Pharmaceutical Microbiology

Essentials for Quality Assurance and Quality Control

Inbunden, Engelska, 2015

Av Tim Sandle, UK) Sandle, Tim (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)

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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

Produktinformation

Utgivningsdatum2015-10-06
Mått152 x 229 x 18 mm
Vikt460 g
FormatInbunden
SpråkEngelska
Antal sidor316
FörlagElsevier Science
ISBN9780081000229

Tillhör följande kategorier

Farmakologi inom Medicin
Projektledning inom Ekonomi och ledarskap
Apotek och farmaceuter inom Medicin
Biologi inom Naturvetenskap och teknik

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 MicrobiologyChapter 2: Microbiology and PharmaceuticalsChapter 3: GMP, regulations and standardsChapter 4: Laboratory management and designChapter 5: Microbiological culture mediaChapter 6: Basic microbiological laboratory techniquesChapter 7: Bioburden testingChapter 8: Assessment of raw materialsChapter 9: Microbial identificationChapter 10: Assessment of pharmaceutical water systemsChapter 11: Endotoxin and pyrogen testingChapter 12: Sterilisation and sterility assuranceChapter 13: Biological indicatorsChapter 14: Antibiotic effectiveness testing and preservative efficacy testingChapter 15: DisinfectionChapter 16: Cleanroom microbiology and contamination controlChapter 17: Rapid microbiological methodsChapter 18: Risk assessment and microbiologyChapter 19: Manufacturing and validationChapter 20: Microbiological batch reviewChapter 21: Microbiological auditsChapter 22: Microbial Challenges in the Pharmaceutical IndustryConclusion