PTFE Gaskets for Pharmaceutical Process Piping

Yes. All PTFE gaskets from Artesian Systems comply with FDA 21CFR177.2600, and screen gaskets additionally meet FDA 21CFR177.1550. The screen gaskets have also passed U.S.P. Class VI Cytotoxicity testing, confirming biocompatibility for sensitive pharmaceutical and biopharmaceutical processing environments. Products are also GMP-compatible for regulated manufacturing systems.

Artesian Systems offers PTFE tri-clamp screen gaskets in two inline filtration ratings: 20 micron and 100 micron. Both utilize a 316L stainless steel filter screen bonded within a PTFE/Teflon gasket body. The 20-micron option provides finer particle retention, while the 100-micron variant suits applications with less stringent filtration requirements.

Solid PTFE-x-EPDM envelope and unitized gaskets are available from 1.5" up to 12" in standard tri-clamp sizes. PTFE screen gaskets (both 20 and 100 micron) are available from 1.5" to 6". All are designed for standard sanitary tri-clamp ferrule connections used in pharmaceutical and food processing piping.

No. PTFE-based gaskets from Artesian Systems are not recommended for use with bolted clamp assemblies. PTFE is susceptible to cold flow under high and uneven compressive loading typical of bolted clamps. These gaskets are designed exclusively for standard sanitary tri-clamp connections to ensure consistent, leak-free sealing performance.

No. The standard 1550 PSI sanitary clamp service ratings do not apply to connections 1" and above using any PTFE-based gaskets, due to the risk of cold flow under sustained pressure. This restriction does not apply to fractional 1/2" and 3/4" connections, which feature a recessed, fully contained design that prevents cold flow.

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