The Effects of Ozone and Various Sterilization Techniques on Elastomeric Rubber Needle Shields and Tip Caps

J. Riter, A. Janssen, D. Engels

Cracking of elastomeric needle shields and tip caps is a costly problem for pharmaceutical manufacturers. Cracked components can cause leaks that can result in loss of drug potency and sterility and may lead to a safety risk for the person administering the drug and the patient. This cracking has been attributed to ozone degradation of the elastomer formulations.

In this study, several elastomeric needle shields and tip caps were exposed to ozone for various time periods and analyzed to determine the effects the ozone had on the elastomers. In addition to being resistant to ozone degradation, elastomeric needle shields must be compatible with various forms of sterilization. In this study, the elastomeric needle shields and tip caps were also exposed to several types of sterilization and evaluated to determine the effects this exposure has on the elastomers.

The effects of the exaggerated ozone exposure study are dependent on the rubber formulation. As was observed in the study, some rubber formulations are more resistant to ozone exposure. The synthetic isoprene rubber formulation (Sample C) was superior to the other formulations as it related to cracking/splitting when exposed to the ozone concentration.

The data collected demonstrates that steam and gamma irradiation-processed samples had no significant differences compared to the unprocessed samples of the synthetic isoprene and bromobutyl blend formulation and the synthetic isoprene formulation. However, the gamma irradiation of the natural rubber formulation appears to have affected the chemical characteristics of the rubber formulation.

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