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 pre-testing analysis on smaller batches of the product before going into full production.
Glass delamination, which is a reaction from a form of glass corrosion, are small, thin, glass fragments, termed “glass lamellae”, which are shed from the interior portion of glass containers and vials. The glass lamellae cause quality control issues as they are shed into, and suspended in the liquid drug contained in the glass vial. Due to the microscopic size of most glass lamellae detection during visual product inspection can be very difficult.
Gateway employs specialized sample preparation protocols, optical microscopy and SEM/EDS methods to provide glass delamination analysis products. Contact us today to request more information about how we can help solve your glass delamination analysis challenges.