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Elsevier

Biocontamination Control for Pharmaceuticals and Healthcare

  • 2nd Edition - January 28, 2024
  • Latest edition
  • Author: Tim Sandle
  • Language: English

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transitio… Read more

Description

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.

Key features

  • 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

Readership

Pharmaceutical microbiologists (Quality Control labs), Pharmaceutical QC lab managers and lab directors. Graduate and postgraduate students in pharmaceuticals and healthcare; Engineers, pharmacologists, Quality Assurance personnel; Medical professionals, medical device specialists

Table of contents

1. Introduction

2. Sources of biocontamination, other forms of contamination, and risk profiling

3. GMP, regulations and standards

4. Biocontamination control

5. Application of Quality Risk Management and its application in biocontamination control

6. Introduction to cleanrooms and environmental monitoring

7. Viable monitoring methods

8. Selection of culture media

9. Airborne particle monitoring

10. Rapid microbiological methods11. Designing an environmental monitoring programme

11. Putting an environmental monitoring plan together: A risk-based case study

12. Special Types of Environmental Monitoring

13. Cleanrooms and microbiota

14. Assessment of pharmaceutical water systems

15. Data handling and trend analysi

16. Bioburden and endotoxin assessment of pharmaceutical processing

17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations

18. Assessing and removing contamination risks from the process

19. The human factor: Training and controlling people in cleanrooms

20. Biocontamination deviation management

21. Synthesis: An anatomy of a contamination control strategy

Product details

  • Edition: 2
  • Latest edition
  • Published: January 28, 2024
  • Language: English

About the author

TS

Tim Sandle

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).
Affiliations and expertise
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), UK

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