Wednesday, 7 May 2014

Understanding Cleanroom Classifications

Jeanne Moldenhauer has written an informative article on cleanroom classifications for Controlled Environments Magazine.

Here is an extract:

“Many global companies choose to use this classification system. All of these systems are acceptable for use. However, we have also tended to link the systems together, e.g., ISO 5/Class 100/Grade A. This type of linkage is seen in the FDA’s Guidance for Aseptic Processing (2004). If you are manufacturing an aseptic product and use this linked classification system it is not likely to be an issue. However, if you are not manufacturing an aseptically processed product, choosing to link the classification systems together may lead to other consequences.”

To read the article, go to Controlled Environments

Posted by Tim Sandle