Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. The monocyte activation test performed with the PyroMAT™ System detects endotoxin and non-endotoxin pyrogens.
Session 1:presented April 9, 2019
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