The Causes and Implications of Glass Delamination - Pharmaceutical Technology

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The Causes and Implications of Glass Delamination
This article focuses on the history of glass delamination and methods that detect it, both from a compendial and a research perspective.


Pharmaceutical Technology
pp. s6-s9

Implications for the pharmaceutical industry

Initially, the concern over glass flakes focused on product quality and patient safety. Recent data have shown, however, that foreign particulate matter such as glass flakes can serve as nucleation sites for protein and peptide fragment aggregation (16–19). Such aggregates have been shown to generate immunological effects and can render biopharmaceuticals ineffective, thus causing considerable risk to the patient (20).

Conclusions

Glass compatibility with pharmaceutical liquids is an ongoing industry challenge. The phenomenon is well described and understood in the literature. Existing analytical techniques can evaluate the suitability of glass packaging for parenteral liquids. These tests should be employed to detect potential problems. Visual inspection continues to be the standard method for detecting glass flakes, but it is a lagging indicator, not a leading one.

Acknowledgments

The author would like to recognize the efforts of the following people who have contributed to this investigation: Nick Toltl, research and development manager at SGS Canada; and Alan Shi, engineer at Medtronix. The author also would like to thank the following current and former employees of Eli Lilly and Company: Matthew Allgeier, research scientist of pharmaceutical sciences R&D; Xia Dong, principal research scientist for analytical sciences R&D; Michael Foubert, associate consultant chemist of analytical sciences R&D; Bethany Bustard, consultant chemist of manufacturing sciences and technology; Sheryl Peoples (retired); Jeffrey Hoefer, director of statistics, manufacturing science, and technology; David Crozier, retired; Nathan Milton, research advisor for pharmaceutical sciences R&D; and Tim Shelbourne, research scientist in analytical sciences R&D. This work could not have been accomplished without the support of the management of Analytical Sciences Research and Development in Eli Lilly and Company.

Ronald G. Iacocca is a senior research advisor in analytical sciences R&D at Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285,
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