Whitepaper
Vial Breakage During Lyophilization
Resource Overview
Lyophilization, a freeze-drying technology that improves the stability of injectable pharmaceuticals, is often used to enable cold storage in a product’s solution form. The process involves freezing of a formulation, removal of water vapor through sublimation under reduced pressure, and removal of unfrozen water during secondary drying. Formulations are filled in glass vials of varying sizes using varying fill volumes for lyophilization.
However, despite the durability of glass used in lyophilization, occasionally, breakage of vials is encountered during manufacturing due to a variety of reasons. Depending on its severity, vial breakage could have an undesired impact on a product.
In this whitepaper, learn more from the Simtra BioPharma Solutions team how controlling freezing rates, utilizing specialized vials, and employing optimized stoppering techniques can tip the scales in favor of preservation, ensuring the safety and quality of your life-saving pharmaceuticals.
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