Sealing Technology Manual for the Process Industry Table of Contents

SEALING TECHNOLOGY MANUAL FOR THE PROCESS INDUSTRY TABLE OF CONTENTS

1 INTRODUCTION 4 4 ENGINEERING PLASTICS 47 Overview of engineering plastics 48 1.1 Company 4 PTFE 49 ePTFE 51 1.2 Market-specific services 6 POM, PA, PU, PEEK 52 Freudenberg Xpress 6 Product marking technology 7 Test facility 8 5 MATERIALS RESISTANCE AND PURITY 54 Damage analysis 10 Temperature and fat resistance 55 Washing and individual packaging 12 Flavoring agents 57 Collaboration with associations 13 Cleaning process 60 Storage tests 63 1.3 The process industry and its requirements 14 Extractables 61 Food industry 14 Hygienic design 63 Pharmaceutical industry 16 Chemical industry 18 6 PRODUCT PORTFOLIO 65 O-rings 66 2 TECHNICAL FUNDAMENTALS 20 Encapsulated O-rings 68 Basic materials testing 21 Seals for pipe connections 70 Storage conditions 25 Diaphragms 74 Approvals, examinations, compliances 26 Hygienic Usit rings 75 Hygienic design 28 Rotary shaft seals 76 Friction optimization 29 V-Seal set packings 78 Stuffing box packings 80 Precision molded parts 82 3 ELASTOMERIC MATERIALS 31 PTFE U-packings 83 Overview of elastomeric materials 32 Butterfly valve seals 84 EPDM 34 Low pressure profiles 86 VMQ 36 Guide strips 87 N B R 37 PTFE bellows 88 HNBR 38 FKM 40 Simriz® 42 7 APPENDIX 89 Fluoroprene® XP 44 List of abbreviations 90 General installation and assembly instructions 92 Legal notices 93

2 3 Introduction INTRODUCTION COMPANY TECHNICAL FUNDAMENTALS

Freudenberg Sealing Technologies is Quality management Certification is intended to give our Our zero-defect policy motivates all the largest business group of the We not only enhance our products customers confidence. Because qual- our employees to excellence and top Freudenberg Group and belongs to the continuously, we also work on the con- ity can only be guaranteed if the inter- achievements. Moreover, our quality business area Seals and Vibration Con- tinuous improvement of our internal nal processes are performed in a management and application support MATERIALS

trol Technology. Together with the processes – with only one goal: to pro- standardized structured and replicable are readily available in the event of partners of NOK Corporation, the vide our customers with consistent manner. From the preparation of a technical problems. company forms a network with the quality. Therefore we are certified quote to the packaging of individual aim of offering local products of uni- according to ISO 9001. O-rings, we have established stream- form quality worldwide. This concept lined processes and constantly strive is supported by global manufacturing, The certification is valid for the follow- for further improvement. ELASTOMERIC innovation, occupational health and ing areas: safety and quality management strat- egies. • Sale of sealing products • Technical advice for sealing products Freudenberg Sealing Technologies is • Provision of services involving seals, organizationally divided into inde- in particular the optimization of the pendently operating market segments. supply system This ensures that the respective indus- NEWS try sectors are managed by specialized BROCHURES

know-how carriers. From the standard AND FLYERS PLASTICSENGINEERING The Freudenberg group of companies plex sealing solutions, the company is seal to the tailormade precision was founded in 1849 and is still family- always considered an innovation and molded part, Freudenberg Sealing owned. The resulting financial stabil- technology leader. Thus, for example, Technologies offers a unique product ity and social awareness are key suc- the famous Simmerring® is a Freuden- range in all segments. The basis of its MATERIAL DATA SHEETS PURITY cess factors that create trust. berg invention dating back to 1929, success are the highly-developed pro- & which is still being used in many prietary materials and products. Today, Freudenberg is a global, broadly- industries and a wide variety of appli- diversified group. While Freudenberg cations today. Sealing solutions specially developed

& Co. KG represents the strategic lead for the process industry in accordance WEBSITE RESISTANCE company, Freudenberg SE as the oper- The pronounced segmentation of the with hygienic design and materials ational holding company reflects the Group has only one goal: to be close to with industry-specific approvals such global nature of the Group of compa- the customer and to meet the require- as FDA or USP Class VI, as well as a MATERIALS nies. ments of a market specialist. Numer- comprehensive resistance database CONTACT ous research and development faci make Freudenberg Sealing Technolo- Freudenberg is divided into business lities ensure the long-term success gies the technology leader in this in- groups which operate in different in- of the company and allow a rapid dustry. As a technology leader, we dustries. From household products of response to market- and customer- want to provide our customers with the Vileda® brand to technically com- specific transformations. exceptional quality at all times and develop the sealing solutions of tomorrow together with them. We in- vest in innovation and partnership and thus ensure our longterm success. PRODUCT PORTFOLIO APPENDIX 4 5 Introduction INTRODUCTION MARKET-SPECIFIC SERVICES MARKET-SPECIFIC SERVICES FREUDENBERG XPRESS PRODUCT MARKING TECHNOLOGY TECHNICAL FUNDAMENTALS

Economical short runs FDA-compliant and hygienic Machining technology cannot be a pro- With the laser marking, Freudenberg duction method equivalent to series abstains from the admixture of marker production. From a certain annual substances or components and thus MATERIALS

quantity, the investment in mass pro- avoids interfering with conformities duction tools becomes worthwhile like FDA or USP Class VI of the sealing from an economic point of view. How- material used. Also unproblematic for ever, by temporarily switching to ma- hygienic applications is the coding chining technology, small batches can depth of the laser marking. For this, be processed, the manufacturing time Freudenberg has carried out extensive ELASTOMERIC of mass production tools can be testing of marked seals in accordance bridged, and market fluctuations with with EHEDG guidelines (European Hy- stagnating demand can be responded gienic Engineering and Design). The to. code structures affect neither the cleanability nor the risk of microbial contamination, for example in the case of a bottling plant.

The Freudenberg Xpress service can Delivery of replacement parts in re- THE ADVANTAGES Freudenberg’s patented laser marking of manufacture, individually definable provide seals in original quality cord time AT A GLANCE technology “safe” (secure adaptive customer-specific application and ap- PLASTICSENGINEERING within a few hours using the latest When a seal fails during the produc- freudenberg encryption) offers the proval information. The readout is CNC technology. Freudenberg Xpress tion process and a replacement part is highest application security through simple and reliable with the help of a THE ADVANTAGES is the best choice not only for the not in stock, every hour counts in order • Production of prototypes to shorten identification and traceability of seals. readout device, our security software AT A GLANCE quick delivery of replacement parts, to prevent costly machine downtime. the development time and a commercially available note- PURITY

but also for the economic production Freudenberg Xpress can normally find • Fast remedy in the event of defects High material purity, reliable media and book computer. The unique aspect & of small series. a remedy within 24 hours. On the basis • Economic production of small temperature resistance, as well as vari- here is this: The product markings can • Unique laser marking system for of a drawing or a sample, the seal can batches without series production ous statutory requirements with re- still be decrypted thanks to the high easy and economical identification Thanks to state-of-the-art manufac- be machined and sent without de- tools spect to sealing components character- redundancy of the code even when up and traceability turing facilities and in-house machin- tours directly to the location where it • Original Freudenberg materials with ize the process industry. Only quality to 60% of the identification marking is • Forgery-proof technology to protect RESISTANCE ing tools development, Freudenberg is required. approvals such as 3-A® Sanitary products designed for this meet the ex- destroyed. In addition, the product against product piracy has achieved a unique surface quality Standards and USP Class VI, as well pectations in terms of smooth produc- markings are also outstandingly pro- • Traceability of article, batch and se- with a mean roughness index of max. Rapid prototyping as FDA conformity tion workflows. Freudenberg product tected by their topography against rial numbers, date of manufacture, MATERIALS

Ra = 2.38 μm (roughness depth Rt = The term “rapid prototyping”, i.e. the • Almost the same mechanical prop- marking technology gives plant opera- mechanical and chemical influences. materials, dimensions and design 13.7 μm). This value is approximately rapid production of functional models, erties as those of mass-produced tors the certainty of using original qual- details equal to that of a conventionally pro- is in actual fact not applicable to elas- seals ity according to individual stipulations, “safe” offers the significant added • High readout reliability even with duced seal. You can find an overview tomer technology. Nevertheless, the • Unique surface quality of preventing the use of unverifiable value that the risk of process disrup- damaged codes of materials suitable for machining specialists at Freudenberg make ex- • Long service lives knock-offs and of ensuring complete tions caused by seals is minimized. Mix- • Protection against product mix-ups technology on page 32 f. actly this possible. Thanks to the pro- traceability of the component used. ups of materials can be excluded and • Safeguarding of guarantee promises duction of prototypes without stand- Download documentation requirements can be and protection against warranty The lip edge is created by cutting, ard tools, sample parts can be created Freudenberg Xpress Unmistakable seals satisfied much more easily. Promises of claims which is a complex process and that can be tested and optimized until for the process industry The safe technology identifies seal guarantee are safeguarded and unjus- • FDA-compliant therefore rarely applied in the mar- the best solution has been found. This components by means of a patented tified warranty claims are averted. PRODUCT PORTFOLIO ket. The machined seals of Freuden- reduces the development time of new laser marking, in a forgery-proof man- With regard to the marking process, berg achieve an exceptionally long plants while minimizing the financial ner with a 24-digit encrypted code. Freudenberg has consistently taken the service life. outlay. Download This code contains information about requirements for contamination-free Freudenberg article, batch and serial numbers, date components into account. Xpress poster

Film Freudenberg Xpress movie APPENDIX 6 7 Introduction INTRODUCTION MARKET-SPECIFIC SERVICES TEST FACILITY TECHNICAL FUNDAMENTALS

The Freudenberg test facility offers ter under real conditions. From the tracks in which three valves are tested new validation options for the perfect O-ring to the butterfly valve seal, veri- in parallel or in series. The operating adjustment of seals to the respective fied statements on the functionality parameters such as temperature, pres- CIP/SIP (Cleaning In Place/Sterilization of the seal used can thus be derived sure and flow rate are recorded digi- MATERIALS

In Place) process. even prior to serial use. tally. For intentional contamination of the valves, a container can be filled CIP/SIP and superheated steam pro- A proactive development partnership, with the medium used in the applica- cesses are an integral part of produc- which significantly increases the relia- tion. In order to create realistic test tion in the process industry. Cleaning bility and thus the cost effectiveness of conditions, customizations to the fit- agents and heat put significant stress valves and customer-specific systems. tings and assemblies can also be car- ELASTOMERIC on the seals, which is a critical factor ried out easily. On this basis, meaning- for smooth workflows if the seal was The system design ful test results can be obtained with badly configured here with respect to The test plant is designed as a multi- respect to service life, resistance or material and design. tank CIP system and thus offers the necessary design optimization of a Test methods and possibilities • Testing of measurement instrumen possibility to demonstrate different seal. This is valuable information in • Sealing tests in conjunction with tation and pump seals Freudenberg’s test plant allows mean- cleaning processes with acids, alkaline order to make the right decisions as acids, alkaline solutions and disin- • Damage analysis in the event of THE ADVANTAGES ingful seal tests in all standard CIP/SIP solutions and disinfectants. The core early as during the conceptual sealing fectants leakage AT A GLANCE media as well as in steam and hot wa- of the system is formed by three test design of the system. • Separate media supply for valve and • Reliable compatibility recommen- seal contamination dations concerning seals and pro-

• Testing of critical applications with cess media • Demonstration of customized CIP/ PLASTICSENGINEERING superheated steam, cooling water SIP processes under real operating and compressed air supply conditions • Testing of all types of seals in fit- • Verified statements concerning re- tings and equipment assemblies, sistances and reliability of material PURITY

such as O-rings, diaphragms, but- and seal design & terfly valve seals and gaskets as well • Validation of the seal selection prior as molded parts to the start of series production • High operational reliability through-

out the product life cycle RESISTANCE • More efficient production processes • Avoidance of time-consuming and cost-intensive field tests Examples of possible testing cycles MATERIALS CIP/SIP MEDIA CONCENTRATION RANGE (%) RESIDENCE TIME (MIN.) TEMPERATURE RANGE Acidic cleaning agents +30 to +80 °C 0.5 to 3.0 20 to 30 e.g. on the basis of HNO3 (+86 to +176 °F) Alkaline cleaning agents +30 to +80 °C 2.0 to 3.0 20 to 120 e.g. on the basis of NaOH (+86 to +176 °F) Disinfectants +25 °C 0.3 to 1.0 30 to 60 e.g. on the basis of H2O2 (+77 °F) PRODUCT PORTFOLIO Acidic disinfectants +25 °C 0.5 to 1.0 20 e.g. on the basis of H2O2 and HNO3 (+77 °F) Alkaline disinfectants H O : 0.5 +80 °C 2 2 30 e.g. on the basis of H2O2 and NaOH NaOH: 1.0 to 2.0 (+176 °F) +120 to +140 °C Sterilization with steam 100.0 20 to 45 (+248 to +284 °F) APPENDIX 8 9 Introduction INTRODUCTION MARKET-SPECIFIC SERVICES DAMAGE ANALYSIS TECHNICAL FUNDAMENTALS

Seals may be damaged in several • Indicate self-inflicted damage (e.g. • Flavoring agents: Typical cases of O-ring damage ways. Damage is often caused by by using a screwdriver during the • If samples are allowed to be taken, changes in the process media and the removal) they should be filled into glass fact that their effects on the seal ma- • Give the exact installation location: bottles MATERIALS

terials were not taken into account in valve number, component etc. • Listing of the flavors, which are in advance. • Observe mating surfaces and direct contact with the seal grooves (condition, roughness, de- After an incident, it is essential to find posits etc.) and document changes • Cleaning media: out the cause in order to prevent sub- • Media sequence sequent damage and to find the right Which media have contact with the • P r e s s u r e s ELASTOMERIC seal for the individual application. seal and what are the circumstances? • Temperatures Twisting during installation – Large Failure due to excessive friction – The Freudenberg’s application support cre- • Concentrations of the cleaning O-rings with a small cross-section are elastomer “scrapes” by friction on the ates meaningful damage analyses and • P r o d u c t s : agents and frequency of cleaning not very dimensionally stable and can opposite surface, whereby particles are helps you fix the problem. When a • Ingredients • If possible, obtain the safety data be twisted when mounted. After re- abraded. Depending on the type of sur- case of damage occurs, the following • Pressures sheets moval, a circumferential track in the face, one can observe different damage documentation has to be carried out. • Temperatures elastomer is visible in case of heavy patterns. To remedy the situation, the • Concentrations strain and wear. If one puts the O-ring condition of the opposite surface should Gap extrusion – Provided that the de- How should seal damage be docu- • If possible, obtain the safety data on a flat surface, a permanent defor- be thoroughly investigated and the sign is consistent, the factors which mented? sheets mation can be noticed as a twist. The product and purity parameters should can push the O-ring into a gap and

• Take photographs of the installed use of an assembly grease suitable for be documented. lead to a shearing-off include varying PLASTICSENGINEERING seals using the maximum resolu- the material and great care during the pressures, dynamic stress and media tion possible installation of O-rings with an unfa- expansion. Depending on the individ- vorable cross-section to diameter ratio ual case, there are diverse manifesta- is recommended. tions, as shown in the sample illustra- PURITY

tions above. With dynamically & stressed seals, one colloquially refers to “mouse nibbling” in the event of damage. RESISTANCE Image above: Gap extrusion in static Explosive decompression – Cracks in application longitudinal directions can be found Image below: Gap extrusion in dy- on the surface. The elastomer satu- namic application MATERIALS rates itself with gas under pressure. When rapid depressurization occurs, Grease swelling – EPDM swells in min- the amount of gas cannot escape fast eral oil and mineral fat and becomes enough from the matrix of the elas- softer. The damage is evident in shell- tomer and forms gas bubbles (similar like disruptions with relatively round to diver’s paralysis/aeroembolism). edges. Even individual pieces can break off. It is necessary to check whether the correct assembly grease was used. Gen- PRODUCT PORTFOLIO erally, EPDM may only be lubricated with silicone grease. In addition, the product-specific information, such as fat concentration, temperature etc., should be recorded in order to verify the possibility of using EPDM. APPENDIX 10 11 EinführungIntroduction INTRODUCTION MARKET-SPECIFIC SERVICES MARKET-SPECIFIC SERVICES WASHING AND INDIVIDUAL PACKAGING COLLABORATION WITH ASSOCIATIONS TECHNICAL FUNDAMENTALS

ISBT (International Society for Bever- age Technologists) The ISBT is an American organization which consists of about 1,000 mem- MATERIALS

bers worldwide. The focus of its activ- ity is the beverage industry and it offers this industry a highly specialized platform which concerns itself with flavor transfer, packaging, ingredients and other current trends. ELASTOMERIC

ISPE (International Society for Pharma- ceutical Engineering) The ISPE is the world‘s largest non- profit organization for the advance- ment of the pharmaceutical industry and the continuing education of its employees. Founded in 1980, it now Freudenberg‘s commitment to coop- ization. The main task of DIN is the de- has more than 18,000 members in 90

eration with associations is an essen- velopment of consensus-based stand- countries. The ISPE is an independent PLASTICSENGINEERING tial basis of its market specialization, ards, together with the representa- organization, led by experienced in order to be able to turn trends and tives of interested stakeholders, in line professionals from prestigious compa- developments into industry-specific with the times and with the market. nies in the pharmaceutical industry. It solutions at an early stage. Freuden- About 26,000 experts contribute their provides a forum for experts from in- PURITY

berg Sealing Technologies is an active know-how to the work of creating dustry and government, independent & For particularly hygienic applications, Furthermore, Freudenberg provides member in the following associations generally accepted standards. Due to consultants and students. we offer our customers a washing ser- the option to apply a removable label amongst others. a contract with the Federal Republic of vice. It includes thorough, reliable with customer-specific information on THE ADVANTAGES Germany, DIN is recognized as a na- VDMA (Verband Deutscher Maschi- cleaning of seals after production, so the package which can be pasted into AT A GLANCE ASME (American Society of Mechani- tional organization in European and nen- und Anlagenbau [German Engi- RESISTANCE that even the smallest impurities or the service manual. This allows for cal Engineers) international standards organizations. neering Association]) particles are removed. In order to pro- comprehensive and continuous docu- ASME is an American non-profit organ- Today, about 90% of the work of DIN The VDMA is one of the leading service tect the purity, we recommend subse- mentation. • Washing service for hygienically ization that has set itself the goal of be- has an international outlook and ori- providers offering the largest industry quent individual packaging. demanding applications ing a platform for engineers. The ASME entation. network of the capital goods industry MATERIALS For an OEM (Original Equipment Man- • Secure traceability to the point of has about 130,000 members in 151 in Europe. The VDMA represents about Especially when seals are not immedi- ufacturer), the individual packaging the individual seal thanks to single- countries worldwide and invests heav- EHEDG (European Hygienic Engineer- 3,200 mainly medium-sized member ately installed, but put into storage, con- has another important advantage. unit packaging ily in education, which is why a large ing and Design Group) companies, making it one of the lead- tamination can occur which may then When seals are resold to MRO custom- • Rapid identification of individually proportion of members are students. The EHEDG is an interest group for op- ing industrial associations in Europe be introduced into the process. Freuden- ers (Maintenance, Repair and Opera- wrapped seals ASME is divided into many specific erators and suppliers of equipment for with one of the largest memberships. berg offers the possibility to create cus- tions), they do not need to be repacka • Removable labels for easy transfer groups such as Manufacturing and Pro- the production of foodstuffs as well as The VDMA covers the entire process tom packaging. For example, we provide ged. Depending on the order quantity, of the information into the service cessing, Automotive and Bioengineer- for testing institutes and maintenance chain – everything from components the bags with logo, article and batch the individually packaged seals can be manual, to ensure comprehensive ing, thus enabling exchanges between companies. More than 300 member to entire plants, from system suppliers numbers and other individual informa- combined in one shipment. traceability professionals. companies participate in the EHEDG. and system integrators to service pro- PRODUCT PORTFOLIO tion. Thus, the individual package not This gives rise to wide support and viders. The VDMA thus facilitates both only fulfills the purpose of protection DIN (Deutsches Institut für Normung sound instructions for all aspects of industry-specific and intersectoral against soiling and contamination, but [German Institute for Standardization]) hygienic design and manufacture of cooperation. also helps to track components up to DIN develops standards as a service to machinery, and equipment for the the seal and thus comply with the pre- industry, government and society. It is production of safe food and pharma- scribed documentation requirements. a private enterprise institution with ceuticals. the legal status of a non-profit organ- APPENDIX 12 13 Introduction INTRODUCTION THE PROCESS INDUSTRY AND ITS REQUIREMENTS

FOOD INDUSTRY TECHNICAL FUNDAMENTALS MATERIALS

ELASTOMERIC

Jam Chocolate Ice cream In the manufacture of jams and pre- Chocolate production and processing The threat to the sealing material in serves, pieces of fruit and crystalliza- is a particular challenge for seals. The the manufacture of ice cream consists, tion of sugar lead to increased wear. ingredients themselves are challen firstly, of the high fat content of the ice Fruit particles can be pressed into the ging because it is a medium contain- cream mixture, and secondly, of addi- seal and cause leakage in extreme ing fat, which may also contain additives such as pieces of fruit which may

cases. The sealing material used here tives such as nuts, raisins or crisps, press themselves into the seal and PLASTICSENGINEERING must be resistant to the fat- and flavor- causing severe abrasion. This is further cause leakage. Large temperature containing additives and to the partly increased when crystallization of the ranges, e.g. from 0 °C (+32 °F) during aggressive cleaning agents. sugar occurs during the manufactur- the transportation of a cold product up ing process. Additives containing fla- to +140 °C (+284 °F) during steam ster- PURITY

Convenience foods voring agents are also an exclusion cri- ilization, must be mastered reliably by & The diversity of the food industry re- lization), high temperatures prevail, Dairy products Different cleaning media for closed and terion for some materials. Then the the seal. Aside from that, resistance to quires separate consideration of the which present a major thermal load In the dairy industry, influences such as open processes greatly stress seals in temperatures must be taken into ac- CIP/SIP media should also be given. different areas, since the respective for seals. Ultimately, the wort also pro- a high fat content of the product me- the production of ready-made meals, count, some of which are very high in requirements are as varied as they are motes a high degree of wear of the dia must be taken into account in the such as frozen pizza. The production of chocolate production in order to make RESISTANCE numerous. seals. For this reason, the sealing ma- selection of materials. An EPDM mate- powders, pastes, liquids etc. requires the ingredients capable of being pro- terial for this application should be rial which has a very good resistance to individual demands on the sealing cessed. The sealing material must Beer carefully selected. CIP/SIP media, for example, has only lim- materials. For some convenience foods, meet all of these requirements. Hygiene and cleanliness of the pro- ited resistance to fatty media. Clean- excellent low-temperature flexibility is MATERIALS duction facilities as well as a variety of Non-alcoholic beverages ing with alkaline solution is also carried also required, which cannot be met by other challenging factors require a While alcoholic and carbonated drinks out very intensively, i.e. at high concen- every seal material in combination precisely matched sealing technology stabilize themselves due to their ingre- trations and temperatures, in order to with the chemical resistance. in the production of beer. In addition dients, still waters are highly sensitive eliminate the fat and protein residues to the sometimes aggressive cleaning products whose production process re- from the pipes. Steam sterilization processes, the sealing materials must quires great attention with respect to methods are also to some extent used withstand salt deposits (beer scale) hygiene and cleanliness. Because of the much more intensively in dairies than and tolerate a high CO2 content. The use of strong cleaning media in the for instance in breweries. The seals preferred cleaning method uses acid production of fruit juice and because of must be designed accordingly for this. PRODUCT PORTFOLIO at a concentration of up to 3% at +80 flavor-containing additives, it is not °C (+176 °F) in order to remove the salt possible to use just any elastomer or deposits from the pipe system. During plastic material. production and cleaning (steam steri- APPENDIX 14 15 Introduction INTRODUCTION THE PROCESS INDUSTRY AND ITS REQUIREMENTS

