Monday, 14 January 2019

Human microbiome and contamination control


The human body is an intricate system that hosts trillions of microbial cells across the epithelial surface, and within the mouth and gut. These microorganisms play a role in human physiology and organ function, including digestion and immunity. The microorganisms also impact on the outside environment as they are shed from the skin or deposited through different orifices. This latter issue has important implications for cleanrooms in pharmaceuticals and healthcare. In recent years, far greater detail about the numbers and complexity of these microorganisms has been gained through the Human Microbiome Project and related research.

In relation to this subject, Tim Sandle has written a review paper.

This paper summarizes some of important findings that have emerged from the Human Mirobiome Project and considers how the findings can inform our understanding of cleanroom microbiology, and presents some thoughts as to whether our enhanced understanding of the human microbiota of the skin should influence the types of controls, supported by testing, that needs to be in place within cleanrooms.

The questions posed by this paper in relation to cleanroom microbiology are:
  • Do environmental monitoring methods remain sufficient in light of Human Microbiome Project findings?
  • Is sterility test media suitable for recovering cleanroom contaminants?
  • Should cleanroom microbiologists be as concerned with anaerobic bacteria as they are with aerobic bacteria?
  • Does the test panel used for disinfectant efficacy tests need to change?
  • Similarly, does the culture media growth promotion panel need to alter?
  • Can the Human Microbiome Project findings aid with the assessment of microbial data deviations?
  • Are cleanroom gowning practices adequate?
The reference is:

Sandle, T. (2018) The Human Microbiome and the implications for cleanroom control, European Journal of Parenteral and Pharmaceutical Science, 23 (3): 89-98

For a copy, please contact Tim Sandle.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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