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ASME-BPE ISO-DIN Clamp gaskets





Guidelines:

This information has been carefully prepared to help in selecting the correct elastomer 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 favourable hygienic seal material for each application. The following criteria are used to determine the correct hygienic seal materials:
· 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
· Animal Derived Ingredient Free
The gasket materials considered are Tuf-Steel® (PTFE/Stainless Steel), Tuf-Flex,® PTFE, Silicone (platinum), FKM Fluoroelastomer, EPDM and Buna.

Downloadable documents available for this product:

ASME-BPE ISO-DIN Clamp gaskets

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