Process Equipment Characterization – How Standardized Extractables Data Support E&L Risk Assessment
In this webinar, we will discuss:
- Current industry standards, including BioPhorum (BPOG) guidelines and upcoming USP <665>
- Standard extractables packages provided by SUS suppliers
- E&L risk evaluations conducted by drug manufacturers
- Practical examples of using extractables data for risk mitigation
- Challenges and areas for improvement
Detailed Description:
The biopharmaceutical industry has increasingly adopted Single-Use Systems (SUS) and components in manufacturing operations. Drug manufacturers are responsible for characterizing SUS components and systems to ensure patient safety, while SUS suppliers are encouraged by BioPhorum (BPOG) and BPSA to provide robust extractables data packages to support manufacturers' extractables and leachables (E&L) assessments.
This webinar offers an overview of the E&L evaluation workflow and practical study approaches from both the supplier and end-user perspectives, aligning with the latest industry standards and upcoming USP <665> requirements. Case studies will demonstrate how supplier-provided data can mitigate risks associated with SUS materials, emphasizing the importance of collaboration between suppliers and drug manufacturers.
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