PHARMACEUTICAL INDUSTRY TECHNICAL FUNDAMENTALS MATERIALS

ELASTOMERIC

In galenics (pharmaceutical technol- Product formulation by blood frac- Biopharmaceuticals ogy), the medicinal product receives tionation Strict hygiene regulations prevail in its form. For example in this step a In the separation of blood, the various the production of vaccines, enzymes tablet is pressed and coated so that blood constituents are separated by or proteins which also apply to all the medication can be taken. Before a centrifugation. For fractionation, pro- other process components, such as tablet can be pressed, the active ingre- teins are separated from blood plasma seals. With respect to separation of

dients and excipients must be manu- with the admixture of ethanol at –3 °C the active ingredients, purity has top PLASTICSENGINEERING factured according to the recipe, wet to –6 °C (+27 °F to +21 °F). The plasma priority, which requires seals without granulated, and then dried and is cooled to –30 °C (–22 °F) very dead space that provide no basis for ground. For seals, this means that they quickly. Not every seal withstands this germs. As in any hygienic area, clean- have to exist in a “dusty” environ- enormous jump in temperature. To ing is carried out with aggressive me- PURITY

ment. In addition, no components of avoid contamination, seals for this dia using the CIP/SIP method in order & The purity requirements with respect material supplier to the patient in the Production of finished medicinal the seal that could negatively alter the area must also be designed free of to clean the plant free of residues. to processes and products in the phar- event of quality problems. Seals are a products pharmaceutical product in its compo- dead space and be resistant to CIP and When mixing the ingredients, cooling maceutical industry require sealing not to be underestimated part in this During the production of chemically sition or color must be allowed to mi- SIP cleaning processes and cleaning is required which involves cold- solutions that reliably prevent process process because they partly have di- produced drugs API (Active Pharma- grate into the production process. The media. Furthermore, defined emission resistant sealing materials. It is also RESISTANCE contamination, beyond their respec- rect contact with the media. And with ceutical Ingredients) or in vivo diag- seal must also protect the pharmaceu- limits must not be exceeded. Freuden- important to protect the pharmaceu- tive media resistance. the appropriate sealing technology, nostics (contrast agents, biomarkers), tical product against external influ- berg offers special sealing materials tical product during filling in order to the risk of contamination and thus of chemicals and toxic substances are ences in the sterile environment. for these aseptic high-purity processes prevent process contamination. Freudenberg has developed special costly and time-consuming retracing used. During organic synthesis, high in the pharmaceutical industry which MATERIALS materials and seals, such as white can be reduced. temperatures and high pressures oc- are resistant to low temperatures and EPDM, Fluoroprene® XP and Simriz® cur, whereas cooling takes place dur- chemicals. (FFKM), which comprehensively satisfy A particular challenge for this industry ing the precipitation of the product. both the demanding operating condi- lies in the versatility of its processes The temperature range is correspond- tions and simultaneously support the where many different demands are ingly quite large. To ensure the hy- hygienic processes. made on the components. To illustrate giene and purity of a batch, special at- this, three areas and their peculiarities tention must be paid to the documen- In the pharmaceutical industry, the are presented in this context. tation of the processes. Thus, the synthesis of products takes place from ingredients of the sealing materials PRODUCT PORTFOLIO basic chemicals. The basic and reactive must be known too, or appropriate chemicals need to be extra pure so confirmation of biocompatibility ac- that no unwanted by-products are cording to USP Chapter 88 (Class VI) generated in the synthesis. In general, must be available. production is done in batches in order to ensure traceability from the raw APPENDIX 16 17 Introduction INTRODUCTION THE PROCESS INDUSTRY AND ITS REQUIREMENTS

CHEMICAL INDUSTRY TECHNICAL FUNDAMENTALS MATERIALS

ELASTOMERIC

Processing inorganic basic chemicals for heating the bottom product, for ex- Fine and specialty chemicals In the field of inorganic chemistry, nu- ample, there are temperatures of up to In the handling of fine and specialty merous completely different applica- +600 °C (+1,112 °F) with simultaneous chemicals, seals with an especially tions occur. In addition to manufactur- pressure and vaporization. During the high thermal and chemical resistance ing, processing, separation, and many subsequent cracking of the resulting are required. In addition to the use of other process steps, particularly ex- gas, the temperatures increase further harsh and sometimes toxic media,

treme parameters always prevail to +850 °C (+1,562 °F). The real chal- temperatures from +300 °C (+572 °F) PLASTICSENGINEERING when handling inorganic basic chemi- lenge for seals is, however, in the in- down to the low-temperature range cals. In addition to aggressive, to some tense temperature changes that occur are not uncommon in crystallization extent also toxic media, high pres- during the subsequent cooling of the processes. The material and the seal sures are prevalent. The seals used gas. The seal must also withstand the made from it must be able to cope PURITY

here must have a broad operating pressure increase during the compres- with this. & The chemical industry is concerned Most of these media require excellent A wide range of thermally and chemi- temperature range. Corresponding sion of the cracked gas to about 30 bar. with both the production of basic and comprehensive resistance charac- cally-resistant flat gaskets is available to the multifaceted applications, The absorption of gases requires the Production of detergents and per- chemicals such as ammonia, acids, al- teristics of the seals used in order to especially for the pipes and flange con- high-quality, robust and chemically- use of chemicals, in particular caustic sonal care products kalis and simple hydrocarbons, and ensure smooth operational processes, nections that are frequently used in resistant materials are required. To solution. The production of detergents and per- RESISTANCE with the further processing of these but also in equal measure robust fea- the chemical industry, as well as uni- meet the high standards of the statu- sonal care products, whose require- materials into high-quality products. tures to withstand the sometimes ex- versally applicable secondary seals for tory emission values for these pro- Polymer production ments are similar to those of the Thus, ammonia is obtained from ni- tremely high pressures. the mechanical seals used in pumps. cesses, the seal must make a signifi- During the handling of polymers (plas- pharmaceutical industry, makes espe- trogen in order to produce a fertilizer cant contribution to this. tics), no particularly high demands in cially high demands in terms of the MATERIALS from the former. For example, crude For this, Freudenberg offers highly-re- The versatility of the processes in the terms of pressure and temperature purity and hygiene of all process me- oil is used to produce simple hydro - sistant sealing solutions made from manufacture and processing of chem- Handling petrochemicals and deriva- resistance prevail most of the time. dia used. In addition to the lack of carbons from which high-grade plas- synthetic materials such as PTFE, as icals requires separate examination of tives Only in some cases, for example, dur- dead space of the sealing point, the tics are then synthesized. well as a wide range of high-quality individual areas. A summary of the A typical application in the petrochem- ing the termination of a reaction, tem- sealing materials must have the prev- elastomeric materials such as perfluo- main applications is presented on the ical industry is so-called steam crack- peratures as low as –80 °C (–112 °F) alent approvals and clearances of the roelastomers like Simriz®, EPDM or following page. ing. In addition to being resistant to may occur, requiring the use of spe- pharmaceutical industry and be able FKM when elastomeric flexibility is re- aggressive chemicals, seals must with- cially developed sealing solutions. In to withstand the sophisticated CIP/SIP quired in less aggressive production stand high temperatures and pres- addition, the use of solvents can at- cleaning media and processes. environments. sures. In a convection-capable furnace tack conventional sealing materials. PRODUCT PORTFOLIO APPENDIX 18 19 INTRODUCTION BASIC MATERIALS TESTING TECHNICAL FUNDAMENTALS

Hardness, compression set (DVR) or the volume change of a In sealing technology, the N and M processes are mainly used. material in use are important parameters which affect the The micro hardness measurements on seals are not directly sealing function but also the lifetime of the seal. Precise comparable to the IRHD values, procedure N and the Shore A statements about the behavior of the material are there- values on test plates. MATERIALS

fore essential. Freudenberg uses a variety of testing procedures and methods for this. Volume change measurement Seals come into contact with a variety of media such as liq- Hardness tests uids and gases which influence the elastomer materials in One of the most important parameters in rubber technology different ways. A distinction is made between the chemical is the hardness. The nominal hardness is specified for all and physical effects of media. If an elastomeric compound ELASTOMERIC Freudenberg materials in the materials designation before is chemically affected, the properties are irreversibly the base elastomer (e.g. 70 EPDM 291) and determined using changed. The splitting of the cross-linking points between various standardized procedures. In the process, the param- the molecular chains leads to a softening and loss of elas- eter which is measured is always how far a given test speci- ticity of the material concerned. The formation of additional men that penetrates into the material under a defined force. cross-linking points entails hardening leading to embrittle- ment of the material. Certain media can also attack the mo- Shore A pursuant to DIN 53 505 – The method according to lecular chains of the elastomer and destroy them. Physical DIN 53 505 was developed by Albert F. Shore in the 1920s processes can be roughly divided into two groups: and is the most commonly used method for measuring

hardness in elastomers. The surfaces of the test specimen PLASTICSENGINEERING must be flat and coplanar. The value is read after a holding a. Absorption of the medium by the elastomer time of three seconds. The test according to Shore A is used b. Extraction of soluble components of the mixture from mainly in materials development and in the clearance of the elastomer mixture batches. It can only be used on molded parts if they PURITY

have a sufficient thickness and flat supporting surfaces for & the measurement. Shore A is suitable for hardnesses be- TECHNICAL tween 10 and 90. Above 90 Shore, Shore D measurements must be made, which, however, are not applied in case of FUNDAMENTALS elastomers. RESISTANCE 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 MATERIALS standard:

1. N (for hardnesses between 30 and 95 IRHD) 2. H (for hardnesses between 85 and 100 IRHD) 3. L (for the range from 10 to 35 IRHD) 4. M (micro hardness for the testing of small or thin-walled samples) PRODUCT PORTFOLIO APPENDIX 20 21 EinführungTechnical fundamentals INTRODUCTION TECHNICAL FUNDAMENTALS

Compression set measurement/elasticity Density measurement The compression set refers to the ability of a material, after The density of vulcanized rubber is a specific characteristic. a certain time of contact with the medium in question, to Through a simple, expeditious measurement of this para generate a sufficient restoring force on the sealing surfaces meter, first conclusions regarding the compound used can MATERIALS

and thus ensure the tightness. In a newly manufactured be drawn. In the preparation of a mixture, the density value seal, the compression set is a measure for assessing the vul- serves as an indication whether all components of the mix- canization and the degree of cross-linking. The lower the ture were added properly. Similarly, the density measure- compression set value, the better the cross-linking and the ment precedes all other tests in the analysis of unknown longer the expected life of the mixture. It should be noted mixtures in order to limit the number of possible materials. that the compression set is not an absolute value, but must In general, the density is measured using the buoyancy-flo- ELASTOMERIC always be considered in comparison with the initial or tar- tation method. According to the “Archimedean principle”, a get values. The compression set is determined according to body experiences a buoyancy force when immersed in a liq- DIN ISO 815 using the following formula: uid. This is calculated from the difference of the weight in air and the weight in liquid. Since the buoyancy force is

Both changes can take place separately but also in parallel. Every volume change, whether swelling or shrinkage, is as- DVR [%] = (h0 – hs) / (h0 – h1) x 100 % equal to the weight of the fluid volume displaced by the These processes are detected by measuring the change in vol- sociated with changes in the physical properties such as body, the volume of the test specimen, regardless of its ge- ume occurring thereby. If an increase in volume is measured, hardness, elasticity, tensile strength and elongation at With: ometric shape, can be derived. The specific density can be the absorption of medium takes precedence, while a decrease break. Therefore, the determination of the volume change h0 = height of the test specimen calculated on the basis of the volume determined in this in volume means a predominant loss of mixture components. after a defined storage period (time and temperature) is a h1 = height of the compressed specimen way and the weight in air.

Swelling processes are usually reversible, which means that the parameter in order to measure and evaluate the stability of hS = height of the relieved specimen PLASTICSENGINEERING absorbed medium can also leave the elastomer again when elastomeric compounds in the media used. Note: In the ρ = [GL / (GL – GF)] x ρF switching to another product. food industry, not only must the production media (e.g. beer, mineral water, dairy products etc.) be tested for A number of conditions must be met during the measure- With: The size of the volume change depends on five factors: their compatibility with the sealing material, but so too ment. Thus, the time between the vulcanization of the test ρ = density to be determined PURITY

must the cleaning and sterilization media used in the pro- specimen and the compression set test should be at least 16 GL = weight in air &

1. Type of medium cesses. hours. The compression is defined and generally amounts to GF = weight in fluid 3 2. Composition of the elastomeric compound 25%. The sample is stored in its apparatus in air (or a me- ρF = density of the fluid (in case of water approx. 1 g/cm ) 3. Interaction parameters (temperature, time) Sequence of the tests according to DIN ISO 1817: dium) for a predetermined period of time at a specified tem-

4. Geometric form (thickness) of the seal perature and removed from the apparatus after expiry of RESISTANCE 5. Stress condition of the seal (in the case of stretched parts, 1. The volume of the test specimen (the seal or a portion the testing period. 30 minutes after removal, the thickness the impact is greater, in the case of compressed parts lower) thereof) is determined is measured again. Please note that compression set values 2. The test specimen is stored in the medium according to are only comparable if the parameters are identical: Due to the cross-linked structure of the elastomers, swelling the standard or to customer specifications MATERIALS is limited, i.e. it no longer changes after reaching a limit 3. At the end of the storage period (and after cooling down), • Deformation (default: 25%) value. the volume of the specimen is measured again • Duration of the deformation (default: 24 or 72 hours) 4. The result is expressed as a percentage of the initial state • Temperature during the deformation • Storage medium (standard: air) • Form of the test specimen

F PRODUCT PORTFOLIO

Testing the F compression set APPENDIX 22 23 Technical fundamentals INTRODUCTION STORAGE CONDITIONS TECHNICAL FUNDAMENTALS

To meet these requirements, all container, cover and packaging materials must be free of substances that have a degradation effect on elastomers. Therefore, primarily PE-coated kraft paper, aluminum foil or opaque polyethyl- MATERIALS

ene film (minimum thickness 0.075 mm) are used.

STORAGE EXTENSION GROUP MATERIALS PERIOD IN PERIOD IN

YEARS YEARS ELASTOMERIC 1 NR, AU, EU, SBR 5 2 NBR, HNBR, XNBR, ACM, 2 7 3 AEM, ECO, CIIR, CR, IIR FKM, FFKM, VMQ, Tensile test Resistance to tear propagation 3 PVMQ, FVMQ, EPDM, 10 5 Tensile tests are used to determine the tear strength, The tear propagation resistance is a measure of the sen Fluoroprene® XP, CSM tensile strength, elongation at break, and the stress val- sitivity of elastomers in the event of cutting and tearing ues of elastomeric materials. The test specimens used for damage. The most common test to determine tear propa- this purpose are usually tensile bars or standardized rings gation resistance is the strip test according to DIN ISO 34-1 The storage and the recording of the time in storage of vul-

with rectangular cross-sections. These are stretched at a (DIN 53 507). In this case, a longitudinal cut is made in the canized rubber products are described in ISO 2230. In this PLASTICSENGINEERING constant speed to break. In the tensile test according to material to be tested, the two half-strips are clamped in a Articles made of rubber are subject to aging. Modern elas standard, the elastomer products are divided into three DIN 53504, as many points as possible of the force-length pulling machine and pulled apart. The force subtended by tomer materials are more stable and have longer service groups to which different storage times are assigned. change curve (tensile force with corresponding change in the test specimen to the tear propagation is measured in lives than their predecessors from earlier generations, both length of the sample) are recorded. relation to the sample thickness. regarding the base rubber and also as a result of suitable PURITY

mixing additives. & The following values can be calculated from the experiment: A further testing method is the angle test specimen according to DIN ISO 34-1 (DIN 53 515). Here, an incision is The aging process depends largely on the following factors: 1. The tear strength is the quotient of the force achieved made in an angled (“bent”) sample manufactured in a

at the moment of rupture and the initial cross-section of form, and the sample is similarly pulled apart using a pull- • Temperature RESISTANCE the specimen ing machine. The measured values do not need to correlate • Thermal radiation 2. The tensile strength is the quotient of the measured with the stress values determined in the tensile test. Since • Solar radiation maximum force and the initial cross-section of the speci- the results of the tear propagation resistance test strongly • Humidity men. Tear strength and tensile strength are generally the depend on the specific test conditions and particularly on • Relative air humidity MATERIALS same in elastomers, if the measurement is performed at the shape of the sample, it is crucial that the test meth- • Ozone and ionizing radiation room temperature or above od and the sample shape are always indicated when the • Stress condition of the component 3. The elongation at break is the ratio of the length change results are stated. achieved at the moment of rupture to the initial length Rules for the storage of elastomer products can be derived 4. The stress value is defined as the quotient of the tensile from this: force existing when a certain elongation is achieved and the initial cross-section 1. The storage temperature must be below +25 °C (+77 °F) 2. There must be no direct heat sources in the storage area The three characteristics tear strength, 100% stress value 3. The seals must not be exposed to direct sunlight PRODUCT PORTFOLIO and elongation at break are indicated on the material data 4. Exposure to ozone and ionizing radiation must strictly be sheets of the Freudenberg elastomers. They describe the excluded behavior of the respective material to tensile stress. 5. The seals must be stored without stress, as far as possible 6. The relative air humidity has to prevent condensation in case of temperature changes in the store room APPENDIX 24 25 26 APPROVALS, EXAMINATIONS, COMPLIANCES Technical fundamentals

PHARMA- CEUTICAL FOOD AND BEVERAGE INDUSTRY DRINKING WATER INDUSTRY INDUSTRY W270 APPROVALS/CONFORMITIES KTW – materials in drinking water drinking in –materials KTW ACS (AFNOR XO P41-250) (AFNOR ACS WRAS (BSI 6920 and BS 2494) BS 6920 and (BSI WRAS Ö Norm B5014 Ö Norm KIWA (Direktive Doc. 94-01) Doc. KIWA (Direktive NSF 61 NSF AS/NZS 4020:2005 AS/NZS USP Chapter 87 Chapter USP 1935/2004 Direktive EU USP Chapter 88 – USP Class VI – 121 °C –121 VI Class –USP 88 Chapter USP 10/2011 (VO) EU BfR 21. recommendation for rubbers for recommendation 21. BfR silicone materials silicone for 15. recommendation BfR Areté 9. Nov. 1994 Areté ADI free – Animal derived ingredient free ingredient derived –Animal free ADI FDA NSF 51 NSF 3-A ® Sanitary Standards Sanitary Germany Germany France Great Britain Great ÖAustria (also accepts the KTW test) KTW the accepts (also ÖAustria Nietherlands USA Australia USA (also accepted in Europe) in accepted (also USA Europe USA (also accepted in Europe) in accepted (also USA Europe Germany Germany France USA (also accepted in Europe) in accepted (also USA Worldwide USA (also accepted in Europe) in accepted (also USA USA AREA OF APPLICATION OF AREA Recommendation LFGB (§ 2 para. 6 sentence 1 no. 1) 1no. 6sentence (§ 2para. LFGB Code Feed and Food German sation) normali de française (Association XO P41-250AFNOR Teil 1–3 BSI 6920 and BS 2494 BS 6920 and BSI ÖNORM B5014/part 1 B5014/part ÖNORM Direktive Doc. 94-01 Doc. Direktive NKB rules + DS/EN standards +DS/EN rules NKB NSF Standard 61 Standard NSF USP 29 USP 4020:2005 AS/NZS USP 29 USP 1935/2004 Reg. EU EU Reg. 10/2011 Reg. EU LFGB (German Food and Feed Code) Feed and Food (German LFGB LFGB (German Food and Feed Code) Feed and Food (German LFGB FDA 177.2600 21 CFR EMEA/410/01 rev2 • Perfluoroelastomers) • • Perfluoroelastomers) •

FDA 177.1500 21 CFR (Plastics) FDA 177.2600 21 CFR (Elastomers & FDA 177.1500 21 CFR (Plastics) FDA 177.2600 21 CFR (Elastomers & LEGAL BASIS LEGAL - 5 years 5 years 5 years 5 years 5 years 5 years annual with audit with annual 5 years unlimited unlimited unlimited unlimited unlimited unlimited unlimited 5 years with annual audit annual with 5 years unlimited unlimited 5 years with annual audit annual with 5 years VALIDITY PERIOD VALIDITY Material Product Material Material Material and Product and Material Material and Product and Material Product Material and Product and Material Material and Product and Material Material Material Material Product and Material Material Material Material Material Material Material Material Material TESTING ON TESTING ingredients) ingredients)

organisms (in vitro) vitro) (in organisms organisms (in vitro) (in organisms depending on the contact time) contact the on depending depending on the contact time) contact the on depending •

• •

• Microbiological examination • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

s t s e t n o i t a r g i M Migration tests Migration level carbon) organic (total TOC loss Chlorine list positive BfR TOC level TOC list Positive Cytotoxicity Material composition Migration tests Migration Cytotoxicity Manufacture Material composition Migration tests Migration level TOC loss Chlorine list Positive Migration tests Migration tests Toxicity Microbiological examination Material composition Toxicity tests Toxicity Microbiological examination Material composition Migration tests Migration tests Toxicity Manufacture composition Material Migration tests tests Migration list Positive Testing of the compatibility on living living on compatibility the Testing of Testing of the compatibility on living living on compatibility the Testing of tests Migration list Positive BfR positive list positive BfR Migration tests (subdivided into categories, into (subdivided tests Migration BfR positive list positive BfR Migration tests (subdivided into categories, into (subdivided tests Migration Positive list Positive Migration tests Migration list FDA positive Testing of the formulation for animal- for formulation the Testing of Tests nitrosamines, formaldehyde Remains peroxide content peroxide Remains Migration tests Migration list FDA positive Toxicity tests Toxicity list Positive TESTING CRITERIA TESTING derived 27

APPENDIX PRODUCT PORTFOLIO MATERIALS RESISTANCE & PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIALS TECHNICAL FUNDAMENTALS INTRODUCTION Technical fundamentals INTRODUCTION HYGIENIC DESIGN FRICTION OPTIMIZATION TECHNICAL FUNDAMENTALS

