Ode to a Sporicide - Can we do better?

Abstract

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.