Notes on USP31-NF26 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>

Modified 20181212 – minor typos corrected. minor updates.

The USP is the United State’s Pharmacopeia.  If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation.  For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.

I last reviewed USP 1116 in 2009 when it was version USP31–NF26.

Where one does not have direct access to the USP (it is behind a pay wall),  there are plenty of sites that review changes and publish their considered opinions.  The USP itself publishes Revision Bulletins, IRA’s (public comment documents showing proposed changes) and Errata.  From these one can build up a fairly accurate picture of the USP.

The latest iteration is USP 41–NF 36 — this became official on May 1, 2018.  The last version I managed to get my hands on was USP36 NF31.  What follows is my original review. Continue reading