Residual Ethylene Oxide Gas Chromatographic Analyzer
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.
在线联系供应商
Other supplier products
 |
Smoke - Emission Testing Machine for Aerospace Wires and Cables | Standards Compliance: In accordance with the provisions of the U.S. military specifications MIL - W5086C and 22759D, as well as "GJB17.17 - 84 Tes... |
 |
Paper quantitative tester | Product Introduction: The circular square quantitative sampler （referred to as quantitative sampler） is a special sampler for the quantitative det... |
 |
Fiber Crimp Elasticity Tester | Product Introduction: YG362C fiber crimp elasticity meter is used for crimp degree of 1-22dtex fiber. Crimp elasticity, crimp recovery rate index... |
 |
Bio-absorbable Internal Fixation Plates Tester | Standard YY/T 0509-2009 (China): Specifies mechanical testing protocols for orthopedic plates/screws made of hydrolyzable polymers, including axia... |
 |
Shoelace Abrasion Tester | Application: This shoelace abrasion tester is used for shoelace against standard eyelet abrasion testing, or eyelet against standard shoelace abra... |
Same products
 |
Plastic Smoke Density Tester F313 | 卖方: Standard International Group (HK) Limited | The F313 Plastic Smoke Density Tester is a precision instrument designed to measure the specific ... |
 |
Xenon Test Chamber | 卖方: 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 | 卖方: 上海千实精密仪器 | Introduction Single Cable Vertical Flame Tester is used for the vertical flame propagation of a ... |
 |
Safety Helmet Flammability Tester | 卖方: 上海千实精密仪器 | Product Introduction: Safety hat flame retardant performance tester for safety hat flame retarda... |
 |
Furniture flammability tester | 卖方: 上海千实精密仪器 | Product details Furniture flammability tester is mainly used to test the combustion performance ... |
