FDA 21CFR177.2600 Compliant certified

FDA 21CFR177.2600 Compliant

3A Sanitary Standards Approved certified

3A Sanitary Standards Approved

ISO 9001 Approved certified

ISO 9001 Approved

PTFE Gaskets — FDA Approved

Artesian Systems' FDA-approved PTFE gaskets are engineered for sanitary tri-clamp piping systems used in pharmaceutical, food and beverage, and chemical processing. Available in envelope, unitized, and screen gasket designs, these PTFE and PTFE/EPDM gaskets comply with FDA 21CFR177.2600, 3A, USDA, and GMP standards, offering superior chemical resistance and reliable sealing performance.

PTFE/Teflon 20 Micron Tri Clamp Screen Gasket
Tri Clamp Envelope Gasket PTFE (Teflon) X EPDM Sanitary Pharmaceutical Grade
PTFE/Teflon 100 Micron Tri Clamp Screen Gasket
Tri Clamp Unitized Gasket PTFE (Teflon) x EPDM Sanitary Pharmaceutical Grade

Our Range of Products

PTFE/Teflon 20 Micron Tri Clamp Screen Gasket

PTFE/Teflon 20 Micron Tri Clamp Screen Gasket

  • Fine 20-micron 316L SS inline filtration
  • 3A, USDA & FDA 21CFR dual-compliant
  • U.S.P. Class VI biocompatibility verified
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 combo resists creep & cold flow
  • Available in 1.5" to 12" tri-clamp sizes
PTFE/Teflon 100 Micron Tri Clamp Screen Gasket

PTFE/Teflon 100 Micron Tri Clamp Screen Gasket

  • 100-micron 316L SS screen filtration
  • 3A, USDA & FDA 21CFR dual-compliant
  • U.S.P. Class VI cytotoxicity tested
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 PTFE x EPDM design
  • FDA 21 CFR 177.2600 & GMP compliant
  • 10-year shelf life from cure date

Frequently Asked Questions

Is PTFE FDA compliant?

Yes, PTFE (polytetrafluoroethylene) is FDA compliant when it meets the requirements outlined in 21CFR177.2600, which governs rubber articles intended for repeated use in food contact applications. Artesian Systems' PTFE gaskets are fully compliant with FDA 21CFR177.2600 and, where applicable, 21CFR177.1550, making them suitable for food, pharmaceutical, and sanitary processing applications.

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

What sizes are available for PTFE tri-clamp gaskets?

Can PTFE gaskets be used with bolted clamps?

What is the shelf life of PTFE/EPDM gaskets?

What filtration ratings are available for PTFE screen gaskets?

Are PTFE gaskets suitable for pharmaceutical and bioprocessing environments?

Didn't find what you're looking for?

Talk to our experts for custom solutions and tailored guidance.

Industries We Serve

Pharmaceutical & Bioprocessing

Pharmaceutical & Bioprocessing

FDA and GMP-compliant PTFE gaskets for sterile fluid handling, bioprocessing, and pharmaceutical manufacturing pipelines.

Food & Beverage Processing

Food & Beverage Processing

USDA and 3A-approved PTFE gaskets ensuring hygienic, chemical-resistant sealing in food and beverage production lines.

Chemical Processing

Chemical Processing

Broad chemical resistance of PTFE makes these gaskets ideal for aggressive media in industrial chemical processing systems.

Dairy & Sanitary Fluid Handling

Dairy & Sanitary Fluid Handling

3A-compliant PTFE screen and solid gaskets designed for dairy processing and clean-in-place sanitary fluid systems.

Didn't find what you're looking for?

Talk to our experts for custom solutions and tailored guidance.

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Why Pharma & Food Processors Choose Artesian Systems

Nearly Two Decades of Industry Expertise

Founded by a mechanical engineer with close to 20 years in petroleum, chemical, and food industries, ensuring products meet real-world process demands.

Rigorous Regulatory Compliance

All PTFE gaskets comply with FDA 21CFR177.2600, 3A Sanitary Standards, USDA, GMP, and U.S.P. Class VI Cytotoxicity requirements for regulated industries.

Engineered for Sanitary Process Systems

Designed with meticulous attention to creep resistance, cold flow prevention, and chemical compatibility for reliable long-term sealing in tri-clamp systems.

Get Expert Guidance on the Right PTFE Gasket

Submit your process requirements and our engineering team will respond with product recommendations, sizing guidance, and a quote.

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.