Glass vial failures, specifically breakage, lensing, and cracks, are a source of product loss and process cost in the freeze-thaw, cryogenic preservation, and lyophilization of pharmaceutical products. Lyophilization is a common method for the preparation of freeze-dried pharmaceutical products, which requires low temperature processing to avoid product damage or decomposition.
Because process times are long and lyophilization is regarded as an expensive process, considerable research has focused on improving lyophilization rates to reduce costs. One contributing factor to cost is the failure of glass vials during the lyophilization cycle, which includes freezing, annealing, and drying process steps. Vial damage or breakage results from elastic stresses generated by the sudden volume expansion of the freezing solutions and crystalline phase changes of solids exceeding the flaw limited strength of the container. This vial breakage results in higher process costs, delays due to destruction of product, and lead to possible drug shortages.
Corning Valor® Glass, specifically designed to meet the needs of the pharmaceutical industry, dramatically reduces breakage and enables lower cost lyophilization compared to conventional borosilicate glass vials.
Corning Valor® Glass
Compared to conventional borosilicate vials during the lyophilization process, Valor vials significantly reduce damage and breakage and may lower manufacturing cost. The chemical strengthening process for Valor vials imparts compressive stress on the glass surface that typically exceeds the tensile stresses generated in the freeze-thaw process dramatically reducing the potential for breakage. In addition to protecting the vial surface, Valor Glass’ low coefficient of friction coating demonstrates faster chamber fill during the lyophilization process and improved manufacturing efficiency with higher run and uptime rates. Overall, Valor Glass vials demonstrate superior performance in low temperature processes compared to conventional borosilicate. The advanced parenteral glass packaging technology of Valor Glass enables the potential for reduced start-to-finish times and improved yields which may reduce total cost of quality as well as manufacturing cost.
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