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Managing Risk and Driving Profitability with Today's Process Analytical Technologies in the Pharmaceutical Industry

17 Aug 2014

Over the past few decades, terms such as Lean Six Sigma, Total Quality Management, and Continuous Improvement Strategy have become increasingly common in discussions of manufacturing plans. These techniques have one goal in common: to develop processes that maximize productivity and consistency and minimize risk to workers, consumers, and to the company. But each of those methods addresses specific aspects of manufacturing quality and efficiency. This whitepaper discusses the essential value a Quality by Design (QbD) approach brings to process design and identifies what process parameters most affect product quality, and which control strategies assure consistent quality production.

ACQUITY UPLC System

Waters

Waters ACQUITY UPLC - Dramatic Improvements in Speed, Sensitivity and Resolution Whether you work in methods development or quality assurance, in drug discovery and development or testing for safety in food supplies, you seek a productivity edge. With the ACQUITY UPLC® System, now you can get more information in a single, short run than you've ever seen with HPLC. Waters ACQUITY UPLC System UltraPerformance LC® (UPLC®) technology starts with unique 1.7 μm small-particle chemistries. Chromatographers no longer need to choose between speed and resolution–with UPLC you get both. Instrument Designed for Chemistry; Chemistry Designed for the Instrument The ACQUITY UPLC System has been holistically designed to match the performance needs of our innovative column chemistries with robust hardware, easy-to-use software and specialized support services. Small, pressure-tolerant particles High-pressure fluidic modules Minimized system volume Negligible carryover Reduced cycle times Fast response detectors Integrated system software and diagnostics With UPLC you have the ability to work more efficiently with higher speed, sensitivity and resolution at a much wider range of linear velocities, flow rates and backpressures to obtain superior results. The Waters ACQUITY UPLC System's high-pressure fluidics optimizes flow rates to make the most of small particle technology. The ACQUITY UPLC System's sample-handling design is designed to ensure exceptionally low carryover and reduced cycle time. And when interfaced with the Sample Organizer, it increases unattended sample capacity by ten times. High-speed detectors, both optical and mass, contribute to increased sensitivity and help manage the heightened speed and resolution requirements of UPLC. ACQUITY UPLC Systems are easily controlled, diagnosed, and monitored via a graphical system console interface. The console offers: Quick and easy access to critical instrument parameters Simple system start-up, elegant system status monitoring and predictive performance indicators to ensure maximum productivity Data management capabilities that are supported by both MassLynx™ and Empower™ software The ACQUITY UPLC System is also supported by Intelligent Device Management technology with our Connections® INSIGHT™ service, providing instrument diagnostics.

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Empower™ Chromatography Data System

Waters

The Empower Chromatography Data System is Waters’ compliance-ready chromatography data software (CDS) for advanced data acquisition, processing, and reporting that simplifies the management of chromatography test results.

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