Tri Clamp Gaskets for Nutraceutical & Supplement Production

Yes. All gaskets in this category comply with FDA 21CFR177.2600 and FDA 21CFR177.1550, carry 3-A Sanitary Standards approval, and are USDA approved. Screen gasket variants have also passed U.S.P. Class VI Cytotoxicity testing, confirming biocompatibility for sensitive supplement and pharmaceutical processing environments.

Screen gaskets are available in 5, 20, and 100 micron ratings, all using 316L Stainless Steel screens. The 5-micron Viton/FKM option provides the finest inline filtration, while 100-micron BUNA-N and PTFE variants are suited for coarser straining. The correct rating depends on particle size tolerances in your specific nutraceutical or supplement process.

Solid envelope and unitized gaskets are available from 1.5" through 12" (1.5", 2", 3", 4", 6", 8", 10", 12"). Screen gaskets are offered in sizes from 1.5" up to 6" (1.5", 2", 2.5", 3", 4", 6" depending on material). This range covers the majority of standard sanitary tri-clamp piping systems used in nutraceutical facilities.

Envelope gaskets feature a PTFE outer shell around an EPDM filler, providing chemical versatility and preventing cold flow better than solid PTFE alone. The unitized design uses a one-piece internal construction bonding the PTFE sealing surface to an EPDM core, offering improved installation stability and reduced component movement. Both are GMP-compatible and rated for sanitary tri-clamp connections.

No. PTFE-based gaskets — including PTFE/Teflon screen gaskets, envelope gaskets, and unitized PTFE×EPDM gaskets — are not recommended for use with bolted clamp assemblies. Additionally, standard PSI service ratings for sanitary clamps do not apply to connections 1" and above using PTFE gaskets due to potential cold flow. Fractional 1/2" and 3/4" sizes are exempt from this restriction.

PTFE×EPDM envelope and unitized gaskets have a shelf life of 10 years from the cure date. They should be stored in original packaging in a clean, dry warehouse environment between 65°F and 85°F, away from direct sunlight, and kept at least 6 feet from electric motors to prevent ozone degradation of the EPDM core material.