The food and beverage industry as well as the pharmaceutical and biomedical industries require seals and rubber products, which are compliant to the various regulations and regulatory institutions. Compound technologies need to be chemically resistant for use with aggressive media seen in Clean in Place (CIP) and Steam in Place (SIP) practices, high temperature steam sterilization and WFI processing.
Commission Regulation (EC) No 1935/2004 provides a harmonised legal EU framework. It sets out the general principles of safety and inertness for all Food Contact Materials (FCMs). The principles set out in this regulation require that materials do not release their constituents into food at levels harmful to human health and change food composition, taste and odour in an unacceptable way. Commission Regulation (EC) No 2023/2006 ensures that the manufacturing process is well controlled so that the specifications for FCMs remain in conformity with the legislation.
The Food and Drug Administration (FDA) has compiled a list of ingredients in a rubber compound that are not classified as toxic or carcinogenic.
USP Class VI materials must consist exclusively of components with a biocompatibility certificate.
GITIS has developed a wide range of medical and food-grade materials for this purpose. These are used for O-Rings and rubber sealings in pumps, valves and fittings in various applications such as in food, beverage, dairy processing and pharmaceutical/biomedical products. Our materials are tested, approved and certified as listed above.