Risk minimization by collecting and processing analytical data for process control in isolators
To effectively minimize risks and increase the overall safety of processes performed inside an isolator system several requirements need to be fulfilled. This article outlines some of the key considerations and proposes appropriate tests that can be performed to ensure product and operator safety. Described testing includes assessment of material persistence, their absorptive properties, as well as ease of decontamination with hydrogen peroxide (H2O2). Such tests will enable the selection of the most appropriate materials and documenting the fulfillment of requirements for aseptic processing. Further tests target the characterization of cleaning and decontamination processes. Understanding the performance and risks of these processes can feed into risk analyses and help to define proper measures to minimize associated risks, such as false negative results in sterility testing. Finally, this article provides some further suggestions of tests that can be carried out to increase confidence for processes performed inside an isolator.