BRIDGEWATER, N.J., Nov. 4, 2016 /PRNewswire/ -- Linde LLC will demonstrate its nucleation and cryogenic lyophilization for use in freeze dryers by pharmaceutical manufacturers involved in preserving delicate biotech and non-biotech materials at the Pack Expo International and Pharma Expo convention to be held at McCormick Place in Chicago, Illinois, November 6-9.
Linde will join IMA Life North America at its booth (S-3547) in the South Hall, to assist in highlighting the advantages of Linde proprietary VERISEQ® Nucleation technology for freezing materials such as injectable solutions, proteins, peptides, and vaccines, as well as Linde's proprietary CUMULUS® Lyophilization system for cooling lyophilizers. IMA Life licenses both systems. Linde's VERISEQ Nucleation improves control and efficiency of pharmaceutical freeze drying processes. The process controls formation of ice crystals using a sterile cryogenic ice fog resulting in enhanced lyophilization (freeze drying) cycles and improved product quality and uniformity. "Our collaboration with IMA Life has facilitated implementation of the VERISEQ Nucleation process on virtually any freeze dryer - from laboratory to commercial-scale lyophilizers 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." Linde's environmentally friendly CUMULUS Lyophilization technology, which replaces traditional mechanical cooling systems, 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. 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. Lyophilization 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 stabilizing these valuable medical substances. The temperature at which a vial starts to freeze (ice nucleation temperature) is critical in the process to optimize production times and improve the uniformity of the final product. Also, 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.