What is the principle of lyophilization?

The basic principle in lyophilization is sublimation, in which the conversion from a solid directly into a gas occur. Just like evaporation, sublimation occurs when a molecule gains enough energy to break free from the molecules around it.

What are the steps in lyophilization?

The steps required to lyophilize a product in a batch process can be summarized as follows:

1. Pretreatment / Formulation.
2. Loading / Container (Bulk, Flask, Vials)
3. Freezing (Thermal Treatment) at atmospheric pressure.
4. Primary Drying (Sublimation) under vacuum.
5. Secondary Drying (Desorption) under vacuum.

How do you optimize lyophilization cycle?

– Freeze the product below the collapse temperature for atleast 2-3 hours and start drying under vacuum. – The chamber pressure to be set should be less than (preferably 1/3rd) the icevapour pressure. For eg if your collapse termperature is -30°C. Freeze you product to -40°C for 2-3 hours.

What is lyophilization and what is its function in those steps?

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 the benefit of lyophilization?

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.

Why do we do lyophilization?

Lyophilization allows us to remove ice or water, from a product without destroying our volatile molecules. Not necessarily volatile, but those that might be susceptible to high heat. So, these products are placed in a lyophilizer, cooled and frozen, and then a vacuum is established to remove ice as sublimation.

What is lyophilization PDF?

Lyophilization or freeze drying is a process in which water is frozen, followed by its removal. from the sample, initially by sublimation (primary drying) and then by desorption (secondary. drying). Freeze drying is a process of drying in which water is sublimed from the product.

What is lyophilization in microbiology?

Lyophilization, also known as freeze-drying, is a process used for preserving biological material by removing the water from the sample, which involves first freezing the sample and then drying it, under a vacuum, at very low temperatures.

Why is lyophilization used?

“If the bulk drug ingredients are not stable in liquid or frozen form, lyophilization is necessary. Lyophilization enables longer shelf life, often as long as two-five years and makes it much easier to transport the product.

What is Triple Point in lyophilization?

Simply put, the triple point of water is the only temperature at which water can exist in all three states of matter; solid (ice), liquid (water), and gas (water vapour).

What is the definition of lyophilized?

[ lī-ŏf′ə-lĭ-zā′shən ] n. The process of isolating a solid substance from solution by freezing the solution and vaporizing the ice away under vacuum conditions. freeze-drying.

Why is lyophilization process transfer and scale up so difficult?

However, lyophilization process transfer and scale up is very difficult to platform. In most cases, this is due to the fact that in large pharmaceutical and biotechnology companies, commercial manufacturing is often performed in multiple locations in collaboration with numerous contract manufacturing organisations.

Is the lyophilization cycle appropriate for your product’S phase of development?

If the lyophilization cycle is appropriate for the product’s phase of development. For early phase products, a more conservative approach is acceptable, and because API is often extremely expensive and in short supply, a more conservative lyophilization cycle can mitigate the risk in production.

What are the acceptable lyophilization process parameters for clinical sites?

From our experience, each commercial or clinical site has its own acceptance criteria for lyophilization process parameters. In relatively old lyophilizers, shelf temperature and pressure are allowed to vary from their set point ±5°C and ±20mT, respectively.

What are the Critical Quality Attributes related to the lyophilization process?

Comparison of several critical quality attributes related to the lyophilization process for products manufactured at pilot scale and at-scale was also completed, including appearance of the lyophilized product and the reconstituted solution, pH, reconstitution time, residual moisture, content by HPLC, and related substances.