Matthew M. Hall, associate professor of glass and director of the Center for Advanced Ceramic Technology at Alfred University, was an invited panelist at a pharmaceutical supply chain conference held recently in Arlington, Va. The conference addressed the delamination of glass pharmaceutical vials, a growing concern in the pharmaceutical community. Delamination occurs when the interior surface of a glass vial flakes off into the pharmaceutical solution. While no specific injuries have been traced to the presence of glass delamination particles, the problem is receiving intensified scrutiny from the U.S. Food & Drug Administration.
Hall presented the experimental design for an upcoming study in conjunction with Gerresheimer Glass Inc. The purpose of this study is to better understand glass delamination and possibly link its occurrence to manufacturing processes employed by the glass vial industry.
The conference was sponsored by Rx-360, a newly formed industrial consortium formed to protect the integrity of pharmaceutical products globally.
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