The selection of materials according to the operating Attention must also be paid to the absence of any dead Reasons for a necessary friction reduction in elastomer conditions, taking into account the required purity with space in the event of dynamic seals, such as rotary shaft products: the corresponding conformities, is only the first step seals. While rotary shaft seals are very difficult to clean, the towards fulfilling the hygiene requirements. HTS II 9539 with no dead space and with its protruding lip • Reduction of the adhesion of seals to each other or to MATERIALS

seal made of PTFE is barely subject to contamination and the container walls. This is particularly necessary in case The most important duty of every plant operator is to very easy to clean. of automatic assembly. O-rings, for example, should not know and to obey all legal requirements and procedures “stick” to each other, but glide easily to ensure a proper product quality. Every food, pharmaceu STANDARDIZED CONNECTIONS • Reduction of friction during installation of seals. For ex- tical and cosmetic product must be clean and not endanger ample, if O-rings must be pushed over shafts or shoul- the health of the consumer in any way. ders, they can easily become twisted in case of excessive ELASTOMERIC friction and therefore also lie twisted in the groove. This A plant constructed according to hygienic design is charac- increases the risk of leakage terized by good cleanability so that contamination by mi- • Reduction of friction in dynamic applications with the croorganisms cannot occur. The more the use of the auto- aim to increase the service life of the seal mated CIP and SIP (Cleaning In Place/Sterilization In Place) processes spreads, the less equipment needs to be disas- Dusting with talc (magnesium silicate hydrate) sembled. This eliminates the possibility of visual control. HTS II 9539 VL DIN 11864 Treatment with talc prevents the seals sticking to each other Version with no dead space Aseptic O-ring screw It must therefore be possible to trust automated cleaning and protruding sealing lip connection and to container walls. It simplifies installation, but is not suit- to achieve a good result and it must be certain that there for applications according to • Metallic stop able as a durable friction reduction for dynamic applications.

are no dead spaces in which product residues can collect hygienic design • Leak-free Automatic assembly equipment can be contaminated by talc. PLASTICSENGINEERING initially and microorganisms can settle later. This means • Aseptic and hygienic The friction of elastic materials on hard surfaces differs connections that rectangular grooves with a degree of filling of about significantly from friction processes between two metals. Immersion in emulsions 80% are not permitted. Hygienically designed grooves are The same effect as in talc coating occurs by wetting the sur- narrower and the evasion spaces for sealing materials are European Hygienic Engineering and Design Group The known states describe the conditions during the fric- face with emulsions. The coat application here does not rest PURITY

correspondingly limited. The EHEDG is an interest group for operators and suppliers tion of sealing materials only insufficiently: loosely and in powder form (and thus dusty) on the surface, & of equipment for the production of food, pharmaceuticals but is liquid and adheres to the surface. Therefore, the con- Elastomers and steel behave differently with respect to and cosmetics as well as for test institutes and mainte- • Fluid friction (the two gliding partners are completely tamination tendency is lower than for talc dusting. production and temperature. Elastomers have significant- nance companies. Freudenberg is a member of the EHEDG separated from each other by a lubricant film) ly greater manufacturing tolerances so that in the event and is very involved in advancing the interests of hygienic • Mixed friction (the gliding partners touch each other RESISTANCE of an incorrect design an overfilling of the groove may in design, including through active participation in the devel- only on the roughness peaks) extreme cases already exist during installation. Elastomers opment of recommended practice. • Dry friction (no lubricant available) are incompressible and need an allowance for expansion. The thermal expansion of elastomers exceeds that of steel Heat exposure of O-rings Due to the elasticity of the sealing material, the elastomer MATERIALS by a factor of 15 and must be taken into account. As a re- adapts to the roughness of the mating surface, which in- sult of overly narrow gaps, extreme stresses can arise dur- creases the friction force significantly. The softer the elas- ing cooling, resulting in shearing of the material. tomer 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 20 °C (68 °F) >100 °C (212 °F) 20 °C (68 °F) those of classical friction between two solid bodies. PRODUCT PORTFOLIO APPENDIX 28 29 Technical fundamentals INTRODUCTION TECHNICAL FUNDAMENTALS

Lubrication with grease or oil Coating with PTFE varnishes If requested, seals can be delivered lightly greased or oiled. PTFE coatings adhering firmly to the surface of elastomers It is important to note that the assembly equipment may provide a high degree of friction reduction. However, the be soiled by the greases or oils. In addition, the compatibil- relatively soft PTFE layer is lightly abraded in dynamic con- ity of the greases and oils must be matched with the seal- tinuous operation. Despite abrasion of the coating, a cer- ing materials. In a dynamic application, the seals should be tain amount of friction reduction is maintained since the lubricated only shortly before assembly, because this will PTFE burrows into the valleys of the roughness profile of achieve good long-term lubrication. the mating surface and fills them. The slide-active PTFE layer is not as elastic as the base material, however. Thus, the RFN treatment (Reduced Friction by Nanotechnology) PTFE layer forms cracks in the event of greater elongation ELASTOMERIC MATERIALS In this procedure developed by Freudenberg New Tech- which may lead to leaks or cause the layer to flake off. nologies, the surface properties can be set in such a way that the adhesion and thus the jamming of the components Halogenation is significantly and permanently reduced. Furthermore, the In this method, the surface is hardened in the micro range surface can be designed extremely hard and thus with and thus does not get pressed as strongly into the rough- low-wear and low-friction properties so that RFN-treated ness profile of the mating surface. The result is a better products are predestined for dynamic applications. Due to gliding property. However, the layer is abraded in the event the special process, the materials retain their elastic behav- of high dynamic stress, so that the seals lose their gliding ior and dimensional stability. RFN treatment has approval property. The method is very well-suited for the automat-

for drinking water applications and is resistant to common ed assembly of O-rings since the rings are dry and pow- PLASTICSENGINEERING CIP/SIP cleaning agents. der-free. The devices remain clean and free of abrasion over a very long period of time. PURITY 1,2 ELASTOMERIC MATERIALS & 1,0 Untreated RESISTANCE 0,8

0,6 μ MATERIALS

0,4 RFN-treated

0,2

0 0 200 400 600 800 1000 1200 Glide path (m) PRODUCT PORTFOLIO APPENDIX 30 31 32 OVERVIEW OF ELASTOMERIC MATERIALS Elastomeric materials MATERIAL TYPE SIMRIZ® FKM FLUOROPRENE® XP VMQ HNBR NBR EPDM 70 EPDM 33170 EPDM 70 EPDM 291 70 EPDM 75 176643 VMQ 70 EPDM 335 70 EPDM 85 EPDM 332 EPDM 85 60 EPDM 334 EPDM 60 253815 70 EPDM 25335675 EPDM 292 EPDM 85 70 EPDM 21767670 EPDM 302 EPDM 85 391 70 EPDM 75 HNBR 231142 75 HNBR 85 NBR 436 NBR 85 70 FKM 37508 70 FKM 41 XP 75 Fluoroprene 216553 HNBR 85 75 Fluoroprene XP 45 XP 75 Fluoroprene 43 XP Fluoroprene 85 75 Simriz 75 Simriz 290 EPDM 60 70 NBR 438 70 NBR 85 Simriz 85 Simriz 80 75 Simriz 70 Simriz 180497 75 FKM 40 XP 75 Fluoroprene 166898 78 VMQ 254067 70 HNBR 70 117055 VMQ 75 Simriz NAME ® ® ® ® ® ® ® 497 495 494 491 506 496 492 black black black black black white black black blue black sblack black black red blue green blau blue black black black blue blue light green black transparent black red white black black black black COLOR

peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic bisphenolic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic bisphenolic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic peroxidic LINKING CROSS-

SHORE A SHORE 75 ±5 75 ±5 70 ±5 85 ±5 85 60 ±5 60 70 ±5 75 ±5 ±5 85 70 ±5 ±5 85 70 ±5 75 ±5 88 ±5 88 75 ±5 75 ±5 ±5 85 75 ±5 ±5 85 65 ±5 65 70 ±5 75 ±5 75 ±5 78 ±5 70 ±5 70 ±5 76 ±5 80 ±5 80 85 ±5 85 75 ±5 75 ±5 75 ±5 70 ±5 72 ±5 72 HARD NESS NESS - RANGE IN AIR °C AIR IN RANGE TEMPERATURE –10 +230 to °C –15 +230 to °C –15 +250 to °C –40 bis +200 bis –40 –25 bis +200 –25 bis –15 +200 bis –40 to +200 to –40 –40 to +150 to –40 –40 to +150 to –40 –40 to +150 to –40 –40 to +150 to –40 +150 to –40 –40 to +150 to –40 +150 to –40 +150 to –40 –40 to +150 to –40 –50 to +200 to –50 –30 to +140 to –30 –30 to +140 to –30 –35 to +140 to –35 –25 +200 to –15 +200 to –25 +140 to –15 +200 to –15 +200 to –25 +100 to –25 +100 to –20 +230 to –15 +325 to –15 +230 to –15 +230 to • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

s g n i r - O s g n i r - O

s g n i r - O s g n i r - O s g n i r - O s g n i r - O s g n i r - O s g n i r - O s g n i r - O s g n i r - O

s g n i r - O

s g n i r - O s g n i r - O Moulded parts Moulded Clamp seals Clamp Hygienic Usit Hygienic Diaphragms Diaphragms Clamp seals Clamp CNC machined CNC Molded part Molded parts Molded parts Molded parts Molded parts Hygienic Usit Hygienic Molded parts seals Clamp Molded parts Molded parts Molded parts Cords Profiles Usit Hygienic Diaphragms seals Clamp Molded parts Molded parts Molded parts Molded parts Molded parts Molded parts Molded parts Molded parts O-Ringe Diaphragms on request on ® ® ® PRODUCTS s g n • i r - O • • • • • • • • • • • s g n i r - O

d e n i h c a m C N C

Diaphragms Simmerringe machined CNC Diaphragms Hygienic Usit Hygienic CNC machined CNC O-rings Molded parts Diaphragms ® • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

A - 3 A - 3 A - 3 A - 3 A - 3 A - 3

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EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR 177.2600 21FDA CFR 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR 177.2600 21FDA CFR 177.2600 21FDA CFR 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR 177.2600 21FDA CFR EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR 2023/2006 and 1935/2004 (VO) EU 2023/2006 and 1935/2004 (VO) EU EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR 177.2600 21FDA CFR 177.2600 21FDA CFR 177.2600 21FDA CFR EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU USP Ch. 87 and Ch. 88 – Class VI – 121 °C –121 VI –Class 88 Ch. and 87 Ch. USP 2023/2006 und 1935/2004 (VO) EU 2023/2006 and 1935/2004 (VO) EU EU Reg. 1935/2004 and 2023/2006 and 1935/2004 Reg. EU FDA 177.2600 21 CFR EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR 2023/2006 und 1935/2004 (VO) EU 177.2600 21FDA CFR 177.2600 21FDA CFR 177.2600 21FDA CFR FDA 21 CFR 177.2600 21FDA CFR EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU 177.2600 21FDA CFR ® ® ® ® ® ® ® ® ® ® ® ® Sanitary Standards Class II Class Standards Sanitary II Class Standards Sanitary II Class Standards Sanitary Sanitary Standards Class II Class Standards Sanitary Sanitary Standards Class I Class Standards Sanitary II Class Standards Sanitary Sanitary Standards Class I Class Standards Sanitary I Class Standards Sanitary I Class Standards Sanitary I Class Standards Sanitary I Class Standards Sanitary II Class Standards Sanitary FOOD/PHARMACEUTICAL • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

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Arreté 9. 1994 Nov. Arreté EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU BfR XV BfR EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU 2023/2006 and 1935/2004 (VO) EU °C –121 VI –Class 88 Ch. and 87 Ch. USP 87 Ch. USP NSF 51 NSF Arreté 9. 1994 Nov. Arreté °C –121 VI –Class 88 Ch. and 87 Ch. USP 9. 1994 Nov. Arreté 51 NSF °C –121 VI –Class 88 Ch. and 87 Ch. USP USP Ch. 87 and Ch. 88 – Class VI – 121 °C –121 VI –Class 88 Ch. and 87 Ch. USP 2023/2006 und 1935/2004 (VO) EU Arreté 9. 1994 Nov. Arreté BfR XV BfR °C –121 VI –Class 88 Ch. und 87 Ch. USP EU (VO) 1935/2004 and 2023/2006 and 1935/2004 (VO) EU NSF 51 NSF (Cognac) BNIC 9. 1994 Nov. Arreté (Cognac) BNIC 9. 1994 Nov. Arreté °C –121 VI –Class 88 Ch. USP Arreté 9. 1994 Nov. Arreté 2023/2006 und 1935/2004 (VO) EU °C –121 VI –Class 88 Ch. and 87 Ch. USP 2023/2006 und 1935/2004 (VO) EU 9. 1994 Nov. Arreté 2023/2006 and 1935/2004 (VO) EU 2023/2006 and 1935/2004 (VO) EU USP Ch. 87 und Ch. 88 – Class VI – 121 °C –121 VI –Class 88 Ch. und 87 Ch. USP USP Ch. 87 and Ch. 88 – Class VI – 121 °C (250 °F) VI – Class 88 Ch. 87 and Ch. USP USP Ch. 87 and Ch. 88 – Class VI – 121 °C –121 VI –Class 88 Ch. and 87 Ch. USP ® ® ® ® Sanitary Standards Class II (in Plan) (in II Class Standards Sanitary Sanitary Standards Class II (in Plan) (in II Class Standards Sanitary Sanitary Standards Class I Class Standards Sanitary Sanitary Standards Class I Class Standards Sanitary • • • • • • • • • • • • WRAS ACS 61 NSF ÖNORM B5014-1 ÖNORM WRAS ACS 61 NSF WRAS ACS 61 NSF ACS 61 NSF DRINKING WATER DRINKING • • • • • • • • • • • • W 270 UBA B5014-1 ÖNORM AS/NZS KTW W 270 UBA W 270 UBA B5014-1 ÖNORM W 270 Plan) (in UBA • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

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APPENDIX PRODUCT PORTFOLIO MATERIALS RESISTANCE & PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIALS TECHNICAL FUNDAMENTALS INTRODUCTION Elastomeric materials INTRODUCTION EPDM TECHNICAL FUNDAMENTALS

100 The excellent resistance to water and aqueous systems 70 EPDM 70 EPDM For the synthesis of many active ingredients, polar solvents makes EPDM (ethylene-propylene-diene rubber) the most RULES AND STANDARDS such as ethanol or isopropanol are used. EPDM is the most 291 253815 90 widely used material in food production and processing, suitable material for this. The exceptions are non-polar sol- with a share of about 70%. FDA-compliant (CFR 21 Part 177.2600) + + vents and aliphatic products, such as water-in-oil emulsions 80 (W/O emulsions). In this case, a fluorinated elastomer should EU Reg. 1935/2004 General properties + + be used. EU Reg. 2023/2006 70 • Very good resistance to aging, ozone and light Fluoroprene® XP ® EPDM in the chemical industry • High heat and cold resistance, approx. –50 °C to +150 °C 3-A Sanitary Standards Class II* + + 60 (–58 °F to +302 °F) In the chemical industry, EPDM is recommended where • Good tensile elongation and strength USP Ch. 87 (in vitro) polar solvents, aqueous salt solutions, diluted acids and ELASTOMERIC MATERIALS + + % in Fat 50 USP Ch. 88 (in vivo), Class VI – 121 °C • Very high abrasion resistance + + alkaline solutions are used. (250 °F) • Very good resistance to water and to polar and oxidative 40 media NSF 51 + EPDM in contact with drinking-water • Excellent elastic behavior 30 Freudenberg developed new EPDM-materials on the basis EPDM of the new elastomer guideline of the Federal Environ- * Note: mental Agency. These materials unite a lot of drinking-wa- • Class II because of the bad resistance against fat and oil (max. 20 ter-approvals. In addition they are conform to the guide- 70 EPDM 291 (black) and 70 EPDM 253815 (white) 8 % butterfat at +70 °C (+158 °F)) • Class I in aqueous CIP/SIP media at +82 °C (+180 °F) 10 lines of FDA and EU 1935/2004. Application profile • Class I in sterilization at +149 °C (+300 °F)

EPDM seals exhibit good chemical resistance in hot wa- 0 Products and materials PLASTICSENGINEERING ter, steam, acids and alkaline solutions. They are very well 0 10 20 30 40 50 60 70 80 90 • O-rings made of 70 EPDM 291, 85 EPDM 292, suited for use in all polar media and therefore also in CIP/ EPDM in the dairy industry Temperature in °C 70 EPDM 253815 and 85 EPDM 332 SIP media. CIP media are diluted acids or alkaline solu- EPDM cannot be used in every product containing fat, EPDM in the beverage industry • Molded parts made of 70 EPDM 291, 85 EPDM 292, 70 tions with cleaning additives. In SIP media, disinfectants, which limits but does not completely rule out its use in the EPDM is recommended for applications in the beverage in- EPDM 253815, 70 EPDM 335 and 85 EPDM 302 PURITY

steam or oxidizing media (e.g. peracetic acid) or polar or- dairy industry. According to DIN 11483, dealing with dairy dustry, since it shows very good performance in the aque- • Butterfly valve seals made of 75 EPDM 253356 and 70 & ganic solvents (e.g. acetic acid) are used. plants, the use of EPDM is only recommended for products ous media of breweries, mineral water and soft drinks man- EPDM 253815 with a fat content of up to 15%. This is no longer true today ufacturers. Whether beer, mineral water or flavored drinks • Clamp seals made of 70 EPDM 291 and 70 EPDM 253815 EPDM is of limited use in products containing fats or oils. as such. The chart gives a rough indication of the usability – butterfly valve seals made of EPDM, for example, are best • Diaphragms made of 70 EPDM 291, 60 EPDM 290

While it can be used well at low temperatures in dairy of EPDM in the interaction between fat content and tem- suited for the application. There are limitations in the con- and 60 EPDM 334 RESISTANCE products with a fat content of up to 70%, it cannot be perature of the medium. If the process parameters are be- tact with citrus juices and drinks with orange flavors. Be- • Elastomer bead of the Hygienic Usit® made of 70 EPDM used in pure fats, oils or non-polar solvents. low the curve, EPDM can and should be used. Only in appli- cause of the same chemical nature of EPDM and limes, a ter- 291, 70 EPDM 217676 and 70 EPDM 253815 cations with parameters above the curve should a different pene (the lead compound in orange flavor), it quickly leads • Profiles and cords made of 70 EPDM 391 EPDM contains no plasticizers and other potential elastomer be selected. EPDM is also of only limited use to swelling of the material in continuous use. Another lim- MATERIALS extractable ingredients and therefore displays negligible according to the 3-A® Sanitary Standards, which have clas- itation is the flavor transfer between the produced drinks amounts of extract in the extractables study (see page sified EPDM as a Class II material. Nevertheless, EPDM is cer- batches. This occurs especially in highly aggressive and 61 f.). Thus, the materials EPDM 291 and EPDM 253815 tainly suitable for contact with perishable foods at low complex assembled aromatic blends, like in energy drinks. Download can be recommended for use in the manufacture of temperatures and less fatty media. In particular, its ex- Data sheet 70 EPDM 291 medical products. cellent cleaning and sterilization properties, which no other EPDM in the pharmaceutical industry elastomer in this price range offers, speak for EPDM. In addition to the cleaning media, EPDM materials are also Suitable areas of application suitable for aqueous pharmaceutical products. Thus, for ex- • Hot water and steam (on a sustained basis up to +180 °C ample, EPDM materials are preferably used in the steriliza- Download (+356 °F) ble biochemical reactor for the fermentation. Furthermore, Data sheet 70 EPDM 253815 PRODUCT PORTFOLIO • Acids (hydrochloric acid, nitric acid and phosphoric acid) EPDM is also used in autoclaves for steam pressure steriliza- • Alkaline solutions (sodium hydroxide solution, potassium tion of culture media for biotechnological production meth- hydroxide solution) ods. • Polar organic solvents • CIP/SIP media for continuous operation plants APPENDIX 34 35 Elastomeric materials INTRODUCTION VMQ NBR TECHNICAL FUNDAMENTALS

VMQ silicone rubbers are highly polymeric vinyl-methyl- Products and materials NBR (acrylonitrile-butadiene-rubber) is a polymer of buta- Application profile polysiloxanes. Silicone is quite widespread as a material in • O-rings made of 70 VMQ 117055 and 78 VMQ 166898 diene and acrylonitrile (ACN). The proportion of acryloni- NBR has very good properties in applications with mechan- butterfly valve seals. Due to its low volumetric expansion • Molded parts made of 70 VMQ 117055 and 76 VMQ trile can be between 18% and 50% and significantly af- ical stress and in oils, fats and waxes. Its temperature re- under the influence of media and its high elasticity, the 176643 fects the properties of the polymer. Thus, an NBR with a sistance in hot water is up to +100 °C (+212 °F). NBR cannot butterfly valve switches reliably until the end of its service • Diaphragms made of 70 VMQ 117055 low acrylonitrile content is characterized by a very good be used in concentrated acids (e.g. nitric acid, formic acid), life. • Clamp seals made of 70 VMQ 117055 low-temperature flexibility and good elastic properties. concentrated oxidizing media (e.g. peracetic acid), and in The higher the ACN content, the better the resistance aromatic and chlorinated hydrocarbons. Another argument for VMQ in contact with food and phar against polar media. maceuticals is its purity, clearly visible in the transparency 70 VMQ 76 VMQ 78 VMQ Products and materials RULES AND STANDARDS ELASTOMERIC MATERIALS of the material, even if the mechanical strength and chem- 117055 176643 166898 The gas permeability and flexibility at low temperature de- • O-rings made of 75 NBR 431 and 90 NBR 43 ical resistance are not optimal, especially during intense FDA-compliant crease in this context. NBR is only used sporadically in the • Molded parts made of 70 NBR 438 and 85 NBR 436 + + + cleaning operations. (CFR 21 Part 177.2600) food industry. The remaining applications are usually charac- • Diaphragms made of 60 NBR 434 terized by high mechanical forces, where a large energy input EU Reg. 1935/2004 General properties + + + into the seal takes place. NBR resists this quite well, if no high • Excellent thermal and heat resistance EU Reg. 2023/2006 demands in terms of temperature are placed on it and if a RULES AND STANSDARDS 70 NBR 438 75 NBR 431 85 NBR 436 ® • Best low-temperature flexibility 3-A Sanitary Standards particularly cost-effective solution is sought. FDA-compliant + + + + • Little temperature dependency of the technological Class I (CFR 21 Part 177.2600) properties General properties USP Ch. 87 (in vitro) + EU Reg. 1935/2004 • Excellent weathering, aging and ozone resistance • Very good abrasion resistance + + + USP Ch. 88 (in vivo), + EU Reg. 2023/2006

• High gas permeability Class VI – 121 °C (250 °F) • The acrylonitrile content must be selected for each PLASTICSENGINEERING • Very good physiological properties application in such a way that the material shows • Very good dielectric properties the optimal combination of chemical resistance and • Good resistance to synthetic, animal and vegetable oils, low-temperature flexibility glycols, fire-resistant hydraulic fluids and various solvents • Good mineral oil and fuel resistance and outstanding re- PURITY

• Not resistant in low-molecular esters and ethers, aliphatic Download sistance to vegetable and animal oils, silicones, as well as Download & and aromatic hydrocarbons Data sheet 70 VMQ 117055 to diluted acids and alkaline solutions at room tempera- Data sheet 70 NBR 438 • Temperature-resistant from –60 °C to +200 °C (–76 °F to ture +392 °F) • NBR tends to swell in aromatic and chlorinated hydrocar-

bons, as well as in polar solvents RESISTANCE Download • Temperature-resistant from –30 °C to +100 °C (–22 °F to Download 70 VMQ 117055, 76 VMQ 176643 and 78 VMQ 166898 Data sheet 76 VMQ 176643 +212 °F), special blends remain flexible at low tempera- Data sheet 85 NBR 436 tures down to –55 °C (–67 °F) Application profile MATERIALS VMQ as a silicone rubber has very good applicability in animal and vegetable fats, oils and waxes and essential oils. Download Moreover, the material also allows application in high tem- Data sheet 78 VMQ 166898 perature 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 excep- tion 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 PRODUCT PORTFOLIO 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. APPENDIX 36 37 Elastomeric materials INTRODUCTION HNBR TECHNICAL FUNDAMENTALS

