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.

Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test.

Delamination, which is the formation of flakes in drug products owing to specific and localized corrosion of glass vials, is a rare but serious problems, on which the FDA (U.S. Food and Drug Administration) put a warning to the pharma industry in 2011.

A quick test to monitor the delamination propensity of glass containers.

Unlabelled: Glass delamination has developed as a quality problem for primary packaging containers over the last years. Beside other factors the container production process can contribute to this phenomenon, and it seems mandatory to steer and control the critical parameters. With the Schott Delamination Quicktest, a rapid test method is developed that provides a rough measure for the container-related properties that affect delamination risk in a simple and reliable manner and in a relatively short time span.

Pharmaceutical vials with extremely high chemical inertness.

Traditional type I glass containers are becoming more unsuitable for packaging modern diagnostics and drugs. When using certain drugs (high-pH formulations, complexing agents, drugs with low dosage, sensitivity to pH-shift or ion release), product degradation can occur, reducing the drug's performance, potency, and shelf-life. To prevent chemical interaction between the container and the content, a coating technology applying a silicon dioxide layer to the internal container surface can bring the solution.