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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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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Discovery SoftwareComputational techniques used in both the chemistry and biology aspects of drug discovery, for data acquisition, processing and storage. Software is used for analysis of pathways, target identification, genomics, proteomics, modelling, lead identification, compound analysis and drug modelling among many others. Development SoftwareComputational techniques used in both the chemistry and biology aspects of drug development, for data acquisition, data analysis, processing and storage. Software is used for analysis of ADME results, toxicology, clinical trials and regulatory processes. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). QbDPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.
Managing Risk and Driving Profitability with Today's Process Analytical Technologies in the Pharmaceutical Industry