Rubber Stopper Quality and Technical Issues: A Global Perspective

by Frances L. DeGrazio
Volume 5, Issue 3 (Fall 2006)

As pharmaceutical and biopharmaceutical companies become more global in nature with products that have the potential to reach into the worldwide marketplace, a special understanding is needed of the requirements that are specific to varying geographical areas. Specifically, the regions for worldwide pharmaceutical distribution can be broken into America, Europe, and Asia-Pacific, with each region presenting its own regulation and technical challenges. There are many issues that are common among these regions, but each region’s focus may be different. Typically, an issue arises in one region and then migrates to another as people become aware of the issues and concerns. For example, the use of prefilled syringe systems in Europe and Asia has migrated to the American marketplace, amounting to a more significant volume…

DeGrazio FL. Rubber Stopper Quality and Technical Issues: A Global Perspective. BioProcess J, 2006; 5(3): 41-45.