Biocontamination Control for Pharmaceuticals and Healthcare

Häftad, Engelska, 2024

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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Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation.

This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

Includes the most current regulations
Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy
Offers practical guidance on building a complete biocontamination strategy

Produktinformation

Utgivningsdatum2024-02-16
Mått191 x 235 x 29 mm
Vikt1 070 g
FormatHäftad
SpråkEngelska
Antal sidor508
Upplaga2
FörlagElsevier Science
ISBN9780443216008

Tillhör följande kategorier

Tillverkningsteknik inom Naturvetenskap och teknik
Tillverkningsindustri inom Ekonomi och ledarskap
Projektledning inom Ekonomi och ledarskap
Farmakologi inom Medicin
Apotek och farmaceuter inom Medicin

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).

1. Introduction2. Sources of biocontamination, other forms of contamination, and risk profiling3. GMP, regulations and standards4. Biocontamination control5. Application of Quality Risk Management and its application in biocontamination control6. Introduction to cleanrooms and environmental monitoring7. Viable monitoring methods8. Selection of culture media9. Airborne particle monitoring10. Rapid microbiological methods11. Designing an environmental monitoring programme11. Putting an environmental monitoring plan together: A risk-based case study12. Special Types of Environmental Monitoring13. Cleanrooms and microbiota14. Assessment of pharmaceutical water systems15. Data handling and trend analysi16. Bioburden and endotoxin assessment of pharmaceutical processing17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations18. Assessing and removing contamination risks from the process19. The human factor: Training and controlling people in cleanrooms20. Biocontamination deviation management21. Synthesis: An anatomy of a contamination control strategy