HNBR (hydrogenated-acrylonitrile-butadiene-rubber) is a HNBR cannot be used in concentrated acids (e.g. nitric acid, material that is generated by full or partial hydrogenation formic acid) and concentrated oxidizing media (e.g. per- IMMERSION RESULTS OF HNBR IN DIFFERENT CIP/SIP CLEANING MEDIA of the double bond-containing butadiene portions of nor- acetic acid). SIP, 0.5% HYDROGEN SIP, 2% PERACETIC ACID CIP, 4% PHOSPHORIC ACID CIP, 2% NITRIC ACID CIP, 5% SODIUM HYDRO- mal NBR polymers. Thus, HNBR offers a similar chemical PEROXIDE CLEANER AT CLEANER AT CLEANER AT CLEANER AT XIDE CLEANER AT resistance to NBR, but has better heat and oxidation sta- HNBR in the beverage industry +80 °C (+176 °F)/168 H +60 °C (+140 °F)/168 H +70 °C (+158 °F)/168 H +80 °C (+176 °F)/168 H +80 °C (+176 °F)/168 H 50 bility. Furthermore, the material is characterized by high Since HNBR has good fat and oil resistance, it is always an

mechanical strength and improved abrasion resistance. interesting alternative material for the beverage industry. 40 The use of essential oils in particular, such as those con- HNBR is often used in dairies, cheese-making facilities and tained in hops, can be reliably ensured here by HNBR. 30 other milk-processing plants, where the fat content of the ELASTOMERIC MATERIALS product to be processed is so high that EPDM is no longer Products and materials 20 deployable. • O-rings made of 75 HNBR 231142 10 • Molded parts made of 70 HNBR 254067 and 85 HNBR % in Change General properties 216553 0 • Partly higher chemical resistance than NBR • Butterfly valve seals made of 70 HNBR 254067 • Better heat and oxidation stability than NBR • Diaphragms made of 75 HNBR 181070 and 85 HNBR –10 • High mechanical strength 181071 • Improved abrasion resistance –20

• Can be used well in water, steam and ultrapure water RULES AND 75 HNBR 70 HNBR 85 HNBR –30

• Temperature-resistant from –30 °C to +150 °C (–22 °F to STANDARDS 231142 254067 216553 PLASTICSENGINEERING +302 °F) –40 FDA-konform + + + (CFR 21 Part 177.2600) –50 75 HNBR 231142, 70 HNBR 254067 and 85 HNBR 216553 EU (VO) 1935/2004 volume in % elongation at break in % tensile strength in % PURITY

as well as EU (VO) + & Application profile 2023/2006 HNBR is very well suited for use under mechanical stress, as well as in oils and waxes, animal and vegetable fats. More-

over, the material is suitable for use in CIP/SIP media with Download RESISTANCE continuously operating plants in the food and pharmaceu- Data sheet 75 HNBR 231142 tical 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 MATERIALS solvents, such as acetic acid, are used. Download Data sheet 85 HNBR 216553

Download Data sheet 70 HNBR 254067 PRODUCT PORTFOLIO APPENDIX 38 39 Elastomeric materials INTRODUCTION FKM TECHNICAL FUNDAMENTALS

FKM (fluororubber) is a high-quality material which can oils and waxes, aliphatic and aromatic hydrocarbons, essen- FKM in the chemical industry be adapted to different applications thanks to its variable tial oils, and at high temperatures. The material also has good FKM is in many cases sufficiently resistant to common or- composition. properties in CIP/SIP media for continuous operation plants ganic solvents. Especially in contact with alkaline solutions, Download in the food and pharmaceutical industries. In cleaning pro- the material is sensitive; for this reason, alkaline cleaning Data sheet 70 FKM 37508 By polymerization of vinylidene-fluoride (VF) and optional cesses, it must be taken into account that the use of alkaline process should be evaluated on a case-by-case basis. use of variable proportions of hexafluoropropylene (HFP), solutions, acids and oxidizing media such as peracetic acid is tetrafluoroethylene (TFE), 1-hydropentafluoropropylene (HFPE) restricted. FKM reacts very sensitively when used with highly Due to the variety of possible applications and application and perfluoromethylvinylether (PMVE), it is possible to pro- oxidizing cleaning agents and disinfectants containing ni- parameters, comprehensive technical clarification by our Download duce co-, ter- and tetrapolymers with different composition tric acid, formic acid or peracetic acid. In any prolonged use application advisory service is recommended. Data sheet 75 FKM 180497 and fluorine contents between 65% and 71%. Thus, the in alkaline solutions, FKM also loses its stability. However, ELASTOMERIC MATERIALS material can be designed for different requirements in terms for short cleaning cycles, this material is still suitable. In the Products and materials of chemical resistance and low-temperature flexibility. In the event of doubt, our materials advisory service can assist in • O-rings made of 70 FKM 37508, 75 FKM 38269 and food industry, FKM is used in applications where tempera- finding an optimal materials solution for the individual re- 75 FKM 180497 Download tures above +140 °C (+284 °F) prevail in the process or where quirements. • Molded parts made of 75 FKM 37508 and 75 FKM 180497 Data sheet 75 FKM 38269 media are used which attack other elastomers such as EPDM • Diaphragms made of 75 FKM 180497 or HNBR. FKM in the beverage and dairy industry FKM is recommended for both the processing and handling General properties of pure citrus juices and for applications with concentrated • Excellent temperature resistance essential oils and dairy products. However, a blanket recom-

• High chemical stability mendation for use in all flavors and their mixtures cannot IMMERSION RESULTS OF FKM IN DIFFERENT CIP/SIP CLEANING MEDIA PLASTICSENGINEERING • Very good resistance to ozone, weathering, aging and ox- be made, because this is an extraordinarily diverse and com- SIP, 0.5% HYDROGEN SIP, 2% PERACETIC CIP, 4% PHOSPHORIC CIP, 2% NITRIC ACID CIP, 10% SODIUM CIP, 5% SODIUM ygen plex media group. But it is worthwhile to discuss the indi- PEROXIDE CLEANER AT ACID CLEANER AT ACID CLEANER AT CLEANER AT HYPOCHLORITE HYDROXIDE • Excellent resistance to mineral oils and fats vidual applications with Freudenberg’s materials technolo- +80 °C (+176 °F)/168 H +60 °C (+140 °F)/168 H +70 °C (+158 °F)/168 H +80 °C (+176 °F)/168 H CLEANER AT CLEANER AT • Low gas permeability gy experts since FKM is in many cases the more economical +40 °C (+104 °F)/168 H +80 °C (+176 °F)/168 H 60 PURITY

• Shows a very good resistance in non-polar media alternative to other material solutions. & • Tends toward increased swelling in polar solvents, ketones and amines FKM in the pharmaceutical industry 40 • Temperature stability from –25 °C to +200 °C (–13 °F to In the pharmaceutical industry, FKM is employed when RESISTANCE +392 °F) non-polar solvents, aliphatic compounds, fats and oils are 20 used. Amines and ketones, however, preclude the choice of FKM materials. 70 FKM 37508, 75 FKM 38269 and 75 FKM 180497 0 MATERIALS

Application profile % in Change –20 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 fats, –40

–60 RULES AND STANDARDS 70 FKM 37508 75 FKM 38269 75 FKM 180497

FDA-compliant (CFR 21 Part 177.2600) + + + –80 PRODUCT PORTFOLIO EU Reg. 1935/2004 + + + volume in % elongation at break in % tensile strength in % EU Reg. 2023/2006 + + + 3-A® Sanitary Standards Class I + + + USP Ch. 87 (in vitro) + USP Ch. 88 (in vivo) Class VI – 121 °C (250 °F) + APPENDIX 40 41 Elastomeric materials INTRODUCTION SIMRIZ® TECHNICAL FUNDAMENTALS

Simriz® perfluoroelastomers (FFKM) are produced using Products and materials Simriz® 70 491, 75 Simriz® 494 (black) special perfluorinated, completely hydrogen-free mon- • O-rings made of 70 Simriz® 491, 75 Simriz® 494, 495, 497 und 75 Simriz® 506 (white) omers, with appropriate compounding and processing and 506 and 85 Simriz® 496 Download techniques. They represent the high-end solution in ma- • Molded parts made of 70 Simriz® 491, 75 Simriz® 494, Data sheet 75 Simriz® 494 terials technology. Application profile 497 and 506 and 80 Simriz® 492 For the prevalent requirements in the food and pharma • Diaphragms made of 70 Simriz® 491 and 75 Simriz® 494 Simriz® is characterized by a broad chemical resistance ceutical industries, Simriz® appears at first glance to be (on request) similar to that of PTFE, combined with the rubber-elastic “over-engineered”. However, its cost effectiveness comes to • Butterfly valve seals made of 75 Simriz® 506 Download properties of an elastomer. With Simriz®, Freudenberg of- the fore in the holistic view of maintenance and downtime Data sheet 75 Simriz® 506 fers a complete range of high-quality FFKM materials. In costs which may occur, especially in safety-related appli ELASTOMERIC MATERIALS addition to the Simriz® compounds for standard and high cations. Here, Simriz® provides reliability which pays off. temperature applications, there is a FDA- and USP Class VI-compliant variant, which is ideally suited for use in the Suitable areas of application Download food and pharmaceutical industries. • Water and water vapor Data sheet 75 Simriz® 491 • Concentrated acids (e.g. nitric acid 60%) General properties • Amines (e.g. ethylenediamine) Thanks to FFKM, utmost temperature and media resistance • Organic acids (e.g. acetic acid) is not reserved only to PTFE materials with a degree of fluor- • Ketones (e.g. methyl-ethyl-ketone) ination of 76%. The operating conditions are limited when • Alkaline solutions (e.g. sodium-hydroxide, potassium-

using PTFE due to its tendency to cold flow and lack of elas- h y d r o x i d e ) PLASTICSENGINEERING ticity. At high pressures and many changes in temperature, • Organic solvents (e.g. methanol) pure PTFE seals prove to be unsuitable. Simriz®, on the other • Aroma concentrates hand, combines almost the identical universal resistance of IMMERSION RESULTS OF SIMRIZ® IN DIFFERENT CIP/SIP CLEANING MEDIA PTFE with the elastic advantages of elastomers. Simriz® replaces elastomers such as EPDM or FKM when METHANOL AT ETHYL ACETATE AT ACETONITRILE AT 20% NITRIC ACID AT 20% SODIUM HYDRO- 20% ACETIC ACID AT PURITY their temperature and media resistance can no longer +64 °C (+147 °F)/72 H +70 °C (+158 °F)/72 H +70 °C (+158 °F)/72 H +98 °C (+208 °F)/72 H XIDE SOLUTION AT +98 °C (+208 °F)/72 H & Therefore, with Simriz® many sealing problems can be cope with the demands of the application area, but rubber- +98 °C (+208 °F)/72 H solved better and easier. Simriz® also shows very reliable elastic behavior is imperative. For example, hygienic design SIMRIZ® 494 SIMRIZ® 506 SIMRIZ® 494 SIMRIZ® 506 SIMRIZ® 494 SIMRIZ® 506 SIMRIZ® 494 SIMRIZ® 506 SIMRIZ® 494 SIMRIZ® 506 SIMRIZ® 494 SIMRIZ® 506 properties in static and dynamic applications, as well as requirements in terms of absence of dead space and good 20 in frequent temperature changes and aggressive media. cleanability only leave a minimal margin to the sealing RESISTANCE In addition, Simriz® as FFKM offers the highest degree element. Thermal expansion and media swelling must be 15 of fluorination among elastomers. The high bond ener- as small as possible here. Under these stricter requirements gy between carbon and fluorine atoms enables excellent with regard to purity and extreme media resistance, even 10 resistance to a variety of chemicals with different reac- in CIP/SIP processes and at temperatures above +150 °C MATERIALS 5 tive functional groups and the use in polar and non-polar (+302 °F), Simriz® delivers a high performance that is widely media, even at high concentrations and temperatures. In acknowledged in the market. 0 addition, the temperature stability with approximately –10 °C to +325 °C (+14 °F to +617 °F) is extraordinarily compre- Simriz® in the food, beverage % in Change –5 hensive for an elastomer. and pharmaceutical industry Simriz® provides highly-reliable performance, especially for –10 aroma-containing media, and thus safeguards the production process flawlessly. –15 PRODUCT PORTFOLIO –20 Simriz®in the chemical industry Simriz® can be used in almost all chemicals. Exceptions are –25 the compounds of the alkali metals. For o-rings, mouldings and membranes 70 Simriz® 491 is especially suitable. –30 volume in % elongation at break in % tensile strength in % APPENDIX 42 43 Elastomeric materials INTRODUCTION FLUOROPRENE® XP TECHNICAL FUNDAMENTALS

Fluoroprene® XP is a very highly-fluorinated material with Suitable applications for Fluoroprene® XP Fluoroprene® XP in the pharmaceutical industry Fluoroprene® XP in the beverage industry a specific monomer composition. As a result of this, the • Animal and vegetable fats, oils and waxes Fluoroprene® XP offers an unbeatable advantage in terms While FKM materials swell significantly even at room tempe- performance almost achieves the capability of a perfluo- • Aliphatic and aromatic hydrocarbons of its excellent resistance to non-polar and oil-based pro- rature in aroma concentrates such as “Raspberry” and “Fan- roelastomer. • Essential oils and flavorings duct media compared to EPDM, both in the dairy indust- tasy Fruit”, Fluoroprene® XP provides a good compatibility • High temperature ranges ry and in the pharmaceutical industry. For instance in the here. However, there are flavoring agents such as “Peach” General properties • CIP/SIP media for continuous operation plants in the food production and packaging of pharmaceutical products such where even Fluoroprene® XP reaches its limits, too. Only a • Excellent temperature resistance up to +200 °C (+392 °F) and pharmaceutical industries as ointments. The special resistance of Fluoroprene® XP to perfluoroelastomer can be used here as a stable solution. • Very good resistance to ozone, weathering, aging and • Oxidizing media (e.g. hypochlorite) or polar organic sol- flavors is also sought-after in ointments containing euca In the application of the material in concentrations that are o x y g e n vents (e.g. acetic acid) lyptus oil. Fluoroprene® XP is the right choice for a wide common for beverages, Fluoroprene® XP offers a significant • Excellent resistance in mineral oils and fats • Concentrated acids (e.g. nitric acid, formic acid) variety of oil-containing preparations such as emulsions advantage, given the limited absorption capacity of flavoring ELASTOMERIC MATERIALS • Low gas permeability • Concentrated oxidizing media (e.g. peracetic acid) or sprays, e.g. nasal sprays with essential oils. Both in the substances (see page 57 f.). • Very good resistance in non-polar media such as hexane synthesis of active ingredients and in their packaging, it is • Tends to increased swelling in polar solvents (e.g. ethylene- Fluoroprene® XP in the dairy industry important to keep in mind that the sealing materials relea- diamine) and ketones (e.g. methyl-ethyl-ketone) A wide variety of material versions has been used in the se as few substances as possible from their matrix into the dairy industry until now. The EPDM material widely used product. In order to ensure the purity of the product, ana- Application profile in the food industry shows indeed the best performance lyses of extractables are necessary. Freudenberg examined Seals made of Fluoroprene® XP are characterized by an in CIP processes here, but is not usable in every product the range of materials for the pharmaceutical industry in an excellent and broad resistance. The blue Fluoroprene® XP containing fat. While FKM and VMQ materials are indeed extractables study. In addition to the EPDM materials, Fluo- material thus allows the replacement of EPDM, VMQ and resistant to fat-containing media, they have only limited roprene® XP compounds were also analyzed (see page 61 f.).

FKM in applications with foodstuffs and pharmaceuticals, resistance in the cleaning media customarily available on PLASTICSENGINEERING as it combines the excellent properties of EPDM materials the market. Fluoroprene® XP was designed specifically for in polar media (water, acid, alkaline solution) with the ex- the high demands of the food industry and thus also the cellent performance characteristics of FKM and VMQ types dairy industry. It is a 3-A® Sanitary Standards Class I mate- in all non-polar media (fats, oils and hydrocarbons). Its rial and can therefore also be used in pure olive oil and in PURITY

outstanding resistance in steam, hot water, alkaline solu butter with a fat content of 82%. In addition, the material & tions and acids as well as in non-polar solvents makes it the is recommended not only for use in diluted, but also in con- VOLUME CHANGE IN FLAVOR CONCENTRATES preferred elastomer for applications with extreme CIP/SIP centrated CIP/SIP media. 100% FANTASY FRUIT FLAVOR 100% RASPBERRY FLAVOR 100% PEACH FLAVOR cleaning media, high temperatures and fat concentrations. 96 H 96 H 96 H Thanks to Fluoroprene® XP, the multiplicity of materials can 180 RESISTANCE thus be reduced significantly, which minimizes the com- plexity and cost of storage and maintenance of plant and 160 equipment on a lasting basis. MATERIALS 140

120 75 FLUOROPRENE® 75 FLUOROPRENE® 85 FLUOROPRENE® 75 FLUOROPRENE® 75 FLUOROPRENE® RULES AND STANDARDS XP 40 XP 41 XP 43 XP 44 XP 45 100 FDA-compilant (CFR 21 Part 177.2600) + + + + + 80 EU (VO) 1935/2004 + + + + +

EU (VO) 2023/2006 + + + + + % in swelling Volume 60 3-A® Sanitary Standards Class I + + + PRODUCT PORTFOLIO

USP Ch. 87 (in vitro) + + 40 USP Ch. 88 (in vivo, Class VI – 121 °C) + + + NSF 51 + 20

0 FKM Fluoroprene® XP APPENDIX 44 45 Elastomeric materials INTRODUCTION TECHNICAL FUNDAMENTALS

Fluoroprene® XP in the chemical industry If the resistance of FKM is insufficient and the use of perfluoroelastomers is assessed as not economical, then Download ® the material Fluoroprene® XP can be an interesting alter- Data sheet 75 Fluoroprene XP 40 MATERIALS

native, provided that the process media used are not too aggressive. Due to the variety of possible applications and parameters, a comprehensive technical clarification is sug- Download ® gested. We recommend that you consult our application Data sheet 75 Fluoroprene XP 41 advisory service. ELASTOMERIC

Products and materials Download • O-rings made of 75 Fluoroprene® XP 40 and 75 Fluoro- Data sheet 85 Fluoroprene® XP 43 prene® XP 41 • Molded parts made of 65 Fluoroprene® XP 46, 75 Fluoroprene® XP 41 and 85 Fluoroprene® XP 43 Download ® PLASTICS • Diaphragms made of 75 Fluoroprene® XP 44 and 75 Data sheet 75 Fluoroprene XP 44 Fluoroprene® XP 41 • Profiles made of 75 Fluoroprene® XP 41 • Clamp seals made of 75 Fluoroprene® XP 41 Download ®

• Elastomer bead of the Hygienic Usit made of 75 Fluoro- Data sheet 75 Fluoroprene XP 45 ENGINEERING prene® XP 45

Download Data sheet 65 Fluoroprene® XP 46 PURITY &

IMMERSION RESULTS OF FLUOROPRENE® XP ENGINEERING

STEAM ALKALINE CIP (NAOH) ACIDIC CIP (HNO3) CIP/ACTIVE CHLORINE CIP/H2O2 +200 °C (+392 °F)/ 5%, +80 °C (+176 °F)/ 2%, +80 °C (+176 °F)/ 3%, +60 °C (+140 °F)/ 0.5%, +80 °C (+176 °F)/ PLASTICS RESISTANCE 72 H 168 H 168 H 168 H 168 H 30 MATERIALS

% in Change 10

0 PRODUCT PORTFOLIO

–10

–20 volume in % hardness IRHD tensile strength in % modulus in % elongation at break in % APPENDIX 46 47 Engineering plastics INTRODUCTION OVERVIEW OF PTFE ENGINEERING PLASTICS TECHNICAL FUNDAMENTALS

Engineering plastics have properties that make them ideal Especially for the food and pharmaceutical industry we Thanks to its composition, PTFE (polytetrafluoroethylene) General properties for a variety of applications in the process industry. The offer engineering plastics with the required approvals: has a number of excellent properties for the food, chemi- • Density: 2.10 to 2.30 g/cm3 combination with other substances, such as reinforcing • EG Nr. 1935/2004 cal and pharmaceutical industries. The chemical resistance • Hardness 55 to 60 Shore D fibers, lubricants or other polymers, can significantly -ex • EU Nr. 10/2011 exceeds that of all elastomer materials and thermoplas- • The thermally reliable application range of PTFE is be- MATERIALS

pand the range of possible applications. • EG Nr. 2023/2006 tics. Thus, a broad portfolio of applications in almost all tween –200 °C and +250 °C (–328 °F and +482 °F). At tem- • FDA 21 CFR 177.1550 (PTFE) media is possible. peratures above +400 °C (+752 °F), highly toxic pyrolysis

It should be noted that thermoplastics, depending on their • FDA 21 CFR 177.2415 (PEEK) products such as fluorophosgene (COF2) are released sophistication, have very different performance limits with • FDA 21 CFR 177.2470 (POM) The extremely large thermal application range of this mate- • Special types of PTFE can be welded respect to temperature, pressure resistance and chemi- • FDA 21 CFR 177.1500 (PA) rial allows it to even be used in contact with liquid gases. It • To a certain degree, PTFE has an innate memory-effect, cal resistance, which should be taken into account when it • FDA 21 CFR 177.1680 (PU) should be kept in mind that the material is not elastic; as which means that it seeks to go back to its original shape. ELASTOMERIC comes to their application. • USP Ch. 87 (in vitro) such, it cannot simply be used to replace elastomer materials. This is based on the extremely long chains of molecules • USP Ch. 88 (in vivo) that build up PTFE Properties of thermoplastics The excellent chemical resistance of PTFE is based on the • Low density strong bond between the carbon and fluorine atoms, which Products • Chemical resistance is due to the strong electronegativity of fluorine. In order to • Rotary shaft seals PLASTICS • High resistance to wear break these bonds, the contacting materials need to use a • B e l l o w s • Excellent electrical properties lot of energy which is not possible in most food and phar- • U - p a c k i n g s • High energy input capacity 260 maceutical applications. PTFE is extremely resistant to all • Slide bearings PEEK • Very good processing properties acids, bases, alcohols, ketones, benzines, oil and other sub- • V-Seal set packings • –100 °C to +260 °C

(–148 °F to +500 °F) stances. The material is only non-resistant to very strong • O - r i n g s ENGINEERING • Good chemical resistance reducing agents, such as solutions of alkali metals (e.g. so- • Highest pressure resistance dium) in liquid ammonia or very strong oxidizing agents, such as elemental fluorine at high temperatures.

