Our Microbiolgy Product Specialist, Andrew Ramage and our Quality Manager, Harshad Joshi, have recently worked together to produce another technical article. The article is featured in the July/August 2016 issue of Manufacturing Chemist Pharma. It discusses the factors to consider when choosing neutralisers for use in growth media and covers:
Choosing a neutraliser
Method validation criteria
Other factors to consider
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.
The environmental monitoring processes and validation guide
Understand the key changes and challenges of the EU GMP Annex 1 draft revision.
What will it mean for your environmental monitoring processes?