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

	Helmet Xenon Aging Tester	Standards GB/T2014-9-19. ISO 4892 ASTM G151. G154. D4329 d4587、d4799、sae j2020 Xenon lamp aging test box structure 1. the box is molded by C...
	Luggage rod reciprocating fatigue testing machine	Product Introduction: Luggage rod reciprocating testing machine for luggage rod reciprocating fatigue test. In the test, the specimen will be stre...
	Standard Helmet Visual Field Tester	Standards EN 1078:2023: Helmets for Pedal Cyclists, Skateboarders, and Roller Skaters CE Certification(Conformité Européenne) Equi...
	Diaper impurity detector	Product Introduction: The diaper impurity detector is used to detect the impurities remaining inside the diaper under a certain strong light irrad...
	Safety hat antistatic performance tester	Product Introduction: Safety hat anti-static performance tester according to the new national standard GB/T 2812-2006 "Safety hat test Method", GB...

Похожие товары

	FH-77 Dissolved hydrogen meter	Продавец: Коллирон электроникс лимитед	Pen type dissolved hydrogen detector / dissolved hydrogen meter: used to measure the dissolved hy...
	Xenon Arc Weather Ometer	Продавец: Standard Group (Hong Kong) Limited	Get a quote： Whats/App: +86 181 0160 0864 SI4000Xenon Arc Weather Ometer utilizes a xenon lamp ...
	Xenotest | Light Fastness Tester Si220 (SunTest)	Продавец: Standard Group (Hong Kong) Limited	Get a quote： Whats/App:+86 180 0160 0864 A Light Fastness Tester, or Xenon Tester, Accelerated ...
	Ozone Aging Chamber	Продавец: Standard Group (Hong Kong) Limited	Get a quote： Whats/App:+86 156 1874 6768 The Ozone Aging Chamber is a precision testing instrum...
	Plastic Smoke Density Tester F313	Продавец: Standard International Group (HK) Limited	Whats/App: +86 156 1874 6768 Web: standard-groups.com The F313 Plastic Smoke Density Tester is ...