USP Class VI O-rings & Seals

The United States Pharmacopeia (USP) is the non-government organisation that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies.

Whilst this organisation is concerned with the pharmaceutical and bio-technology industries, many manufacturers of hygienic equipment will be designing multipurpose designs that may be used in a range of different industry sectors.

Standards are published in the US Pharmocopeia and the National Formulary (USP NF). Compliance to USP Class VI is often requested by end users. Testing for compliance involves an assessment of the effects of the material, and extractables, on tissue.

United States Pharmacopeia USP 26, NF21, 2003 Class VI

Three chapters are applicable to elastomers, plastics and polymeric materials.  
PPE manufactures O-rings and other sealing products from a range of 15 USP Class VI compliant elastomers:-

  • Chapter 87 (biological reactivity in vitro testing): EPDM, Silicone, FKM, FFKM (Perlast®)
  • Chapter 88 (biological reactivity in vivo testing): EPDM, Silicone, FKM, FFKM (Perlast®)
  • Chapter 381 (physicochemical tests - closures for injections): EPDM

Browse the full range of PPE elastomer materials

 

How can we help you?  If you need USP Class VI rubber seals or components, contact us to discuss your requirements.

Document Downloads
Document Description Chapter/Temp Download
Certificate USP Class VI 87 / 37C Download File
Certificate USP Class VI 88 / 70C Download File
Certificate USP Class VI 88 / 121C Download File
Brochure Food, Pharma & Life-science Download File
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