Helpful hints in analyzing glass delamination
Kristie J. Diebold, McCrone Associates, Inc., Westmont, Illinois
Healthcare Packaging and Packaging World - September 28, 2011
Concerns with glass delamination are causing many pharmaceutical companies to take a closer look at their packaging containers. Many are stability testing their products with several types of vials to find the proper combination to prevent glass delamination. Some manufacturers are using surface-treated vials to improve chemical resistance, and others are investigating the performance of these vials with their products. Nonetheless, a company's Quality Control department must be able to identify glass delamination in its products. Companies may have a laboratory with the equipment and expertise to test for glass delamination, or they may send their samples out to an independent laboratory for analysis.
Glass delamination is defined as degradation of surface glass, as from a vial, that produces glass flakes. Several mechanisms have been proposed to explain how glass delamination can occur in vials. Two common mechanisms may be (1) during manufacture when the vials are fused at the neck or base, or (2) chemical reaction with the vial contents. An indicator of adverse reactions is observed frequently at the fill line, so if a vial is stored inverted the delamination may be seen near the base of the vial instead of near the neck when stored upright.