On November 2022, at Polpharma API Plant, we implemented freeze-drying machine!
Crunchy habits
It has become a habit of the modern world to choose healthy rather than a junk food. Therefore, when we feel like having a popcorn, we often choose to crunch… a strawberry instead.
However, can we actually enjoy all natural and healthy features of a fruit for a whole year, whilst it would not lose its taste and nutritional values without preservatives? The answer is, yes, we can and here come the lyophilisates!
It was already during the World War 2, when freeze drying process was applied for the first time! The purpose was to maximise reduction of food’s weight.
Today, often unconsciously, we use freeze-dried products in our day-to-day life! It is not dedicated only for fruits, but also so commonly consumed products like powdered milk, or instant coffee, which are also lyophilizates.
Similarly to the food industry, the freeze-drying process is also used in pharmaceutical industry! Consequently, freeze-dried active pharmaceutical ingredients developed at Polpharma API facility can have a significant impact on the finished dosage production.
On November 2022, at Polpharma API Plant, we implemented freeze-drying machine!
The new installation is dedicated for the process of obtaining Isavuconazonium sulfate API on a semi-technical scale (with the prospect of increasing the scale). Due to products’ sensitiveness to temperature and humidity, the traditional drying methods can interfere the quality of compound.
High quality APIs
As a European producer, we want to ensure the highest possible quality of our active pharmaceutical ingredients. This is why, we decided to take advantage of the lyophilization process.
Lyophilization process is to remove the water from frozen material by ice sublimation. It means the transition of ice into water vapor without the liquid state. This is possible by freezing a product inside the lyophilizer chamber to low temperatures, e.g. -50°C, and then lowering the pressure in this chamber. Residual organic solvents evaporate along with water. Remains of water and solvents are removed by heating the material to a temperature above 0°C and drying under reduced pressure.
Effective partnership: knowledge & experience
Elaboration of a drying program requires a lot of know-how and experience, which we all have at Polpharma API facility. Additionally, we are proud of cooperation with Polpharma Biologics during the development process of the Isavconazonium sulfate.
At Polpharma API, we are ready to handle different ways of cooperation to provide you with high quality APIs and to develop tailor-made solutions.
Authors:
Slawomir Dorn, API Production specialist, PS V Area
Tomasz Zasiewski, to Senior Warehouse Management Operator