Pharmaceutical Microbiology
Woodhead Publishing Ltd (Verlag)
978-0-08-100022-9 (ISBN)
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.
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).
Chapter 1: Introduction to Pharmaceutical Microbiology
Chapter 2: Microbiology and Pharmaceuticals
Chapter 3: GMP, regulations and standards
Chapter 4: Laboratory management and design
Chapter 5: Microbiological culture media
Chapter 6: Basic microbiological laboratory techniques
Chapter 7: Bioburden testing
Chapter 8: Assessment of raw materials
Chapter 9: Microbial identification
Chapter 10: Assessment of pharmaceutical water systems
Chapter 11: Endotoxin and pyrogen testing
Chapter 12: Sterilisation and sterility assurance
Chapter 13: Biological indicators
Chapter 14: Antibiotic effectiveness testing and preservative efficacy testing
Chapter 15: Disinfection
Chapter 16: Cleanroom microbiology and contamination control
Chapter 17: Rapid microbiological methods
Chapter 18: Risk assessment and microbiology
Chapter 19: Manufacturing and validation
Chapter 20: Microbiological batch review
Chapter 21: Microbiological audits
Chapter 22: Microbial Challenges in the Pharmaceutical Industry
Conclusion
| Erscheint lt. Verlag | 6.10.2015 |
|---|---|
| Verlagsort | Cambridge |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 460 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| ISBN-10 | 0-08-100022-7 / 0081000227 |
| ISBN-13 | 978-0-08-100022-9 / 9780081000229 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
aus dem Bereich