130 PURITY

PTFE has a very low coefficient of friction. This means that & PA/POM it glides as well over PTFE as wet ice over wet ice. In addition, the static friction is equal to the dynamic friction, so • –40 °C to +100 °C (–40 °F to +212 °F) that the transition from standstill to movement takes place • Limited chemical and without jerking. The “stick-slip” effect is thereby prevented. RESISTANCE pressure resistance 0 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. MATERIALS resistanceTemperature °C in

PTFE • –130 –250 °C to +250 °C (–418 °F to +482 °F) • Highest chemical resistance • Good pressure resistance PRODUCT PORTFOLIO

–260

Pressure resistance Chemical resistance PA/POM PEEK PTFE APPENDIX 48 49 Engineering plastics INTRODUCTION ePTFE TECHNICAL FUNDAMENTALS

Optimization possibilities of PTFE Processing of PTFE ePTFE is an expanded PTFE material with improved me- Products Unfilled PTFE as a base material has some disadvantageous PTFE cannot be processed by injection molding. For the pro- chanical properties as a result of the multi-directional • FG-360 Joint Sealant is a sealant tape with adhesive strips properties, such as poor cold flow behavior, relatively low duction of components, different compounds, depending alignment of the polymer chains. on the back for ease of installation. It is an excellent prod- wear resistance, low resistance to high-energy radiation on the desired properties, can be used to produce semi- uct for heat exchangers, irregular flanges, fuel caps, man- MATERIALS

and poor adhesion behavior. All of these can be eliminated finished products (pipes, rods and plates), which are further Freudenberg’s FG-360 has a denser form and therefore of- holes and hand holes by the addition of various additives. processed into finished products in a subsequent process- fers better stability and even less creep relaxation and cold • FG-360 Seal Plates are produced in 1.5 mm, 2 mm and 3 ing step. flow than existing expanded PTFE products. This eliminates mm plate thickness. The panel size is 1,500 mm x 1,500 Reasons for admixing fillers in PTFE: the need for a reinforcing effect by means of fillers and mm. Other thicknesses are also available on request binding agents. FG-360 is thus a 100% pure ePTFE - without • FG-360 Packing Cord is a round cord pack that does not • The wear resistance is increased many times over additives. harden in use. It is suitable for almost all conceivable ap- ELASTOMERIC • The resistance to creep or deformation under load is in- plications. The low friction coefficients ensure the valve creased to a multiple of the original value Because of its purity, the material can be used in the bio- function even after a long period of inactivity. Packing • Depending on the filler, the thermal conductivity can be technology and pharmaceutical industry without concerns. cords are available as standard sizes with a diameter of 2 increased significantly Damaged or worn flange surfaces are easily offset by this mm to 25 mm • The thermal expansion is reduced material. It is a soft, extremely compressible and at the same PLASTICS • If necessary, the electrical properties of PTFE can be time very strong material that has excellent sealing proper- changed by appropriate filler selection ties even at low surface pressures and tightening torques. PROPERTIES 1.5 MM THICK 3.0 MM THICK • The choice of filler also influences the wear behavior of TF-0-0 TF-0-0 Type the opposing surface Due to the impermeability effect at low surface pressures, DIN 28091-3 DIN 28091-3

it is ideally suited for plastic and glass-lined flanges. Its low Color white white ENGINEERING friction coefficient of 0.2 (similar to wet ice) allows easy in- MATERIAL • FDA 21 CFR • FDA 21 CFR PTFE PTFE + PTFE + PTFE + PTFE + stallation and dismantling. ePTFE has an unlimited shelf life 177.1550 177.1550 TEST MEASURING PROPERTIES VIRGIN GLAS FIBER CARBON CARBON FIBER BRONZE because it does not embrittle or age. This material is resist- • USP Ch. 88 • USP Ch. 88 STANDARD UNIT (in vivo, (in vivo, ant to UV radiation, ozone and almost all chemicals. It is Rules and standards Class VI – 121 °C) Class VI – 121 °C) PURITY

Filler content % of weight 25.0 25.0 10.0 40.0 very easy to cut or punch by hand. & • TA Luft • TA Luft Density ASTM D792 g/cm2 2.15 2.22 2.10 2.03 3.0 • EU (VO) • EU (VO) General properties 1935/2004 1935/2004 Ball indentation DIN 2039-1 N/mm2 27.0 34.0 37.0 35.0 41.0 hardness • Well-suited for applications in the temperature range Density g/cm3 0.85 0.85 from –200 °C to +300 °C (–328 °F to +572 °F) RESISTANCE Tensile strength DIN 12086-2 MPa PR 29/UR 33 PR 14/UR 17 PR 12/UR 16 PR 18/UR 19 PR 24/UR 25 Tensile strength longitudi- 14 18 • Usable in the pressure range from vacuum to 200 bar nally N/mm2 Elongation at break DIN 12086-2 % PR 354/UR 357 PR 353/UR 356 PR 120/UR 170 PR 307/UR 295 PR 343/UR 293 • Chemically inert over the pH range from 0 to 14 In -house • FDA-compliant Compression % 69 66.2 Tensile modulus of standard MATERIALS elasticity T= +40 °C MPa PR 446/UR 383 PR 674/UR 752 PR 925/UR 959 PR 673/UR 670 PR 760/UR 771 • USP Ch. 88 Class VI–121°C (250 °F) Resilience % 7.6 11.6 (+104 °F) –268 to +315 °C –268 to +315 °C Temperature range (–450 to +599 °F) (–450 to +599 °F) Deformation under comp. to load at +23 °C (+73 °F), ASTM D621 % PR 13.8/UR 16.4 PR 11.6/UR 13.9 PR 7.0/UR 6.3 PR 11.9/ UR 13.0 PR 8.4/UR 9.1 24 h, 15 N/mm2 Irreversible comp. to deformation ASTM D621 % PR 7.0/UR 8.3 PR 6.2/UR 7.8 PR 3.2/UR 2.8 PR 5.9/UR 6.8 PR 4.1/UR 4.8 Tensile yield point 1% ASTM D695 MPa PR 11.0 PR 12.5 PR 13.7 PR 11.9 PR 13.1

Tensile yield point 5% ASTM D695 MPa PR 15.7 PR 16.8 PR 19.6 PR 16.8 PR 19.1

Surface resistance ASTM D257 Ω > 1017 > 1015 > 102 > 1010 > 1012 PRODUCT PORTFOLIO

Thermal conductivity ASTM 1461 W/m·K 0.24 0.30 0.68 0.37 0.47 Coefficient of linear expansion at +50 to DIN 53752 105·K4 10.6 9.8 8.2 11.7 8.8 +100 °C (+122 to +212 °F)

PR = Pressing direction, UR = Circumferential direction APPENDIX 50 51 Engineering plastics INTRODUCTION POM, PA, PU, PEEK TECHNICAL FUNDAMENTALS

POM – Polyoxymethylene PA – Polyamide PU – Polyurethane PEEK – Polyetheretherketone Polyoxymethylene (POM, also called polyacetal) is a semi- Most commercially important polyamides are partially crys- Polyurethane (PU or PUR) is a plastic that can be processed PEEK (Polyether-ether-ketone) has a similar chemical resis crystalline thermoplastic. POM has been on the market talline, thermoplastic polymers. They are characterized by with almost all methods of plastics technology. Polyure- tance to PTFE, but with improved mechanical properties. since 1956 and is used especially for precision parts because high strength, stiffness and toughness, and have good thanes are linear or cross-linked high polymers that are This material is renowned for its almost universal chemical MATERIALS

of its high rigidity, low friction coefficients and excellent di- chemical resistance and workability. The properties of the formed by the reaction of di- or polyisocyanates and hy- resistance and high temperature resistance (+260 °C/+500 mensional stability. POM is characterized by high stability, polyamides are largely dominated by the amide groups, droxyl carriers such as polyols, chain extenders and °F continuous operating temperature) and is therefore hardness and rigidity over a wide temperature range. It re- which interact with each other via hydrogen bonds. Polyam- cross-linkers and potentially other components. Common to growing in popularity. tains its high strength even at low temperatures down to ides have a high wear resistance and good sliding properties. all of them is the urethane bond created by this reaction, –40 °C (–40 °F). Its natural color is opaque white due to high The mechanical properties can be further improved by which gives the name to this material group. Thanks to the Suitable areas of application crystallinity, but the material can also be dyed in all muted means of fiber composites with glass or carbon fibers so highly polar urethane group common to all polyurethanes, While only of limited use in seals due to its lack of elastici- ELASTOMERIC colors. POM has a density of ρ = 1.41 to 1.42 kg /m3. The that, for example, strength and impact resistance can be ad- this plastic is characterized particularly by: ty, PEEK is increasingly finding application opportunities as water absorbtion factor is so low that it is of no importance justed to suit the application. a backup ring for O-rings under high pressure, or in V-Seal for its use: at standard climatic conditions about 0.2%, and • High tensile strengths (far in excess of 60 MPa) set packings as backup rings or compression rings. Unfilled at full saturation with water at +23 °C (+73 °F) only about Suitable areas of application • High elongations at break (in some cases more than PEEK is FDA-compliant, but there are also options here to 0.8%. The physical characteristics of the molded parts thus PA is distinguished by its high strength values as an ideal 1,000%) modify the mechanical properties by means of fillers such PLASTICS vary only slightly. material for use in mechanical elements such as gears, fric- • E l a s t i c i t y as glass fiber and carbon fiber or PTFE. In contrast to PTFE, tion bearings or guide rails. In the sealing area, PA rings are • Abrasion resistance PEEK can also be processed by injection molding. The good chemical resistance and low water absorption often used as backup rings for a wide variety of sealing ele- • O i l r e s i s t a n c e predestine POM for use in contact with food. Many types ments. PA is characterized in particular by: • Ozone resistance Products

are FDA-compliant. Due to its high crystallinity, POM is • Backup rings for O-rings ENGINEERING more rigid and firmer than other thermoplastics, especially • High wear resistance Suitable areas of application • Backup rings in V-Seal set packings in the temperature range of +50 °C to +120 °C (+122 °F to • Good damping power Using special raw materials, it is possible to achieve good • Compression rings in V-Seal set packings +248 °F). POM has a clearly defined tensile yield point at • Good dry running characteristics hydrolysis, acid and alkali resistances as well. Polyurethanes about 8% elongation at room temperature. Below this yield • Low tendency to creep and cannot be used in contact with amines, glycols and chlorin- PURITY

point, it demonstrates good resilience even under repeated • Low water absorption PA6: 2.5% – 3.5% ated solvents. Since the urethane group is non-toxic and bi- & stress and is therefore particularly well-suited for elastic el- • PA12: 0.2% – 0.5% ologically very compatible, polyurethanes are especially ements. The high creep rupture strength and low tendency well-suited for drinking water and food applications in com- to creep round off the benefits of POM. Products pliance with KTW and FDA standards. A high-quality sub-

• B a c k u p r i n g s group of the polyurethanes are the thermoplastic polyure- RESISTANCE Suitable areas of application • Guide rings thanes. These often expensive granulates can be processed The mechanical properties of POM in conjunction with into extremely high-quality components, e.g. by means of good friction and wear performance make this material pre- injection molding or extrusion processes, with reasonable destined for a wide range of engineering applications. processing costs. MATERIALS

Products Products • Molded parts • U-packings • Backup rings • W i p e r s • Guide rings PRODUCT PORTFOLIO APPENDIX 52 53 Materials resistance and purity INTRODUCTION TEMPERATURE AND FAT RESISTANCE TECHNICAL FUNDAMENTALS

Seals are used in a broad variety of media, resulting in very Elastomeric materials

specific operational conditions. Depending on the duration m a x . 3 2 5 and nature of their exposure to these media, aging processes FFKM in the elastomer trigger changes that could lead to harden-

200 MATERIALS

ing or softening. This is reflected, for example, by swelling, Fluoroprene® XP FKM °C cracking and brittleness or discoloration of the material. The VMQ

in EPDM higher the temperature, the faster aging proceeds. HNBR During contact with the media, there are always two different processes impacting the elastomer material which may 100 NBR ELASTOMERIC Temperature affect physical swelling and chemical reaction. In contrast to pure swelling, the chemical processes are irreversible. In general, the chemical principle is “like dissolves like”. This Polar media Resistance to Non-polar media means that polar elastomers swell in polar media and non-polar elastomers are only conditionally stable in non-polar media. 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. PLASTICSENGINEERING PURITY & Aging and viscous flow MATERIALS RESISTANCE Diagram 1 AND PURITY RESISTANCE Glass state Glass transition temperature Tg MATERIALS modulus Elastic Elastic behavior Viscous flow PRODUCT PORTFOLIO Rubbery-elastic plateau

Temperature application range threshold range glass condition APPENDIX 54 55 Materials resistance and purity INTRODUCTION FLAVORING AGENTS TECHNICAL FUNDAMENTALS

Temperature and fat resistance Although fat causes problems for many sealing materials, In addition to the demanding cleaning processes, flavoring alternative but to resort to FDA-compliant perfluoro The temperature significantly affects the physical proper- it is in the traditional sense not an aggressive medium. In agents in the food industry require an equally careful se- elastomers. Fluoroprene® XP, with its significantly better ties of rubbery-elastic materials. If the modulus of elastici- processing plants for the food industry, about 70% of the lection of the right material. The various flavors affect the chemical resistance compared to an FKM, can be an inter- ty (E-modulus/elastic modulus) is considered in relation to seals used are made of EPDM. Only if EPDM cannot be material resistance very differently. Especially peach and esting alternative to this solution. MATERIALS

the temperature, a constant E-modulus at a high level and used, as is the case with products with a high fat content, tropical fruit flavors as well as orange oil can result in prob- at a low temperature is visible, which identifies the glassy must an alternative be found. The use of other materials lems with regard to material resistance. At any rate, what is important in terms of reliable material state. As the temperature rises, the area of the glass tran- may have disadvantages such as a change of the cleaning recommendations are well-grounded resistance tests. In sition is entered where the elastic modulus drops sharply. cycle, higher costs and additional storage overheads. In the Flavoring agents consist of various chemical ingredients. order to be able to make a reliable assessment of the A constant level follows subsequently. The rubbery-elastic past, EPDM was not used at all in the dairy industry. Today’s Therefore a classification based on their elastomer-dest suitability of an elastomer, not only should the physical in- plateau, where the material displays elastic behavior, rep- technologically advanced EPDM materials demonstrate a roying potential is difficult, even more difficult than for CIP fluences through the usual tests of mass and volume ELASTOMERIC resents its application range as a sealing material. If the significantly better performance and are quite usable in cleaning agents, for example. In addition, the ingredients changes be used here, but also the no less hazardous chem- temperature rises further, the modulus of elasticity drops, many applications – despite fatty products. If EPDM seals which are dangerous for elastomers may potentiate their ical effects of the media on the mechanical properties of indicating aging or viscous flow of the material (diagram 1). are to be used, there are different upper temperature limits effect or, conversely, may greatly attenuate each other. It is the material. These can be determined through comparative The transition from the rubbery-elastic state to the glassy for various kinds of products containing fat: very difficult to gain systematic knowledge here. measurements of elongation at break, 100% modulus and state is particularly important because in many cases it tensile strength. Because even in dilutions as low as one represents the lower limit of the possible operating tem- • Milk with 3.5% fat content can be processed up to a tem- Traditionally, FKM is used in these media because FKM has tenth of one percent, flavoring agents may lead to partly perature. Depending on the stress, the actual operating perature of +80 °C (+176 °F). excellent resistances to aliphatic and aromatic hydro fatal changes in the tensile strength of elastomers. limit for the specific application is slightly higher (at the • For cream with 30% fat content, the temperature limit is carbons as well as oils and fats. FKM can also be used in me- beginning of the glass transition range) or slightly lower already reached at +35 °C (+95 °F). dia such as essential oils and citrus flavorings, whereas

(at the beginning of the glassy state). Simply stated, this • Butter with 82% fat content can only be processed up to EPDM swells a lot due to its high proportion of non-polar PLASTICSENGINEERING means that in static applications elastomers can be used at a maximum of +8 °C (+46 °F). ingredients. Since most flavoring agents in addition contain lower temperatures than in dynamic applications. Diagram aldehydes, ketones and carboxylic acids, which are known 2 shows an overview of the thermal application ranges of The diagram on page 35 illustrates the use of EPDM as a to be harmful to elastomers, there is sometimes no other various types of elastomers. The grey areas indicate tem- function of fat content and temperature. EPDM is applicable PURITY

perature application ranges to which standard types may below the line; above it Fluoroprene® XP should be used if & only be exposed. there are no restrictions regarding the cleaning process.

Thermal field of application of FFKM, VMQ, FKM, HNBR, NBR, EPDM IMMERSION RESULTS OF EPDM, FKM, FLUOROPRENE® XP, HNBR AND VMQ IN ORANGE OIL RESISTANCE Diagram 2 EPDM FKM FLUOROPRENE® XP HNBR VMQ

24 H 96 H 24 H 96 H 96 H 336 H 672 H 24 H 96 H 24 H 96 H 150 MATERIALS FFKM

100 VMQ

FKM 50

Rubbers HNBR % in Change PRODUCT PORTFOLIO NBR –50

EPDM –100 volume in % elongation at break in % tensile strength in % VMQ and EPDM materials clearly swell far too much in orange oil. Even the –100 –50 0 50 100 150 200 250 300 swelling behavior of HNBR exceeds the tolerable limit. Fluororubbers, on the other hand, are very resistant. Temperature in °C

application range threshold range APPENDIX 56 57 Materials resistance and purity INTRODUCTION TECHNICAL FUNDAMENTALS

® IMMERSION RESULTS OF EPDM, FKM, VMQ AND HNBR IN 0.1% FANTASY-FRUIT-FLAVOR-SOLUTION Flavor carry-over Washing-out test EPDM/Fluoroprene XP 40 Flavor transfer or flavor carry-over is a well-known problem First rinse cycle EPDM assumed as 100% EPDM FKM VMQ HNBR in beverage bottling. The seals absorb the ingredients of Ester 1 24 H 96 H 24 H 96 H 24 H 96 H 24 H 96 H the flavoring mixture during the bottling of a flavored drink

10 100 MATERIALS

and gradually release them again during the next bottling process for another product. This may well go unnoticed 90 5 if the products bottled successively are both flavored and 80 70 0 one of the products merely has a slightly stronger raspber- Ketone 3 60 Ester 2 ry taste, for example. It is different when after a slightly 50 –5 ELASTOMERIC flavored water (so-called near-water products), the thus 40 –10 far flavorless mineral water is bottled and the subsequent 30 batch has unintentionally absorbed a peach or cherry fla- 20 –15 vor, for example. In order to find the most suitable mate- 10 % in Change 0 –20 rial for this application, different materials were analyzed by Freudenberg with respect to their flavor absorption and –25 release capacity. Ketone 2 Ester 3

–30 Studies by Freudenberg related to the flavor carry-over of –35 different materials, such as EPDM, FKM and Fluoroprene® volume in % elongation at break in % tensile strength in % Due to the poor strength properties in Fantasy-Fruit-flavor, HNBR should XP, have shown that EPDM materials absorb and release PLASTICSENGINEERING not be used there. flavor the most. The remigration rate of an EPDM material is 100 times greater than the uptake and release capacity Ketone 1 Ester 4 of Fluoroprene® XP. In addition, the fluorinated material does not absorb all the components of the flavor mixture precleaned EPDM water +80 °C (+176 °F) EPDM PURITY

in equal measure. After the investigation, it turned out that & the esters present in the flavor mixture could not be de- precleaned XP 40 water +80 °C (+176 °F) XP 40 tected, i.e. that they had been absorbed by Fluoroprene® XP IMMERSION RESULTS OF EPDM, FKM, VMQ AND HNBR IN 0.1% PEACH-FLAVOR-SOLUTION at a small, undetectable rate. However, the ketones migrat- RESISTANCE EPDM FKM VMQ HNBR ed into the elastomer matrix and decreased by half after the cleaning step. In bottling establishments where mul- 24 H 96 H 24 H 96 H 24 H 96 H 24 H 96 H tiple products of different flavor intensity are bottled on 20 the same bottling line, it must be ensured that the quality MATERIALS 10 of the product made remains constant after each production cycle and is not contaminated by the flavoring agents 0 from the batch that was bottled last. Due to the negligible absorption of flavoring substances, the Fluoroprene® XP –10 materials portfolio qualifies as especially suitable for such

% in –20 applications.

–30 Change

–40 PRODUCT PORTFOLIO

–50

–60

volume in % elongation at break in % 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. APPENDIX 58 59 Materials resistance and purity INTRODUCTION

CLEANING PROCESS STORAGE TESTS TECHNICAL FUNDAMENTALS

The cleaning methods at a glance 3. Flushing out the alkaline detergent with water Freudenberg has carried out extensive exposure testing. is resistant to non-polar and polar media, but in steam it can only • CIP (“Cleaning In Place”) is the fully-automatic cleaning 4. Acidic cleaning to remove, e.g. limescale (phosphoric acid The database for the CIP/SIP cleaning agents consists of be used in temperatures up to +120 °C (+248 °F). Its temperature without disassembly of the equipment or nitric acid as well as additives) over 200 compositions and 5,100 measurements. The range in air is from –50 °C to +200 °C (–58 °F to +392 °F). • COP (“Cleaning Out of Place” or “Cleaning Open Plant”) re- 5. Flushing out the acid with water tests were conducted using the highest recommended MATERIALS

fers to cleaning after disassembly, opening of the plant, etc. 6. Disinfection for elimination of microorganisms (peracetic operational concentrations and temperatures. FKM • SIP (“Sterilization In Place”) is the sterilization, either with acid and/or hydrogen peroxide mixtures, alternatively us- If a seal is required that can be used in non-polar media such as peracetic acid, hydrogen peroxide (“cold sterilization”), or ing steam) EPDM fat and oil up to +180 °C (+356 °F) and that is also resistant to CIP/ with hot steam 7. Final rinsing with water of drinking water quality or EPDM is highly resistant to acids, alkaline solutions, oxidizing me- SIP media and steam, FKM should be used. FKM is also well- • WIP (“Washing In Place”) requires partly manual work higher, depending on the application dia, cleaning agents and sterilization (including steam). But at suited for use with citrus juices and aromatic oils. Its temperature (brushing, scrubbing etc.) in some places higher temperatures and concentrations, EPDM swells in media range in air is from –15 °C to +200 °C (+5 °F to +392 °F). If alkaline ELASTOMERIC • WOP (“Washing Out of Place”) means the complete dis- Among the most important requirements when designing containing fat and cannot therefore be used everywhere. The cleaners are in operation, FKM is not the optimal solution. In this mantling and cleaning of the plant by hand a seal is not only the resistance of the sealing material to the operational temperatures range between –40 °C to +150 °C (–40 case Fluoroprene® XP is the better material. • OPC (“Open Plant Cleaning”) is the external cleaning of a product itself in which the seal is used, but also the °F to +302 °F) in air and up to +180 °C (+356 °F) in steam (briefly plant without disassembly compatibility with various cleaning agents and steam tem- up to +210 °C (+410 °F)). Fluoroprene® XP peratures of up to +140 °C (+284 °F). The aggressive cleaning Seals made of Fluoroprene® XP can also be used if EPDM is infea- A typical cleaning procedure consists of seven steps: media on the basis of acid, alkali and peroxides pose to HNBR sible because the fat concentration is too high. This material not some extent even greater challenges for the sealing mate- If a seal is intended to be mainly resistant to non-polar media, only shows excellent resistance to acid, alkaline solutions and 1. Pre-rinsing to roughly remove product residues (with cold rials than the product medium itself. In addition, the high HNBR can be taken into consideration. Seals made of HNBR can steam, but also to fats and most flavoring agents. It can be used or warm water, depending on the product) cleaning temperatures exacerbate the effects of the media cover a broader range of applications; however, their durability in at temperatures of –10 °C to +200 °C (+14 °F to +392 °F).

