Glass delamination(1) has become a bit of a hot topic in the area of parenterals over the past several years. Glass delamination is, indeed, a serious issue which can not only cause pharmaceutical companies millions of dollars in recalls, but also stands as a safety hazard to end users. Delamination is essentially the flaking off of the top layers of a glass surface into the liquid contents of a pharmaceutical vial, syringe, or other container. Numerous companies have experienced this issue, and have had to open investigations(2) to address the issue. The question is, how can we be proactive, rather than reactive, in addressing concerns with glass delamination? How can we minimize the risk of experiencing a delamination issue, in order to protect the welfare of end-users and uphold the quality of our products?
