An Extractable and Leachable Program for Assessing Single-Use Components and Systems

BPB_Tank_SS_NewBag_ToteThis webcast features: Chris Shields, Director of Global Product Validation Services at Saint-Gobain Life Sciences.

Extractable testing is traditionally performed by single-use suppliers, and while not required by industry regulations, it is the drug manufacturer’s expectation that this information form part of a product’s data package. Extractable and leachable testing is designed to determine the chemical compounds that may migrate into the customer’s fluid from the single-use product’s fluid contact layer. Extractable testing utilizes aggressive but relevant test conditions, while leachable testing uses process-specific conditions.

The biopharmaceutical industry has not agreed on a consensus standard by which extractable or in-process leachable testing should be performed. Multiple organizations, including BPSA, ASME-BPE, ASTM and BPOG have produced guidance documents or draft standards, but these are not entirely aligned. As a result, end users continue to receive data packages from suppliers that were generated using differing methodologies, test conditions and data output.
Saint-Gobain Life Sciences is committed to generating and publishing data that provide a more fundamental understanding of the impact on extractables of testing conditions, materials of construction and product form factors to assist the industry in establishing a consensus Standard.

This presentation will provide an overview of the Saint-Gobain Single-Use Component and System extractable and in-process leachable program methodology with a focus on extraction techniques, materials of construction, analytical analysis and how the generated data can provide meaningful information for end user product prequalification, initial risk assessment or as the basis for determining an appropriate leachable study.

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