White Paper

Vial Breakage During Lyophilization: Root Causes And Mitigation


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. It could result in loss of an entire batch of a product, and even the loss of a partial batch is very costly and could result in safety hazards. During lyophilization, vials encounter several stresses associated with drastic temperature differences, changes in pressure, mechanical force, stoppering of vials, and unloading from the dryer.

Learn 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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