Critical Time-Dependent Evaluation and Modeling of Rubber Stopper Seal Performance for Drug Product Life Cycle

It is essential to have sufficient rubber seal performance for the critical life cycle of a sealed drug product. However, prior work has little considered the influence on medical rubber stopper seal performance that results from time-dependent effects of viscoelastic rubber stoppers. The present work represents a new methodology breakthrough in this field. We are taking a unique approach by employing a combination of multi disciplines: polymer science, materials technology, non-linear mathematical modeling, advanced data processing, and computer simulation algorithms. By employing both experimental evaluation and modeling on a typical vial/stopper container system, an in-depth understanding of critical time-dependent effects on medical rubber stopper is developed. Experimental and modeling data match well, showing seal performance changes during the medical product life cycle. Further, modeling is shown to numerically predict seal performance through the drug product life cycle. The modeling prediction provides a quantitative base from which to proactively manage the changing seal performance. The conclusions provide scientific insights and methodology into how to practically consider, set up, control, and maintain the medical rubber stopper seal performance throughout the critical drug product life cycle.