As well as the harmlessness test according to FDA 21. CFR 177.2600, AP 306 is approved according to USP class VI in chapter 88 up to +121°C and chapter 87. The EPDM compound also successfully passed the cytotoxicity test (according to ISO 10993-5:2009).
This EPDM compound has extremely low migration values, which are in particular demand in applications in which there is a risk of contamination with the media to be sealed, e.g. in cell cultivation or insulin production.
The high-performance material furthermore has excellent resistance to contact with CIP and SIP media and, in addition, is suitable for applications with WFI water. Owing to the operating temperature range from -40°C to +150°C, AP 306 is adaptable to the particular requirements of the production process.
Properties of AP 306
-Special-EPDM compound for the medical technology, pharmaceutical industry and biotechnology
-Excellent resistance to CIP and SIP procedures
-Suitable for use with WFI water
-Good resistance to aqueous media
-Excellent resistance to hot water and water vapour
-Certified according to USP Class VI chapter 88 to +121°C and chapter 87
-Approval according to FDA and ISO 10993 part 5 (cytotoxicity test)