Residual Ethylene Oxide Gas Chromatograph

• 

The ethylene oxide residual gas chromatograph is a professional analytical instrument for detecting the residual amount of ethylene oxide in medical-related products.

Applicable standards:

The testing of ethylene oxide residuals is subject to strict international and national regulations and pharmacopoeial requirements to ensure patient and user safety:

ISO 10993-7:2021: "Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals." This is the definitive international standard specifying allowable limits for EO, ECH, and EG based on product contact duration and patient exposure, and outlines test methods.

United States Pharmacopeia (USP): Various chapters, notably those related to chromatography (e.g., USP ) and biocompatibility, which often reference ISO 10993-7.

European Pharmacopoeia (Ph. Eur.): Contains monographs and general chapters (e.g., 2.2.28 Gas Chromatography) that specify methods for the determination of residues of sterilizing agents.

Japanese Pharmacopoeia (JP): Also includes methods for testing residual solvents and sterilizing agents.

National Standards (e.g., GB/T 16886.7 in China): Many countries have adopted or developed national standards that are equivalent to or aligned with ISO 10993-7.

Product Advantages:

High Accuracy and Sensitivity: Capable of detecting trace amounts of EO, ECH, and EG (often in the parts per million or µg/g range), essential for regulatory compliance.

Compliance Assurance: Designed to meet the requirements of key international standards and pharmacopoeias (ISO 10993-7. USP, Ph. Eur.), ensuring validity of test results for regulatory submissions.

Reliable Detection: Utilizes the highly sensitive Hydrogen Flame Ionization Detector (FID) for robust and consistent detection of carbon-containing compounds.

Automated Sample Preparation: Often features automated headspace samplers, reducing manual labor, improving reproducibility, and enhancing safety by minimizing exposure to EO.

Comprehensive Data Analysis: Advanced software provides detailed chromatograms, quantitative results, and reporting capabilities, simplifying data interpretation and compliance documentation.

Ensures Product Safety: Directly contributes to reducing medical risks by controlling residual toxins in sterilized medical supplies, protecting patients and healthcare workers.

Technical Parameters:

1. Precise EPC electronic flow control, controlling the flow or pressure of 18 gas channels.

2. Independently temperature-controlled injectors, with the option to install up to three injectors.

3. High-precision temperature control with 10 independent temperature control zones.

4. Brand-new detector design significantly improves sensitivity.

5. Six independent temperature control systems, suitable for installations requiring multiple temperature control channels, such as a converter. The column chamber, vaporization chamber, hydrogen flame detection chamber, thermal conductivity detection chamber, auxiliary 1. and auxiliary 2 chambers all feature a modular design, making installation and replacement easier.

6. Power-off protection with automatic parameter memorization. It also features immunity to sudden power fluctuations and a stopwatch function.

7. Extensive self-diagnosis with a variety of diagnostic messages, displaying fault causes and solutions at any time.

8. Fully integrated control workstation with three independent digital and three analog outputs.

Другие товары поставщика

	Initial Adhesion Tester	The initial - tack tester, also known as the initial - tack property tester or adhesive tape tackiness tester, is an instrument specifically used t...
	Automobile wire corrugated pipe drag grinding machine	Applicable standards: ISO 6722, QC/T730, JIS C 3046, JASO D 611, SAEJ1128-2005, JBT 8139,TBT 1484.1-2001 Part1, EN50305, EN50306and other standard...
	Paper whiteness tester	Product Introduction: Paper whiteness tester is suitable for the whiteness measurement of non-color surface flat objects or powders, and can accur...
	Ozone Test Chamber STD-AC22	Feature Whole chamber inside and gripers made up of stainless steel, anti-corrosion. Outside of the chamber is baking finish (can choose SUS 304 ...
	Textile Thermal Insulation Property Tester	Standard GB/T 41560-2022 (China): Specifies thermal resistance testing protocols for protective clothing and industrial fabrics. BS 6526:1998 (UK...

Похожие товары

	Xenon Test Chamber	Продавец: Standard International Group (HK) Limited	Features and Benefits 1.The use of xenon arc lamp as a light source, can simulate the full sunli...
	Single Cable Vertical Flame Tester	Продавец: Qinsun Instruments Co., LTD	Introduction Single Cable Vertical Flame Tester is used for the vertical flame propagation of a ...
	Safety Helmet Flammability Tester	Продавец: Qinsun Instruments Co., LTD	Product Introduction: Safety hat flame retardant performance tester for safety hat flame retarda...
	Furniture flammability tester	Продавец: Qinsun Instruments Co., LTD	Product details Furniture flammability tester is mainly used to test the combustion performance ...
	Flame retardant testing machine	Продавец: Qinsun Instruments Co., LTD	Feature highlights: Flame Retardant Tester is designed for testing plastic runway surface layers...