What are the advantages of Lyophilisation?

What are the advantages of Lyophilisation?

Some of the advantages of lyophilization, according to the FDA, include: Processing a liquid with ease (and thereby simplifying aseptic handling) Enhancing the stability of a dry powder as well as the product stability in a dry state. Removing water without having to heat the product excessively.

What are the advantages of freeze-drying?

Freeze-drying retains nutritional value better than other drying methods, further supporting consumers’ desire for nutrition from whole foods. The process also preserves the actual color and shape of the original raw material, reassuring consumers they are actually getting real fruits and vegetables in their diets.

What is the principle of freeze-drying?

The essence of the freeze-drying process depends on maintaining a critical balance between the conversion of ice into water vapor by sublimation under vacuum and the removal of that vapor from the frozen mass. To maintain sublimation, heat energy is applied to the product to compensate for sublimation cooling.

What is eutectic point in lyophilization?

The eutectic temperature (triple point) is the temperature at which your sample only exists in the solid phase. If your frozen sample goes to a temperature higher than the eutectic temperature, it will begin to melt.

What is a lyophilizer used for?

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

What is lyophilization in chemistry?

Lyophilization is a method of cell and protein preservation by removing a solvent such as water from a substance followed by freezing.

Who is lyophilization technology?

Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products. LTI is recognized as an industry leader with unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical services.

What happens during lyophilization?

During lyophilization, the maximum temperature of the product before its quality degrades by melt-back or collapse. The material forms crystals when frozen. Multi-component mixtures which do not crystallize and do not have a eutectic point. They turn into a ‘glass.’

Why are manufacturers unaware of the eutectic point of lyophilization?

Many manufacturers file (in applications) their normal lyophilization cycles and validate the lyophilization process based on these cycles. Unfortunately, such data would be of little value to substantiate shorter or abnormal cycles. In some cases, manufacturers are unaware of the eutectic point.

Why do vials need to be stopped prior to lyophilization?

Ice on shelves prior to loading can cause partial or complete stoppering of vials prior to lyophilization of the product. A recent field complaint of a product in solution and not lyophilized was attributed to preliminary stoppering of a few vials prior to exposure to the lyophilization cycle.