The ever-increasing use of highly potent compounds in the pharmaceutical and chemical industries means that containment strategies need to be put in place. These containment strategies are based on several factors, including engineering controls. Engineering controls are often used without first being tested. These containment tests must be based on strategies with performance objectives. What are the limitations of these tests? How should they be organised? The keys to successful testing. Based on the case study of the validation of an active pharmaceutical ingredient loading isolator, we will discuss the various difficulties involved in setting up tests and the keys to success. The session aims to open discussion on lessons learned and case studies, and to raise the need for knowledge sharing between industries, through the implementation of testing strategies for these engineering controls.
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Pascal Kerneis (2024) studied this question.
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