When the current revision of Annex 1 was made enforceable in August of 2023, industry was faced with new regulatory expectations and many decisions as to how to achieve compliance. Development of a holistic contamination control strategy, being one of the major challenges. A robust contamination control program is a pillar of a contamination control strategy. The initial step to demonstrating the effectiveness of a control program is disinfectant qualification also known as disinfectant efficacy testing (DET).Annex 1 introduced multiple new regulatory expectations for DET study execution and there is not yet consensus in industry on best practice to comply with these expectations. One of the primary areas of uncertainty surrounds demonstrating efficacy of disinfectants, "in the manner in which they are used". This presentation will evaluate through a data-based case study, if mechanical action and application method inclusion in DET coupon studies or in situ field studies is the most scientifically sound, best practice. This presentation will also cover the Annex 1 expectation surrounding liquid chemical material transfer validation and best practices and how to incorporate DET into your contamination control strategy.
Dave Shields (Thu,) studied this question.