Manufacturing and QA/QC

Process for production, Quality control & assurance

Shimadzu's solutions for pharmaceutical manufacturing QA/QC cover a broad range of applications while fulfilling the regulatory compliance needs.

  • Solutions
  • System Lineup

LC systems for QA/QC

Shimadzu HPLC systems are widely used in manufacturing QA/QC laboratories around the world because of their reliability and robustness. Modular types of LC (Prominence series) and integrated types of LC (i-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. LabSolutions 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 functions are provided as standard features.

LC systems for QA/QC

GC systems for QA/QC

GC systems for QA/QCThe 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

Cleaning Validation TOC systemMany 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.
TheTOC-L series with TOC-L/V control software supports cleaning validation work that uses swab-sampling and rinse-sampling methods. CLASS-Agent data management systems ensure reliability for regulatory compliance needs.



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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.

Impurity identification LC/MS system


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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-7000 is a great instrument with improved sensitivity for lead (Pb) and cadmium (Cd) which are important elements for human health related analysis.
Impurity identification LC/MS system


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Laboratory data & knowledge/record management solutions



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Data Systems Data Systems and Data Management Tools
In the pharmaceutical industry, compliance to regulations and guidelines, such as CSV and PIC/S GMP and U.S. FDA 21 CFR Part 11, and the proper, efficient management of instrumentation and analytical data is required. Shimadzu's LabSolutions network-compatible analysis data system provides a fast and efficient management of instruments. Review our lineup of Data Management Software tools: LabSolutions LC/GC, LabSolutions DB, LabSolutions CS, LabSolutions GPC, LabSolutions IR, LabSolutions RF, Class-Agent and C-R8A Integrator.
Multi-vender software support Multi-vendor software support
Shimadzu has worked closely with other chromatography vendors to provide software drivers enabling other vendor's software to control our instrumentation. Review our lineup of vendor software drivers: LC driver for Waters Empower 3, GC driver for Waters Empower 3, i-Series LC driver for Waters Empower 3, LC drivers for Agilent's OpenLAB CDS EZChrom, GC driver for Agilent's OpenLAB CDS EZChrom, LC driver for Thermo Scientific Chromeleon 6.8, SPD-M30A Photodiode-array LC detector driver for Thermo Scientific Chromeleon 7.2.
LC/HPLC Liquid Chromatography
For over 40 years Shimadzu has been recognized as a leader in innovative and robust Liquid Chromatography instrumentation. Liquid chromatography has become an integral analytical tool for researchers and analysts across the entire workflow of Pharmaceutical and Biopharmaceutical analysis from Drug Discovery through Clinical Trials and into production and Quality Assurance. Whether your requirements are for a stand-a-lone HPLC/UHPLC or as a front-end to Mass Spectrometry Shimadzu's line of liquid chromatography products will meet or extend your application needs. Review our comprehensive lineup of instruments: Nexera X2 UHPLC, Nexera SR UHPLC, Nexera MP Front End UHPLC, Nexera UC SFE-SFC, Nexera-e 2D-LC, Nexera-i Integrated UHPLC, Nexera HPLC/UHPLC Method Scouting, Prominence HPLC, Prominence UFLC, Prominence-I Integrated HPLC, Prominence nano LC, Co-Sense 2D-LC system for Bioanalysis.
LC-MS LCMS and LC/MS/MS
With the fastest multiple reaction monitoring (MRM) transition times available today, high-speed multi-analyte detection with 500 MRM transitions in one second, and unsurpassed polarity switching speed, the LCMS-8060, LCMS-8050, LCMS-8040 and LCMS-8030 triple quadrupole LC/MS/MS systems delivers speed beyond compare. Combining these advanced mass spectrometry technologies with Shimadzu's world-leading Nexera UHPLC performance creates a unique system approach to ultra fast mass spectrometry detection.
Gas Chromatography Gas Chromatography
Since our first GC was introduced in 1956, Shimadzu has been developing innovative Gas Chromatography solutions. The Shimadzu GC product line encompasses the widest range of GC models, allowing the user to find an instrument matching the application requirements. Combining engineering expertise with the ability to listen to customer needs has resulted in an extensive array of GCs, sample handling, and data processing solutions.
Gas Chromatography Mass Spetrometry Gas Chromatography Mass Spectrometry
For over 30 years Shimadzu has been a leader in design innovations, such as our front access ion source, high efficiency ion optics, 20,000 µ/second scan speed, and post-quadrupole focusing lenses. Shimadzu is a market leader in system ruggedness combined with exceptional performance, simplified operation, and maintenance. Review our comprehensive lineup of instruments: the GCMS-TQ8040 with Smart MRM, GCMS-QP2010 Ultra, and the GCMS-QP2010 SE.
ICPE-9800 ICPE-9800 Series
The new Shimadzu ICPE-9800 series is designed to help you meet the latest regulatory sensitivity guidelines for metal impurities in pharmaceuticals using ICPE. Support for the management of electronic data in compliance with 21 CFR Part 11 is available.
X-ray X-Ray Instruments
The Energy Dispersive X-Ray EDX) Fluorescence spectrometers enable high-speed, high precision elemental analysis of a variety of Pharmaceutical samples such as metal impurities and catalysts during synthesis. The 12-position sample turret enhances productivity in combination with virtually no sample preparation.
Micro-volume UV-Visible Spectrophotometers Micro-volume UV-Visible Spectrophotometers
