Implementation of the BPOG Extractables Testing Protocols

摘要

Benefits of single-use technologies over traditional stainless-steel solutions in biopharmaceutical manufacturing include reductions in set-up times, cleaning/cleaning validation costs, elimination of cross-contamination risks, and smaller operating footprints. But despite increasing adoption of such systems, concerns remain about extractable and leachable (E&L) compounds from plastic single-use systems (SUS) components with the potential to compromise the efficacy and safety of final drug products. Such concerns are magnified by the growing number of SUS suppliers and the complex supply chain for SUS and components.