In the aseptic manufacture of parenteral drug products and 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 serve 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 in which increased microbial risks occur. The major source of microbial risks in the controlled clean room 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 the potential risk that this microorganism represents. This review provides a case-study assessment of this microorganism in the context of parenteral manufacture for the purpose of assisting in the deciding the necessary controls and the potential monitoring addressing this microbial risk.
Keywords: Controls; Culture medium; Cutibacterium acnes; Incubation conditions; Microbiological risk; Monitoring.
© PDA, Inc. 2020.