The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.
The second part of the Workshop focused on the Performance Qualification studies that are needed to properly validate the gaseous decontamination method in sterility test isolator systems. Practical examples, a discussion of acceptance criteria, and the demonstration of test methods were included. Key learning objectives included determining a D-value for your BIs, developing and qualifying decontamination cycles, isolator aeration, sterilant ingress methods, and creating a meaningful process simulation (no false negative) study.
