Pharmaceutical Microbiology
Essentials for Quality Assurance and Quality Control
- 2nd Edition - March 1, 2027
- Latest edition
- Author: Tim Sandle
- Language: English
The second edition of Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control is an authoritative reference designed for pharmaceutical microb… Read more
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Description
Description
The second edition of Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control is an authoritative reference designed for pharmaceutical microbiologists, sterilization personnel, and production scientists. It addresses the evolving landscape of microbiological standards, regulatory requirements, and scientific innovations in the pharmaceutical industry. The book emphasizes the importance of maintaining compliance through updated practices, new testing methodologies, and comprehensive contamination control strategies, ensuring safety and quality in pharmaceutical manufacturing.
This book provides invaluable insights for professionals seeking to optimize microbiological quality assurance, meet regulatory expectations, and adopt innovative technologies. It supports laboratory managers, microbiologists, and quality assurance specialists in implementing best practices, ensuring product safety, and staying abreast of scientific progress in pharmaceutical microbiology.
This book provides invaluable insights for professionals seeking to optimize microbiological quality assurance, meet regulatory expectations, and adopt innovative technologies. It supports laboratory managers, microbiologists, and quality assurance specialists in implementing best practices, ensuring product safety, and staying abreast of scientific progress in pharmaceutical microbiology.
Key features
Key features
- Updates regulations, standards, and scientific advancements in pharmaceutical microbiology
- Introduces new chapters on cell culture, biocontamination control, and beneficial microorganism uses
- Expands on rapid microbiological methods, water system assessment, and container closure integrity
- Reflects recent developments in GMP, endotoxin testing, and sterilization technologies
- Provides comprehensive guidance for microbiology laboratories and quality assurance
Readership
Readership
Pharmaceutical microbiologists and quality assurance professionals
Table of contents
Table of contents
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 and enzymatic indicators: Measuring sterilization
14. Maintaining sterility: Container closure integrity
15. Antibiotics and preservatives
16. Cleaning and disinfection
17. Cleanrooms and environmental monitoring
18. Particle counting: Conventional and spectrophotometric
19. Biocontamination control strategies
20. Rapid microbiological methods
21. Risk assessment and microbiology
22. Manufacturing and validation
23. Beneficial uses of microorganisms: Biofermentation and beyond
24. Cell culture, mycoplasma, and virus testing
25. Microbiological data
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 and enzymatic indicators: Measuring sterilization
14. Maintaining sterility: Container closure integrity
15. Antibiotics and preservatives
16. Cleaning and disinfection
17. Cleanrooms and environmental monitoring
18. Particle counting: Conventional and spectrophotometric
19. Biocontamination control strategies
20. Rapid microbiological methods
21. Risk assessment and microbiology
22. Manufacturing and validation
23. Beneficial uses of microorganisms: Biofermentation and beyond
24. Cell culture, mycoplasma, and virus testing
25. Microbiological data
Product details
Product details
- Edition: 2
- Latest edition
- Published: March 1, 2027
- Language: English
About the author
About the author
TS
Tim Sandle
Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.
He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.
Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).
Affiliations and expertise
Head of Microbiology, Bio Products Laboratory, Elstree, UKVisiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UKCommittee Member of the Pharmaceutical Microbiology Interest Group (Pharmig), UK