Byline author: Daniel Kramer, Senior Development Scientist
Co-author: Rob Schaut, Senior Research Scientist
For years, the pharmaceutical industry has been challenged by the risk of delaminated flakes in sterile injectables and associated product recalls 1. Corning developed Valor® Glass, a boron-free glass composition designed, specifically, for pharmaceutical use that eliminates delamination. The uniform surface chemistry and chemically-durable drug contact surface makes Valor Glass ideally-suited for sterile, injectable medicines.
A Boron-Free Glass to Eliminate Delamination
Glass can be a durable material well-suited for primary packaging. For decades, the industry has relied on borosilicate glass containers due to their hydrolytic resistance, but these glasses have not been used without their own issues 2. Delamination, the appearance of visible flakes / lamellae in filled vials has been the subject of many product recalls and regulatory advisories 3. Glass packaging suppliers attempt to mitigate the risk of delamination by changing manufacturing process steps, specifically during tubular conversion. These changes only reduce the risk of delamination, whereas Valor Glass eliminates it regardless of the tubular conversion process.