Developing a Holistic Disinfectant Validation and Efficacy Testing Program

This course will explore debates and challenges related to coupon testing and disinfectant field trials, with an emphasis on current regulatory expectations. In addition to a practical demonstration of the different types of coupon testing, we will use Annex 1, IEST-RP-CC018.5, USP 43<1072>, and recent FDA Warning Letters for an in-depth look at both sides of the debate on disinfectant validation. We will also discuss the importance of disinfectant efficacy testing for specific bacterial spores that can be more difficult to kill than ATCC strains. 


Course outline     Course materials


Course outline

  • Regulations
    • Annex 1
    • Recent FDA Observations and Warning Letters
  • Disinfectant Chemistry and Validation Components
    • Disinfectant Hierarchy (Pyramid)
    • Disinfectant Components
    • Validation Components
  • Disinfectant Testing
    • Types of Supplier Testing
    • Test Methods and Standards
  • Testing Challenges
  • In situ testing

 

Course materials

  • Copy of PowerPoint presentation in course binder

Continuing Education Units: .3 CEUs


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