Addressing Glass Particulates In Injectable Drug Formulations

Particulate contamination in drug formulations continues to be a cause for concern in the manufacture of injectable drugs and is a leading cause of injectable drug recalls. These recalls represent a significant cost and liability to drug manufacturers, placing significant value on any emerging technologies that can mitigate the risks of particulate generation and improve patient safety.

Glassmaker Corning has studied the root causes and engineered a new glass product in partnership with West Pharmaceutical Services, Inc. for use on existing equipment that significantly reduces that risk. Corning scientists determined significant particulate generation was the result of frictive sliding contact and impact events between vials on filling lines, opening the pathway to explore new materials and methods that substantially reduce this mechanism of glass particle contamination, thereby mitigating a risk for drug products.

A new vial made from an aluminosilicate glass composition and strengthened to provide superior strength is capable of reducing the propensity for glass particulate generation on filling lines. Examine the study to learn about the new vial design that uses a low coefficient-of-friction (COF) external surface to produce a significant, positive impact on product quality and safety.