Guide to the completion of the BioPhorum extractables data template

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.

The extractables test report provides comprehensive information on the SUS component tested, including details of the testing setup, testing conditions and analytical methods applied, and identity and quantity of extracted compounds.

The extractables testing data should be compiled into an extractables test report with summary tables of the results. The report should include the amount and identity of each known compound and the estimated amount of each unknown compound. It should also include the study design, deviations, the analytical methods and associated method qualifications, data tables for each individual analysis technique, as well as a summary including any additional discussion necessary to provide enough context such that the results are readily interpretable by end-users. It is not required to include chromatograms or spectra in the report, but these shall be made available upon request. Chromatographic data should then be presented using the total ion current (TIC). Presentation of spectra is primarily of interest for unknown compounds.