Monitoring, Media Fills, And QC: Demonstrating Sterility Assurance At Your CDMO

This CDMO-focused piece explains how environmental monitoring (EM), media fills, and Quality Control (QC) prove sterility assurance in aseptic manufacturing, tying into the broader Contamination Control Strategy (CCS). Sterility can't be tested into batches, so EM tracks non-viable particles, viable microbes, and conditions like temperature and pressure in real time, with risk-based sampling and excursion investigations. Media fills simulate worst-case processes using growth media to challenge aseptic steps, targeting zero growth and requiring thorough failure probes. QC handles validated sterility tests, trend analysis, and release decisions based on full data review—not just end results.

For sponsors, strong programs mean lower risks to trials and supply: expect documented EM protocols, media fill success trends, robust investigations, and microbiology expertise during audits. Overall, integrating these with facility design drives continuous CCS improvement.