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.