Microscopical Evaluation of Glass Delamination in Pharmaceutical Vials: A Look at Three Different Vial Manufacturers

Abstract

Delamination is defined as separation into constituent thin layers (lamellae). Glass delamination, which can have several causes, could then be defined as a separation of surface glass, as from a vial, into thin layers resulting in a flaky appearance. Pitting could be related to, or even be the initial stages of glass delamination; data will be provided that supports a relationship. The presence of glass delamination is a serious concern to the pharmaceutical industry, not only because suspended glass flakes in any pharmaceutical product poses an obvious health hazard, but because of regulatory quality control standards, and medical profession requirements.There are, of course, many ways of addressing the problem of glass delamination in pharmaceutical vials, including looking into the relationship of chemical nature of vial contents to degree of delamination and conditions of vial manufacture. Specialized lighting and imaging methods are other research approaches.