m Standard dimensions trom 10 to 125 mm shaft diameter available in stock m Smaller or larger dimensions available upon request Installation and assembly m Must always be assembled as a combination of sealing ring and retaining ring a f seal is disassembled the clamping ring must be replaced since it is deformed by the pressing operation a f possible use pressing tools with builtin stops to avoid excessive axial compression and the risk ot damaging the seal m lo aid assemb
135. which all EU countries must fully implement E F Bellow Faltenbalg A federal body in the United States responsible for the regulation of medications Food and Drug Administration and pharmaceuticals part of the United States Department of Health and Human Services Finite Elemente Methode A calculation method used to determine forces and loads in components Fluorinated Ethylene Propylene A thermoplastic material used as a material for encapsulation of O rings Perfluoroelastomer A base elastomer Fluoroelastomer A base elastomer G Analytical method for mixtures which can be converted into the gaseous phase Gas chromatography and can then be separated and detected Elastomer diaphragm with fabric H Elastomer diaphragm with metal insert and fabric film Hydrogenated Nitrile Butadiene Rubber A base elastomer Hardness Rockwell C Rockwell hardness test with scale C for materials with a high hardness High Temperature and Speed Rotary shaft seal Abbreviation Full name Description e nec nom rte i ISBT United States organization for the beverage industry ISO International Organization for Standardization ISPE International industry association for the pharmaceutical industry K KIWA Directive from the Netherlands Subcommittee Iw tects ao aaa M MB Elastomer diaphragm MBM ss Elastomer diaphragm with metal inserts MRO MS Da to separate particles according to their mass an
136. xtremely small allowing material saving designs Though simple in form O rings can nonetheless be reliably used in a variety of installation configurations as static seals in axial or radial direction or for dynamic applications involving translatory and or rotary movements Function m Static sealing for axial and radial applications m Dynamic sealing for applications with translatory and rotary movements Dimensions m Available in inch US standard and metric dimensions Numerous intermediate sizes are also available thanks to our extensive inventory of tools m Special sizes of over 500 mm generally require new tools m Standardized cross section diameters from mm to 6 99 mm smaller and larger dimensions available on request Types m Compression or injection molded standard models m Special designs and large dimensions of endless extruded cord spliced or vulcanized In addition to round cross sections oval rectangular semicircular or xshaped cross sections are possible m Special customerspecitic types can be created with new molding tools Surtacetreated special designs such as non stick and lubricated applications painting coating nanotechno logical modification for the optimization of tunction and application PTFE casing with separating joint or complete FEP encapsulation for use in highly corrosive media 68 POSSIBLE RWIS oe IKONS Installation and assembly Edges should be rounded wit
137. y on the roughness peaks and m dry friction no lubricant available describe the conditions during the friction of sealing materials only insutticiently Due to the elasticity of the sealing material the elastomer adapts to the roughness of the mating surface which increases the friction force significantly The softer the elastomer and the higher the force with which it is pressed against the mating surface the more this effect is evident The conditions are therefore significantly different from those of classical friction between two solid bodies Reasons for a necessary friction reduction in elastomer products m Reduction of the adhesion of seals to each other or to the container walls This is particularly necessary in case of automatic assembly O rings for example should not stick to each other but glide easily m Reduction of friction during installation of seals For example it O rings must be pushed over shafts or shoulders they can easily become twisted in case of excessive friction and therefore also lie twisted in the groove This increases the risk of leakage m Reduction of friction in dynamic applications with the aim to increase the service life of the seal 30 The most important coating methods AccV SpotMagn Det WD Exp 4 10 um 20 0 kV 5 0 3000x SE 225 2352 M2000 01158 Zn RFN treatment Reduced Friction by Nanotechnology In this procedure developed b
138. y then slightly flexed radially and laid over the shaft cut end first Next press the sleeve completely into the installation space and tighten it according to the component specifications Please refer to page 98 for general installation and assembly instructions Applications Valves Mixers Homogenizers Piston and plunger pumps Fittings Stuffing box design The advantages at a glance Broad variety of applications Ideal for higher pressures up to 1 000 bar in special cases up to 3 000 bar Broad temperature range from 200 C to 550 C 328 F to 1 022 F as graphite variant up to 1 00 C 1 292 F High media resistance Numerous economical standard dimensions Simple assembly Special solutions in compliance with TA Luft FDA compliant materials 85 PRODUCT PORTFOLIO MOLDED PARTS MOLDED PARTS ARE COMPONENTS THAT CANNOT BE ASSIGNED TO A STANDARDIZED GROUP IN TERMS OF THEIR GEOMETRIES AND APPLICATIONS INSTEAD THEY ARE DESIGNED FOR SPECIFIC SEALING APPLICATIONS In complex applications it is often difficult if not impossible to use standard components to ensure an optimal sealing function In such cases molded parts are designed to precisely match the application in question the molded part becomes a customerspecific solution This can be accomplished by modifying a standard component for example an O ring or by designing the materials and geometry for an entirely individuali
