Monday 21 November 2022

Tracking and tracing to the root cause: case studies in microbial contamination


In this article, pharmaceutical microbiologist and contamination control expert Tim Sandle presents three microbial contamination investigation case studies, highlighting the key lessons for pharmaceutical microbiologists to take away and the underlying importance of identifying the root cause of microbial data deviations.


One of the main activities of the pharmaceutical microbiologist is with determining the contamination control strategy and proactively identifying measures to lower identified risks and, where risks remain of concern, to introduce monitoring. However, there will invariably be microbial recovery, from product (intermediate and finished), from water, cleanrooms and other utilities. 



A common term of these events is ‘microbial data deviations’, although other terminology can apply. These microbial events require investigation and the importance of such an investigation is elevated where there is recurrence. While investigations are referred to in regulatory documents, there is a dearth of case studies to help guide microbiologists and Quality Assurance departments. This article presents three case studies. While the specific issues may or may not be of direct relevance, the areas examined and the thought processes will be of wider applicability.


Sandle, T. (2022) Tracking and tracing to the root cause: case studies in microbial contamination, European Pharmaceutical Review, April 2022:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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