Biological products like proteins, vaccines and other injectables must remain effective from manufacture to patient administration. These substances are expensive and fragile, and can easily lose their efficacy during storage.
Valuable biologicals can, however, be stabilised by dehydrating them. This pharmaceutical freeze-drying process is referred to as lyophilisation, and is carried out in highly controlled environments in compliance with increasingly strict regulatory guidelines. Successful lyophilisation extends shelf life and prevents many bio-pharmaceuticals from degrading. The challenge lies in controlling the nucleation temperature (the temperature at which a biological vial freezes). This is the most effective way of producing a homogenous structure within the product.
Cryogenic nitrogen is used to improve various aspects of lyophilisation, improving process controllability and product quality while reducing costs.
Traditional mechanical cooling systems can be replaced with cryogenic cooling systems, targeting both the shelves and condenser coils. Based on our patented CUMULUS® design, our technology seamlessly integrates into existing lyophilisers, allowing pharmaceutical producers to reach lower temperatures than those previously possible with heat transfer fluids such as SYLTHERM™ XLT. In addition to providing a reliable source of cooling, our solution eliminates the maintenance associated with compressors.
Liquid nitrogen creates a sterile ice fog that is distributed inside the lyophiliser to simultaneously and uniformly nucleate all of the vials. The uniformity provided by our nucleation technology results in a wide range of benefits, including cycle time reduction, enhanced process control, process repeatability and improved product quality.