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

Area of Science:

• Materials Science
• Pharmaceutical Packaging
• Analytical Chemistry

Background:

• Glass delamination in pharmaceutical vials, a localized corrosion issue producing flakes, poses a rare but serious risk to drug products.
• The U.S. Food and Drug Administration (FDA) issued a warning in 2011, prompting the International Commission on Glass (ICG) to form Technical Committee (TC) TC12 in 2012 to address pharmaceutical packaging concerns.
• TC12's initial focus was developing a reliable method to predict glass vial delamination propensity.

Purpose of the Study:

• To report on the results of a round-robin test evaluating a novel protocol for predicting glass vial delamination.
• To assess the effectiveness of the developed test protocol in identifying vials prone to corrosion and potential delamination.

Main Methods:

• A round-robin test was conducted involving multiple laboratories and five types of glass vials with varying expected delamination propensities.
• Vials were filled with a NaCl solution adjusted to pH 8 and subjected to autoclaving at 121°C.
• Post-autoclaving, vials underwent a coloration test and Inductively Coupled Plasma - Optical Emission Spectrometry (ICP-OES) analysis for Si, B, and Al content.

Main Results:

• No glass flakes (delamination) were observed in any of the tested vials, confirming the rarity of the event.
• A correlation was found between strong bottom coloration, high silicon concentration in the solution, and observable morphological modification/corrosion of the inner vial surface.
• The test protocol effectively differentiated corrosion behavior, particularly between vials with comparable surface-to-volume ratios.

Conclusions:

• The developed test protocol is a valuable tool for assessing glass vial quality concerning corrosion propensity.
• While the protocol does not directly predict delamination, it identifies underlying corrosion issues that could lead to it.
• The method is recommended for evaluating differences in glass vial corrosion behavior, contributing to enhanced pharmaceutical packaging safety.