1.1.This practice is intended to provide guidance to standard methodologies for the generation, analysis and reporting of extractables data for Single-use Systems (SUS) and / or their components when exposed to biopharmaceutical process solutions. (note, from this point, the use of the abbreviation SUS may indicate either the systems or their components, unless it is explicitly delineated) 1.2.The data are intended to provide biopharmaceutical end users a consistent set of data to facilitate their risk based assessment of the potential of leachables in their final finished drug substance or drug product. 1.3.The data are not intended to be data on the actual leachables in a final finished biopharmaceutical. The generation of these data remains the responsibility of the biopharmaceutical end user. 1.4.The solvents outlined and extraction time points given provide the samples for assays to collect the desired body of data to encompass the majority of buffer types and time periods used by the biotechnology industry. The goal is to have this data for all new single-use systems. However, some solvents and time points may not be initially completed. 1.5.Suppliers may have legacy data available for other solvents and test conditions. These data can continue to be used as long as the supplier can provide a sound scientific rationale for their utility in meeting the goal of paragraph 1.2 above. However, the suppliers should be able to provide a schedule working in good faith to generate the data as provided in this standard. Likewise during the course of preparation of this data package, all data may not be available simultaneously. End users should accept the data available as long as the supplier can provide a schedule working in good faith to generate the data as provided in this standard. 1.6.Specific equipment or methods of sample preparation are provided within this standard. These may be replaced by other alternative methods as long as a sound scientific rationale can be provided and appropriate data validating the acceptability of the alternative method is provided.
Keywordsextractables, leachables, single-use applications, SUT, biopharmaceuticals, pharmaceuticals, risk assesssment, toxicological
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top