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The two most common means of sterilizing elastomeric parenteral packaging components are steam autoclave and gamma irradiation processes. When appropriately validated, both processes are very effective at eliminating concerns around microbial contamination of the components used for container closure of sterile liquid, lyophilized or powder drug products. Despite the ability of both methods to reach the required sterilization specifications and requirements, the overall impact that these processes have on the elastomeric component can be quite different.

A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry

The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization