Pharmaceutical Tri Clamp Gaskets — USP & FDA Compliant

Yes. All gaskets in this category comply with FDA 21CFR177.2600 and FDA 21CFR177.1550. Screen gasket products in BUNA-N, PTFE, and VITON/FKM have additionally passed U.S.P. Class VI Cytotoxicity testing, confirming biocompatibility for pharmaceutical, biotechnology, and medical-grade fluid handling environments.

Screen gaskets are available in sizes ranging from 1.5" to 6", while PTFE x EPDM envelope and unitized gaskets are available in sizes from 1.5" up to 12". This covers the majority of standard sanitary tri clamp ferrule connections used in pharmaceutical and food processing piping systems.

Screen gaskets combine a gasket seal with an integrated 316L stainless steel filtration mesh (5, 20, or 100 micron) to filter particles in-line. Envelope and unitized gaskets are solid sealing gaskets without a screen, designed to provide superior chemical resistance and sealing performance compared to solid PTFE-only gaskets, especially under slight ferrule misalignment.

Tri clamp screen gaskets are available in 5 micron, 20 micron, and 100 micron ratings. The 5 and 20 micron options are suited for fine-particle removal in pharmaceutical and biotechnology applications, while the 100 micron screens are ideal for coarse straining in food, beverage, and general sanitary processing lines.

No. PTFE-based gaskets — including PTFE screen gaskets and PTFE x EPDM envelope and unitized designs — 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 the risk of cold flow. This restriction does not apply to 1/2" and 3/4" fractional sizes.

PTFE x 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 environment between 65°F and 85°F, away from direct sunlight and at least 6 feet from electric motors to prevent premature material degradation.