Platinum-cured high purity silicone gaskets

High purity gaskets

High purity gaskets

Contact Us

To order this product please contact us on:

Tel: +1 978 658 6168 and Toll free +1 800 282-8823

You can also send us an email or find your nearest distributor

 

Overview

BioPure fluid path components brochure

BioPure fluid path components brochure

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Platinum-cured high purity silicone gaskets

BioPure platinum-cured high purity silicone gasket

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

Validation

BioPure high purity gaskets and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:

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.

Datasheet

high purity gasket datasheet thumbnail

  • Contact Us

    To order this product please contact us on:

    Tel: +1 978 658 6168 and Toll free +1 800 282-8823

    You can also send us an email or find your nearest distributor