Comparative assessment of potential risks associated with variable fill volumes in biopharmaceutical glass injection vials
LI Xiao-yu
QI Yan-fei
YUAN Shu-sheng
ZHAO Xia
Abstract：Objective:This study,focusing on the field of biopharmaceuticals,aims to investigate the impact of fill volume variation in commonly used small-volume glass injection vials on drug compatibility.Methods:Four types of 2 mL glass injection vials were selected and filled with simulated solutions at different volumes.The migration levels of primary glass constituent elements into the solutions and the erosion of the vials were analyzed.Results:As the fill volume decreased,the migration of glass elements increased to varying degrees across all vial types.Significant inner surface erosion was observed in tubular borosilicate glass vials,with a notable correlation to reduced fill volume.In contrast,molded middle borosilicate glass vials and aluminosilicate glass tubing vials exhibited no visible erosion,maintaining consistent performance across fill volumes.Conclusion:Low fill volumes in pharmaceutical products increase exposure to the"susceptible regions"of tubular borosilicate glass vials.In contrast,molded borosilicate glass vials and aluminosilicate glass vials lack such vulnerable areas.Therefore,comprehensive compatibility studies should be conducted when selecting glass vial packaging or adjusting fill volumes for injectable formulations.
Keywords：injection vialsfill volumecompatibilitybiopharmaceuticals
Publication Date：2026-03-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 530-537 )