PDA Letter Article

Why the Surface is Critical to Disinfection Testing

by James Polarine, Jr., and David Shields, STERIS

Central to recent debates about disinfectant validation is whether value is added by individual facilities performing studies, or if a large central study could be relied upon to demonstrate the efficacy of biocides. Regulators expect disinfectant validation to be conducted by facilities in the pharmaceutical, biotech, medical device and 503B compounding pharmacy industries. As regulators look more closely at disinfectant validation, the role of the surface in the disinfectant process has been heightened.