Cleaning and Disinfection Validation Studies

Disinfection Validation Studies

FDA requires manufacturers of pharmaceuticals to validate disinfection procedures on a facility-by-facility basis, because facilities vary in terms of products used, surface types and predominant microbial contaminants.

Antimicrobial Test Laboratories specializes in the testing of disinfectants and other antimicrobial products, is FDA registered and is GLP-compliant. As such, we are in an excellent position to assist companies in designing and executing disinfection validation studies.

Basic Requirements of a Good Disinfection Validation Study

The study is designed and run under GLP test conditions.
A standard test method, such as a modified AOAC Germicidal Spray Test or modified ASTM E 1153 is chosen for use in the study.
Disinfectants, sterilants, and sporicides used in the facility are tested.
Surfaces representative of those found in the facility are used in the study.
A broad range of microorganisms is tested, including "standard" cultures such as S. aureus, E. coli, P. aeruginosa and A. niger.
An additional set of microorganisms is tested, representing common environmental isolates. Typically, three isolates are chosen. Common problematic contaminants include Micrococcus species, Bacillus species, and Pseudomonas species.
Each individual validation test is run in triplicate (three individual replicates).

Table Summarizing a Moderate to Large Disinfection Validation Study

As you may have guessed from reading the "basic requirements" section above, disinfection validation studies can get quite large. The table below summarizes the testing involved in a moderate to large disinfection validation study. Such a study would be appropriate to a large pharmaceutical or medical device manufacturing facility.

*Antimicrobial Test Laboratories would hate to see your firm run a study such as the one outlined above in its entirety - it's just not necessary to do all of those iterations. If your firm needs to contract a disinfection validation study, give us a call or use our contact form to discuss scientifcally defensible strategies to reduce the study size.

Regulatory Considerations

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