Designing for the Lyophilization Process
The freeze-thaw process, cryogenic preservation, and lyophilization of pharmaceutical products demand durable containers capable of withstanding extreme temperatures and resisting damage or breakage. During lyophilization, the liquid inside the container freezes and expands, exerting stress on the container. This stress can lead to glass vial failures, causing product loss, increased process costs, delays due to damaged products, and potential shortages of pharmaceutical glass and drugs.
Vial breakage during production of an expensive drug or novel vaccine can be costly since it decreases the yield and effective batch-size, extends line stoppage, and wastes drug resources. Valor glass vials maintain their high initial strength even after transport, handling, and the rigorous industrial lyophilization process.
A Superior Solution for Low Temperature Processing
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.1 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.2
The advanced parenteral glass packaging technology of Valor glass enables the potential for reduced start-to-finish times and improves yields which may reduce total cost of quality as well as manufacturing cost.
1. Schaut, R.A., et al., “Enhancing patient safety through the use of a pharmaceutical glass designed to prevent cracked containers.” PDA J. of Pharm. Sci. & Tech. 71 (6): 2017 pp. 511–528.
2. Timmons, C.L., et al. “Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial.” PDA J. Pharm. Sci. & Tech., 71 (5): 2017. pp. 379-392.