USP Class VI O-rings, Gaskets & Seals
What is USP Class VI?
The United States Pharmacopeia (USP) is a non-government organisation that promotes 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 medical and pharmaceutical grade gaskets and seals, including O-rings, sanitary gaskets and other high performance seals from a range of 15 USP Class VI compliant elastomers:-
- Chapter 87 (biological reactivity in vitro testing): EPDM, Silicone, FKM, FFKM (Perlast® seals for life sciences)
- Chapter 88 (biological reactivity in vivo testing): EPDM, Silicone, FKM, FFKM (Perlast® seals for life sciences)
- 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 | |
| Certificate | USP Class VI | 88 / 70C | |
| Certificate | USP Class VI | 88 / 121C | |
| Certificate | USP <381> | Closures | |
| Brochure | Food, Pharma & Life-science |