1.1This practice provides a standardized approach for determining the most likely extractables profile from materials used in single-use applications, including the assays for these materials. 1.2The scope of this practice is limited to materials and process practices used in biopharmaceutical development and manufacturing. 1.3 It is not intended to provide information on the impact of any leached material on product compatibility or process performance. Nor is it intended to provide information on any leached material resulting from interaction of final formulation with finished packaging material.
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
Robert Steininger II
Draft Under Development