Pharmaceutical manufacturing relies on consistent efficacy and extended shelf life. Lyophilization or freeze-drying plays a pivotal role in helping achieve these goals. It is a critical process that involves freezing a substance while minimising the pressure to allow frozen water to be sublime from solid to water vapour to the gas phase. Let’s understand the science behind lyophilisation and how it can preserve your pharmaceutical products.
What is Lyophilisation?
Lyophilisation is a water-removal process that is used to preserve perishable components and materials. This process helps to prolong the shelf life of pharmaceuticals and make them convenient for transportation. Lyophilisation works basically by freezing the sample of interest, then minimising the pressure and adding heat for the frozen water in the sample to sublimate from solid to water vapour to gas. Aral Research provides high-quality lyophilisation services in Ahmedabad. We have extensive experience in the development and optimisation of lyophilisation to ensure seamless scale-up of your products.
How Does Lyophilisation Work?
Lyophilisation or freeze drying is a 3-stage process that includes freezing, sublimation, and adsorption phases to preserve products. Lyophilised products reduce storage and shipping costs, along with longer shelf life, resulting in less waste. This process occurs in three stages:
Freezing Stage
There are different techniques to freeze the product, such as freezers, shell freezers or a freeze dryer. The material is frozen below the triple point to ensure sublimation and rapid melting to preserve its physical form. Lyophilisation makes this easier through large ice crystals that are formed by slow freezing. It is important to note that in the case of biological materials, crystals may be too large, and they can break the cell walls, leading to undesired freezing drying results. To avoid this, the freezing needs to be done quickly. For materials that are prone to precipitate, annealing should be used.
Sublimation Stage (Primary Drying)
The second stage of lyophilisation is the sublimation phase. In this, the pressure is lowered, and the material is heated for the water to sublimate. The cold condenser offers a surface for the water vapour to solidify and protect the vacuum pump from the water vapour. In the primary drying stage, nearly 95% of water is removed from the product.
Adsorption Stage (Secondary Drying)
In the final stage of lyophilisation viz the adsorption phase, the ionically-bound water molecules are removed by increasing the temperature. This phase ensures the achievement of the perfect moisture content while focusing on the stability and preservation of the lyophilised product.
Expert Lyophilisation Services
At Aral Research, we ensure careful monitoring, temperature control, and pressure control for precise stability and quality of the final product. We use advanced equipment and technology to develop and optimise lyophilisation cycles in our analytical lab to allow you to scale up commercial production seamlessly. Our team is well-equipped to provide custom lyophilisation formulations for proteins, anti-biotics, small molecules, and other combination products.
Moreover, as a leading research and analytical lab, we also provide LCMS service in Ahmedabad. Aral Research is your one-stop destination for all your analytical needs. To discuss your lyophilisation project needs, get in touch with us today.