2. Cleaning with an alkaline cleaner (sodium or potassium on the material. aggressive CIP/SIP cleaning agents is lower than EPDM. HNBR PLASTICSENGINEERING hydroxide), plus various additives (surfactants, complex- should not be used in concentrated acids. Operational tempera- Simriz® ing agents, anti-foaming agents etc.) tures in air and in water reach up to +150 °C (+302 °F). If the requirements are so high that none of the previously mentioned sealing materials is suitable, seals made of FFKM are used. OPERATING CONCENTRA- VMQ Simriz® offers comprehensive media resistance in a temperature CLASS DETAIL PRODUCT TEMPERATURE EXPOSURE TIME (MIN.) PURITY

TION (%) If the seal does not necessarily have to be sterilized with hot range of up to +260 °C (+500 °F). & CIP or circulation cleaners cont- +20 to +80 °C steam, silicone (VMQ) can also be used apart from HNBR. VMQ Acidplus VA 35 0.5 – 2.0 Not specified aining nitric acid and surfactants (+68 to +176 °F) CIP or circulation cleaners cont- +10 to +70 °C Beta VA 11 0.5 – 3.0 30 – 60 aining formic acid and surfactants (+50 to +158 °F) RESISTANCE ® ® CIP or circulation cleaners con- Resistance of EPDM, HNBR and VMQ Resistance of FKM, Fluoroprene XP and Simriz +10 to +70 °C taining phosphoric acid and Divbrau VA 10 1.0 – 4.0 20 – 60 (+50 to +158 °F) surfactants Nitric acid (2 %, +80 °C (176 °F)) Nitric acid (2 %, +80 °C (176 °F)) 100 100 Phosphoric acid-based foam +20 to +40 °C MATERIALS Acifoam VF 10 3.0 – 10.0 Not specified 90 90 cleaners (+68 to +104 °F 80 80 Alkaline, single-phase cleaners Steam 70 Steam 70 +40 to +80 °C Phosphoric acid Phosphoric acid containing EDTA for circulation Solo VC 27 0.5 – 5.0 Not specified (+140 °C 60 (+140 °C 60 (+104 to +176 °F) (4%, +70 °C (4%, +70 °C cleaning (+284 °F)) 50 (+158 °F)) (+284 °F)) 50 (+158 °F)) CIP or circulation cleaners cont- +40 to +80 °C 40 40 Highstar VC 77 0.5 – 5.0 Not specified aining bases and surfactants (+104 to +176 °F) 30 30 20 20 +20 to +40 °C Alkali gel cleaners Powergel VG 1 2.0 – 10.0 Not specified 10 10 (+68 to +104 °F) 0 0 Chlorinated alkali CIP or circulati- +20 to +60 °C Fat Sodium hydroxide Fat Sodium hydroxide

Divo CIP VC 94 0.3 – 3.0 Not specified PRODUCT PORTFOLIO on cleaners (+68 to +140 °F) (> 40 %, (5%, +80 °C (> 40 %, (5%, +80 °C RT) (+176 °F)) RT) (+176 °F)) Divosan Hypochlorite Hypochlorite-based disinfectants 0.25 – 1.0 Room temperature Not specified VT 3 Cleaning boosters containing +20 to +80 °C Divo Peroxy 0.2 – 0.5 Not specified surfactants, oxidants (+68 to +176 °F) EPDM FKM Disinfectants containing peracetic +20 to +60 °C Divosan forte VT 6 0.04 – 2.0 Not specified HNBR Active chlorine Active oxygen Fluoroprene® XP Active chlorine Active oxygen acid (+68 to +140 °F) VMQ (2 %, +80 °C (+176 °F)) (<1%, +35 °C (+95 °F)) Simriz® (3%, +60 °C (+140 °F)) (<1%, +35 °C (+95 °F)) Amphoteric surfactant-based TEGO 2000 VT 25 0.25 – 1.0 Room temperature > 20 disinfectants APPENDIX 60 61 Materials resistance and purity INTRODUCTION EXTRACTABLES TECHNICAL FUNDAMENTALS

Particularly high purity requirements apply to elastomers Extractables study EXTRACT VALUES AFTER 24 HOURS REFLUX BOILING IN ETHANOL AND N-HEXANE in the pharmaceutical industry, including the desire for Freudenberg conducted an extractables study on O-rings ETHANOL N-HEXANE disclosure of the ingredients of the compounds. This does with different media at high temperatures. not provide the desired information about the interac- 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 MATERIALS

tions that can take place during the production process. 3,0 EPDM 291 black 70 That is why manufacturers in the pharmaceutical industry EPDM 292 black 85 2,5 want to examine materials for a possible interaction with the EPDM 253815 white 70 pharmaceutical preparation. For example, they want to know ® Fluoroprene XP 41 blue 75 ELASTOMERIC how an O-ring for the sealing of an inhalation spray head be- 2,0 haves in contact with the drug. It is also of interest to mini- Fluoroprene® XP 43 blue 85 mize the influence of the seals from production on the prod- Simriz® 494 black 75 1,5 uct. In addition to studies at ambient temperatures – Simriz® 506 white 75 with respect to the completeness of the packaging, the stor-

Extract values % in 1,0 age conditions and test substances (leachables study) – tests are slated in the worst-case scenario with more stringent conditions such as elevated temperatures and solvent 0,5 strengths (extractables study). Apart from the quantifica- The tested O-rings were extracted, without prior cleaning tion, the identification of the migrated substances is particu- steps, in a low ratio of elastomer to extract medium for 24 0

larly important for a subsequent toxicological evaluation. hours under reflux to achieve the most stringent conditions PLASTICSENGINEERING possible for evaluation. To ensure the comparability of re- In addition, Total Organic Carbon (TOC) studies were per- found in the liquid sample was again quantitatively assessed Compared to storage, a multiple of the volume flows by the sults of different O-rings, the ratio between surface and formed on the extract solutions of the phosphate buffers as in comparable proportion to the elastomer sample. seal in the production process. The ratio of surface area to media volume was kept constant. In line with the recom- a measure of the organic contamination. The TOC amount volume and hence the concentration of possibly leached mendations of the FDA, the BfR and other relevant sources, PURITY

compounds is therefore much smaller. Nevertheless, an four media were used: & interaction between the sealing material or the soluble TOC VALUES components of the elastomeric compound and the active • E t h a n o l pharmaceutical ingredient can occur. This interaction might • N - h e x a n e PHOSPHATE BUFFER PH 2.5 PHOSPHATE BUFFER PH 9.5

alter the pharmaceutical product and, in the worst case, • Phosphate buffer pH 2.5 EPDM EPDM EPDM XP 41 XP 43 SIMRIZ® SIMRIZ® EPDM EPDM EPDM XP 41 XP 43 SIMRIZ® SIMRIZ® RESISTANCE adversely affect its efficacy. If the interactions between the • Phosphate buffer pH 9.5 291 292 253815 494 506 291 292 253815 494 506 400 seals in valves and other system components and the products therein are known to the pharmaceutical manufactur- In addition to a gravimetric evaluation, the extractable MATERIALS ers, possible contamination can already be evaluated during contents were analyzed by means of gas chromatography- 300 the production process. This safeguards the processes and mass spectrometry (GC-MS). For this purpose, the eva ensures the necessary purity of the products. porated extracts were absorbed in the respective extract- 200 ing agent and the extracts of the buffer solutions in methanol and injected into the gas stream. The chromatograms TOC ppm in 100 were plotted 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 0 main compounds found. By means of the Extractables-study it could be found out was under 3%. With the fluorous materials the portion was PRODUCT PORTFOLIO that the tested materials of Freudenberg show a very slight under the detection limit. Additionally the TOC-results prove extract value. The extractable portion of EPDM-compounds the purity of the tested materials. APPENDIX 62 63 Materials resistance and purity INTRODUCTION HYGIENIC DESIGN TECHNICAL FUNDAMENTALS In sterile technology, there is a rule that a seal must be in- materials that come into contact with the actual product stalled free of dead space and leaks. The groove must be must be sufficiently resistant to preclude their breakdown – 90% filled and the material must not have any swelling in production or in cleaning and sterilization cycles – and greater than 5%, otherwise gap extrusion will allow sea- the subsequent possibility of a deterioration of the product ling material particles to contaminate the process medium. quality as a result of foreign matter stripped or dissolved MATERIALS from the interior of the plant. The resistance of the sealing materials, taking into account the production, CIP and SIP parameters and the require- By means of a FEM-calculation the use of a seal under ments of Hygienic Design, must be ensured. The elastomer different conditions can be simulated. Consequently ELASTOMERIC if necessary the geometry can be optimized, in order to prevent the above mentioned effects. PLASTICSENGINEERING PURITY &

PRODUCT PORTFOLIO RESISTANCE MATERIALS PORTFOLIO

PRODUCT APPENDIX 64 65 Product portfolio INTRODUCTION O-RINGS TECHNICAL FUNDAMENTALS

As a universal sealing element, the O-ring is a sealing com- Possible cross-sections Applications ponent used in all industrial sectors. It is characterized by O-rings are utilized in numerous applications and in nearly its excellent price-performance ratio and broad range of all industries. An overview of the primary applications is THE ADVANTAGES AT A GLANCE applications. given below. MATERIALS

• Can be used universally O-rings can be manufactured in nearly all conventional • Static cover seals, axial sealing • Available in all dimensions elastomer materials as a standard part in large quantities • Static piston or rod seals, radial sealing • Available in all types of elastomer or in smaller quantities for customer-specific applications. • Dynamic seals involving translatory movement (hydraulic • Easy to install and assemble In comparison to other sealing systems, the required instal- or pneumatic) • Good price-performance ratio lation space is extremely small, allowing material-saving • Dynamic seals involving rotation • Small installation space ELASTOMERIC designs. Though simple in form, O-rings can nonetheless • V a l v e s e a l s be reliably used in a variety of installation configurations: • F l a n g e s e a l s as static seals in axial or radial direction, or for dynamic applications involving translatory and/or rotary movements. DESIGN NOTES Function Installation and assembly The design of O-ring sealing systems (groove, sealing surface) is described in the relevant standards (e.g. • Static sealing for axial and radial applications • Edges should be rounded with at least r = 0.1 mm General DIN 3771 and DIN ISO 3601-1) • Dynamic sealing for applications with translatory and • If O-rings must be stretched over sharp corners or thread- rotary movements ed parts due to the design of the application, these sur- Depending on the application, the following benchmarks apply for standard cases (compression in % of the

faces should be covered with bushings/casings where cross-section diameter): PLASTICSENGINEERING Dimensions possible Compression • Static seals: 15 – 30% • Available in inch (US standard) and metric dimensions • In radial sealing applications, there should be lead-in • Dynamic seals - hydraulic: at least 6% • Numerous intermediate sizes are also available thanks to chamfers on the pistons/rods (on the housing) • Dynamic seals - pneumatic: 2 – 6% our extensive inventory of tools • When installing in pistons, avoid twisting. If necessary, • In standard applications there is the rule that the O-ring volume is 70 – 90% of the groove volume PURITY

• Special sizes of over 500 mm generally require new tools use a compatible lubricant for easier assembly & • It should be kept in mind that the elastomer is more susceptible to thermal expansion than the metal housing Degree of groove fill • Standardized cross-section diameters from 1 mm to • For applications in the food and beverage industry, the • Applications in the food and beverage industry must be leak-free. The degree of groove fill can be more than 6.99 mm, smaller and larger dimensions available on re- use of coated O-rings is recommended (e.g. PTFE lacquer, 100%; specialized types of grooves should be utilized quest RFN treatment)

• When O-rings are installed in housings, the O-ring is • Max. 6% in constant use RESISTANCE Types compressed. Here it must be ensured that the O-ring Elongation • Max. 25% of the elongation at break cited in the data sheet when assembled • Compression- or injection-molded standard models does not warp (form a loop) • In the case of greater elongations, corresponding elastic recovery time should be taken into account • Special designs and large dimensions of endless extruded • General installation and assembly instructions, see page 94 MATERIALS cord, spliced or vulcanized Compression strain Max. 3% after installation, otherwise risk of deformation and shearing during installation • In addition to round cross-sections, oval, rectangular, semicircular or x-shaped cross-sections are possible • The acceptable gap widths and surface qualities depend on the material’s hardness rating and the operational • Special, customer-specific types can be created with new 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 molding tools • In dynamic applications or those involving pulsating pressures, no plastics reinforced with glass fibers should be • Surface-treated special designs such as non-stick and used since otherwise extensive wear will occur PORTFOLIO lubricated applications, painting, coating, nano-techno logical modification for the optimization of function and application • PTFE casing (with separating joint) or complete FEP encap PRODUCT sulation for use in highly corrosive media APPENDIX 66 67 Product portfolio INTRODUCTION ENCAPSULATED O-RINGS TECHNICAL FUNDAMENTALS

Encapsulated O-rings are a combination of an elastomeric TYPES Outside sealing – grooves on shafts: O-ring and a closed encapsulation of modified PTFE, which Very good compression set and permitted FKM core/ THE ADVANTAGES AT A GLANCE combine high chemical resistance and elasticity in an ex- temperature range from –20 to +200 °C • Use an assembly aid for installation FEP encapsulation cellent sealing function. (–4 to +392 °F) • Soak the ring in hot water for 10 minutes, then slide over MATERIALS

the installation aid quickly and smoothly until the ring • Highly resistant to nearly all chemicals VMQ core/ For low temperatures from –60 to +200 °C They consist of an elastomer core that provides elastic FEP encapsulation (–76 to +392 °F) snaps into the groove • Can be used universally contact pressure, as well as a jacket for reliable sealing in • If necessary, compress the ring to its original form by • Tool-independent dimensions, many standard dimensions FKM core/ For high abrasion resistance and tempera aggressive media. The core material used is either FKM or PFA encapsulation tures from –20 to +200 °C (–4 to +392 °F) means of a second ring (by applying pressure) available in stock VMQ, depending on the required temperature resistance.

For high abrasion resistance and extreme ELASTOMERIC FKM core/ The encapsulation is made of FEP (fluorinated ethylene temperature ranges from –60 to +260 °C (–76 PFA encapsulation propylene) or PFA (perfluoroalkoxy copolymer). Encapsulat- to +500 °F) DESIGN NOTES ed O-rings are used exclusively for static applications, since For applications in delicate devices and requi- Coarseness No more than 50 μm on contact surfaces movements or abrasive media would destroy them. VMQ hollow core ring little contact pressure Lead-in Chamfer angle of 30° to 40°, length must be min. For profiles with oval, rectangular or semicircular cross-sections (all chamfers 50% of the cord thickness Encapsulated O-rings are basically available in all desired with rounded edges), please contact Freudenberg • Any parts that come into contact with the seal dimensions, internal diameters and cord thicknesses – in during assembly or in operation must be clean metric and inch sizes. Since they are only slightly expand- and free of flash Outside sealing – grooves on shafts able and compressible, the installation spaces should be Possible design FEP encapsulation • All edges must be rounded designed accordingly, especially for seals with small diam- • Given the reduced elasticity and compressibility of the ring, the installation space should be

eters. Preparation PLASTICSENGINEERING axially accessible Applications • Otherwise, extra care should be given to using FEP/PFA encapsulation as well as the VMQ and FKM core FEP/PFA-encapsulated O-rings are primarily used in chal- clean, smooth and flash-free pins or mounting are FDA-and USP-compliant as a standard. The different lenging applications: sleeves material types affect both the sealing properties and the • After insertion in the groove, the ring should return to its normal dimensions PURITY

price level. Thus, PTFE-encapsulated O-rings are less ex- • With aggressive media that require universal chemical re- & pensive, but must be protected against ingress of media Installation and assembly sistance at the seam in terms of their constructional design. Solid Inside sealing – grooves in housings: • In case of high thermal stresses at high and low temper- PTFE O-rings in contrast are extremely resistant to media atures

but lack elasticity. • Seal must be deformed to fit in the housing • For applications in equipment in the food and beverage RESISTANCE • To facilitate assembly, soak the ring in hot water for 10 industry using different media and aggressive cleaning Function minutes and then immediately fit it into the groove. To do agents • Elastomer core provides elastic contact pressure so, push the ring’s leading edge past the groove • In small quantities as an economical alternative since no MATERIALS • FEP or PFA encapsulation effectively protects the seal • Carefully position the ring’s trailing edge in the groove tools are necessary for manufacture against aggressive media and pull back on the leading edge until the ring snaps into the groove (rod should be inserted while the ring is still Dimensions Dimensions warm and pliable) • Cross-sections from 1.6 to 25.4 mm • All metric and inch cross-sections are available, all stand- • Use installation aids if necessary • Internal diameters from 10 to 600 mm ard dimensions are in stock • Special dimensions available on request PORTFOLIO • 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 • Pure PTFE O-rings are available in all dimensions, as they PRODUCT are manufactured by machining

Inside sealing – groove in housing Inside sealing – groove in housing APPENDIX 68 69 Product portfolio INTRODUCTION SEALS FOR PIPE CONNECTIONS TECHNICAL FUNDAMENTALS

Clamp seals Freudenberg offers different models for static seals in Applications standardized pipe connections used in the food, chemical Seals for dairy couplings cover a broad range of applications THE ADVANTAGES AT A GLANCE and pharmaceutical industries. for the sealing of pipe connections: MATERIALS

These four different models are available: • Suitable for use in a wide variety of pipe connections in • Standardized sealing element the food, beverage and pharmaceutical industries • High density of use • The classic seal for dairy couplings in compliance with • Ideal for flange connections that need to be opened on a • Especially fast and easy assembly, regardless of the direc- DIN 11851 regular basis tion of installation • Clamp seals in compliance with DIN 32676 and ISO 2852 • Used in non-critical media • Can be removed quickly ELASTOMERIC • O-rings for aseptic clamp connections in compliance with Conventional clamp seal • Available in numerous approved materials variants DIN 11864 • Flat gaskets in compliance with DIN 28091-2 and DIN Clamp seals were developed for a quick and secure pipe con- 28091-3 THE ADVANTAGES AT A GLANCE nection for continuously operating systems. The main advantage of clamp connections is their simple installation, since Seals for dairy couplings the flanges are designed symmetrically and thus the seals do • Standardized sealing element not need to be installed with a particular orientation. The di- • High density of use mensions are standardized in accordance with ISO 2852 (inch • Especially fast and easy assembly, regardless of the direc- dimensions) and DIN 32676 (metric dimensions), the standard- tion of installation ized seals are therefore particularly economical and available

• Can be removed quickly from stock. Since the clamp connection does not have a me- PLASTICSENGINEERING • Available in numerous approved material variants tallic stop, there is the danger that leakage can occur if the seal is overly compressed or not seated properly on installation. 1 2 3 DESIGN NOTES Freudenberg offers a portfolio of four materials that can be

Standard With lip High version PURITY

General Adhere to the relevant standards processed into clamp seals from a single tool: 1 Clamp connection with nominal diameter DN 6 to DN/OD ¾″ & As laid out in the relevant standards, inner surfaces that Series A: DN 6 to DN 8 Surfaces Seals for dairy couplings can be used to easily connect and come into contact with media R ≤0.8 μm • 70 EPDM 291 (black) Series B: DN/OD 10.2 to DN/OD 17.2 Series C: DN/OD ¼″ to DN/OD ¾″ seal pipe connections for liquid media. The dairy couplings • FDA-compliant • 70 EPDM 253815 (white) RESISTANCE standardized according to DIN 11851 are very common in • Hardness between 75 and 85 IRHD • 75 Fluoroprene® XP 41 (blue) 2 Clamp connection with nominal diameter DN 10 to DN/OD 6″ the food and beverage industry. Their essential advantage Material • Homogeneous material • 70 VMQ 117055 (transparent) Series A: DN 10 to DN 200 is the extremely quick and easy installation thanks to their • No damage during deflashing Series B: DN/OD 21.3 to DN/OD 219.1 • No visible inclusions or pores allowed simple separation from the flange, so that they can also be Applications Series C: DN/OD 1″ to DN/OD 6″ Preferably clamp seals with aseptic O-rings in compliance MATERIALS frequently disassembled without difficulty. Dairy couplings Design Clamp seals cover a broad range of applications for the seal- with DIN 11864 3 A version with truncated lip pursuant to ISO 2852 is also available are an economical solution and are particularly suitable for ing of pipe connections: • Where applicable, check pipe inclinations for cracking smaller plants not operating continuously. However, it Preparation • Ensure proper pipe alignment during assembly should be taken into account that this seal component is • Suitable for use in a wide variety of pipe connections in best suited for less demanding applications. Consequently, the food, beverage and pharmaceutical industries seals for dairy couplings do not meet Hygienic Design re- • Ideal for flange connections that need to be opened on a PORTFOLIO quirements, since compression is problematic due to the regular basis lack of metallic stops, and the formation of gaps into the • Used in non-critical media product area could occur. Seals for dairy couplings are available in various materials, from NBR, EPDM, FKM to VMQ and Dimensions PRODUCT PTFE, for a maximum operating pressure of up to 40 bar. • According to ISO 2852 • Nominal dimensions from DN 10.2 to DN 219.1 Dimensions • According to DIN 32676 • Standard form, with lip, and high version • Nominal dimensions from DN 6 to DN 200 • Standard dimensions from DN 15 to DN 100 • Nominal dimensions from 1/4” to 6” APPENDIX 70 71 Product portfolio INTRODUCTION TECHNICAL FUNDAMENTALS

O-rings for aseptic clamp connections A flat gasket, on which a compacting pressure greater than the internal pressure is applied, is used to create a secure FG-120 – FG-120 is a fiber-reinforced graphite seal in an In addition to the conventional flat gasket form made of FG- seal. Freudenberg‘s flat gasket portfolio covers all these re- unmistakable royal blue color. This flat gasket is reinforced 360, Freudenberg also offers a sealing band (joint sealant). quirements and also enjoys market-specific approvals. There with aramid fibers (bound with NBR) and thus withstands a This sealing band, delivered in rolls, can be individually cut MATERIALS

is a choice of gaskets of the following three material classes wide variety of chemical and thermal stresses. and is self-adhesive on one side. That means it can seal according to DIN 28091. joints, covers or frames quickly and reliably – without tool- FG-180 – FG-180 is a silica-filled flat gasket made of modi- ing costs. The FG-360 joint sealant is 25 m long and is avail- fied PTFE. Its very good mechanical characteristics, thermal able in a variety of widths. NAME PANEL FORMAT IN MM THICKNESS IN MM resistance and white color make it a particular favorite of ELASTOMERIC Aseptic clamp seal 0.5 the pharmaceutical industry. FG-120 1,500 x 1,500 0.8 1.0 FG-360 – The unique flexibility of FG-360 is due to the fact In order to ensure that Hygienic Design requirements are 1.5 that it consists of 100% expanded PTFE (ePTFE). Gaskets 2,000 x 1,500 met, clamp seals with aseptic O-rings compliant with DIN 2.0 made from expanded PTFE stand out for their high temper- 11864 were developed. They optimally combine the advan- 3.0 ature cycle resistance. They also resist cold flow and are con- tages of easy installation and a sealing area free of dead FG-180 1,200 x 1,200 1.0 sidered especially pure. space. Aseptic O-rings are available in stock in specialized 1.0 1.5 high-performance materials with various approvals. 1,500 x 1,500 2.0 FG-360 3.0 CHARACTERISTICS FG-120 FG-180