The Shimadzu BioSpec-nano is a low-maintenance micro-volume spectrophotometer designed for the modern life science laboratory. It offers superior detection limits compared to comparable competitive systems, making it the perfect instrument for quantitation of DNA, RNA, protein analysis, and photometric measurements. Quantitation can be rapidly and simply measured required volumes of only 1µL. And, with dedicated functions, such as automated sample mounting and wiping, the BioSpec-nano offers a rapid 3-second analysis time and a 10-second cycle time between samples.
UV-Visible Spectrophotometers UV-Visible Spectrophotometers
Shimadzu has been developing UV-Vis spectrophotometers for 60 years, and continues to manufacture instruments that meet scientists' needs for ruggedness, ease of use, validation and applications. Our current lineup features the general, all-purpose UV-1800 with best-in-class resolution (1nm) and built-in biological software, introductory research-grade UV-2600, with an extended range to 1400nm, and the double monochromator UV-2700, which is capable of high Abs measurements. These compact systems are equipped with proprietary low-ray-ligh gratings, offer USB connectivity, and come with the full-featured UVProbe software.
FTIR FTIR Spectrophotometers
Whether you are looking for a simple instrument for a teaching lab or a sophisticated research instrument, Shimadzu can provide you with a high-performance option. Combining high speed, best-in-class 60,000:1 S/N ratio, and excellent resolution with enhanced expandability and easy-to-use software, the IRTracer-100 quickly and easily obtains high-quality data for a wide range of samples. Designed with the teaching and general research laboratories in mind, the compact, robust IRAffinity-1s FTIR is ideal for high-precision infrared analysis to confirm, identify, and detect foreign matter in a multitude of application areas.
TOC TOC
Shimadzu has been a world leader in the design and manufacture of high-quality and robust Total Organic Carbon (TOC) analyzers for over 40 years. They are used for the analysis of waste water from manufacturing plants and helping to manage Pharmaceutical manufacturing processes such as Cleaning Validation. Both bench-top and on-line analyzers are available. Review our comprehensive lineup of instruments: TOC-L Laboratory Total Organic Carbon Analyzer, TOC-VW Wet Chemical Total Organic Carbon Analyzer, TOC-VCSH for automatic online TOC analysis complying with USP/EP.
Edman Chemistry Protein Sequencer Edman Chemistry Protein Sequencer
Protein sequencing via automated Edman degradation chemistry remains a simple and robust solution for many labs, delivering unambiguous data that is much less complex than the data obtained through mass spectrometry-based techniques.
Prep-scale liquid chromatography Prep-scale liquid chromatography
Shimadzu has installed more than 2000 preparative HPLC systems throughout the world, and remains committed to improving the purity and speed of separation and making this technique more cost effective. Using our broad experience and technologies at various scales and in diverse fields, we have significantly enhanced the performance that can be obtained from preparative HPLC.
LC-MS Nexera Comprehensive 2D-LC
Nexera-e enables the separation of even the most complex mixtures, providing a new level of knowledge and understanding of sample analytes. This is especially beneficial for the identification and quantitation of analytes in pharmaceutical impurities, peptides, lipids, and proteolytic digests.
LC-MS Nano-scale Liquid Chromatography
The Prominence nano is a nanoflow LC system consisting of Prominence Series units, including a flow line switching valve for nano-level flow control, and a solvent delivery unit that demonstrates excellent flow rate accuracy even at nano-level flows. Two system configurations are available, including a basic 1-dimensional system that adopts the trap injection system and a 2-dimensional system in which reversed-phase separation is automatically conducted following the first stage cation-exchange separation.
Automated Protein Seperation Automated Protein Seperation
Perfinity technology, through automation and patented immobilized enzyme reactor columns, accelerates protein sample preparation workflows and provides reproducibility to proteolysis which cannot be obtained through traditional methods.
Thermal Analysis Thermal analysis
Shimadzu Thermal Analysis Systems offer unmatched flexibility in material characterization with either complete standalone functionality or multi-system operation for up to 4 units. Regulatory compliance is strongly supported.
Universal Testing Universal Testing
Shimadzu offers a range of first-class testing instruments to meet R&D requirements in the development of safer and higher quality materials and products. With Universal/Tensile Testers like the AG-X Series, the new AGS-Xplus series and the bench-top EZ Test, Capillary Flow and Endurance Testers, and a variety of Micro Hardness Testers like the DUH-211 Series, the choice is yours. Combined with Shimadzu's selection of accessories, including grips, extensometers, and jigs, and the optional Windows®-compatible Trapezium X Software, which provides simplified user operation with Wizards and the industry's premier navigation system, Shimadzu can provide you with a solution for any environment or application.
Balances Balances
Shimadzu has introduced user-friendly instruments and features to the market, such as: the temperature-based fully-automatic calibration in 1985, the first one-piece force cell (OPF, later renamed UniBloc) in 1989, the high-sensitivity AEM-5200 Micro Balance in 1993, and the unique Windows® Direct feature perfectly suited for the computerized laboratory of the 21st Century. Moving forward, Shimadzu is committed to providing innovative products for the analytical marketplace. Learn more now.