
Pharmaceutical Microbiology
Essentials for Quality Assurance and Quality Control
- 316 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
About this book
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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Information
Table of contents
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- Introduction
- 1: Introduction to pharmaceutical microbiology
- 2: Microbiology and pharmaceuticals
- 3: GMP and regulations
- 4: Laboratory management and design
- 5: Microbiological culture media
- 6: Microbiology laboratory techniques
- 7: Bioburden determination
- 8: Specified and objectionable microorganisms
- 9: Microbial identification
- 10: Assessment of pharmaceutical water systems
- 11: Endotoxin and pyrogen testing
- 12: Sterilization and sterility assurance
- 13: Biological indicators: Measuring sterilization
- 14: Antibiotics and preservatives
- 15: Cleaning and disinfection
- 16: Cleanrooms and environmental monitoring
- 17: Rapid microbiological methods
- 18: Risk assessment and microbiology
- 19: Manufacturing and validation
- 20: Microbiological data
- 21: Auditing the microbiology laboratory
- 22: Microbiological challenges to the pharmaceuticals and healthcare
- Index