Platinum-cured silicone gaskets validation summary guide

The 5000 series platinum-cured silicone gaskets and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:

• USP Biocompatibility in vivo and in vitro
• European Pharmacopoeia, 3.1.9
• ISO 10993

Additional testing carried out includes extractables testing.

The full validation guide including additional information regarding test methods and actual test reports is available on request.

BioPure high purity gaskets (5000 series silicone only), its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the compliance guide.

Both the full validation guide and the compliance guide can be requested by submitting the below form.