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.
About Linde LLC in North America
Linde LLC is a member of The Linde Group, a world leading gases and engineering company. IMA Life North America, headquartered in Tonawanda, New York, manufacturers industrial, pilot and laboratory freeze dryers.
In the 2015 financial year, The Linde Group generated revenue of USD19.7 bn (EUR 17.944 bn), making it one of the leading gases and engineering companies in the world, with approximately 65,000 employees working in more than 100 countries worldwide. The strategy of The Linde Group is geared towards long-term profitable growth and focuses on the expansion of its international business with forward-looking products and services. Linde acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.
For more information, visit www.lindeus.com
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SOURCE Linde North America, Inc.