Glass vial delamination/corrosion has resulted in an increasing number of recalls. Our scientists have developed a protocol for preparation and examination of glass vials for assessing the interaction of the drug product with the glass. The analysis involves filtering the drug product, examining the filter for glass lamellae, and inspecting the vial’s interior surface for corrosion. The insights gained from the results can help the manufacturer take preemptive action early in the delamination/corrosion process.
