Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare

1st Edition - November 30, 2018

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  • Author: Tim Sandle
  • eBook ISBN: 9780128149126
  • Paperback ISBN: 9780128149119

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Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.

Key Features

  • Provides the information necessary for a facility to build a complete biocontamination strategy
  • Helps facilities understand the main biocontamination risks to medicinal products
  • Assists the reader in navigating regulatory requirements
  • Provides insight into developing an environmental monitoring program
  • Covers the types of rapid microbiological monitoring methods now available, as well as current legislation


Researchers in pharmaceutical companies, pharmacies, biotechnology companies, 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 microbial contamination and risk profiling
    3. GMP, regulations and standards
    4. Biocontamination control
    5. Introduction to cleanrooms and environmental monitoring
    6. Viable monitoring methods
    7. Selection of culture media
    8. Non-viable monitoring
    9. Rapid microbiological methods
    10. Designing an environmental monitoring programme
    11. Special Types of Environmental Monitoring
    12. Cleanrooms and microflora
    13. Assessment of pharmaceutical water systems
    14. Data handling and trend analysis
    15. Bioburden and endotoxin assessment of pharmaceutical processing
    16. Risk assessment and investigation for environmental monitoring
    17. Assessing and removing contamination risks from the process
    18. The human factor
    19. Biocontamination deviation management

Product details

  • No. of pages: 374
  • Language: English
  • Copyright: © Academic Press 2018
  • Published: November 30, 2018
  • Imprint: Academic Press
  • eBook ISBN: 9780128149126
  • Paperback ISBN: 9780128149119

About the Author

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, UK Visiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK Committee Member of the Pharmaceutical Microbiology Interest Group (Pharmig)

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  • Victor G. Sun Dec 09 2018

    Very useful book for meeting regulatory requirements

    With the revised EU GMP Annex 1 and similar requirements from US FDA, this book proves extremely useful for those who need to develop a contamination control strategy and to meet regulatory expectations.