Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission.
The regulatory process for the CBER licensing of an isolated filling line is discussed, including media fill data and FDA feedback from the pre-approval inspection (PAI) and FDA response letter.
This section discussed the environmental qualification data and established action/alert limits for a vaccine filling system housed within an isolator. A comparison is made to conventional clean room monitoring techniques and limits.
This session discusses approaches to environment monitoring in isolator systems, including comparisons to conventional cleanroom aseptic process monitoring, measurement methods, alert and action limits, regulatory expectations, and related validation requirements.
