What is Disinfectant Validation?

José E. Martinez
Pharmaceutical Technology, Mar 2, 2006
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Although we commonly talk about "disinfectant validation," the US Food and Drug Administration validates only processes (1). Disinfectants themselves are qualified—that is, found to be effective in the context of a given process, just as we qualify the clean steam supply for an autoclave and then validate the steam sterilization process. The approach to disinfection should be similar, so that a working definition for disinfection process validation would be "establishing documented evidence that a disinfection process will consistently remove or inactivate known or possible pathogens from inanimate objects."

The working definition becomes critical as process operators attempt to comply with the current good manufacturing practice (CGMP) requirements of 21 CFR 211.56 (Sanitation) and 21 CFR 211.67 (Equipment cleaning and maintenance). The Sanitation clauses require that "any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition." And, the Cleaning and Maintenance provisions stipulate that "Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements."

Even though the regulators have never formally defined "disinfectant validation," FDA Form 483 observations and Warning Letters frequently cite failures to ensure proper disinfection.

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