Experimental And Theoretical Evaluation Of Vial Container Closure System Components Using The DeltaCube™ Modeling Platform

By Anthony J. 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.

The purpose of this case study was to compare two container closure systems (CCSs) which differ by stopper hardness using comprehensive stack-up calculations performed by West's DeltaCube™ Modeling Platform and link the predictions to small scale capping studies and CCI evaluation.