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.