Disinfectants must be qualified on the surfaces in a pharmacopeial-manufacturing environment prior to their use in the facility. Building a study with robust parameters and avoiding common pitfalls are critical to avoid negative responses from regulatory agencies. Spending more time on study design and development upfront will save valuable resources in the long run.
The presenters (learn more about them below) attempt to bridge the gap between laboratory conditions and environmental conditions. Test-method acceptance criteria and interpretation of coupon study results are also discussed. This webinar provides insight into how the results of a coupon study can be utilized to improve cleaning procedures.
The following important points are discussed:
- Study Design: How to choose parameters that are representative of your facility while meeting regulatory expectations.
- Indications that initial or subsequent disinfectant-efficacy testing needs to be performed.
- Interpretation of results: Translating microorganism log reductions into useful information on the efficacy of facility cleaning procedures and disinfectants.
The goal of this webinar is to provide a general overview of disinfectant-efficacy testing and to provide a detailed methodology to assist in designing coupon studies that accurately represent facility procedures.