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Biocontamination Control for Pharmaceuticals and Healthcare - 1st Edition - ISBN: 9780128149119, 9780128149126

Biocontamination Control for Pharmaceuticals and Healthcare

1st Edition

Author: Tim Sandle
eBook ISBN: 9780128149126
Paperback ISBN: 9780128149119
Imprint: Academic Press
Published Date: 30th November 2018
Page Count: 374
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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


No. of pages:
© Academic Press 2018
30th November 2018
Academic Press
eBook ISBN:
Paperback ISBN:

About the Author

Tim Sandle

Tim Sandle, PhD, is a chartered biologist and holds a first-class honours degree in Applied Biology, a Master’s degree in education, and a doctorate from Keele University in the UK. Dr. Sandle has over 25 years’ experience of microbiological research and biopharmaceutical processing; this includes experience of designing, validating and operating a range of microbiological tests and implementing sterility assurance programmes. In addition, he is experienced in pharmaceutical microbiological risk assessment and investigation. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and a UK disinfectant advisory committee). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig). Dr. Sandle has written over 550 book chapters, peer reviewed papers and technical articles relating to microbiology; he has also authored the books Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals, and Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control.

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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