Evaluation of extreme depyrogenation conditions on the surface hydrolytic resistance of glass containers for pharmaceutical use.

This paper is the result of a round robin activity run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). The study was motivated by a concern about the risk that the depyrogenation treatment of glass vials, when performed in an abnormal way that deviates from the usual procedure, may have a negative impact on the hydrolytic resistance of the container inner surface. The study was executed by using 10 ml clear type I Borosilicate glass vials representing four different compositions.