Pharmaceutical Microbiology

Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).

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• Chapter 1: Introduction to Pharmaceutical MicrobiologyChapter 2: Microbiology and PharmaceuticalsChapter 3: GMP, regulations and standardsChapter 4: Laboratory management and designChapter 5: Microbiological culture mediaChapter 6: Basic microbiological laboratory techniquesChapter 7: Bioburden testingChapter 8: Assessment of raw materialsChapter 9: Microbial identificationChapter 10: Assessment of pharmaceutical water systemsChapter 11: Endotoxin and pyrogen testingChapter 12: Sterilisation and sterility assuranceChapter 13: Biological indicatorsChapter 14: Antibiotic effectiveness testing and preservative efficacy testingChapter 15: DisinfectionChapter 16: Cleanroom microbiology and contamination controlChapter 17: Rapid microbiological methodsChapter 18: Risk assessment and microbiologyChapter 19: Manufacturing and validationChapter 20: Microbiological batch reviewChapter 21: Microbiological auditsChapter 22: Microbial Challenges in the Pharmaceutical IndustryConclusion