USP Class VI Seals
USP Class VI – Medical grade elastomer sealing solutions
M Barnwell Services have been providing USP Class VI Seals to the Food, Pharmaceutical, and Life Science industries for over 50 years. We are the industry experts in fluid sealing products and be assured that full documentation and certificates can be provided.
The United States Pharmacopeia (USP) is the non-government organization that promotes the public health by appointing the newest standards to guarantee the quality of medications and different healthcare technologies.
While USP is occupied with the biotechnology and pharmaceutical industries, many manufacturers of hygienic equipment will be planning versatile designs that may be used in a span of other industry divisions.
Standards are released in the US Pharmacopeia and the National Formulary. Compliance with these standards is frequently demanded by end users. Examining for compliance implies an evaluation of the result of the material, and extractable, on the tissue.
United States Pharmacopeia USP 26, NF21, 2003 Class VI
There are three chapters applicable to plastics, polymeric materials and elastomers. M Barnwell Services produces O Rings and other sealing products from a span of 15 USP Class VI compliant elastomers.
Chapter 87 – Biological reactivity in vitro testing: EPDM, Silicone (VMQ), FKM (Viton®), FFKM (Perfluoroelastomer)
Chapter 88 – Biological reactivity in vivo testing: EPDM, Silicone (VMQ), FKM (Viton®), FFKM (Perfluoroelastomer)
Chapter 381 – Physiochemical tests – closures for injections: EPDM
If you would like more information about our range of USP Class VI Seals, contact a member of the team.
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