NovaPure® Stoppers - The Right Choice For Oncology Drugs

By L. Fang, M. Gehrmann, R. Singh, C. Zhao, P. McAndrew

Vial containment systems with NovaPure^® elastomer stoppers offer substantial performance benefits. There are several reasons: enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec^® film. Based on fluoropolymer chemistry, FluroTec film reduce both migration of leachables from stoppers into drug products, and interaction of drug products with stoppers. And as compared to stoppers without films, there is no change in long-term container closure integrity (CCI) performance. This article presents research that demonstrates the performance of FluroTec film, and thus illustrates why NovaPure stoppers should be the choice for sensitive drug products such as those for oncology.