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GE Healthcare Introduces ÄKTA™ready Liquid Chromatography System
GE Healthcare has launched ÄKTA™ready a liquid chromatography system designed for process scale-up and production for Phase I-III drug development and full scale production to GLP and cGMP standards.
ÄKTAready operates with ready-to-use, disposable flow paths, eliminating the risk of cross-contamination and the need for cleaning and validation of cleaning procedures.
ÄKTAready comprises the chromatography unit, UNICORN™ software, and a disposable ReadyToProcess™ Flow Kit including sensors and detection flow cells.
UNICORN includes an installation wizard that provides instructions and reports for column installation and ensures correct functionality of the Flow Kit. All ÄKTA systems use the same software, which enables process scale-up and transfer to ÄKTAprocess for use in full cGMP production.
The ÄKTAready system is supported by extensive regulatory product documentation and services, including validation documentation, product documentation with information about materials used, USP Class VI CFR 177 and AOF certificates and a Regulatory Support File (RSF).