You’ve
identified an organism in your environment. Now what? If you work in a
non-sterile pharmaceutical manufacturing laboratory, chances are you’ve
encountered this question.
The
Microbiologics blog has an interesting guide to examining environmental
isolates. Here is an extract:
“You
know environmental monitoring doesn’t stop at detection, but what are the
correct next steps to keep your products safe and laboratory in compliance?
Instances of U.S. Food and Drug Administration (FDA) warning letters and
observations associated with inadequate environmental isolate testing are on
the rise. As a result, laboratories are seeking guidance to determine what to
do with their environmental isolates. These laboratories may consider including
the isolates in disinfectant efficacy, growth promotion or antimicrobial
effectiveness challenge tests.”
Posted by Dr. Tim Sandle
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