USP Class VI Tri Clamp Gaskets for Pharmaceutical

An envelope gasket features a PTFE outer shell wrapped around an EPDM filler core, with the two components remaining semi-independent. A unitized gasket bonds the PTFE sealing surface directly to the EPDM elastomer core into one integrated piece, reducing component movement, improving installation stability, and offering superior sealing consistency under minor ferrule misalignment.

Yes. Both the envelope and unitized PTFE x EPDM tri clamp gaskets comply with FDA 21 CFR 177.2600, which governs rubber articles intended for repeated use in food and pharmaceutical contact applications. They are also compatible with GMP-regulated manufacturing environments and meet USDA material standards.

Both gasket designs are available in 1.5", 2", 3", 4", 6", 8", 10", and 12" sizes to suit a wide range of sanitary tri-clamp pipeline configurations in pharmaceutical, food processing, and biotech facilities.

Solid PTFE gaskets are prone to cold flow and creep over time, especially in larger diameter connections, which can lead to leaks and unplanned shutdowns. The PTFE x EPDM composite construction retains the broad chemical resistance of PTFE on the contact surface while the EPDM core provides elasticity, sealing memory, and better performance under slight ferrule misalignment.

Both tri clamp gasket types carry a 10-year shelf life from the cure date. They should be stored in their original packaging in a clean, dry warehouse maintained between 65°F and 85°F, away from direct sunlight and at least 6 feet from electric motors to prevent ozone degradation of the elastomer core.

No. Both the envelope and unitized PTFE x EPDM gaskets are designed specifically for sanitary tri-clamp fittings and are not recommended for bolted clamp assemblies. Additionally, the standard 1550 PSI sanitary clamp service pressure rating does not apply to connections 1" and larger when using any PTFE-based gasket due to cold flow potential.