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.
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