Cleanroom Technology - July 2016 issue
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.
You'll find the article in the July 2016 issue of Cleanroom Technology or you can read more on the article on the Cleanroom Technology website.
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.
Cleanroom Technology is a global platform, providing information through cleanroomtechnology.com, Cleanroom Technology Global Conferences and a monthly print magazine. The publication brings you the latest industry and products news, updates on regulation and standards, technical articles and design and product innovations. It informs, educates and connects the industry, addressing today’s challenges including environmental, social and governance.
