Monday, 25 March 2019

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



Reference:

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

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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