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Gas chromatograph×サーモフィッシャーサイエンティフィック株式会社／Thermo Fisher Scientific K.K. - List of Manufacturers, Suppliers, Companies and Products

Gas chromatograph Product List

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[Case Study] Analysis of Residual Solvents in Pharmaceuticals for Data Integrity Compliance

[Case Study] Analysis of Residual Solvents in Pharmaceuticals for Data Integrity Compliance

Immediate start of residual solvent analysis in pharmaceuticals using the HS-GC/FID method with data integrity compliance.

Information has become increasingly diverse in recent years, and there is a growing demand for tools that can handle vast amounts of data accurately and conveniently. For example, analytical researchers may find it sufficient to obtain calibration curves and quantitative data from chromatograms and spectral information as chromatography data. However, it may be necessary to ensure that these data were obtained under conditions where the equipment operated correctly. Computerized systems used in the development and manufacturing of pharmaceuticals and medical devices must be properly developed, implemented, and operated, leaving evidence that proves there are no issues with the quality of the pharmaceuticals or medical devices, as well as their quality assurance. Computerized System Validation (CSV) is mandated by pharmaceutical regulations. Achieving Data Integrity (DI) requires essential support from software. This technical note outlines the overview of DI and the software functions required for DI, and introduces examples of residual solvent testing as specified in USP<467> using a headspace-specific autosampler and gas chromatograph that comply with DI.

  • Analytical Equipment and Devices

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[Case Study] Analysis of Ethylene Oxide by HS-GC-FID Method

[Case Study] Analysis of Ethylene Oxide by HS-GC-FID Method

A simple and cost-effective HS-GC-FID analysis for ethylene oxide analysis of surgical masks.

Surgical masks are worn by healthcare professionals during tasks such as surgeries, and like other medical devices, they need to be sterilized to eliminate bacteria and viruses. In some countries, sterilization using ethylene oxide is performed. On the other hand, the Centers for Disease Control and Prevention (CDC) has stated that "ethylene oxide may have harmful effects on the wearer, and therefore is not recommended for the sterilization of masks that are worn on the face," and the Occupational Safety and Health Administration (OSHA) does not approve the use of ethylene oxide as a sterilant. Therefore, it is necessary to test that ethylene oxide and 2-chloroethanol, which is generated during its sterilization process, are sufficiently removed from the final product. This technical document introduces a high-sensitivity and cost-effective analysis method for ethylene oxide and 2-chloroethanol in medical masks using capillary column GC-FID analysis.

  • Analytical Equipment and Devices

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Gas Chromatograph "Trace 1600 Series GC"

Gas Chromatograph "Trace 1600 Series GC"

Flexible configuration and simple controls that meet customer analysis needs.

If your customer's GC is only operating intermittently, they are losing the profits that could have been generated by continuous operation. The Thermo Scientific TRACE 1600 series gas chromatograph (GC) was developed with time and space efficiency in mind. Our patented modular design features plug-and-play injectors and detectors, enabling offline maintenance and allowing for easy changes to different configurations with a single GC, thereby enhancing productivity. When combined with the Thermo Scientific AI/AS 1610 liquid autosampler, this system enables simple and reliable automatic sample injection, meeting a wide range of sample throughput demands. Additionally, the optional He-Saver H2-Safer module addresses helium shortages, significantly reducing helium consumption. *For more details, please refer to the PDF document or feel free to contact us.*

  • TRACE1600_01.jpg
  • Analytical Equipment and Devices

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