Pharmaceutical microbiology: essentials for quality assurance and quality control
by Sandle, Tim
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, …
Read More ↓Title Statements
- Full title :Pharmaceutical microbiology : essentials for quality assurance and quality control / Tim Sandle.
Summary
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.
Read More ↓Edition Statements
- Publication Date:2016
Publication Statements
- Publisher(s):Woodhead Publishing Limited
- Place of Publication:Cambridge, UK
- Language:eng
- Publication Date:2016
The Physical Object
- Description:1 online resource
Edition Identifiers
- ISBN:9780081000441, 0081000448, 0081000227, 9780081000229
- oclc:ocn923807961
- LC Classification:QR46.5
- Dewey Decimal:615/.101579
Table of Contents
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.
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