Performance Evaluation of Vial Containment Systems

This technical report presents findings from two extensive studies conducted over two years, focusing on vial containment systems utilizing elastomer 4031/45 Gray. The studies aimed to evaluate the container closure integrity (CCI) performance of various stopper configurations and vial designs. The first study assessed the performance of two established elastomer formulations with different serum stopper configurations, demonstrating that configuration changes did not affect performance. The second study expanded the evaluation to include various elastomer formulations, stopper configurations, and vial styles, confirming that for elastomer 4031/45 Gray, variations in stopper configuration or vial style did not influence performance. The results indicate that a properly assembled vial containment system can achieve reliable performance independent of the stopper configuration or vial design, emphasizing the importance of informed component selection in drug product storage. The report includes detailed data and analysis of the studies conducted, supporting the conclusions drawn regarding the performance consistency of the elastomer.