Biocontamination Control for Pharmaceuticals and Healthcare
Autor Tim Sandleen Limba Engleză Paperback – 4 dec 2018
- Provides the information necessary for a facility to build a complete biocontamination strategy
- Helps facilities understand the main biocontamination risks to medicinal products
- Assists the reader in navigating regulatory requirements
- Provides insight into developing an environmental monitoring program
- Covers the types of rapid microbiological monitoring methods now available, as well as current legislation
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Specificații
ISBN-13: 9780128149119
ISBN-10: 0128149116
Pagini: 374
Dimensiuni: 191 x 235 x 25 mm
Greutate: 0.64 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128149116
Pagini: 374
Dimensiuni: 191 x 235 x 25 mm
Greutate: 0.64 kg
Editura: ELSEVIER SCIENCE
Public țintă
Researchers in pharmaceutical companies, pharmacies, biotechnology companies, graduate and postgraduate students in pharmaceuticals and healthcare; Engineers, pharmacologists, Quality Assurance personnel; Medical professionals, medical device specialists.Cuprins
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