Abstract
In the aseptic manufacture of parenteral drug products, low bioburden, cell and gene therapy products the control and monitoring of environmental and personnel associated microorganisms is an imperative for the confirmation of controlled conditions, and the assessment of microbial risks. Environmental and personnel monitoring programs exist to assure product quality and as one of the several means of removing the emphasis on finished drug product testing. Therefore, these programs must adequately assess these risks and identify situations where increased microbial risks occur. The major source of microbial risks in the controlled cleanroom environments for parenteral drug product manufacture are personnel; modern microbial analytical methods, including metagenomic analysis have identified a greater abundance of Cutibacterium acnes; traditional culture-based monitoring fails to consistently recover and assist in the identification of potential risk that this microorganism represents. This review provides a case-study assessment of this microorganism in the context of parenteral manufacture, purposed to assist in the decision of the necessary controls and potential monitoring addressing this microbial risk.
- Received September 23, 2019.
- Accepted January 17, 2020.
- Copyright © 2020, Parenteral Drug Association
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