This presentation reviewed the physical and microbiological testing performed by Millipore on Steritest canisters following their exposure to
hydrogen peroxide gas. The microbiological test results on new line of agar plates containing a sterilant neutralizer were also shared with the attendess.
This presentation thoroughly reviewed the overall strategies and basic validation methodologies for isolator system validation utilizing gaseous decontamination methods. Facility design and qualification, equipment qualification, performance qualification, and process simulation testing was reviewed, with practical examples and demonstrations of key methods and techniques.