Pharmaceutical Microbiology
Essentials for Quality Assurance and Quality Control
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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.
Key Features
- 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
Readership
The audience for this book includes Pharmaceutical companies, pharmacies, Biotechnology companies and students primarily undertaking MSc courses.
Table of Contents
- Dedication
- Introduction
- 1: Introduction to pharmaceutical microbiology
- Abstract
- 1.1 Introduction
- 1.2 Overview of pharmaceutical microbiology
- 1.3 Microbiological test methods
- 1.4 The application of pharmaceutical microbiology
- 1.5 Conclusion
- 2: Microbiology and pharmaceuticals
- Abstract
- 2.1 Introduction
- 2.2 The basics of the pharmaceutical sector
- 2.3 Role of the microbiologist
- 2.4 Conclusion
- 3: GMP and regulations
- Abstract
- 3.1 Introduction
- 3.2 Good manufacturing practice
- 3.3 Importance of medicines in public health
- 3.4 The role and development of pharmacopoeias
- 3.5 Importance of inspections in the lifecycle of medicines
- 3.6 Role of the company regulatory affairs department
- 3.7 Documentation
- 3.8 Conclusion
- 4: Laboratory management and design
- Abstract
- 4.1 Introduction
- 4.2 Pharmaceutical microbiology laboratories
- 4.3 Laboratory management
- 4.4 Laboratory design
- 4.5 Conclusion
- 5: Microbiological culture media
- Abstract
- 5.1 Introduction
- 5.2 Cultivation
- 5.3 A short history of culture media
- 5.4 Types of culture media
- 5.5 Quality control of culture media
- 5.6 Manufacture of culture media
- 5.7 Media release and quarantine
- 5.8 Summary
- 6: Microbiology laboratory techniques
- Abstract
- 6.1 Introduction
- 6.2 Good laboratory practice and laboratory safety
- 6.3 Aseptic technique
- 6.4 Cultures and identifications
- 6.5 Microscopy
- 6.6 Pharmacopeia and microbiological tests
- 6.7 Microbiological examination of nonsterile products
- 6.8 Measurement of cell concentration in suspension by optical density
- 6.9 Sterility testing
- 6.10 In vitro and in vivo testing for pyrogens and endotoxins
- 6.11 Microbiological assay of antibiotics
- 6.12 Environmental monitoring
- 6.13 Water analysis
- 6.14 Conclusion
- 7: Bioburden determination
- Abstract
- 7.1 Introduction
- 7.2 Total microbial count
- 7.3 Units of measurement
- 7.4 Nonsterile products and microbial limits testing
- 7.5 In-process material bioburden assessment
- 7.6 Presterilization bioburden assessment
- 7.7 Alternative methods of bioburden assessment
- 7.8 Conclusion
- 8: Specified and objectionable microorganisms
- Abstract
- 8.1 Introduction
- 8.2 Indicator microorganisms
- 8.3 Determining which microorganisms are objectionable and assessing risk
- 8.4 Human microbiome project
- 8.5 Conclusion
- 9: Microbial identification
- Abstract
- 9.1 Introduction
- 9.2 Microbial taxonomy
- 9.3 Identification methods
- 9.4 Phenotypic methods
- 9.5 Genotypic methods
- 9.6 Method validation
- 9.7 Conclusion
- 10: Assessment of pharmaceutical water systems
- Abstract
- 10.1 Introduction
- 10.2 Pharmaceutical facility water
- 10.3 The microbial ecology of water
- 10.4 Design and control of water systems
- 10.5 Qualifying water systems
- 10.6 Microbial contamination
- 10.7 Microbiological sampling and testing
- 10.8 Action and alert limits
- 10.9 Undesirable (objectionable) microorganisms
- 10.10 Rapid microbiological methods
- 10.11 Microbiological assessment
- 10.12 Summary
- 11: Endotoxin and pyrogen testing
- Abstract
- 11.1 Introduction
- 11.2 Pyrogenicity
- 11.3 Bacterial endotoxin
- 11.4 Quantifying endotoxin
- 11.5 The limulus amebocyte lysate test
