Media Fills in Microbiology
A media fill (also known as process simulation) test is a critical microbiological test carried out to assess the performance of an aseptic manufacturing procedure by replacing the pharmaceutical or beverage product with a sterile culture media. Aseptic manufacturing is a complex process used in the pharmaceutical, food, and beverage industries. Good manufacturing practices (GMP) require pharmaceutical and beverage companies to regularly perform media fill tests to verify the microbiological state of their aseptic production process.
The nutrient medium is selected based on the product quantity and the selectivity, clarity, concentration, and suitability of the medium for sterilization. The process simulation test should imitate, as closely as possible, the routine aseptic manufacturing process and include all critical subsequent manufacturing steps.
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