Laurent Leblanc, products manager for Biopharma Culture Media at bioMérieux, examines the crucial role of Media Fill Tests in assuring the sterility of pharmaceutical processes.
Production of parenteral drugs is considered one of the most complex processes in the pharmaceutical industry. To ensure sterility of the products, manufacturers use an aseptic filling process and must prove that this practice is under control using a Media Fill Test (MFT).
European and US regulatory agencies describe MFT as a standard approach for validating aseptic filling lines. Qualification of a line requires three successful MFTs in a row, in addition to a periodic re-evaluation of lines at least twice a year. Resources dedicated to this operation could be considerable, depending on the number of units to inspect.
However, MFT is indispensible for guaranteeing the manufacturing process will remain under control. Not only does it simulate manufacturing conditions, but it also tests their robustness by evaluating the worst-case production conditions, such as planned interventions of operators or the number of authorised actions in a protected environment.
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