Manufacturing Chemist Pharma - July/August 2016
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 - including common neutralising agents for interfering substances
- Regulatory perspectives - It is important to take a closer look at the types of product testing to highlight the regulatory requirements. There are typically two types of products – filterable and non-filterable.
- Method validation criteria - There is excellent guidance in The Pharmaceutical Microbiology Manual (PMM) that covers in detail the possible methods and rationale but this needs to be applied to each validation method appropriately.
- Other factors to consider - the neutraliser chosen should not have a detrimental effect on the growth potential of the growth medium.
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 August 2016 issue of Manufacturing Chemist Pharma or you can read more on the article on the Manufacturing Chemist website.
We must be aware of the challenges involved when choosing the correct growth media, in the correct container, let alone what neutralisers (if any) to choose. The advice in the article should help in not only choosing the correct neutraliser but also in using the most appropriate method to meet regulatory requirements.
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.
