US Pharmacopeia (USP NF) Class VI

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 Pharmacoepeia USP 26, NF21, 2003 Class VI

Two types of biological reactivity test are applicable to elastomers, plastics and polymeric materials; Chapter <87>  involves in vitro testing and Chapter <88> involves in vivo testing.

PPE manufacturers USP Class VI compliant O-rings and seals in various elastomer types, including EPDM, Silicone, FKM and FFKM.

>More information: www.usp.org