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
Tim Sandle, PhD, is a chartered biologist and holds a first-class honours degree in Applied Biology, a Master's degree in education, and a doctorate from Keele University in the UK. Dr. Sandle has over 25 years' experience of microbiological research and biopharmaceutical processing; this includes experience of designing, validating and operating a range of microbiological tests and implementing sterility assurance programmes. In addition, he is experienced in pharmaceutical microbiological risk assessment and investigation. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and a UK disinfectant advisory committee). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig). Dr. Sandle has written over 550 book chapters, peer reviewed papers and technical articles relating to microbiology; he has also authored the books Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals, and Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control.