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Corrosive attack of glass by a pharmaceutical compound

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Abstract

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.

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Notes

  1. Pharmaceutical nomenclature for borosilicate glass.

  2. Upon heating, the ammonium sulfate decomposes. The gaseous sulfate reacts with the sodium in the glass, forming sodium sulfate, which is then removed when the vials are washed.

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Acknowledgments

The authors would like to acknowledge the many participants in this study including: Dr. Dinesh Mishra, Dr. Heather Weimer, Mr. Eric Olsen, Ms. Sheryl Peoples, and Mr. David Crozier.

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Authors and Affiliations

  1. Materials Science and Physical Characterization, Eli Lilly and Company, MC 3811, Indianapolis, IN, 46033, USA

    Ronald G. Iacocca & Matthew Allgeier

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  1. Ronald G. Iacocca
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  2. Matthew Allgeier
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Correspondence to Ronald G. Iacocca.

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Iacocca, R.G., Allgeier, M. Corrosive attack of glass by a pharmaceutical compound. J Mater Sci 42, 801–811 (2007). https://doi.org/10.1007/s10853-006-0156-y

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  • DOI: https://doi.org/10.1007/s10853-006-0156-y

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