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Manufacturing and QA/QC
Process for production, Quality control & assurance
Shimadzu's solutions for pharmaceutical manufacturing QA/QC cover a broad range of
applications with fulfilling the regulatory compliance needs.
LC systems for QA/QC
Shimadzu HPLC systems are widely used in manufacturing QA/QC laboratorys around the world because of their reliability and robustness. Modular types of LC (Prominence series) and integrated types of LC(LC-2010 series) cover many different types of applications.
High throughput LC dissolution testing with Prominence UFLCXR is one of the more recent solutions for improving efficiency. LCsolution software offers easy operation with a convenient Assistant bar , Data explorer, and Batch table wizard. GLP/GMP regulatory compliance, user management functions, validation assistance, audit trail assistance, and QA/QC function are provided as standard features.
GC systems for QA/QC
The Shimadzu GC product line encompasses the widest range of GC models, allowing the user to find an instrument matching the application requirements in their particular pharmaceutical area.
GC-2010 Plus high-end GCs can be configured as multidimensional GC systems or headspace GC systems. GC-2014 is a versatile standard capillary and packed column GC.
GCsolution is flexible but easy-to-operate software that supports regulatory compliance environments, including pharmaceutical manufacturing QA/QC. It is equipped with GLP/GMP assistance functions.
Cleaning Validation TOC system
Many pharmaceutical manufacturing facilities use TOC detection for the cleaning validation process. Biopharmaceutical QA/QC labs require TOC cleaning validation systems to analyze proteins/peptides as total amounts.
TOC-V series with TOC-V control software supports cleaning validation work that use swab-sampling and rinse-sampling methods. CLASS-Agent data management systems ensure reliability for regulatory compliance needs.
Impurity identification LC/MS system
When unexpected peaks appear in LC data, LCMS-2020 with Prominence UFLC quickly gets mass information for the unknown peaks in the chromatogram. LCMS-2020 has many beneficial features, including higher sensitivity, faster positive/negative polarity switching and faster scan speeds. These are ideal for ultra fast chromatography analyses. DUIS ion source enables the use of ESI and APCI simultaneously without exchanging hardware. It does not need to shut down the vacuum pumping for daily ion source maintenance.
Non-destructive testing system for tablets
The inspeXio SMX-90CT, bench top micro CT system is compact and easy to use with simplified calibration. It is ideal for non-destructive testing for pharmaceutical, tablets crack check, layer uniformity control, core position check of dry-coated tablets and check of injection solution/infusion solution.
Non-destructive testing system for foreign substances
Energy Dispersive X-ray fluorescence (EDX) spectrometers are used to perform qualitative and quantitative analyses for elements comprising a material by measuring re-emitted characteristic X-rays from elements.
EDX is non-destructive and therefore can be used for various applications like analysis of foreign substances.The EDX-720 is released with improved sensitivity for lead (Pb) and cadmium (Cd) which are important elements for human health related analysis.
