Corrosive attack of glass by a pharmaceutical compound

Glass delamination, or the generation of glass flakes, continues to be an unwanted occurrence in the manufacture of parenteral (injectable) solutions and suspensions. In this root cause analysis study, advanced analytical tools including atomic force microscopy, environmental scanning electron microscopy, quantitative image analysis, and dynamic secondary ion mass spectroscopy (D-SIMS) showed significant differences in glass characteristics and performance. By observing the size and spatial arrangement of defects found on the interior surface of vials used as primary packaging for these products, in conjunction with the chemical changes that can occur to the glass because of product contact, a considerable amount of insight can be obtained into this phenomenon. Elemental depth profiling obtained by D-SIMS revealed that the interior vial surface was significantly altered by the presence of the parenteral solution, while another vial (manufactured by another vendor) was not. Although significant chemical changes can occur to the glass, the surface defect structure appears to be the dominant factor controlling the generation of glass flakes.