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Microbial Limit and Bioburden Tests
Considered the "industry bible," this text provides a practical guide to microbial limit methodologies. Presenting microbial limit tests and bioburden testing mandated by USP-NF, the comprehensive second edition reflects current industry standards, regulatory expectations, and critical technical and scientific information. This edition explores microbial contamination and control, environmental monitoring, method validation and media, suitability testing, the microbial quality of pharmaceutical and biopharmaceutical products and raw materials, and alternative methods in microbiology. It also discusses biofilms and handling aberrant and out-of-specification microbial data.
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