Best Practices For Designing Microbiology Experiments

Qualifying microbiological methods is not easy, compared with analytical ones. This partly rests with the relatively high variation inherent in many methods, especially the culture-based ones. While it is unlikely that microbiological methods will meet the more exacting demands of their chemical counterparts, a sound scientific approach can be taken for running experiments and “qualification” of microbiological methods.

This article looks at factors to consider in drawing up assessment criteria for a microbiological test, including the limit of detection (for example, what is the lowest level of microorganisms that can be detected?), specificity (for example, what range of different microorganisms can be detected?), and quantification (for example, the counting accuracy). These types of questions should form the basis of a microbiological method’s validation strategy.

Tim Sandle has writen a new article, the reference is:  

Sandle, T. (2021) Best Practices For Designing Microbiology Experiments, Pharmaceutical Online, at: https://www.pharmaceuticalonline.com/doc/best-practices-for-designing-microbiology-experiments-0001

To access the aricle, see:  Outsourced Pharma

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)