Linde LLC is to join IMA Life North America at the Pack Expo International and Pharma Expo conventions to demonstrate its proprietary VERISEQ® Nucleation CUMULUS® Lyophilisation technologies.
Linde’s VERISEQ Nucleation improves the control and efficiency of pharmaceutical freeze drying processes. The process controls formation of ice crystals using a sterile cryogenic ice fog resulting in enhanced lyophilisation (freeze drying) cycles and improved product quality and uniformity.
Its CUMULUS Lyophilisation technology is environmentally friendly and replaces traditional mechanical cooling systems. The system allows pharmaceutical producers to attain unparalleled cooling rates under a linear cooling profile over a wide range of temperatures, as well as reduced maintenance issues and dependence on electric power.
IMA Life North America licences both systems.
“Our collaboration with IMA Life has facilitated implementation of the VERISEQ Nucleation process on virtually any freeze dryer – from laboratory to commercial-scale lyophilisers in aseptic and non-aseptic environments, regardless of pressure rating,” said Linde’s Eugene Wexler, Senior Project Manager for Chemicals & Environment, Applications. “Our flexible solution can be installed on new units and/or retrofit onto existing systems.”
Biologics, such as proteins, vaccines and other injectables, must remain effective from manufacture to patient administration. These substances are expensive, fragile and can lose their efficacy during storage. Lyophilisation involves the removal of solvent in such a way that the active substance of the drug product is least disturbed in highly controlled environments in compliance with strict regulatory guidelines for stabilising these valuable medical substances. The temperature at which a vial starts to freeze (ice nucleation temperature) is critical in the process to optimise production times and improve the uniformity of the final product.
Further still, achieving lower operating temperatures and well-controlled cooling rates with liquid nitrogen cooling systems on both the shelf and the condenser sides of the freeze dryer, allows pharmaceutical companies to increase both productivity and efficiency.
The convention is being held at McCormick place in Chicago, Illinois from the 6th to the 9th of November at booth S-3547 in the South Hall.