Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

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Woodhead Publishing, Oct 9, 2015 - Science - 316 pages

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.

  • 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
 

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This book is an overview of current approaches to pharmaceutical microbiology, outlining classic methods and rapid microbiology. The central theme is the use of risk assessment, supported by sound scientific principles, to assess product and patient safety.

Contents

Introduction to pharmaceutical microbiology
1
Microbiology and pharmaceuticals
15
GMP and regulations
25
Laboratory management and design
35
Microbiological culture media
47
Microbiology laboratory techniques
63
Bioburden determination
81
Specified and objectionable microorganisms
93
Antibiotics and preservatives
171
Cleaning and disinfection
185
Cleanrooms and environmental monitoring
199
Rapid microbiological methods
219
Risk assessment and microbiology
233
Manufacturing and validation
247
Microbiological data
257
Auditing the microbiology laboratory
271

Microbial identification
103
Assessment of pharmaceutical water systems
115
Endotoxin and pyrogen testing
131
Sterilization and sterility assurance
147
Biological indicators Measuring sterilization
161
Microbiological challenges to the pharmaceuticals and healthcare
281
Index
295
Back Cover
299
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About the author (2015)

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.

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