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Biocontamination control for pharmaceuticals and healthcare

A new book has been published – “Biocontamination Control for Pharmaceuticals and
Healthcare” by written Tim Sandle.

The book 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 of the book are:

• Providing the information necessary for a facility to build a complete

biocontamination strategy.
• Helping facilities understand the main biocontamination risks to medicinal products.
• Assisting the reader in navigating regulatory requirements.
• Providing insight into developing an environmental monitoring program.
• Covering the types of rapid microbiological monitoring methods now available, as
well as current legislation.

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

374 pages

From Academic Press at:


From Amazon at:



Sandle, T. (2019) Biocontamination Control for Pharmaceuticals and Healthcare, Academic

Press, London, UK