Sanitary Gasket Material Guidelines

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Sanitary Gasket Material Guidelines

Most decisions driving seal type selection are based on chemistry, temperature, exposure limits, USP, FDA qualifications, and curing methods.

Please refer to the
Sanitary Gasket Material Guidelines
pdf for detailed information.

The summary includes:

  • Guidelines
  • Main Goals
  • Exposure Limits
  • FDA and USP Qualifications
  • Curing Methods
  • What Material(s) Can Be Used
  • What Material(s) Should Be Used
  • Gasket Material Reference

In determining correct sanitary gasket materials, the following criteria is used:

  • U.S. Pharmacopeia Class VI Certification
  • Cytotoxicity Criteria
  • CFR Title 21 Section 177.1550
  • CFR Title 21 Section 177.2600
  • Traceability: Lot and Batch
  • Certification: Lot and Batch
  • ASME-BPE Standards
  • USDA Standards
  • 3-A Sanitary Standards
  • Current Good Manufacturing Practices (CGMP)
  • Manufacturer data and specifications
  • Consultation with various pharmaceutical users

The gasket materials considered are Tuf-Steel® (PTFE/Stainless Steel),Tuf-Flex®, PTFE, Silicone (Platinum), FKM Fluoroelastomer, EPDM and Buna-N.
The 3 main goals are:

  • To protect products from contamination, spalling, particulates and TOCs resulting from the use of improper sanitary hygienic seal material.
  • To protect facilities from unnecessary downtime associated with sanitary hygienic seal failure and replacement from use of improper hygienic seal material.
  • To provide a standard of consistency of sanitary seal selection between multiple facilities.