Dimensions 1.5 MM THICK 3.0 MM THICK PLASTICSENGINEERING • Series A: nominal dimensions from DN 10 to DN 100 0.5 1.5 Type FA-A1-0 TF-M-0 TF-0-0 TF-0-0 • Series B: nominal dimensions from DN 13.5 to DN 114.3 FG-360 1,500 x 1,500 3.0 DIN 28091-2 DIN 28091-3 DIN 28091-3 DIN 28091-3 • Series C: nominal dimensions from 1/2‘‘ to 4“ 6.0 Material Graphite, aramid fibers Silica-filled PTFE Expanded PTFE Expanded PTFE (bound with NBR) PURITY

Flat gaskets & Color blue white white white Another option to seal a pipe joint is a flat gasket. It is inserted between two flat flanges, which are connected to Approvals • EU Reg. 1935/2004 • EU Reg. 1935/2004 • FDA 21 CFR 177.1550 • FDA 21 CFR 177.1550 each other by screws. With the help of such flanges, differ- • TA Luft • FDA 21 CFR 177.1550 • USP Class VI –121 °C • USP Class VI –121 °C • DVGW • TA Luft (250 °F) (250 °F) ent system elements, such as valves, fittings, pipelines, • KTW • DVGW • TA Luft • TA Luft RESISTANCE pumps etc. are added together. The sealing material should • WRAS • EU (VO) 1935/2004 • EU (VO) 1935/2004 offset and seal the macro unevenness of the flanges well, • W 270 on the one hand, and be resistant to the media flowing in Densitiy g/cm3 1.74 2.10 0.85 0.85 MATERIALS the pipes on the other. An almost inert material is needed Tensile strength 18.0 17.0 14.0 18.0 both in the food (e.g. detergent concentrates) as well as in longitudinal N/mm2 the pharmaceutical and chemical industries (aggressive sol- Compression % 6.0 5.0 69.0 66.2 vents and chemicals). Freudenberg offers a range of flat gasket materials with excellent chemical resistance to suit any Recovery % 60.0 45.0 7.6 11.6 application. Flat gaskets primarily provide the static sealing –100 to +300 °C –200 to +210 °C –268 to +315 °C –268 to +315 °C Temperature range PORTFOLIO of two sealing surfaces. (–148 to +572 °F) (–328 to +410 °F) (–450 to +599 °F) (–450 to +599 °F) PRODUCT APPENDIX 72 73 Product portfolio INTRODUCTION DIAPHRAGMS HYGIENIC USIT RINGS TECHNICAL FUNDAMENTALS

Diaphragms form a reliable but flexible separating wall Freudenberg‘s Hygienic Usit® is a product developed specifi- Compounds between two component spaces. The volume changes of cally for the requirements of the process industry which sets The elastomer bead of the standard Hygienic Usit® is made the separated media can be converted into force. THE ADVANTAGES AT A GLANCE standards in purity. from three EPDM variants. They are all suited for direct contact with food and pharmaceuticals and are resistant MATERIALS

Diaphragms are especially interesting sealing components • Good media resistance Since it was in the past not possible to implement hygienic against CIP/SIP media. The black EPDM 291 ist the standard for the food and beverage industry where they can perform • Broad range of functions and applications screw fittings, machine manufacturers and operators re- compound for the process industry. The white EPDM a number of different functions. Available in all basic elas- • E c o n o m i c a l sorted to welding solutions. However, welded connections 253815 is especially interesting for the pharmaceutical in- tomer variants, or with application-specific modifications • Highly dependable cannot be separated again easily. Still other system manu- dustry, while the blue EPDM 217676 is used as a variant in such as fabric reinforcements, metal inserts or foil layers, facturers often employ conventional, non EHEDG-compliant color. For applications with aggressive media or high tem- diaphragms are extremely dependable and resistant to me- fittings in or on the product space. This carries the risk that peratures, we offer the Hygienic Usit® made from our fluor- ELASTOMERIC dia. They are very affordable solutions, as the minimal re- TYPES product residues accumulate under the screw head and be- inated Fluoroprene® XP 45 material (on request). This blue quirements with regard to tolerances and surface qualities • Flat diaphragms come a source of contamination. The tightening of the universal material also minimizes flavor transfer. of the surrounding components make it possible to produce • Convoluted diaphragms screw already holds numerous sources of error, e.g. damage them inexpensively. Diaphragm types • Plate-shaped diaphragms to the surface of conventional screws by the mounting tool. • Rolling diaphragms Function • Individual designs available upon request Freudenberg‘s Hygienic Usit® offers the possibility to realize THE ADVANTAGES AT A GLANCE • Regulation and switching using pressure that is converted • MB as pure rubber diaphragm hygienic screw connections. Thanks to the cooperation with into rod force • GMB with fabric insert or overlay the company NovoNox, the washers can be purchased with • Separation of media in component spaces with nearly • MBM with metal insert and/or film hygienic screws and cap nuts. The connection is available in • EHEDG- and 3-A® Sanitary Standards-certified • GMBM with metal insert and fabric overlay

Materials PLASTICSENGINEERING identical pressure levels or insert and/or film the dimensions M4, M5, M6, M8, M10, M12 and M16. Addi- • Optimally matched screw-cap nut-Usit composite composition • Pumping and compression of liquids and gases • Diaphragms with film overlay made of PTFE, tionally we offer bolts and cap nuts in M3 designed for the • Prevention of contamination due to dead space-free design • Measuring volume flows modified PTFE, electrically conductive foils M4 washer. Also in combination with a standard hexagon • Cleaning with CIP, SIP, WIP, COP, OPC and WOP process • Actuation of valves etc. screw with flange according to DIN EN 1665, the Hygienic possible • Diaphragms made of pure PTFE Usit® prevents the formation of bacteria. In open processes, PURITY

Dimensions where corrosion is an issue due to the wet environment, the & From 5 mm to maximum diameter of 1,000 mm (or larger Hygienic Usit® minimizes the risk of corrosion because of for individualized applications). DESIGN NOTES the prevention of bacteria. But the surface properties of the • In designing diaphragms, it is advisable to use FEM standard screws are not compliant to Hygienic Design NovoNox cap nut Installation and assembly calculations to reduce development and testing standards. For this reason they are not recommended for Material: 1.4404 in A4-70 quality RESISTANCE

Please refer to page 94 for general assembly and installation times applications with direct product contact. Highly polished with up to max. Ra < 0.04 μm instructions. • The diaphragm’s construction position (0 position) should be selected such that the diaphragm is not The screws and cap nuts with collar from NovoNox conform under load Freudenberg washer MATERIALS Applications Design • The deflection of the diaphragm during operation to 3-A® Sanitary Standards, are polished to a high shine and Material: Elastomer made of 70 EPDM 291, 70 EPDM 253815, 70 EPDM 217676 or Fluoroprene® XP 45 Since diaphragms can be very closely tailored to specific ap- should be designed in such a way that no overstret- achieve a roughness depth of up to max. Ra = 0.04 µm, plications in terms of their shape and materials compo ching and no excessive stress peaks can occur thanks to special manufacturing processes. The unique sur- Shim of 1.4404 sition, they can be used in a very broad spectrum of appli- • The diaphragm’s mountings must in some cases be face finish is free of flash and dimples which would preclude able to withstand considerable forces and should be cations. Typical areas are: designed accordingly. It is advisable to utilize FEM a hygienic design. Furthermore, NovoNox has patented spe- calculations here, too cial sockets with protective plastic inserts that do not dam- PORTFOLIO • A c t u a t o r s age the screws when tightening. • F i t t i n g s • The elastomer base material, as well as any applicable fabric, metal or plastic inserts, must be resistant to Choice of • Water reservoirs all media involved in operation Applications materials PRODUCT • Pumps and compressors • For applications in particularly aggressive media, it is • In closed process steps for areas in contact with the • Valves and controllers advisable to add a layer of PTFE to the diaphragm p r o d u c t • In open processes, to ensure the complete exterior NovoNox hexagon head screw with collar cleaning and steam sterilization of the plant Material: 1.4404 in A4-70 quality Highly polished with up to max. Ra <0.04 µm APPENDIX 74 75 Product portfolio INTRODUCTION ROTARY SHAFT SEALS TECHNICAL FUNDAMENTALS

Only Freudenberg offers the original Simmerring® as a rota- PTFE is a material that performs exceptionally well in nearly Function ry shaft seal for the sealing of rotary shafts and spindles and all media and cleaning agents and makes especially hygienic • Dynamic sealing for applications involving rotary motion the protection of bearings. This sealing system is primarily processes in food and beverage production possible. HTS II • Sealing pressure is generated by the special lip design and THE ADVANTAGES AT A GLANCE intended for use in applications involving rotary motion. rotary shaft seals also offer outstanding sealing perfor- PTFE’s memory effect MATERIALS

mance with minimal contact pressure, which is generated • Variable and reliable use in the food and beverage industry Simmerring® Radiamatic® HTS II rotary shaft seals are a cus- by the geometry of the sealing lip joint and the memory ef- Dimensions • Highly resistant to media and temperatures tom-developed product made of PTFE and can be used in a fect of the PTFE. This concept minimizes abrasion while si- • Manufactured by machining independent of molds, • Dead space-free variants available for hygienic applications broad spectrum of food and beverage industry applications. multaneously ensuring a reliable sealing performance. Spe- therefore no limits on any dimension • Minimal abrasion The product stands out because of its low friction, a result cial variants are also available for more extreme demands, • Standard dimensions from 10 to 125 mm shaft diameter • Available in all dimensions of PTFE’s own low coefficient of friction, in conjunction with e.g. higher pressures, dead space-free design, or dusty oper- available in stock • Economical to use, as they make secondary seals un ELASTOMERIC the low contact pressure exerted on the rotary shaft by the ating conditions. Lastly, the seal’s innovative lip design also • Smaller or larger dimensions available upon request necessary lip. The primary advantage of HTS II rotary shaft seals is makes it possible to affordably reduce the number of com- their high media resistance, since the media to be sealed ponents needed for individual applications. Installation and assembly come into contact exclusively with PTFE. • Must always be assembled as a combination of sealing DESIGN NOTES ring and retaining ring • HTS II rotary shaft seals must be installed as a unit • If seal is disassembled, the clamping ring must be re- consisting of a PTFE sealing ring and a stainless steel TYPES placed since it is deformed by the pressing operation retaining ring • The retaining ring is deformed during installation • If possible, use pressing tools with built-in stops to avoid General excessive axial compression and the risk of damaging the and cannot therefore be reused HTS II 9535 With standard lip for conventional applications • The installation space must be axially accessible

seal • Lead-in chamfers on both the shaft and housing PLASTICSENGINEERING • To aid assembly, the rotary shaft seal can be lightly oiled should be included to prevent ring damage if desired Peak-to-valley R R With additional dust lip for use in dirty and dusty environments that pose a risk of foreign objects • If possible, disassemble the sealing ring from the inside a t HTS II 9536 SL heights getting under the sealing lip and in applications involving alternating pressure-vacuum operation using a shaft sleeve; alternatively, a bearing remover can

Housing <1.8 μm <10 μm PURITY

be used, provided there is sufficient room. If the seal is Surfaces & damaged, replace the sealing ring Shaft, twist-free 0.1 to 0.2 μm 0.5 to 1.0 μm • Please refer to page 94 for general installation and assem- Hardness of 45 to 65 HRC HTS II 9538 DL With a double sealing lip for high security standards bly instructions running surface RESISTANCE Applications Due to their variable designs, the HTS II rotary shaft seals HTS II 9539 VL Dead space-free version with protruding sealing lip for Hygienic Design applications offer an enormous application range for production pro- MATERIALS cesses involving the sealing of media, the separation of lubricants and media and the secure sealing of cleaning pro- • Extremely compact shaft seal for tight installation spaces cesses. WADB 9461 • 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 Suitable for use in • Beverage filling facilities PORTFOLIO • Food and beverage production machinery With dynamic return capability for applications with high liquid level or increased demands on HTS II 9541 with twist impermeability • Process equipment used in pharmaceutical and cosmetics manufacturing • Mixers and separators PRODUCT • For use at elevated levels of shaft runout • Machines with a high rotational speed HTS II EWS • With integrated flexible bellows element • Cleaning and sterilization processes • Application limits up to 1 m/s and 3 bar • The reliable sealing of dangerous substances and highly valuable production media APPENDIX 76 77 Product portfolio INTRODUCTION V-SEAL SET PACKINGS TECHNICAL FUNDAMENTALS

V-Seal set packings are multi-part sealing sets primarily Installation and assembly Composition and installation used in applications involving translatory motion. As they Please refer to page 94 for general installation and assembly offer lower friction and require less pre-tensioning forces, instructions. Pure PTFE PTFE-impregnated L they represent a worthwhile alternative to U-packings. synthetic fabric MATERIALS

Primary applications V-Seal set packings normally consist of a compression ring, • Regulation and shut-off valves several V-shaped packing rings and a backup ring, providing • D o s i n g s y s t e m s reliable sealing for spindles on regulating and shut-off • M i x e r s valves, rods on plunger pumps, hydraulic cylinders as well as • P i v o t j o i n t s swivel joints and mixers. Predominantly used with transla- ELASTOMERIC tory motion but also with slow rotation, they generate less Predominantly used to seal friction and require considerably less initial axial pretension- • Spindles of control and regulation valves ing force than stuffing box packings, for instance. • Rods (translatory motion, possibly in combination with ø D minor rotation) ø d As the standard materials for V-Seal set packings are PTFE • Low-speed shafts and PTFE-carbon compounds, they can be manufactured by

machining from semifinished products in a particularly eco- Spacers for balancing heights nomical manner without the use of tools. Special-purpose TYPES V-Seal set packings made of PTFE-impregnated Nomex fab- • DM 9403: stable profile for static sealing and pulsa-

ric require tools, but are also better suited for higher pres- ting pressures up to 300 bar PLASTICSENGINEERING • DM 9406: relatively rigid lip profile for dynamic sures, as they are less susceptible to cold flow. Freudenberg PTFE has a broad range of suitable tools in its inventory for this. sealing and pressures up to 200 bar • DM 9409: flexible lip profile for dynamic sealing and pressures up to 50 bar as well as vacuum Further materials such as polyethylene, PEEK and Univerdit (a • Packing rings made of PTFE-impregnated fabric DESIGN NOTES PURITY

compound of PTFE and graphite) are also available on request, & • For certain applications packing ring combination as are specialized profiles, should none of the three standard PTFE-fabric • Due to their lack of elasticity and high degree of thermal expansion, V-Seal set packings must be preloa- of PTFE-impregnated fabric and virgin PTFE/PTFE form-pressed ded using a spring device options be compatible with the individual application. compound for pressures up to 700 bar with low • The spring force should be tailored to the seal’s design, dimensions and operating conditions. The higher friction Virgin PTFE/ the spring force, the less leakage. The parameters can be requested from Freudenberg Function RESISTANCE PTFE compound V-Seal set packings • When using a spring device for installation on the side turned away from the pressure, set the spring • Multi-part sealing set consisting of a compression ring, force to maximum pressure V-packing rings and a backup ring • For information on permissible installation space tolerances and the characteristics of their surfaces, • Predominantly used with translatory motion, or occasion- please consult Freudenberg MATERIALS ally with slower axial motion THE ADVANTAGES AT A GLANCE • Can usually be installed without spring pre-load PTFE/fabric V-Seal set packings • Installation space must be adjustable (see diagram) Dimensions • Highly variable to cover a broad range of applications • Tolerances and surface characteristics match those of the virgin PTFE/PTFE compound variant Virgin PTFE and PTFE compounds: • High pressure resistance (virgin PTFE and PTFE com- In the standard version, V-Seal set packings consist of a compression ring, a backup ring, and three pounds up to 30 MPa, fabric-reinforced V-packing rings up General • Available in all inventory-standard dimensions to 70 MPa) V-packing rings PORTFOLIO • Special customer-specific dimensions are possible with- • Very good temperature resistance (–200 °C to +260 °C In order to avoid damaging the seal during installation, the installation space and rods and/or shafts should out difficulty (–328 °F to +500 °F)) Special installation notes include lead-in chamfers • No tooling costs for virgin PTFE/PTFE compound variants PTFE fabric: • Adjustable set heights PRODUCT • L o w f r i c t i o n • Extensive inventory of tools available • Universal chemical resistance • Special customer-specific dimensions available upon re- • Low susceptibility to cold flow and extrusion in PTFE-fab- quest ric variant APPENDIX 78 79 Product portfolio INTRODUCTION STUFFING BOX PACKINGS TECHNICAL FUNDAMENTALS

From centrifugal and piston pumps to applications on spin- Function Recommended number of rings for valves Installation and assembly dles and valves – stuffing box packings are a type of seal • Sealing in pressure-free environments by means of restor- • Installation space must be axially accessible broadly used throughout the food and beverage industry ing force MEDIA PRESSURE (BAR) RECOMMENDED NUMBER OF RINGS • Ensure that the gland packing goes far enough into the where sealing is achieved by compressing the packing. • Self-amplifying sealing function under pressure (the <10 3 stuffing box and check the reset path MATERIALS

higher the pressure, the better the sealing) • Use a cutting gauge when cutting the material 10 – 30 4 The functional principle of a stuffing box packing consists • Form-pressed rings should be opened axially, then slightly in the axial compression of endless woven cords pressed Dimensions and types 30 – 60 5 flexed radially and laid over the shaft, cut end first. Next, into rings. This process generates a radial compression on • Double, triple and quadruple diagonally braided, with 60 – 100 6 press the sleeve completely into the installation space the sealing location, which must be greater than the inter- quadratic cross-section from 3 mm to 25 mm, available and tighten it according to the component specifications

100 – 250 7 ELASTOMERIC nal pressure to ensure reliable sealing. Using different types by the meter • Please refer to page 94 for general installation and assem- of stranding and packing materials to match the respective • Tube-braided packings, also available as double-layer 250 – 500 8 bly instructions chemical and thermal requirements, stuffing box packings bands can be tailored to a variety of application scenarios. In addi- • Braided packings as pre-cut components or pressed in Applications tion to the classic woven packings, Freudenberg also offers ring form Recommended number of rings for centrifugal pumps • Valves the special Valtec variant, made of a non-woven material • Graphite versions as pre-pressed rings and bushings and mixers • M i x e r s impregnated with PTFE which is wound and compressed • PTFE-impregnated packings (Valtec) as rings or bushings • Homogenizers into rings. • Combination of different packing rings to a set, e.g. with MEDIA PRESSURE (BAR) RECOMMENDED NUMBER OF RINGS • Piston and plunger pumps anti-extrusion versions on the outside and low-friction <5 3 • F i t t i n g s Pressures play an important role in the sealing function. rings on the inside 5 – 10 4

When there is no pressure on the packing, a good compres- • Use of “lantern rings” for lubrication, shut-off or cooling Stuffing box design PLASTICSENGINEERING sion set is necessary to maintain a good seal using resilience. • Versions with internal or external springs for plunger 10 – 20 5 Stuffing box packings are self-amplifying under pressure: pumps 20 – 30 6 their maximum pressure load is influenced by the gap • Grafiflex as cover seals in internal pressure-supported >30 7 width. To improve their gliding ability and therefore the systems PURITY

cross-section impermeability, stuffing box packings are also & impregnated with lubricants. Recommended number of rings for plungers Types of stranding DESIGN NOTES

RECOMMENDED NUMBER OF RINGS RESISTANCE • For centrifugal pumps, plunger pumps and Packing mixers: s = 1.4 x ½ d (d = shaft diameter in mm) MEDIA PRESSURE (BAR) WITHOUT SPRING WITH SPRING cross-sections • For valves: s = 1.2 x ½ d (d = spindle diameter PRELOADING PRELOADING in mm)

10 3 2 MATERIALS

• Surface roughness for shafts, spindles, and 16 3 – 4 2 – 3 THE ADVANTAGES AT A GLANCE Surfaces valves: Ra <0.25 μm 25 4 2 – 3 • Surface roughness for housings: Ra <0.25 μm • Broad variety of applications Spindle hard- 40 4 – 5 3 Double Triple Quadruple Concentric Min. 40 HRc, for heavier loads 60 HRc • Ideal for higher pressures up to 1,000 bar (in special cases ness 64 5 3 – 4 up to 3,000 bar) PORTFOLIO

Amount of 100 5 – 6 3 – 4 1 • Broad temperature range from –200 °C to +550 °C (–328 °F guide play in Less than /1,000 of the spindle diameter 160 6 4 the spindle to +1,022 °F) as graphite variant up to +700 °C (+1,292 °F) 250 6 – 7 4 • High media resistance • Max. permissible gap between spindle and gland • Numerous economical standard dimensions PRODUCT 2 packings/housing bore = /100 of the packing 400 7 4 – 5 • Simple assembly Gap widths width 630 7 – 8 4 – 5 • For larger widths use packings with high-strength • Special solutions in compliance with TA Luft aramid yarns 1,000 8 5 • FDA-compliant materials

Radial shaft Max. 0.001 x the shaft diameter deflection APPENDIX 80 81 Product portfolio INTRODUCTION

PRECISION MOLDED PARTS PTFE U-PACKINGS TECHNICAL FUNDAMENTALS

Molded parts are components that cannot be assigned Dimensions U-packings are unidirectional sealing elements with a • Variants with dynamic internal sealing lip for use as a to a standardized group in terms of their geometries and Vary widely depending on the design and application, from U-shaped cross-section and a reinforcing metal spring rod seal: standard rod diameters from 10 to 200 mm Axial sealing applications; instead, they are designed for specific sealing only a few millimeters up to one meter. which are used for sealing applications involving rotary or • Variants with external sealing lip for use as a piston applications. translatory motion. seal: standard piston diameters from 15 to 200 mm MATERIALS

Types • With inward sealing function for use as a pressure In complex applications, it is often difficult if not impossible • Elastomer composites in material combinations with PTFE U-packings are sealing components that enjoy a wide Radial seal (dimensions on request) to use standard components to ensure an optimal sealing metals, ceramics or plastics range of uses in the food and beverage industry, from ball sealing • With outward sealing function for use as a vacuum function. In such cases, molded parts are designed to pre- • Precision molded parts valves to piston pumps. They are ideal for the sealing of seal (dimensions on request) cisely match the application in question – the molded part • E l a s t o m e r b e l l o w s pressures, as the system pressure amplifies their sealing

