Tim Sandle,
Tim, PhD (Head of Microbiology, Bio Products Laboratory, Elstree, UKVisiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UKCommittee Member of the Pharmaceutical Microbiology Interest Group (Pharmig), UK) Sandle
Elsevier Science
e druk, 2018
9780128149119
Biocontamination Control for Pharmaceuticals and Healthcare
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
e druk, 2018
ISBN13: 9780128149119
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Juridisch
:
Levertijd ongeveer 9 werkdagen
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Samenvatting
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.
Specificaties
Inhoudsopgave
1. Introduction2. Sources of microbial contamination and risk profiling3. GMP, regulations and standards4. Biocontamination control5. Introduction to cleanrooms and environmental monitoring6. Viable monitoring methods7. Selection of culture media8. Non-viable monitoring 9. Rapid microbiological methods10. Designing an environmental monitoring programme11. Special Types of Environmental Monitoring12. Cleanrooms and microflora13. Assessment of pharmaceutical water systems14. Data handling and trend analysis15. Bioburden and endotoxin assessment of pharmaceutical processing16. Risk assessment and investigation for environmental monitoring17. Assessing and removing contamination risks from the process18. The human factor19. Biocontamination deviation management
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