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A Novel Approach to Cleaning Validation for Pharmaceutical Manufacturing by Online Supercritical Fluid Extraction/Supercritical Fluid Chromatography

A Novel Approach to Cleaning Validation for Pharmaceutical Manufacturing by Online Supercritical Fluid Extraction/Supercritical Fluid Chromatography

21 Jan 2016

This application note from Shimadzu Scientific Instruments examines the quality of current cleaning validation methods, looking at how improper methods affect results and how they can be changed to improve the quality in the future.

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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.Washing EquipmentWashing equipment is more convenient than ever before with automated systems, integrated and multi-application systems available. For instance microplate washers can be programmable, combined with reagents dispensers and used for applications such as ELISA, multiplex assays and PCR clean up.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Automation Supplies / AccessoriesAutomated accessories and consumables make lab processes fast, efficient and reliable. Useful automation accessories include microplate sealers, label printers and reagent reservoirs.Automated Liquid HandlingAutomated liquid handling equipment is used to mix, dilute and dispense allotted volumes of liquid into microplates and other vessels automatically. The robotic, liquid handling arms can dispense from single channel to 3456 multichannel as well as operate nanoliter dispensing, enabling high throughput of samples. Find the best automated liquid handlers in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Quality ManagementQuality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Sample HandlingProper and careful handling of samples is important in scientific studies to ensure the integrity of specimens. This will prevent deterioration and cross contamination, and improve the accuracy of sample tracking procedures.ChromatographyChromatography is a powerful technique used to separate and analyze components of mixtures based on their chemical properties. It is widely used in fields like biochemistry, pharmaceuticals, and environmental analysis. By exploiting differences in the interaction of substances with a stationary phase and a mobile phase, chromatography enables precise purification and quantification of compounds. Whether you're working with complex biological samples or industrial chemicals, chromatography is essential for obtaining high-quality results. Browse our peer-reviewed product directory to find the best chromatography systems, compare products, read customer reviews, and get pricing directly from manufacturers.Environmental ContaminationContaminants in the environment are harmful chemicals that are present in the air, land and water. These include pesticides, pharmaceuticals, persistent organic pollutants (POPs) and many more.Solvent ExtractionSample ProcessingSample processing is required to prepare samples prior to analysis. Technologies used for sample processing include homogenizers, grinders, mills and mixers.