Platinum-cured high purity silicone gaskets
High purity Platinum-cured silicone gaskets precision engineered to achieve a smooth bore, contamination free fluid path under clamping compression.
Gaskets are supported by an industry leading validation package, meeting current industry requirements including ISO 10993: Parts 5, 6, 10, and 11, USP <88> and USP <87>.
The gaskets have also been evaluated for extractables using a multi solvent approach to BPOG guidelines. Quality management systems of the production facilities are certified to ISO9001
- Manufactured and packed within an ISO 14644 Class 7 cleanroom
- Available in a range of flanged and unflanged size options
- Sterilisation through gamma irradiation or autoclave
- Laser etch LOT numbering enables full product traceability
BioPure high purity 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. For a summary of the validation/qualification testing that has been carried out on BioPure high purity gaskets, please download the high purity gasket validation summary guide.
The full validation guide including additional information regarding test methods and actual test reports is available on request by submitting a validation request form.
BioPure high purity gaskets, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the compliance guide and is available on request by filling in the form found here.