Cherwell Laboratories' Quality Manager, Harshad Joshi and Microbiology Product Specialist, Andrew Ramage have written an article discussing neutralisers for use in growth media, which features in July's issue of Cleanroom Technology.
The article, titled 'Factors to consider when choosing neutralisers for use in growth media' covers:
Why use neutralisers? - There is an expectation for neutralisers to be used in the testing of sterile and non-sterile products according to the harmonised methods.
What microbiological methods require neutralisers?
Regulatory requirements (if any)
Specified neutralisers as per pharmacopoeia methods (and a mention of non-specified)
Making the choice
Validation criteria with a mention of methods - Method validation is the process of determining whether a method is suitable for its intended use
Here's an abstract from the article:
Environmental Monitoring is a GMP requirement to ensure drug products are made in a non-contaminating environment. Andrew Ramage and Harshad Joshi, Cherwell Laboratories, give a scientific and regulatory perspective on considerations when using neutralisers in growth media.
We have a range of irradiated media for environmental monitoring that contain various combinations of the popular neutralisers mentioned in the article. Please contact us if you would like more details of the range available. Alternatively, you can download our Redipor Prepared Media Price List.
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