Per USP <1072>, we provide expert services to test disinfectant efficacy. Disinfection and cleaning of critical areas is a key component to successful control of these environments. In addition to validating the cleaning process, the disinfectants and antiseptics implemented should be qualified. At the minimum, this should include a review of vendor certificates and data. Actual testing is also often required, such as use-dilution tests (e.g., AOAC 955.14, 955.15, 964.02), which verify the dilution of disinfectants against specified microbial strains. Additional tests needed may also include Sporicidal Activity of Disinfectants (AOAC 966.04), germicidal spray products tests, confirmatory tuberculocidal activity tests and fungicidal activity.

For your sanitizer or disinfectant efficacy study, we can also perform simulation studies, hard surface tests and tests under nominal conditions/procedures. Disinfectant validation may also include in vitro tests: a time kill study or suspension testing, coupon or carrier testing, environmental monitoring and in situ testing.

In designing a disinfectant efficacy validation or verification solution, our experts consider the following factors:

  • Surfaces present in the critical area, including different conditions or types of the same material
  • Each disinfectant and dilution to be challenged by a panel of representative organisms
  • Testing for standard USP organisms: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis (spore), Candida albicans and Aspergillus brasiliensis
  • Panel to include environmental isolates collected from environmental monitoring of the facility or critical area
  • Expiration verification through the use of aged disinfectant preparations
  • Neutralization of the disinfectant, e.g., suitability testing
  • Recovery method evaluation or control
  • Cleaning process overview and validation: Facility materials and environment, disinfectant preparation, cleaning procedure and contact time, facility surfaces, facility-specific bacteria and fungi

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