Wednesday, 13 June 2018

Next Steps After Finding an Environmental Isolate


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.”

For details see: Microbiologics



Posted by Dr. Tim Sandle

Special offers