Monday, 21 November 2016

Mold Monitoring and Control in Pharmaceutical Manufacturing Areas


Tony Cundell has written an important article on fungi for American Pharmaceutical Review.

The introduction reads:

“Recent high profile product recalls associated with mold contamination has resulted in more attention from the FDA to fungal isolation in environmental monitoring and product testing in the pharmaceutical industry. Companies need to anticipate these FDA concerns especially with respect to the upcoming regulatory inspections and institute remediation when mold is found in their products and manufacturing facilities to protect patient safety.”

In the article, Cundell reviews fungal isolation media and enumeration methods for cleanrooms, as well as identification strategies.

The article can be accessed here.

Posted by Dr. Tim Sandle