Certification



FDA


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.
 

TSE


(Transmissible Spongiform Encephalopathy)


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).
Rubberfab has enhanced this topic by the use of the logo below.

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