Disinfectants must be qualified on the surfaces present within a pharmaceutical manufacturing environment before they are approved for use in the facility. Designing a study with robust parameters, including information from in-house environmental monitor programs and avoiding common pitfalls is essential to prevent negative feedback from regulatory agencies. Investing time in thoughtful study design and development at the outset can ultimately save significant resources and effort. This presentation aims to outline the objectives of disinfectant efficacy testing and its relationship to in-house environmental monitoring programs, while emphasizing practical guidance on developing methodology for designing coupon studies that accurately represent facility procedures and needs. Additionally, we discussed how the results of a coupon study can be leveraged to enhance and strengthen contamination control strategies.
Key takeaways:
• How to choose parameters that are representative of your facility and meet regulatory expectations.
•How environmental monitoring programs assist in determining testing scope.
• Indications that initial or subsequent disinfectant efficacy testing is required.
• Obtaining microorganism log reductions and translating into useful information on the efficacy of facility cleaning procedures and disinfectants.
The Q&A following the presentation includes the following Nelson Experts:
Michelle Lee, Scientific Improvement Director, Nelson Labs
Tonya Morris, Global Segment Director, Nelson Labs
