Today the need for traceability in the pharmaceutical industry is imminent. We need to know what we are getting and we need to know if the supply chain is consistent time after time. Certification is based on designated compounds and final products, many of the tests performed are done with the final article that we supply to the market. The end-user expects to receive articles made the same way as before, in the same compound. The complex validation of a system is only valuable if the consumable parts such as gaskets are consistent in the way they are manufactured. We secure this philosophy with tight procedures and quality inspections. Together with market-driven certification protocols, we deliver a consistent quality product, day in day out.
Food and Drugs Administration is a US government agency within the Department of Health and Human Services. FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA has written codes (CFR’s) to ensure that seals that we make conform to certain standards when in contact with food or pharmaceutical processing systems.
FDA CFR 177.1550 Perfluorocarbon resins. A detailed description of methods of processing and substances that can be safely used.
FDA CFR 177.2600 Rubber articles intended for repeated us may be safely used in producing, manufacturing, packaging, processing, preparing, treating, transporting or holding food, subject to the provisions of this section. It also describes a test for impurities from elastomeric closures. The purpose of the study is to analyze total extractables.
The United States Pharmacopoeia and the National Formulary are the official compendia of standards for drug, excipients dietary supplements, and other therapeutic products for the United States and several other countries. It is an independent organization under one cover. The USP contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for more than 3400 drug substances, preparations and products. When a standard is published in the USP-NF, federal and state government agencies, such as FDA have the authority to enforce them and to ensure that products comply.
Most important test protocols for elastomer and perfluorocarbon products (seals) are:
USP Class VI testing Part 88, Biological reactivity test Part 87, in vivo. It is designed to determine the biological response of animals to elastomeric, plastic and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the article under test.
USP testing Part 87, Cytotoxicity test, Biological reactivity test, in vitro. It is designed to determine the biological reactivity of mammalian cell cultures following contact with the elastomeric plastics and other polymeric materials with direct or indirect patient contact or of specific extracts prepared from the article under test.
USP testing Part 661, is a Physicochemical Test which determines the Physicochemical properties of certain material. This test measures defined properties of impurities in plastics. The material is for example PTFE or TFM.
USP testing Part 381, is a Physicochemical Test which determines the Physicochemical properties of certain material and impurities extracted from elastomeric closures. The material is for example EPDM and FKM. Not Silicone.
In order to comply with European legislation many guidelines have been written.
Common guidelines and test protocols are:
EP 3.1.9 A European Pharmacopoeia study to perform physico-chemical tests of silicone materials in order to determine physico-chemical properties of this material.
TSE also known as BSE (Bovine Spongiform Encephalopathy) has been addressed by FDA and the European Union. The use of animal derived ingredients in the production of medicine and other related products has in the past lead to the transmit of TSE disease. TSE disease is a central nervous disease.
The European Union has written a journal (EMEA/410/01) in which they give guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medical products.
Whereas many of our products are used in human or veterinary medicine production plants, it is important to know if any of our products have been in contact or are produced with animal derived ingredients.
The only product (compound) that is made manufactured with animal derived ingredients is NBR (buna). All other products such as EPDM, FKM, PTFE and Silicone are Animal Derived Ingredient free. (ADIF).
ISO10993, Biological evaluation of medical devices. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).