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.
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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
AuthorsTim Sandle Head of Microbiology, Bio Products Laboratory, Elstree, UK
Visiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK
Committee Member of the Pharmaceutical Microbiology Interest Group (Pharmig). 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.