The three key elements of disinfectant validation will be covered including coupon studies. The topics of how to choose the isolates, testing methods, choosing substrates, log reduction required, and neutralization will all be covered. A case study will be covered and discussed regarding coupon studies. Overcoming common disinfectant coupon testing challenges will be addressed. The latest ASTM, AOAC, and EN test methods methods will be compared and accessed. Recent FDA 483s and Warning Letters related to disinfectant validation will be discussed.
Starting up a new cleanroom operation and how to address cleanroom excursions will be covered. The cleaning methods required for start up and how to handling trending data will be discussed. Obtaining isolates and choosing isolates for disinfectant validation will be covered as a new cleanroom is brought online. Cleanroom utilities such as HEPA filtration, HVAC, Temperature, Humidity, and Differential Pressures will all be covered.