• V-springs with a great degree of spring travel and ELASTOMERIC becomes a customer-specific solution. This can be accom- • Extruded profile sections function, as well as for aggressive media, thanks to PTFE’s soft spring characteristic for reduced friction, can be plished by modifying a standard component, for example excellent media resistance. used for dynamic and static sealing and for rotation an O-ring, or by designing the materials and geometry for Design notes sealing • U-spring with a great degree of spring travel and hig- an entirely individualized molded seal. Typical molded seals When developing molded seals, the user and the seal man- PTFE U-packings contain a metal spring, which compen Spring types her spring rate for sealing of higher pressures in the food and beverage industry include butterfly valve ufacturer should work together intensively from the outset sates for the loss of initial load caused by PTFE’s tendency • Round springs for high spring force with a lower de- seals and U-packings, as well as impellers for pumps. in order to avoid unnecessary steps and to keep the develop- to creep. The contact pressure can be tailored to the param- gree of spring travel for sealing of extremely high Another typical example for molded parts is a pig. Pigs se- ment time as short as possible. So as to preclude the need eters of the individual application scenario by means of u-, pressures. Its special design distributes the spring cure a residue-free cleaning process and an efficient use of for multiple revisions, new versions and repeated testing in v- or o-shaped springs – open or crimped. PTFE U-packings load over a number of different sealing lips products. Freudenberg offers pigs made from highly resist- the development process, Freudenberg can use FEM analysis are available as axial or radial sealing models for sealing ap- ant low-friction-elastomers like EPDM and Fluoroprene® XP. prior to construction of the sample mold in order to deter- plications involving translatory or rotary motion. Radial seal-

mine potential strains on and deformations of the molded ing models are available in inside and outside sealing ver- PLASTICSENGINEERING The use of a molded seal is preceded by a comprehensive seal, taking into account the temperature and swelling. sions. • Maximum permissible pressure for dynamic development process, in which the customer is usually applications: 45 MPa • Maximum permissible pressure for static appli- Pressures closely involved. Not infrequently, Freudenberg is also al- Installation and assembly Function cations: 120 MPa ready involved at the start in a machine or component de- Please refer to page 94 for general installation and assembly • Sealing of rotary and translatory motions • For 25 MPa or more, please consult Freudenberg, if necessary use backup rings PURITY

velopment in order to ensure high system reliability from instructions. • Sealing of aggressive media and pressures &

the outset with specially matched sealing solutions. Lead-in 20° standard Applications Dimensions chamfers Function • Filling head seals and valve seats for beverage systems • Manufactured by machining, therefore available in nearly Sealing surfaces in accordance with the diagram Various sealing functions, depending on the requirement • Molded seals for double seat valves and sterile valves all dimensions Surface RESISTANCE • Lead-in chamfers <1.6 μm roughness and component, such as: • Profile gaskets for separators • Springs to match the dimensions are manufactured from • Groove flanks <2.5 μm • Frame gaskets for filters endless material • Pressure-free sealing through the use of restoring force • Joining technology (fittings) • Standard dimensions (see types) available in stock • Optimal running surface hardness 20 HRC to MATERIALS • Self-amplifying sealing function under pressure Hardness 65 HRC • Penetration depth min. 300 μm • Reduction of incoming pressure Installation and assembly • Sealing against media permeation • Installation preferably without stretching or compressing THE ADVANTAGES AT A GLANCE of the rings. If stretching or compression is unavoidable, please consult Freudenberg. Lightly oil the rings prior to installation PORTFOLIO • Global leader in sealing expertise • Please refer to page 94 for general installation and assem- • Focused industry-specific and application-specific know- bly instructions THE ADVANTAGES AT A GLANCE how Applications • Extensive materials and manufacturing expertise • Ball valves • Universal media resistance PRODUCT • Reliable quality management • Flanges and lids • Broad temperature range • Extensive testing facilities for dependable prognoses • S w i v e l j o i n t s • Highly dependable • Innovative simulation and analysis methods • Distribution m a n i f o l d s • Resistant to aging • Hot water and steam valves • No stick-slip effect • F i t t i n g s • Special variants for higher pressures • P i s t o n p u m p s • Special hygienic variants with minimal dead space • B e a r i n g s APPENDIX 82 83 Product portfolio INTRODUCTION BUTTERFLY VALVE SEALS TECHNICAL FUNDAMENTALS

Seals for butterfly valves ensure the reliable function of but- Types Applications terfly and disc valves. In the food and beverage industry, they • Customer-specific types available on request thanks to FEM are used wherever a shut-off valve is sufficient and a more calculations • Beverage industry: THE ADVANTAGES AT A GLANCE extensive flow regulation is not necessary. • Special models with additional treatment (e.g. RFN) • Use of EPDM materials

MATERIALS

• Thermal resistance in steam and sterilization to +140 °C • Patented torque-reducing design allows high-frequency Shut-off butterflies, butterfly or disc valves are normally four- Installation and assembly (+284 °F), for brief periods up to +160 °C (+320 °F) operating cycles with low actuating forces and minimal part units composed of a two-part housing with a threaded • When stretching the gasket over the valve, avoid ledges, • Suitable for aqueous media and cleaning processes abrasion connector, weld-on ends or a clamp connector; a valve disc and sharp edges and threaded surfaces on the shafts • For applications involving nitric or formic acid, high tem- • Extremely easy to assemble a butterfly valve seal. It is only the last component that guar- • Please refer to page 94 for general installation and assembly peratures and media concentrations, EPDM represents • Leak-free and dead space-free variants available antees the integrity of the entire unit, making it indispensable instructions the most economical solution in comparison to other ma- • Low-friction coatings available ELASTOMERIC in preventing all three types of potential leakage – at the pipe terials. In extreme cases, however, EPDM is not optimal • A broad range of material versions for high media and seal, the flange and the actuator. either and alternatives may have to be used temperature resistance 3 Despite the simplicity of their basic design, seals for butterfly • Dairy industry: valves are expected to master extremely demanding operating • EPDM, FKM, VMQ or HNBR materials are used, depending DESIGN NOTES conditions: when the valve is open, the gasket should only min- on the fat content and temperature • Information on the minimum and maximum imally reduce the pipe diameter, and must be nearly free of • In certain cleaning media, HNBR, FKM and VMQ cannot dimensions of the flanges and valves are necessary dead space. The valve should be easy to close, but at the same match the service life of EPDM; however, unlike EPDM for gasket design • Minimum necessary and maximum permissible time exhibit high compression when closed to provide a per- they are resistant to fats, thus making them well-suited Dimensions 3 actuating forces should be included in design consi-

fect seal. Optimum materials, torque-reducing geometries, for use at high temperatures and concentrations derations PLASTICSENGINEERING and highly realistic testing are needed in order to combine all • Use of a patented Freudenberg design to reduce of the desired qualities. • Pharmaceutical and chemical industry: torque 1 1 • EPDM, FKM, VMQ or HNBR materials are used, depending Lowest possible tolerances with regard to the seal and The requirements are further intensified by the high flow 2 on the production media and solvents Tolerances installation space PURITY

speed when the valve is closing. This flow creates a major pres- • FKM is resistant to certain oils and some aromatic oils, but & sure differential and pressure fluctuations, both of which can shows limited resistance to alkaline cleaning media. It is • Perfectly smooth (no gaps or seams) in the dynamic blow the seal out of its seat into the pipe. In order to optimally also more prone to swelling in acids, making it necessary area • The sealing butterfly should be polished on the tailor the seal design to prevent this, Freudenberg utilizes effi- to select compatible cleaning media when using FKM Surfaces sealing surface (Rmax 2.5 μm, Ra 0.05 – 0.3 μm) cient and highly-effective computational models such as FEM. • Certain applications in the production of flavorings, in RESISTANCE 2 • The shaft should be polished in the sealing area pharmaceutical and chemical processes exceed the resist- (Rmax 2.5 μm, Ra 0.05 – 0.3 μm) Dimensions ance properties of EPDM, VMQ, and HNBR. In such cases, • Dimensions fit standard DIN and ISO pipe dimensions Freudenberg recommends the use of Fluoroprene® XP MATERIALS • Standard metric: DN 15 to DN 250 1 Optimal compression on the butterfly valve (or “valve disc”) ensures materials that the sealing location is reliably sealed. Here the goal is an ideal • Standard inch: 1” to 6” compromise between the integrity of the closed valve and the torque • Individual dimensions available on request 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 PORTFOLIO

3 The axle lead-through represents a particularly difficult sealing location. The optimal design dependably prevents leaks PRODUCT APPENDIX 84 85 Product portfolio INTRODUCTION LOW PRESSURE GUIDE STRIPS PROFILES TECHNICAL FUNDAMENTALS

Large areas are difficult to seal with commonly made To produce a seal that is fully closed around the entire door Guide strips are used in various machines for the food and products because tools are too expensive or unfeasible to frame, the two ends of the profile are butt joint-vulcanized. beverage industry to compensate for the lateral forces and realize. With the help of low pressure profiles, it is possible The molecules cross-link at the joint to the same material as deflections occurring. THE ADVANTAGES AT A GLANCE to seal these difficult points. the profile. Consequently, the profile at the joint seals as re- MATERIALS

liably as at all other points. The FDA-compliant material 70 This requires a high pressure resistance of the material. At • High compressive strength with simultaneous flexibility Profiles and cords EPDM 471 is ideal for use under aggressive sterilization and the same time, the material used must have sufficient • Resistant to CIP/SIP cleaning media Typical examples are oven door seals. For the standard pro- cleaning conditions. Thanks to its high abrasion resistance, flexibility to prevent it from being damaged during assem- • Low extrusion propensity gram, there is a variety of different tools for different ma- long service lives can be achieved. During the cleaning pro- bly. In food and beverage applications where guide strips • Low wear ensures a long service life terials available. By switching from mold-based to low pres- cess, the gasket is inflated, resulting in high contact stress have direct contact with the medium, the materials used • Different sizes up to 200 mm available at short notice sure parts, tool costs can be saved when developing cus- preventing leakage. After cleaning, the seal is relaxed again must comply with the legal framework. Comparable com- • Food-grade materials ELASTOMERIC tomized individual applications. and the door opens without damaging the seal. Freuden- binations of approved materials demonstrated in a bench- berg offers inflatable seals on request even with a specific mark that they do not withstand the high forces, e.g. in Freudenberg has developed a special vulcanization process valve matched to the seal that controls the supply of com- homogenizers, and have a propensity to gap extrusion. in which the cord and the joint are made of the same mate- pressed air. Instead of a threaded coupling, this valve works This leads to increased wear and thus to a significantly rial. Thus, a uniform quality of the seal is achieved. In by means of a click mechanism, making it easier to install. reduced service life. Guide strips made of PTFE Y005 ensure conventional low pressure gaskets of other manufacturers, low wear and a much longer durability thanks to minimized the joint is often connected by means of an adhesive, result- extrusion propensity. PTFE Y005 is a special compound and ing in a significant difference in quality. In contrast to the consists of a virgin, high-grade pure PTFE and a filler. seals made by Freudenberg, the joint here is not reliably re-

sistant to thermal influences and process media or to clean- PLASTICSENGINEERING ing agents and steam sterilization.

Freudenberg offers low pressure profiles and rings in the following elastomers: Extrusion length PURITY & • 70 EPDM 391: resistant to water, steam, acid and alkali Evacuated state Seal under pressure PTFE-MATERIAL solution Y005 (VIRIGN) K202 (CARBON-FILLED) G216 (GLASS FIBER-FILLED) • 70 EPDM 471: resistant to disinfectants and CIP/SIP media 1,6

• 75 Fluoroprene® XP 41: resistant to steam, fat and CIP/SIP RESISTANCE media THE ADVANTAGES AT A GLANCE 1,4 • 80 NBR 217383: good low temperature flexibility and abrasion resistance 1,2 MATERIALS • Seals reliably against external influences Inflatable seals • Easy opening and closing of doors, for example 1,0 Wherever the containers and doors of systems must be pro- • Long service life tected against germs and dirt, the gap bridgings are sealed • Very good chemical and thermal resistance 0,8 with inflatable profiles. In laboratories and research insti- • Seal and valve are perfectly matched tutes, the standard silicone material often creates problems • Individual dimensions by means of butt joint-vulcanization 0,6 PORTFOLIO due to insufficient stability. Also, the profiles of conventional inflatable seals often stick to the door frame and Extrusion length mm in make it difficult to open the door, which in turn damages 0,4 the seal. PRODUCT 0,2

80 °C (176 °F) 120 °C (248 °F) APPENDIX 86 87 Product portfolio INTRODUCTION PTFE BELLOWS TECHNICAL FUNDAMENTALS

Bellows are components which are primarily used to pro- Applications of bellows as compensators tect moving machine parts from external influences. • Compensation for expansion and vibration • Compensation for axle offset, misalignments and dis- Wherever reciprocating mechanical parts need to be protec- placements in pipes MATERIALS

ted from environmental influences or aggressive media, bel- • Fluid circulation in chemical, food and beverage industries lows serve as reliable sealing components. They can also be • Rod protection in chemical, food and beverage industries used to compensate for movements, expansions, as well as • Protection from dust and contamination, e.g. for weigh- axle offset, misalignments and vibrations. When used in ing equipment in filling plants combination with check valves, they can also be used to cir- culate or pump gases and liquids utilizing volume changes Applications of valve and pump bellows ELASTOMERIC in the bellows, provided the installation space allows it. • In feed pumps and metering pumps • For control and shut-off valves in chemical, pharmaceuti- Application range of bellows cal and food and beverage industries • Virgin PTFE: Broad application range throughout the chemical industry • Modified PTFE: Low-porosity variant for the food, bever- DESIGN NOTES age and pharmaceutical industries • Conductive PTFE: Designed to prevent static electrical Compen Standard bellows, as well as metal-reinforced special sators variants possible buildup Valve and • Filled PTFE: Reinforcement with glass fibers or carbon fib- Design guidelines based on individual experience in PLASTICSENGINEERING pump ers of those parts of the bellows under the most stress, development and testing bellows e.g. where the bellows are mounted on a pump head • The flange contact surfaces must be smooth and clean Function • PTFE bellows should not be over-expanded

• PTFE flanges should be handled carefully due to their PURITY Special • Protection of piston rods, linkages and other machine ductility & installation parts involving axial and in some cases radial motion • It may be advisable to use soft packings between notes • Compensation of movements and displacements be- flange and bellows APPENDIX tween two connecting components • The screw holes and flange thickness listed for types FBA-9000 and FBC-9002 are smaller than those indica- • Circulation and pumping of gases and liquids using vol- RESISTANCE ted in the DIN standard sheets ume changes

Dimensions MATERIALS • Smallest standardized internal diameter: 10 mm (smaller diameters available on request) THE ADVANTAGES AT A GLANCE • Largest external diameter: theoretically unlimited

Installation and assembly • Highly resistant to nearly all chemicals Please refer to page 94 for general installation and assembly • Dependable sealing to prevent media contamination instructions. • High cost effectiveness thanks to production by machining • Special variants, made-to-order and small batches are TYPES possible PRODUCT PORTFOLIO FBA-9000 Compensators for low pressures • Compensator bellows in nominal widths of DN 10 to DN 500 available in stock FBC-9002 Compensators for moderate pressures

FV-series Individual solutions for pump and valve bellows

Variant of FBA-9000 available on request, as well as an FBAX-9001 extensive range of customer-specific variants APPENDIX 88 89 Appendix INTRODUCTION LIST OF ABBREVIATIONS

ABBRE ABBRE VIATION FULL NAME DESCRIPTION VIATION FULL NAME DESCRIPTION A I The higher the ACN content of an NBR or HNBR elastomer, the better the re- Measure of the hardness of an elastomeric material, especially in case of small

IRHD International Rubber Hardness Degree TECHNICAL FUNDAMENTALS ACN Acrylnitril sistance against non-polar media. The smaller the ACN content, the better the cord sizes, German term also “microhardness determination” low-temperature flexibility. The ACN content ranges between 18% and 50% ISBT International Society for Beverage Technologists United States organization for the beverage industry ACS Attestation de Conformité Sanitaire French drinking water approval ISO International Organization for Standardization ADI-free Animal Derived Ingredient free Assurance that no products derived from animals are used in manufacture International Society for Pharmaceutical ISPE International industry association for the pharmaceutical industry API Active Pharmaceutical Ingredients The pharmaceutically active ingredients in a medicinal product Engineering ASME American Society of Mechanical Engineers United States platform for engineers and students K AU Polyesterurethan Ministerial Expert Committee + Toxicity Sub- KIWA Directive from the Netherlands MATERIALS AWQC Australian Water Quality Centre Australian organization for drinking water standards committee Plastics in drinking water: a German norm for the use of plastics and B KTW Kunststoffe im Trinkwasser German Federal Office for Risk Assessment: BfR focusses on the assessment of elastomers in drinking water facilities risks in the field of consumer health protection and food and feed safety, e.g. BfR M BfR Bundesinstitut für Risikobewertung Recommendation 15 for silicones, BfR Recommendation / 21: Recommendation MB Membran Elastomer diaphragm

for articles of daily use based on natural and synthetic rubber material for silico- MBM Elastomermembran mit Metalleinlage Elastomer diaphragm with metal inserts ELASTOMERIC ne material/rubber in food use MRO Maintenance, Repair and Operations C Analysis method to separate particles according to their mass and to identify MS Mass spectrometry CIP Cleaning In Place Cleaning processes in closed plants of the process industry, without disassembly them hereby CNC Computerized Numerical Control Method in machining technology N COP Cleaning Out of Place Cleaning method in the process industry with disassembly NBR Acrylo-Nitrile-Butadiene-Rubber A base elastomer D The NSF defines standards for applications in the food industry (NSF 51) and NSF National Sanitation Foundation DIN Deutsches Institut für Normung German institute for standardization drinking water applications (NSF 61) DM Dachmanschetten Rod seal set consisting of roof-shaped seals and supporting rings O DN Diameter nominal Nominal diameter, e.g. for pipes OEM Original Equipment Manufacturer DVGW Deutscher Verein des Gas- und Wasserfaches German Technical and Scientific Association for Gas and Water Total amount of substances escaping from a sealing material under certain test OML Overall Migration Limit Compression set, a mechanical performance parameter for elastomers. The conditions (EU Reg. 10/2011) compression set describes the ability of a material to generate a sufficient res- DVR Druckverformungsrest OPC Open Plant Cleaning A cleaning method used in the process industry PLASTICSENGINEERING toring force on the sealing surfaces and thus ensure the tightness, even after a ÖVGW Österreichischer Verein des Gas- und Wasserfaches Austrian Gas and Water Union certain contact time with the media in question P E PA Polyamide A thermoplastic EDTA Ethylene-diamine-tetra-acetic-acid PE Polyethylene A thermoplastic Consortium of plant engineers and operators in the food and pharmaceuticals EHEDG European Hygienic Engineering & Design Group PEEK Polyetheretherketone A thermoplastic PURITY industries PFA Perfluoralkoxy Copolymer A thermoplastic & EPDM Ethylene-Propylene-Diene-Rubber A base elastomer POM Polyoxymethylene A thermoplastic In a special process, the molecular chains of ultra-thin PTFE layers are stretched, PTFE Polytetrafluoroethylene A thermoplastic these layers are stacked multi-directionally and loosely pressed. As a result, the ePTFE Expanded PTFE PU Polyurethane A thermoplastic cold flow is optimized, the seals are very adaptable and meet, after pressing on R RESISTANCE site, the highest leak tightness requirements, e.g. according to TA Luft RFN Reduced Friction by Nanotechnology A patented Freudenberg method for reducing friction in elastomer seals ETA-DK European Technical Approvals – Denmark Danish organization for issues concerning drinking water RWDR Radialwellendichtring Rotary shaft seal A regulation is a legally binding act (directive) which all EU countries must fully EU Reg. Regulation of the European Union S implement

safe secure adaptive freudenberg encryption A product marking technology ensuring reliable identification MATERIALS EU Polyetherurethan SIP Sterilization In Place A sterilization method used in the process industry F Migration value of a single substance in tests according to EU Reg. 10/2011, SML Specific Migration Limit FB Faltenbalg Bellow see also OML A federal body in the United States responsible for the regulation of medications T FDA Food and Drug Administration and pharmaceuticals, part of the United States Department of Health and TOC Total Organic Carbon Sum parameter for the carbon content in water and wastewater analysis Human Services U FEM Finite-Elemente-Methode A calculation method used to determine forces and loads in components USP United States Pharmacopeia Collection of recognized pharmaceutical rules originating in the USA FEP Fluorinated-Ethylene-Propylene A thermoplastic material used as a material for encapsulation of O-rings V FFKM Perfluoroelastomer A base elastomer VDMA Verein Deutscher Maschinen- und Anlagenbau German Engineering Federation: a German industrial association FKM Fluoroelastomer A base elastomer VMQ Vinyl-Methyl-Polysiloxane A base elastomer, silicone

G W PRODUCT PORTFOLIO Analytical method for mixtures which can be converted into the gaseous phase W 270 is concerned with the “propagation of microorganisms on materials used in GC Gas chromatography W 270 Part of KTW testing and can then be separated and detected drinking water applications – testing and assessment“ GMB Elastomer diaphragm with fabric Elastomer diaphragm with fabric WDR Wellendichtring Shaft seals GMBM Elastomer diaphragm with metal insert and fabric/film Elastomer diaphragm with metal insert and fabric/film WIP Washing In Place A cleaning method used in the process industries H WOP Washing Out of Place A cleaning method used in the process industries HNBR Hydrogenated-Nitrile-Butadiene-Rubber A base elastomer A standard / An organization responsible for the approval of machinery used in WRAS Water Regulations Advisory Scheme HRC Hardness Rockwell C Rockwell hardness test with scale C (for materials with a high hardness) drinking water plants (Great Britain) HTS II High Temperature and Speed Rotary shaft seal APPENDIX 90 91 Appendix INTRODUCTION GENERAL INSTALLATION AND LEGAL NOTICES ASSEMBLY INSTRUCTIONS

GENERAL INSTALLATION AND ASSEMBLY INSTRUCTIONS The contents of this handbook have been carefully prepared. As such, the information contained in this handbook can The information is based on our decades of research into provide only general and non-binding guidelines. We For all types of seals, it is imperative that both the installation space and the seal itself are clean. Metallic processing Cleanliness the development and manufacture of sealing solutions recommend that you discuss specific, individual applications TECHNICAL FUNDAMENTALS residues, such as particles and cuttings, are particularly dangerous as part of the Freudenberg Group and reflects our current with our technical consultants as a matter of principle. state of knowledge. However, as seal performance is not The sealing surfaces must at least have the surface roughness indicated in the catalogs. Check for scratches, gouges and only dependent on the seal itself, but also on various other All rights, in particular to texts, images and other work Sealing surfaces cavities parameters connected to the individual application, which protected by copyright and published in the handbook, are are beyond our control, we do not assume any liability for reserved by Freudenberg. Any reproduction, distribution, MATERIALS

the statements made in this document. transmission, and other utilization of the contents without If seals have to be stretched and pushed over sharp edges or threaded surfaces during installation, these should be rounded Surrounding area off or covered with protective sleeves written permission is expressly prohibited.

Prior to installation, ensure that the seal was properly stored. If the seal is individually wrapped, do not remove it from its

Storage conditions ELASTOMERIC package until you are ready to install it (see page 25)

It is always important to ensure that mounting tools and other aids do not damage the seal or the installation space. Assembly aids Installation sleeves, expansion mandrels, chamfers on pistons and cylinders and rounded brass pins are well-suited. A screwdriver is not a suitable assembly tool

If the use of lubricants is required for assembly or installation, it must be verified whether the seal material is resistant to the Lubricants lubricant

For many seals (e.g. U-packings and radial shaft seals), it is important to install them with the correct positioning/ Positioning PLASTICSENGINEERING in the correct direction PURITY & RESISTANCE MATERIALS PRODUCT PORTFOLIO APPENDIX 92 93 Notes Editorial Information

Freudenberg Freudenberg Sealing Technologies Freudenberg Process Seals GmbH & Co. KG Lorscher Straße 13 69469 Weinheim, Germany Phone: +49 (0) 6201 80 8919-00 Fax: +49 (0) 6201 88 8919-69 E-Mail: [email protected] www.fst.com

2017