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Our FDA, NSF, and 3-A sanitary gaskets are specifically engineered to meet the rigorous safety and hygiene standards required in food, beverage, and pharmaceutical processing. Manufactured from high-purity, compliant materials like EPDM, silicone, and PTFE, these gaskets ensure non-toxic, non-leaching performance in critical applications. Designed for clean-in-place (CIP) and steam-in-place (SIP) systems, they offer excellent chemical resistance, thermal stability, and long-lasting sealing under dynamic operating conditions. Whether you're designing new equipment or maintaining existing systems, our sanitary gaskets provide the reliability and regulatory compliance you need to protect product integrity and meet industry certifications.

American Biltrite Sanitary Materials

Material Number Description FDA NSF 51/61 3A USP Class VI Metal Detectable Datasheet
AB-138 Natural Rubber (NF). ASTM D2000: 2AA420A13F17. AB-138 Datasheet
AB-366 Nitrile (NBR). Meets FDA 21 CFR 177.2600 as well as Dairy 3A Specs. ASTM D2000: 1BF610. AB-366 Datasheet
AB-566 Ethylene Propylene Diene (EPDM) FDA Grade, meets FDA 21 CFR 177.2600 AB-566 Datasheet
AB-266 Neoprene (CR), moderate resistance to petroleum products and good weathering resistance. ASTM Grade. AB-266 Datasheet

Klinger Sanitary Materials

Material Number Description FDA NSF 51/61 3A USP Class VI Metal Detectable Datasheet
top-chem 2000 Suitable for an extremely wide range of applications in the chemical and petrochemical industry, as well as in the ship building industry for the transport of chemicals. Meets FDA conformity. top-chem 2000 Datasheet
soft-chem Soft-chem® expanded 100% virgin PTFE sealing materials provides excellent corrosion resistance and impermeability along with superior creep resistance and sealability for us in all types of applications. FDA compliant. soft-chem Datasheet
tc-1005 Is a high quality, yet cost-effective biaxial oriented modified PTFE gasket material with silica. tc-1005 Datasheet
Quantum Is the first fiber reinforced gasket material in the world that is exclusively HNBR-bound. Quantum Datasheet

Garlock Sanitary Materials

Material Number Description FDA NSF 51/61 3A USP Class VI Metal Detectable Datasheet
GYLON BIO-LINE® GYLON BIO-LINE® – A PTFE gasket family designed for hygienic sealing in food, beverage, pharmaceutical, and biotech equipment, meeting FDA, USP Class VI, and 3-A Sanitary standards. GYLON BIO-LINE® Datasheet


Frequently Asked Questions: Sanitary Gaskets


What are sanitary gaskets and why are they important?

Sanitary gaskets—also called food-grade or hygienic gaskets—are seals specifically engineered for food, beverage, and pharmaceutical industries. They’re made from non-toxic, non-leaching materials that resist bacterial growth and withstand rigorous cleaning such as CIP (Clean-in-Place) and SIP (Steam-in-Place), preserving product safety and integrity.

What does it mean for a gasket to be FDA compliant?

An FDA-compliant gasket is formulated using ingredients listed as safe under FDA regulations (e.g., 21 CFR 177.2600 for elastomers, or 21 CFR 177.1550 for PTFE) or is designated GRAS (Generally Recognized As Safe). Adhesives and inks used must also meet FDA standards.

What is the NSF certification for gaskets, and how does it differ from FDA compliance?

NSF/ANSI 51 covers food equipment materials, while NSF/ANSI 61 applies to drinking water systems. Unlike FDA, which doesn’t certify products, NSF conducts third-party testing and certification—offering an additional level of assurance.

What are 3‑A Sanitary Standards, and how do they apply to gaskets?

3‑A Sanitary Standards (developed by the dairy and food industries) set strict criteria for cleanability and performance under sanitation. For rubber gaskets, they include tests such as milk fat absorption, aging, and resistance to cleaning agents, on top of basic FDA ingredient requirements.

Why might a gasket need to meet FDA, NSF, and 3‑A standards simultaneously?

To ensure comprehensive compliance across various regulatory and operational requirements. FDA ensures safety of ingredients; NSF validates suitability for food or potable water; 3‑A ensures sanitary design and cleanability. Together, they significantly reduce contamination risks.

What materials are commonly used in FDA, NSF, & 3‑A sanitary gaskets?

Common materials include EPDM, silicone, PTFE, nitrile (NBR), neoprene, and Viton®, each offering different benefits like thermal stability, chemical resistance, and durability. Southern Rubber’s product lines include these materials designed to meet FDA, NSF 51/61, and/or 3‑A standards.

How do I choose the right sanitary gasket material?

Select based on application needs:

  • PTFE for chemical resistance and high temperatures;
  • Elastomers (EPDM, silicone, nitrile) for flexibility and compatibility with CIP/SIP;
  • Viton® (FKM) for extreme chemical and temperature conditions. Always confirm performance compatibility and compliance with relevant standards

How often should sanitary gaskets be inspected or replaced?

It depends on usage and conditions. High-temperature or chemically aggressive environments may require checks and replacement every few months. Regular inspection ensures reliability and hygiene; consult the manufacturer for specific guidance.