PureFlex™ Plus Single-Use Process Container Film Extractables and Leachables Study

Biopharmaceutical companies are using single-use disposable sterile containers and assemblies for upstream and downstream processes at an ever increasing rate, as these specialized technologies and products enable efficient and scalable processes.

The newly developed PureFlex™ Plus film contains many of the same ultra low density polyethylene, poly(vinyl acetate) and poly(vinyl alcohol co-ethylene) layers that are in current PureFlex™ film.  The only modification is the outer layer, to provide enhanced mechanical strength, creep resistance and limited permeability to air and gases.  Since the process fluids contact the inner film layer, there is a need for understanding extractables from such containers at room and elevated temperatures and over prolonged time of exposure.  For this purpose, EMD Millipore conducted an extractables study on newly developed PureFlex™ Plus film and current PureFlex™ film.  A model stream approach was performed instead of conducting in actual formations to minimize the analytical issues.  The model streams selected for this study were water, 50% ethanol, 1N hydrochloric acid, 1N sodium hydroxide and 10% dimethyl sulfoxide.