All starting materials should have minimal microbiological contamination. Your contamination control strategy should document the quality of the materials in terms of microbiological monitoring or other requirements. The bioburden assay should be performed for each batch for both aseptically-filled products and terminally-sterilized products. Use the results as part of the final batch review.
Aseptic Process Simulation
Validation of aseptic processing should include an aseptic process simulation (APS) test. This test measures the performance of the manufacturing process using a sterile microbiological growth medium and/or placebo (e.g., culture media of cells which is demonstrated to support the growth of bacteria). The test determines whether the manufacturing procedures are adequate to prevent contamination during production. The results of the test should be assessed in terms of the overall product quality and the suitability of the production processes1.
Environmental Monitoring Program
The manufacturer’s environmental monitoring program is an essential part of the overall contamination control strategy. This strategy is designed to limit and minimize risk of microbial and particulate contamination. The monitoring method itself should not pose a contamination risk.
The monitoring program is comprised of total particle (non-viable), viable, and APS testing in the case of aseptic manufacturing. It provides process and facility information with respect to sterility assurance. The information found with this program should be used for routine batch release and periodic assessment during process review and investigations.
Be sure to read the final blog in this series where we take a look at monitoring principles, and what sort of contamination is under analysis. Click here to download the full paper. For more information about our advisory services, go to our Advisory and Training page.
- European Commission. Good Manufacturing Practice for Advanced Therapy Medicinal Products. Nov 2017.
Want to read more? Jump to other released posts in this series:
Part 1 of 4: Recent Developments in Regulation
Part 2 of 4: ATMP’s and Regulation
Part 4 of 4: Stem Cell Process Monitoring
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