GYLON Bio-Pro® Gaskets

Tri-Clamp® connections are the standard connection in the pharmaceutical industry. Seals of varying quality and materials are often used regardless of their suitability for constantly increasing operating parameters. GYLON BIO-PRO® seals offer a safe solution with its modified and restructured PTFE material, pre-formed and stress controlled, for all Tri-Clamp® standards. It is dimensionally stable and resists intrusion.

Main features :

  • Dimensional stability
  • No extrusion and cold flow
  • High resistance to most chemicals and temperature cycles

You may notice our GYLON BIO-PRO® gaskets have printing on them so we thought it would be beneficial to explain what it meets from a certification standpoint.

A specific branding ink is used to mark the sheet material (GYLON® Style 3504) from which the final products are manufactured.

The branding ink complies with FDA Code of Federal Regulations Title 21, Section 175.300. GYLON BIO-PRO® has successfully passed all third-party laboratory testing (e.g. Migration testing according to (EU) No 10/2011, FDA extraction testing or biocompatibility testing according to USP VI <87> and <88>) with the branding ink being applied to the product.

Additional features :

  • Size : TC 1/2" au TC 12’’
  • Standards : DIN 11850 – ISO 1127-ISO 2852 ASME-BPE 2014 – SMS 3019
  • Material : Gylon Blue 3501
  • Temperature range : -346°F to 500°F (-210°C - +260°C)
  • Certifications : FDA 21 CFR177.1550, EC1935/2004 – Inc. C10/2011, USP Class VI <87> & <88>
  • ADI Free


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