On the leading edge
A closer look at the Lyophiliser
Pharma Production in Mannheim is state-of-the-art. It uses all available technologies to manufacture sterile drugs, including lyophilisation to make unstable products easier to store.
Gentle drying is half the battle
External factors such as light or temperature fluctuations can destabilise sensitive active pharmaceutical ingredients. Lyophilisation extends the shelf lives of our therapeutic proteins without changing their characteristics. The product of lyophilisation is called the lyophilisate.
What do instant coffee and therapeutic proteins have in common?
The method used to preserve them! “Lyophilisation” (freeze-drying) is used to extend the shelve lives of both instant coffee and biological active pharmaceutical ingredients. Freeze drying is a procedure that preserves coffee or drugs without changing the product’s desired characteristics.
How does freeze-drying work?
Companies like Roche use computer-controlled plants with vacuum chambers for lyophilisation. These also contain a cooled condenser. The water in the product enters the plant in a gaseous state and condenses on its surface, “accreting” in the form of ice. The entire process is as follows: First, the product is deep-frozen in the chamber at temperatures as low as -60°C. Once it has frozen, the chamber is “evacuated”, i.e. a vacuum is generated which acts like a pump and empties the chamber. Heat is then added, causing the ice crystals contained in the product to change directly to a vapour – without going through a liquid phase. This process is called “sublimation”. This marks the end of the “primary drying” stage. It is followed by secondary drying, where the chamber is evacuated further to remove more strongly bound water molecules.
Before freeze-dried drugs are administered...
...they have to be reconstituted using water. The special structure of the freeze-dried substances means that this is quick and easy.
Freeze-drying at the hi-tech Mannheim site
At Pharma Production in Mannheim, lyophilisation plants are mainly used to preserve cancer drugs. The Mannheim modules have a freeze-drying capacity of 20 m² (three modules) and 40 m² (one module).
Sublimation: Turning a solid into gas!
The physical process underlying lyophilisation is called sublimation. This involves removing the fluid (water) in the product by first freezing it and then changing the ice crystals contained in it directly to a gaseous phase (water vapour), without going through the liquid state.
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Photographer: Philipp Wente