By Anthony Bucci, Ph.D.
The pharmaceutical and biotech industries face many challenges when selecting the appropriate vial, stopper and seal combination for a drug product. Compounding those challenges is the manufacturing process capability of potentially three or more suppliers. Supplier manufacturing capabilities paired with lot-to-lot variation can result in unexpected failure during production. Therefore, it is important to take a holistic1 system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and to 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 will examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.