This book provides pharmaceutical microbiologists with everything they need to know, from regulatory filing and GMP information, to laboratory design and management, compendia tests, and the risk assessment tools and techniques for both sterile and non-sterile products.
Chapter 1: Introduction to Pharmaceutical Microbiology
Chapter 2: Microbiology and Pharmaceuticals
Chapter 3: GMP, regulations and standards
Chapter 4: Laboratory management and design
Chapter 5: Microbiological culture media
Chapter 6: Basic microbiological laboratory techniques
Chapter 7: Bioburden testing
Chapter 8: Assessment of raw materials
Chapter 9: Microbial identification
Chapter 10: Assessment of pharmaceutical water systems
Chapter 11: Endotoxin and pyrogen testing
Chapter 12: Sterilisation and sterility assurance
Chapter 13: Biological indicators
Chapter 14: Antibiotic effectiveness testing and preservative
efficacy testing
Chapter 15: Disinfection
Chapter 16: Cleanroom microbiology and contamination control
Chapter 17: Rapid microbiological methods
Chapter 18: Risk assessment and microbiology
Chapter 19: Manufacturing and validation
Chapter 20: Microbiological batch review
Chapter 21: Microbiological audits
Chapter 22: Microbial Challenges in the Pharmaceutical Industry
Conclusion
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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