Pharmaceutical Microbiology (ePub)
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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.
- 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
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.
- Autor: Tim Sandle
- 2015, 316 Seiten, Englisch
- Verlag: Elsevier Science & Techn.
- ISBN-10: 0081000448
- ISBN-13: 9780081000441
- Erscheinungsdatum: 09.10.2015
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
- Dateiformat: ePub
- Größe: 7.34 MB
- Mit Kopierschutz
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