Biocontamination Control for Pharmaceuticals and Healthcare

ISBN-13: 9780443216008 / Miękka / 2024 / 400 str.

Elstree Bio Products Laboratory Tim (Head of Microbiology

Spis treści

1. Introduction
2. Sources of biocontamination, other forms of contamination, and risk profiling
3. GMP, regulations and standards
4. Biocontamination control
5. Application of Quality Risk Management and its application in biocontamination control
6. Introduction to cleanrooms and environmental monitoring
7. Viable monitoring methods
8. Selection of culture media
9. Airborne particle monitoring
10. Rapid microbiological methods11. Designing an environmental monitoring programme
11. Putting an environmental monitoring plan together: A risk-based case study
12. Special Types of Environmental Monitoring
13. Cleanrooms and microbiota
14. Assessment of pharmaceutical water systems
15. Data handling and trend analysi
16. Bioburden and endotoxin assessment of pharmaceutical processing
17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations
18. Assessing and removing contamination risks from the process
19. The human factor: Training and controlling people in cleanrooms
20. Biocontamination deviation management
21. Synthesis: An anatomy of a contamination control strategy