- 11.6 Limulus amebocyte lysate test methods
- 11.7 Limulus amebocyte lysate test applications
- 11.8 Limulus amebocyte lysate test interference
- 11.9 Alternative test methods
- 11.10 Conclusion
- 12: Sterilization and sterility assurance
- Abstract
- 12.1 Introduction
- 12.2 Sterility
- 12.3 Sterility assurance and the sterility assurance level
- 12.4 Sterility testing
- 12.5 Parametric release
- 12.6 Sterile products
- 12.7 Sterilization
- 12.8 Factors affecting sterilization effectiveness
- 12.9 Good manufacturing practice
- 12.10 Risk assessment
- 12.11 Conclusion
- 13: Biological indicators: Measuring sterilization
- Abstract
- 13.1 Introduction
- 13.2 Origins
- 13.3 Types of biological indicators
- 13.4 Characteristics of biological indicators
- 13.5 Testing issues
- 13.6 Areas of concern and testing errors
- 13.7 Summary
- 14: Antibiotics and preservatives
- Abstract
- 14.1 Introduction
- 14.2 Antibiotic susceptibility testing
- 14.3 Antimicrobial efficacy testing (preservative efficacy testing)
- 14.4 Conclusion
- 15: Cleaning and disinfection
- Abstract
- 15.1 Introduction
- 15.2 Cleaning
- 15.3 Disinfection
- 15.4 Good manufacturing practice requirements
- 15.5 Measuring disinfection effectiveness: Environmental monitoring
- 15.6 Disinfectant efficacy
- 15.7 Conclusion
- 16: Cleanrooms and environmental monitoring
- Abstract
- 16.1 Introduction
- 16.2 Cleanroom contamination
- 16.3 Cleanroom classification
- 16.4 Isolators
- 16.5 Cleanroom certification
- 16.6 Cleanroom testing
- 16.7 Microbiological environmental monitoring
- 16.8 Aseptic technique
- 16.9 Other cleanroom disciplines
- 16.10 Cleaning
- 16.11 Conclusion
- 17: Rapid microbiological methods
- Abstract
- 17.1 Introduction
- 17.2 Changing world of microbiology
- 17.3 Advantages of rapid methods
- 17.4 Regulatory acceptance
- 17.5 Types of rapid microbiological methods
- 17.6 Selection of rapid microbiological methods
- 17.7 Summary
- 18: Risk assessment and microbiology
- Abstract
- 18.1 Introduction
- 18.2 The nature of risk
- 18.3 The need for microbiological risk assessment
- 18.4 Microbial contamination transfer
- 18.5 Identification of sources and routes of contamination
- 18.6 Routes of transfer
- 18.7 Risk assessments for general cleanroom areas
- 18.8 Risk scoring systems
- 18.9 Conclusion
- 19: Manufacturing and validation
- Abstract
- 19.1 Introduction
- 19.2 Manufacturing procedures
- 19.3 Validation
- 19.4 Conclusion
- 20: Microbiological data
- Abstract
- 20.1 Introduction
- 20.2 Counting microorganisms
- 20.3 Sampling
- 20.4 Microbial distribution
- 20.5 Data trending
- 20.6 The use of alert and action levels and the setting monitoring limits
- 20.7 Data reporting
- 20.8 Conclusion
- 21: Auditing the microbiology laboratory
- Abstract
- 21.1 Introduction
- 21.2 Quality audits
- 21.3 Auditors and the audit process
- 21.4 Auditing the microbiology laboratory
- 21.5 Conclusion
- 22: Microbiological challenges to the pharmaceuticals and healthcare
- Abstract
- 22.1 Introduction
- 22.2 Microbial risks to pharmaceuticals
- 22.3 Microbial challenges to process environments
- 22.4 Sources of microbial contamination
- 22.5 Fate of microbial contamination in pharmaceutical products
- 22.6 Consequences for microbial growth
- 22.7 Microbiological testing
- 22.8 Conclusion
- Index
Product details
- No. of pages: 316
- Language: English
- Copyright: © Woodhead Publishing 2015
- Published: October 6, 2015
- Imprint: Woodhead Publishing
- Hardcover ISBN: 9780081000229
- eBook ISBN: 9780081000441
About the Author
Tim Sandle
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.
Affiliations and Expertise
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)