Vial Containment Systems Based On Elastomer 4031/45 Gray

By T. Page McAndrew, Ph.D., Director, Scientific Communications, and Victoria Morgan, Director, Strategic Marketing

To create a robust containment system for drug storage, vials, stoppers, and seals are assembled. These components are available in a wide range of options, including:

• Vials: Glass type, configuration, and size
• Stoppers: Elastomer type, configuration, size, and coating/laminate
• Seals: Materials of construction, configuration, and size

The selection of components depends on their ability to protect the drug product throughout its shelf life. While it's ideal to evaluate every possible combination of vial, stopper, and seal, time constraints often limit this. However, drug developers can assess key combinations to inform potential performance. This knowledge aids in making informed decisions during component selection.

To contribute to this understanding, West conducted two extensive studies over two years. The first study examined the impact of stopper configuration on performance using two well-established elastomer formulations and serum stopper configurations. Results indicated that configuration changes had no significant effect.

The second study explored the influence of elastomer formulation, stopper configuration, and vial design. It found that for a given elastomer formulation, variations in stopper and vial had minimal impact on performance.

Based on these studies, we can infer that for a properly assembled system using elastomer formulation 4031/45 Gray, good performance can be achieved regardless of the specific stopper configuration or vial design.