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This information has been carefully prepared
to help in selecting the correct
elastomer or perfluorocarbon utilized in
high purity sanitary hygienic seals where
critical pure water, process fluids (both
ambient and hot), and SIP environments
exist. The intention is to consider the different
uses, applications and conditions
to determine the most favorable hygienic
seal material for each application.
Click here to download the Rubber Fab Hygienic Seal Material Guideline summary. 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
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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.
Most decisions driving seal type selection are based on chemistry, temperature,
exposure limits, USP, FDA qualifications, and curing methods. Please refer to the
Rubber Fab Hygienic Seal Material Guidelines pdf for detailed information
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