139. y Freudenberg New Technologies the surface properties can be set in such a way that the adhesion and thus the jamming of the components is signiticantly and permanently reduced Furthermore the surface can be designed extremely hard and thus with low wear and low friction properties so that RFN treated products are predestined for dyno mic applications Due to the special process the materials retain their elastic behavior and dimensional stability RFN treatment has approval for drinking water applications and is resistant to common CIP SIP cleaning agents Dusting with talc magnesium silicate hydrate Treatment with talc prevents the seals sticking to each other and to container walls It simplifies installation but is not suitable as a durable friction reduction for dynamic applications Automatic assembly equipment can be contaminated by talc Immersion in emulsions The same effect as in talc coating occurs by wetting the surface with emulsions The coat application here does not rest loosely and in powder form and thus dusty on the surface but is liquid and adhering to the surface Therefore the contamination tendency is lower than for talc dusting Lubrication with grease or oil It requested seals can be delivered lightly greased or oiled It is important to note that the assembly equipment may be soiled by the greases or oils In addition the compatibility of the greases and oils must be matched with the sealing
140. y used in challenging applications a With aggressive media that require universal chemical resistance m n case of high thermal stresses at high and low temperatures m For applications in equipment in the food and beverage industry using different media and aggressive cleaning agents n small quantities as an economical alternative since no tools are necessary for manufacture The advantages at a glance m Highly resistant to nearly all chemicals Can be used universally m Toolindependent dimensions many standard dimensions available in stock am Inside sealing grooves in housing Inside sealing grooves in housing Outside sealing grooves on shafts Y NN INTRO ENTALS PRODUCT PORTFOLIO SEALS FOR PIPE CONNECTIONS FREUDENBERG OFFERS DIFFERENT MODELS FOR STATIC SEALS IN STANDARDIZED PIPE CONNECTIONS USED IN THE FOOD CHEMICAL AND PHARMACEUTICAL INDUSTRIES These four different models are available The classic seal for dairy couplings in compliance with DIN 11851 Clamp seals in compliance with DIN 32676 and ISO 2852 O rings for aseptic clamp connections in compliance with DIN 11864 and Flat gaskets in compliance with DIN 28091 2 and DIN 28091 3 General Adhere to the relevant standards As laid out in the relevant standards inner surfaces that come into Surfaces contact with media R lt O 8 um FDAcompliant Hardness between 75 and 85 IRHD Material Homogeneous ma
141. yers diaphragms are extremely dependable and resistant to media They are also very affordable solutions as the minimal requirements with regard to tolerances and surface qualities of the surrounding components make it possible to produce them inexpensively Function m Regulation and switching using pressure that is converted into rod force m Separation of media in component spaces with nearly identical pressure levels Pumping and compression of liquids and gases Measuring volume flows Actuation of valves 7O Dimensions From minimum diameter of 5 mm to maximum diameter of 1 000 mm or larger for individualized applications Diaphragm types Materials composition Hat diaphragms Convoluted diaphragms Plate shaped diaphragms Rolling diaphragms Individual designs available upon request MB as pure rubber diaphragm CMB with fabric insert or overlay MBM with metal insert and or film GMBM with metal insert and fabric overlay or insert and or film Diaphragms with film overlay made of PTFE modified PTFE electrically conductive foils etc Diaphragms made of pure PTFE In designing diaphragms it is advisable to use FEM calculations to reduce development and testing times The diaphragm s construction position O position should be selected such that the diaphragm is not under load when the machinery is not in use Design The deflection of the diaphragm during operation should
142. zed molded seal Typical molded seals in the food and beverage industry include butterfly valve seals and U packings as well as impellers for pumps The use of a molded seal is preceded by a comprehen sive development process in which the customer is usually closely involved Not intrequently Freudenberg is also already involved at the start in a machine or component development in order to ensure high system reliability from the outset with specially matched sealing solutions Function Various sealing functions depending on the requirement and component such as M pressure tree sealing through the use of restoring force m sel amplitying sealing function under pressure m reduction of incoming pressure and sealing against media permeation Dimensions Vary widely depending on the design and application from only a few millimeters up to one meter 86 Types Elastomer composites in materials combinations with metals ceramics or plastics m Precision molded parts m Elastomer bellows m Extruded profile sections Design notes When developing molded seals the user and the seal manufacturer should work together intensively from the outset in order to avoid unnecessary steps and to keep the development time as short as possible So as to preclude the need for multiple revisions new versions and repeated testing in the development process Freudenberg can use FEM analysis prior to construction of the sample mold in

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