The standardized extractables testing protocol provides suppliers with a set of procedures agreed upon as representative of a comprehensive range of conditions by a broad group of companies. Suppliers can use this to prepare standardized extractables test reports for single-use systems (SUS) components including, but not limited to, films, tubing, tubing connectors and disconnectors, aseptic connectors and disconnectors, sterilizing-grade and process filters, tangential-flow filter cassettes, sensors, valves, chromatography columns, impellers, and filling needles. This template supports the completion of the extractables test report.
Guide to the completion of the BioPhorum extractables data template
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