Biocontamination Control for Pharmaceuticals and Healthcare

Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University. He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation. Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).

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