Biocontamination Control for Pharmaceutical and Healthcare

  • ID: 4593684
  • Book
  • 250 Pages
  • Elsevier Science and Technology
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Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that tracks through a facility with bio-burden control and reduction at each transition in classified areas; this is a key part of controlling risk escalation to contaminating medicinal products. Regulatory authorities have challenged pharmaceutical and healthcare sectors, and those involved in Good Manufacturing Practice (GMP), to adopt a holistic approach to contamination control. Established ways of assessing contamination are limited, and therefore risk-based approaches are required. As well as using risk to assess types of contamination and where contamination can arise, 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 an up to date and complete biocontamination strategy.

  • Provides the information for a facility to build a complete biocontamination strategy
  • Allows a facility to understand the main biocontamination risks to medicinal products
  • Assists the reader in navigating regulatory requirements and reducing process risks
  • Provides insight into developing an environmental monitoring programme
  • Covers the types of rapid microbiological monitoring methods now available, as well as current legislation
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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
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Sandle, Tim
Tim Sandle 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. Tim has over 25 years' experience of microbiological research and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests. In addition, Tim is experienced in pharmaceutical microbiological risk assessment and investigation. Tim serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of several editorials boards for scientific journals. Tim has written over 400 book chapters, peer reviewed papers and technical articles relating to microbiology.
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