Rubber Fab

Gaskets that comply with Food and Drug Administration (FDA) regulations

This is a broad and complex area and frequently extends beyond food processing plants to those involved in the making of pharmaceutical products. The information that follows will help explain some of the requirements for FDA compliant gaskets.

A gasket is considered FDA compliant through three methods:

  • GRAS—Materials that are generally regarded as safe (GRAS). Many materials have been used without problems in FDA applications and are listed as GRAS. The use of a food substance gasket may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
  • Existing FDA Regulations—Some materials are already covered by existing regulations. For example, perfluorocarbon resins and PTFE are found in 21 CFR 177.1550.
  • FDA FCN—New materials not covered by either of the above can be submitted to the FDA under a food control notification (FCN).

PTFE gaskets and elastomer (rubber) gasket materials are the most common gasket materials used for FDA applications.

  • Replacement Diaphragms for ITT, Gemu, and Saunders Valves
  • USP Class 6 Gaskets & Seals
  • Screen Gaskets & Orifice Plates
  • Validation & Steam Tech Products

Seal design is an important factor in food, dairy, beverage and pharmaceutical processing. An o-ring is a very important part of that design and are generally installed in a seal to prevent leaking, or loss of fluid. O-rings and gaskets are FDA Compliant for use in food applications and Class VI tested for pharmaceutical applications.

Rubber Fab offers a wide variety of sanitary gaskets and o-rings to seal clamp connections in sanitary pipe lines. We offer the entire product range of specialty gaskets in several elastomers, and fluoroelastomers.