Why doesn’t the industry move to standardized testing for single-use films and bags?

Answer

Although single-use technology is broadly accepted in pharmaceutical manufacturing, the industry continues to evolve with respect to the qualification requirements for these systems. Industry-wide discussions aimed at aligning on standardized approaches for qualifying single-use technologies have been ongoing for several years. Standard methodologies exist in some areas, such as ASTM methods for tensile properties and the USP testing for Class VI plastics. Progress is being made in several other areas, such as extactables testing protocols and cell culture evaluations, through joint efforts of pharmaceutical manufacturers and single-use suppliers. GE Healthcare is actively participating in many activities with members of BPSA and BPOG in order to drive toward the goal of standardization. As the implementation of single-use technology continues to grow, the industry will be presented with new challenges and requirements. In recent years, GE Healthcare has invested in expanding our internal capabilities for characterizing the materials used in our single-use systems. Through collaboration with our Global Research Centers, we draw upon our strong foundation of material science knowledge and combine it with our understanding of bioprocess application to be able to tackle both current and future challenges with bioprocess films and design the next generation of film technology.