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January 15, 2009 (Vol. 29, No. 2)

Online Monitoring of In-Process Samples

Waters Applies Its UPLC Technology to Obtain QC Results on the Biomanufacturing Floor

  • Manufacturing Efficiency

    With the introduction of Waters’ UltraPerformance LC® (UPLC®) technology it is now possible to achieve near real-time chromatographic analysis for in-process samples. The Patrol™ UPLC Process Analyzer brings reference-standard methodology and performance to the manufacturing floor, eliminating the need to send in-process samples to an offline QC laboratory.

    The biggest advantage of UPLC is its reliability, resolving power, sensitivity, and analytical speed. For example, UPLC is able to deliver analysis speeds up to ten times faster than HPLC. The improvements in speed, resolution, and sensitivity made possible by UPLC technology drew the attention of process engineers and support chemists seeking ways to improve the manufacturing efficiency and quality of biopharmaceuticals and small molecule pharmaceuticals.

    The Patrol UPLC Process Analyzer has been designed and optimized to leverage and take advantage of new sub 2 µm hybrid particle technology. It features integrated hardware, chemistry, control and communication software, and a ruggedly engineered sample-introduction technology—all contained within a NEMA 3R- or NEMA 4X-rated enclosure purpose-built for the manufacturing environment.

    The Patrol UPLC Process Analyzer is compatible for both online and at-line analysis of process streams or reactors providing fully automated real-time analysis of in-process samples with no need for user intervention. Results can be sent directly to a distributed control systems or a LIMS completing a closed-loop monitoring process. For at-line applications where it may be desired to have samples extracted from a reactor or the process stream by a technician, the system features a walk-up interface with internal barcode scanning capabilities eliminating the need for a technician to key in sample or analysis information.

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