Published in August 2022, the revised version of EU GMP Annex 1, Manufacture of sterile medicinal products expanded and clarified the regulatory requirements of cleaning and disinfection in life science cleanrooms. 

Disinfection section, 4.34 Annex 1 states that “…The disinfection process should be validated. Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner in which they are used and on the type of surface material, or representative material if justified..” This session will look in detail at this requirement to assess the effectiveness of disinfectants on cleanroom surfaces.  

Following on from Session 1, which will describe the tests available, Neil will discuss how to make the tests more appropriate for the testing of a cleanroom disinfectant.  Also, give guidance on how to decide on your high-risk surfaces and share whether the 10 organisms on 10 different surfaces test data acquired for two Contec disinfectants reinforces the need for efficacy testing on different surfaces.