Custom-made seals for the pharmaceutical industry

27th November 2017

MEPAX

Enaie Azambuja

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Datasheet

The independent seal manufacturer C. Otto Gehrckens has developed the sealing EPDM compound 'AP 306' for highly sensitive production processes in the pharmaceutical industry, biotechnology and medical technology. The special material in the COG HygienicSeal series has been granted the most important approvals for application in these highly demanding industries.

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)