1 Sealing elements High purity FDA and USP class VI. compliant O-rings High purity elastomers for pharmaceutical, biochemical and food industries ERIKS nv ERIKS bv Boombekelaan 3, Toermalijnstraat 5. B-2660 Hoboken, 1812 RL Alkmaar tel.: 03 Postbus 280, 1800 BK Alkmaar fax: 03 Tel. +31 72 / 514 15 14. Fax +31 72 / 515 56 45. e-mail: ERIKS sa Avenue Lenoir 2a ERIKS pte ltd 1348 Louvain-La-Neuve 151, Pasir Panjang Road t l. : 010 #02-22/25. fax : 010 Pasir Panjang Distripark Signapore 118480. Tel. +65 62 72 24 05. Fax +65 62 74 17 06. ERIKS sas e-mail: 52, avenue des Fr res-Lumi re BP 151. F-78196 Trappes cedex Tel. +33 1 / 34 82 10 00. Fax +33 1 / 34 82 10 20. HIGH PURITY FDA & USP COMPLIANT O-RINGS / HIGH PURITY elastomers . FOR PHARMACEUTICAL, BIOCHEMICAL AND FOOD INDUSTRIES. Content 1. General introduction 3. 2. Classes of use FDA-USP 4. 3. Introduction to FDA-USP concept 5. 4. O-rings FDA-USP 6.
2 5. FDA-USP compounds, O-rings and mouldings 8. 6. High Purity seals card 9. 7. Approved compounds for potable water 10. 8. The High Purity Kalrez O-ring concept 12. 9. Elastoguard Microbiological growth - problems and solutions 16. 10. Addendum - legal institutes 18. 2. HIGH PURITY FDA & USP COMPLIANT O-RINGS / HIGH PURITY elastomers . FOR PHARMACEUTICAL, BIOCHEMICAL AND FOOD INDUSTRIES. 1. General introduction Efficientlyprotectingprocessintegrityis Seal performance is paramount Customer needs achallengeforallpharamceuticalmanu- Experience has shown that the weak- ERIKS is focused on meeting facturers. est links in manufacturing processes customer needs and on assisting are often the seals in couplings, solving customer problems. Today's pharmaceuticl and biophar- flanges and other connection points in maceutical manufacturing processes piping and equipment. To respond to the higher needs of require the efficient handling of a wide Degradation of these joint seals can purity in pharma, biochemical and range of process fluids under varying result in: food industries, ERIKS developed conditions of temperature and pres- a range of high purity' elastomers , sure.
3 From basic chemical storage contamination of the final or inter- described in this leaflet. and handling to manufacturing and mediate products during manufac- waste management, process lines and ture and/or We developed a technical education vessels must be resistant to a variety leakage that may require a process program on legislation of FDA and of fluids. shutdown. USP' as well as on the theoretical and Many of these are toxic and corrosive, practical issues of migration of including raw materials, intermedi- Even with the availability of specialty rubber substances. ate chemicals, active pharmaceutical elastomers such as Viton fluoro- More info on www. ingredients (APIs), cleaning/sterilizing elastomer (FKM) or chemically-inert agents and by-products. What's more, Teflon polytetrafluoroethylene (PTFE), during sterilization, temperatures can the problems of seal failure have not reach up to 160 C.
4 Been solved. With increased aware- Whatever the finished product, tablet, ness and stricter guidelines regarding capsule, ointment or liquid suspen- product and environmental safety, sion, the fluid-handling system plays a selection of proper sealing materials is critical role. critical for maximizing production up- time. High-performance sealing materials should offer the chemical inertness and cleanliness of PTFE. without sacrificing the resilience and associated sealing benefits of true elastomers . 3. HIGH PURITY FDA & USP COMPLIANT O-RINGS / HIGH PURITY elastomers . FOR PHARMACEUTICAL, BIOCHEMICAL AND FOOD INDUSTRIES. 2. Classes of use FDA-USP. FDA compounds USP compounds FDA CFR sets the USP class VI compounds are con- standard for ensuring that foods are trolled by United States Pharmacopeia safe and sanitary; that human and (USP), a non-governmental organisa- veterinary drugs, biological products, tion that promotes the public health medical devices are safe and effec- by establishing state-of-the-art stan- tive.
5 Dards to ensure the quality of medi- cines and other health care technolo- FDA also ensures that these products gies. are honest, accurate and are informa- tively represented to the public. The standards are published in the UP-NF which is officially recognised in CFR sets out the rel- FDA act (21 usc 321 et seq.). evant regulations for rubber articles intended for repeated use'. These list USP class VI compounds have under- the ingredients that may form part of gone tests to: a rubber compound. The list includes cytotoxicity elastomers , accelerators, plasticisers, hemolysis fillers, emulsifiers, etc. pyrogenicity sensitisation There are also certain quantative Some elastomers are also formulated limitations on different ingredients. following the European Pharmacopeia. ERIKS FDA compounds are produced to meet class 1 for fatty foods. This means that the high purity' carbon black does not exceed 10%.
