This two-day workshop will look at aspects of "Extractables and Leachables" from many different angles: Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, and Toxicology & Assessment.
In addition, during the workshop, there will be multiple case study discussion and activities to improvise your learning experience.
Topics of discussion will include:
- Polymers in the Sterile Drug Products - Sources & Effects
- Regulatory requirements-US FDA/MHRA/EU/WHO/ANVISA
- Approaches for designing studies of E&L
- The Threshold approach and its execution-E&L
- Analytical Techniques - The challenges in classical pharmaceutical molecules
- Leachables studies - Design & execution
- Selection of Closures - Points for consideration to avoid rework
- Selection of Containers - Points for consideration to avoid rework
- Formulation & Development Case Study for E&L
- E&L - Single Use systems
- Risk Assessment Techniques - Activity and the case study
- Toxicology and assessment
- Extractables & Leachables in Pharmaceutical Packaging/Delivery System: USP Perspective