Microbiological testing in all stages and environments of the pharmaceutical manufacturing workflow is important. It is a set of protocols that tests for contaminations that may be harmful to patient safety. The goal of this family of testing is to provide a monitoring framework for all possible microbiological contaminants throughout the manufacturing process.
Sterility testing is the monitoring of microbial contamination via the Membrane Filtration or Direct Inoculation method.
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.
Culture media must be robust enough to withstand the rigorous conditions in today’s pharmaceutical cleanrooms. Culture media needs to be both reliable and sensitive to promptly detect stressed organisms inherent to aseptic manufacturing areas.
Regular environmental monitoring of samples for microbiological quality must be performed at various defined locations in pharmaceutical facilities. It is a very critical measure for controlling clean areas and environments, which has a direct impact on the microbiological quality of the final pharmaceutical products.
Bacterial endotoxins are remnants of bacterial cells and are not detected by a sterility test. Potential sources of endotoxins include water, packaging components, equipment and chemical/raw materials used during compounding of a drug product. Traditionally performed with LAL Assays, new-generation recombinant Cascade Reagent (rCR) Assays are now Horseshoe Crab Blood free.
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