caa a22 4500 463226712 CHVBK 20180405153229.0 cr unu---uuuuu 170326e20070201xx s 000 0 eng 10.1007/s10853-006-0156-y doi (NATIONALLICENCE)springer-10.1007/s10853-006-0156-y Corrosive attack of glass by a pharmaceutical compound [Elektronische Daten] [Ronald Iacocca, Matthew Allgeier] 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. Springer Science+Business Media, LLC, 2007 Iacocca Ronald Materials Science and Physical Characterization, Eli Lilly and Company, MC 3811, 46033, Indianapolis, IN, USA aut Allgeier Matthew Materials Science and Physical Characterization, Eli Lilly and Company, MC 3811, 46033, Indianapolis, IN, USA aut Journal of Materials Science Kluwer Academic Publishers-Plenum Publishers; http://www.springer-ny.com 42/3(2007-02-01), 801-811 0022-2461 42:3<801 2007 42 10853 https://doi.org/10.1007/s10853-006-0156-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10853-006-0156-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Iacocca Ronald Materials Science and Physical Characterization, Eli Lilly and Company, MC 3811, 46033, Indianapolis, IN, USA aut NATIONALLICENCE 700 1- Allgeier Matthew Materials Science and Physical Characterization, Eli Lilly and Company, MC 3811, 46033, Indianapolis, IN, USA aut NATIONALLICENCE 773 0- Journal of Materials Science Kluwer Academic Publishers-Plenum Publishers; http://www.springer-ny.com 42/3(2007-02-01), 801-811 0022-2461 42:3<801 2007 42 10853 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer