USP 1116 and cleanroom environmental monitoring

Tim Sandle has written an article reviewing the changes to the USP chapter relating to the environmental monitoring of areas used for the manufacture of sterile products (chapter 1116, which was issued in the 35^th edition of the USP).  The analysis is from a European perspective.

The main changes with the USP were:

To focus the chapter on environmental monitoring only, by removing information relating to aseptic process validation and to the physical aspects of cleanroom operations.

To focus the document exclusively on the monitoring of aseptic environments, by removing references to the monitoring of non-sterile environments.

To reconsider the alert and action level (limit) concept.

The article has been published in the latest edition of the GMPReview. The reference is:

Sandle, T. (2013). New guidance for environmental monitoring in cleanrooms, GMP Review, Vol. 11, No.4, pp9-11.

Posted by Tim Sandle