Validation Requirements for Disinfection Efficacy
Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.
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Q Is the periodic re-evaluation of disinfectant efficacy useful in any way? I have been asked to repeat these studies even though they have been done in the past. There's been no change to the materials or methods since that time.
A
In the pharmaceutical manufacturing industry, operating under GMPs, the periodic revalidation of disinfection efficacy is not scientifically justified or required provided the disinfectant used remains the same, the dilution of the disinfectant is still the same, the challenge organisms (including environmental isolates) are still the same, the manufacturing environment surfaces are still the same and the vendor for the disinfectant is still the same. To my knowledge, only when one of these five elements regarding cleanroom disinfection is changed are you required to repeat the validation of disinfection efficacy testing. Periodic revalidation of a disinfectant serves no useful scientific purpose and I do not know of an FDA regulation that states that one must periodically revalidate disinfectants. Be sure to execute the disinfection efficacy validation properly and have complete documentation.
John S. Kent, PhD
Principal, Pharmaceutical Development Consulting
San Mateo, CA (USA) 94403
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
