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Format: Inbunden (Hardback)
Språk: Engelska
Antal sidor: 316
Utgivningsdatum: 2015-10-06
Förlag: Woodhead Publishing
Dimensioner: 231 x 155 x 15 mm
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Antal komponenter: 1
ISBN: 9780081000229

Pharmaceutical Microbiology

Name: Pharmaceutical Microbiology
Price: 2051.00 SEK
Availability: InStock
Author: Tim Sandle
ISBN: 9780081000229

Essentials for Quality Assurance and Quality Control

av Tim Sandle

Inbunden, Engelska, 2015-10-06

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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

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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).