Abstract

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.