Pharmaceutical microbiogy. Essentials for quality assurance and quality control /

Sandle, Tim

Pharmaceutical microbiogy. Essentials for quality assurance and quality control / Tim Sandle. - Cambridge, UK : Elsevier, 2016. Waltham, MA (USA) : Elsevier, 2016. - xii, 298 p. : figures, tables.

References at the end of each chapter.

Introduction to pharmaceutical microbiology -- Microbiology and pharmaceuticals -- GMP and regulations -- Laboratory management and design --Microbiological culture media -- Microbiology laboratory techniques -- Bioburden determination -- Specified and objectionable microorganisms -- Microbial identification -- Assessment of pharmaceutical water systems -- Endotoxin and pyrogen testing -- Sterilization and sterility assurance -- Biological indicators -- Antibiotics and preservatives -- Cleaning and disinfection -- Cleanrooms and environmental monitoring -- Rapid microbiological methods -- Risk assessment and microbiology -- Manufacturing and validation -- Microbiological data -- Auditing the microbiology laboratory -- Microbiological challenges too the pharmaceuticals and healthcare.

9780081000229 (print) 9780081000441 (online)


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