The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process.
To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
This article reviews how to use the DeltaCube™ Modeling Platform to help assess and select a vial container closure system. The DeltaCube™ Modeling Platform can rapidly compare up to four CCSs at one time.