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.






Examples:
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.




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 organisation under one cover. The USP contains legally recognized standards of identity, strength, quality, purity, packaging, and labelling 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 (seal) are:
USP Class VI testing Part 88, Biological reactivity test, in vivo. It is designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test.

USP Class VI 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 material under test.








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).
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