The ABCs of disinfectant validation

摘要

I recently attended a meeting with several members of the pharmaceutical, biotechnology and medical device industries. During our discussions of cleanroom decontamination, it quickly became apparent that the subject of disinfectant validation was a considerable source of both regulatory pressure and internal frustration. One of the key concerns was that regulatory authorities have provided very little guidance as to how they expect a disinfectant validation to look. Some also stated that what may be acceptable to one investigator might not be acceptable to another. While I agree that there may be some variability inherent in the regulatory inspection process and consequently, some variability in what is considered an acceptable validation study, there are a few absolute expectations that anyone involved in disinfectant validation should meet.