3: A Science-Based Approach to APS: Using Headspace Analysis for Automated Analytical Media Fill Inspection

The new EU GMP Annex 1 contains language that stresses an APS design that is scientifically justified including, among other things, the method of detection of microbial contamination, the selection of incubation conditions and duration, and the testing of media used for growth promotion. This presentation will describe the use of rapid non-destructive headspace analysis to analyze media vials. Experimental data will be presented demonstrating the use of headspace analysis to execute an automated media fill inspection process based on analytical headspace measurements instead of a subjective visual inspection by operators. In addition, analytical headspace data will be presented from studies demonstrating the optimization of incubation conditions. Each of these applications could contribute to a more robust, scientifically justified APS design as required by the new EU GMP Annex 1.