Whitney Winters

Director, Sales, Emerging Biologics

June 13, 2013

When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers.

West’s global premier elastomer formulations include 4023/50 and 4432/50. Steam sterilization is now also available for ready-to-use plungers , which can help companies moving from a vial and stopper combination to prefillable syringe system. Because the same elastomer formulation can be used to manufacture stopper and plunger configurations , manufacturers can move from the initial container closure system to a prefillable syringe system with minimal data on component to drug product compatibility. While stability testing still needs to occur, maintaining the same elastomer formulation in a different configuration,  can reduce risks associated with a new formula selection because chemical compatibility, toxicity data and extractables profiles will remain the same. For example, both vial stoppers and syringe plungers are available in formulation 4432/50 and in a steam sterilized format.

Also, maintaining components with the same elastomer formulation can be safe for patients because the formulation has been proven to work with the drug product, and the manufacturer is aware of any possible interaction between the product and components.

West offers steam-sterilized components in the 4432/50 and 4023/50 formulations that provide functionality and compatibility in a variety of container closure and delivery systems. Contact West today to discuss the best options for your drug product.