A new book of interest has been published – “Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control” – written by Dr. Tim Sandle.
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.
- Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
Presents the practical aspects of pharmaceutical microbiology testing
Provides contamination control risks and remediation strategies, along with rapid microbiological methods
Includes bioburden, endotoxin, and specific microbial risks
Highlights relevant case studies and risk assessment scenarios
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.
The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.
Table of contents
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
The audience for this book includes Pharmaceutical companies, pharmacies, Biotechnology companies and students primarily undertaking MSc courses.
About the author:
- Dr. Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor at the University of Manchester.
- Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); active within the Parenteral Drug Association (PDA); and is a member of several editorials boards for scientific journals.
- Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.
Sandle, T. (2016) Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, Woodhead Publishing, Cambridge, UK