What is lyophilization method?

Lyophilization is a water removal process typically used to preserve perishable materials, to extend shelf life or make the material more convenient for transport. Lyophilization works by freezing the material, then reducing the pressure and adding heat to allow the frozen water in the material to sublimate.

What is lyophilization used for?

“Think of lyophilization as basically freeze-drying—it is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport.

What are the defects in lyophilization?

While the possible deviations to the lyophilization process are endless, they will often fall into one of the following three failure modes: (1) Shelf temperature excursions from set point, (2) Chamber pressure leak into the lyophilizer system, and (3) Variables extrinsic to the lyophilization process itself, such as …

What is the difference between freeze drying and lyophilization?

Freeze drying, also known as lyophilisation or cryodesiccation, is a low temperature dehydration process that involves freezing the product, lowering pressure, then removing the ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.

Why is the appearance of a lyophilized cake important?

Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophilized drug product.

What should a lyophilized drug product look like?

Lyophilized drug product should ideally exhibit a uniform cake color 36 (generally white to off-white). However, in some cases colored cakes may be observed, for example, in case of a colored active pharmaceutical ingredient . The authors are not aware of any systematic study assessing the impact of a non-uniform color on product quality.

Why is my lyophilized cake cracked and cracked?

In some cases, meltback may also indicate an issue with the formulation itself. Lyophilized cakes that are slanted, cracked, or otherwise physically damaged may be indicative of issues with the loading or transportation processes.

Why is cake appearance important in freeze dried drugs?

Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophilized drug product.