Glass delamination if not discovered early can be big problem for pharmaceutical manufacturers. It has the potential to cause costly product recalls and investigations. Because of this, the FDA highly recommends that manufacturers perform stability studies to evaluate the interaction of the drug formulation with the glass vial in addition to pretesting analysis on smaller batches of the product before going into full production.
A leading pharmaceutical manufacturer suspected that their drug formulation was crystallizing in the liquid after observing a twinkling effect in the filled vials. Though they did some initial analysis in-house, they lacked the technology necessary to fully assess the drug formulation and determine the cause.
The manufacturer decided to select two filled vial samples, one for analysis and one for reference from the lot and send them to Gateway Analytical for detailed analysis. Initial review of the drug formulation yielded that no crystallization was present. However, after further visual inspection, Gateway Analytical deducted that glass delamination could be the cause of the twinkling that was observed. Samples were then prepared for further evaluation in order to determine the presence or absence of glass delamination in the vial.