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Biocontamination Control for Pharmaceuticals and Healthcare


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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

About the Author

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.

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