6 All our compounds have been tested by an independent certified lab in Germany following the class 1 rules in n-hexane at reflex temperature. Certificates on demand. 4. HIGH PURITY FDA & USP COMPLIANT O-RINGS / HIGH PURITY elastomers . FOR PHARMACEUTICAL, BIOCHEMICAL AND FOOD INDUSTRIES. 3. Introduction to FDA-USP concept General information on FDA Migration tests FDA. Since many years ERIKS has a leading Some compounds have been tested role in the production and marketing of by independent laboratories (for high quality seals. example Rapra' in England). ERIKS has also developed a vast range Rubber articles intended for repeated of elastomeric compounds that are for- use in contact with aqueous food shall mulated to comply with the meet the following specifications: The regulations issued by the United States food-contact surface of the rubber Federal Food and Drug Administration' article in the finished form in which (FDA).
7 These regulations are stipulated it is to contact food, when extracted in Title 21, chapter 1, subchapter B, with distilled water at reflux 20 mil- section of the Federal food ligrams per square inch during the first and Cosmetic Act'. 7 hours of extraction, nor to exceed 1 USP Pharmacopoeia Class VI-XXII. These regulations define which rubber milligram per square inch during the Certification polymers and compounding ingredients succeeding 2 hours of extraction'. Cytotoxicity Criteria can be used in rubber articles, intended CFR Title 21 Section for repeated contact with food and Rubber articles intended for repeated CFR Title 21 Section preventing the use of dangerous use in contact with fatty foods shall Traceability: Lot and Batch substances that might cause cancer. meet the following specifications: Certification: Lot and Batch The food-contact surface of the ASME-BPE Standards rubber article in the finished form USD Standards in which it is to contact food, when 3-A Sanitary Standards Types of FDA extracted with n-hexane at reflux Current Good Manufacturing temperature, shall yield total extrac- Practices (CGMP).
8 Two important types (class 1 and class tives not to exceed 175 milligrams per Manufacturer data and specifications 2) of FDA exist, depending on the per- square inch during the first 78 hours Consultation with various pharma- centage of furnace carbon/black that is of extraction, nor to exceed 4 milli- ceutical users added to the compound. grams per square inch during the Class 1: for edible oils, greasy media; succeeding 2 hours of extraction'. The gasket materials considered are Class 2: for aqueous media. Tef-Steel (Teflon/Stainless Steel), Teflon (PTFE), Silicone (platinum cured), Viton , EPDM and Buna-N. Certification USP The 3 main goals are: To protect products from contamina- ERIKS guarantees the conformity' by: USP class VI was especially devel- tion, spalling, particulates and TOCs strict production methods, oped for the pharmaceutical industry. resulting from the use of improper an FDA-sticker which is put on the This information has been carefully sanitary gasket material.
9 Packaging, prepared to help in selecting the cor- To protect facilities from unnecessary a certificate of conformity which can rect elastomer or perfluorocarbon downtime associated with sanitary be obtained (on payment) with every utilized in high purity sanitary hygenic gasket failure and replacement from delivery. seals where critical pure water, pro- use of improper gasket material. cess fluids (both ambient and hot), To provide a standard of consistency In general ERIKS guarantees that the and SIP environment exist. of sanitary gaskets selection between FDA-materials are FDA-compliant' The intention is to consider the differ- multiple facilities. which means they are composed ent uses, applications and conditions with ingredients according the FDA- to determine the most favorable gas- Most decisions driving gasket type regulations under on this page. ket material for each application.
10 The selection are based on chemistry, tem- following criteria is used in determin- perature, exposure limits, USP, FDA. ing correct sanitary gasket materials. qualifications, and curing methods. 5. HIGH PURITY FDA & USP COMPLIANT O-RINGS / HIGH PURITY elastomers . FOR PHARMACEUTICAL, BIOCHEMICAL AND FOOD INDUSTRIES. 4. O-rings FDA-USP. Introduction Since many years ERIKS has a leading role in the production and marketing of high quality seals. ERIKS has also developed a vast range of elastomeric compounds that are for- mulated to comply with the regulations issued by the United States Federal Food and Drug Administration'. These regulations are stipulated in Title 21, Chapter 1, subchapter B, section of the federal food and cosmetic Act. Types of FDA Two important classes (class 1 and 2) of FDA exist, depending on the percentage of furnace black that is added to the compound. Class 1: for aqueous media, edible oils and greasy media (max.)