Reading the MFT signs
Pharmaceutical manufacturers using an aseptic filling process must prove that this practice is under control using a Media Fill Test (MFT). Qualification of an aseptic filling line requires three successful MFTs in a row, in addition to a periodic re-evaluation of lines at least twice a year. Reading a MFT result is a delicate exercise and can be prone to human error. bioMérieux, has developed TSB 3P with Vegetable Peptones, which offers a growth-based colour indicator as well as an optimised formulation for the growth of a broad range of environmental micro-organisms studied under aerobic and anaerobic conditions.
Improving MFT precision – TSB 3P Vegetable Peptone Media and the colour indicator. The pink media corresponds to uncontaminated media; the yellow to media inoculated with strains of E. coli and S. aureus (18 hours of incubation at 30-35°C)
Photo courtesy of bioMérieux
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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