FDA 21CFR177.2600 certified

FDA 21CFR177.2600

ISO 9001 Approved certified

ISO 9001 Approved

GMP compliant certified

GMP Compliant

12 Inch Sanitary Gaskets — PTFE & FDA Approved

Artesian Systems' 12 inch sanitary gaskets include FDA-approved PTFE envelope and unitized designs engineered for tri-clamp connections in pharmaceutical, food, and chemical processing. Combining PTFE's chemical resistance with EPDM elasticity, these gaskets meet 21CFR177.2600 and GMP standards, offering a 10-year shelf life and superior sealing performance.

Tri Clamp Envelope Gasket PTFE (Teflon) X EPDM Sanitary Pharmaceutical Grade
Tri Clamp Unitized Gasket PTFE (Teflon) x EPDM Sanitary Pharmaceutical Grade

Our Range of Products

Tri Clamp Envelope Gasket PTFE (Teflon) X EPDM Sanitary Pharmaceutical Grade

Tri Clamp Envelope Gasket PTFE (Teflon) X EPDM Sanitary Pharmaceutical Grade

  • FDA 21CFR177.2600 & GMP compliant
  • PTFE + EPDM resists creep & cold flow
  • 10-year shelf life from cure date
Tri Clamp Unitized Gasket PTFE (Teflon) x EPDM Sanitary Pharmaceutical Grade

Tri Clamp Unitized Gasket PTFE (Teflon) x EPDM Sanitary Pharmaceutical Grade

  • One-piece unitized, stable installation
  • FDA 21CFR177.2600 & GMP compatible
  • PTFE surface with EPDM core elasticity

Frequently Asked Questions

Are these 12 inch sanitary gaskets FDA approved?

Yes. Both the Tri Clamp Envelope and Unitized PTFE x EPDM gaskets comply with FDA 21 CFR 177.2600, which governs rubber articles intended for repeated use in food-contact applications. They are also suitable for GMP-regulated pharmaceutical and biotech processing systems.

What is the difference between an envelope gasket and a unitized gasket?

Can I use these PTFE gaskets with bolted clamp assemblies?

What pressure ratings apply to 12 inch PTFE sanitary gaskets?

What is the shelf life of these sanitary gaskets?

What industries are these 12 inch sanitary gaskets suited for?

Why choose a PTFE x EPDM gasket over a solid PTFE gasket?

Didn't find what you're looking for?

Talk to our experts for custom solutions and tailored guidance.

Industries We Serve

Pharmaceutical & Biotech

Pharmaceutical & Biotech

FDA 21CFR177.2600-compliant PTFE gaskets support GMP-regulated pharma and biotech tri-clamp piping systems.

Food & Beverage Processing

Food & Beverage Processing

GMP-compliant PTFE gaskets ensure safe, hygienic sealing in food-grade tri-clamp processing lines and fluid systems.

Chemical Processing

Chemical Processing

Broad chemical resistance of PTFE contact surfaces makes these gaskets ideal for aggressive chemical process pipelines.

Hemp & Cannabis Extraction

Hemp & Cannabis Extraction

Sanitary PTFE gaskets support clean, compliant sealing in hemp oil and cannabis extraction tri-clamp process systems.

Didn't find what you're looking for?

Talk to our experts for custom solutions and tailored guidance.

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Why Pharmaceutical & Food Processors Choose Artesian Systems

FDA & GMP Compliant Materials

All gaskets meet FDA 21CFR177.2600, USDA, and GMP standards, ensuring full regulatory compliance for food, pharma, and biotech processing lines.

Nearly Two Decades of Engineering Expertise

Founded by a mechanical engineer with close to 20 years in petroleum, chemical, and food industries — precision and process knowledge built into every component.

Superior PTFE-EPDM Hybrid Construction

Envelope and unitized designs combine PTFE chemical resistance with EPDM elasticity, reducing cold flow, creep, and leaks versus standard PTFE-only gaskets.

Request a Quote for 12 Inch Sanitary Gaskets

Submit your inquiry and our team will respond with pricing, size availability, and technical guidance within one business day.

Contact Us Today

For immediate assistance, feel free to give us a direct call at +(801) 318 – 4079. You can also send us a quick email at artesiansystems@gmail.com.