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