Extractable & Leachable considerations for Single Use components

This webinar will deal with Extractable & Leachable Considerations for Adoption of Single-Use components: Regulatory & Pragmatic Approach.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps: as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams, which ultimately relate to the patient safety risk.
This conference will address the following with reference polymeric materials used in pharmaceutical manufacturing
• Regulatory Requirements including the ICH Q3E
• Safety assessment of extractables/leachables
• Challenges and pitfalls during E&L studies and how to handle them.
• Setting up effective E & L Studies
• Extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.
Speakers:
Jessica Shea, E & L Global Technical Services Manager, BioReliance Validation Services.
Ramesh Raju, Head – BioReliance Validation Laboratory Services