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Good contamination control practices in a controlled manufacturing environment demand consistency, which can be undermined by the common belief that the use of disinfectants alone will control the microbiological risk. This comes from a legacy misunderstanding that use of a sporicide will correct other control failures.  The use of a sporicide in a cleanroom is not meant to replace good cleaning and broad-spectrum microbial disinfection but to complement broad spectrum efficacy when bacterial spore-formers are a persistent risk to the process . Along with the rotation of a sporicidal disinfectant, a good balance of microbiological control for incoming materials and good gowning practices reduce the risk of introduction of microbiological contamination into a cleanroom or controlled environment. Clear understanding of bacterial spore-formers and a risk-based approach to the removal of potential sources of bacterial spore-formers will lead to a good practice for the use of a sporicide in sterile pharmaceutical manufacturing environments.
Published in: PDA Journal of Pharmaceutical Science and Technology
Volume 80, Issue 1, pp. 71-76