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.
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