Extrait
Table of Contents
Abstract
List of Figures Tables
List of Acronyms
1. Introduction
2. Literature Review
2.1 Overview
2.1.1 History
2.2 Single-Use Technology (SUT)
2.2.1 Advantages of SUT
2.2.2 Concerns with SUT
2.3 Regulatory Outlook
2.4 Primary Data
3. Current Methodologies for EL testing
3.1 Extractable and Leachable studies
3.1.1 Solvent selection
3.1.2 Worst-case conditions
3.2 Extraction Techniques
3.3 Analytical techniques
3.4 Evaluation of Data
3.5 Leachables Studies
3.5.1 Application-specific evaluation
4. Regulatory Perspective
4.1 Official guidance documents
4.2 Industry groups contributions
4.3 Current Regulatory Outlook
5. Risk Assessment Current Best Practice
5.1 Risk Identification
5.2 Risk Analysis
5.2.1 Quality by Design
5.3 Risk Control
5.4 Risk reduction
6. Conclusion
6.1 Discussion
6.2 Future trends and improvements
7. Bibliography
8. Appendices
8.1 Appendix – A
8.2 Appendix – B
8.3 Appendix – C
8.4 Appendix – D
8.5 Appendix – E
- Citation du texte
- Suzanne Culleton (Auteur), 2015, Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables, Munich, GRIN Verlag, https://www.grin.com/document/507038
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