SARTORIUS STEDIM BIOTECH LAUNCHES FLEXSAFE SINGLE-USE POLYETHYLENE BAG FAMILY

摘要

Sartorius Stedim Biotech, a global supplier to the biopharmaceutical industry, is introducing a scalable range of single-use bags in the Flexsafe family. Flexsafe enables single-use bioprocessing to be implemented throughout all steps of drug manufacture, from process development to production, upstream and downstream - all using just one innovative polyethylene film. Flexsafe is based on a multilayer, proprietary polyethylene (PE) film, called S80, and has been developed in collaboration with resin and film suppliers. A standardised cell growth assay has been used to optimise film formulation, determine the operating ranges for extrusion, welding and gamma-irradiation processes and to establish specifications and process controls.