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.

Другие товары поставщика

	Photovoltaic module wire tube bending testing machine	Standard IEC 61730-2:2004: Photovoltaic (PV) Module Safety Qualification – Requirements for Testing CE Certification(Conformité Euro...
	5kN Universal Testing Machine	Standards: 1. Test machine host 1 set, 2. 1 set of test control software, 3. 1 set of data acquisition card, 4. Stepper motor 1 set, 5. Decelera...
	Shoelace Wicking Tester	Product Introduction: Paste the cut sample on the test fixture of the portable MARK-II anti-slip testing machine, put down the weight of the rotat...
	Paper and cardboard crease stiffness meter	Paper and cardboard crease stiffness meter - Other test instrument - standard Product Introduction: ZY-TDY300 microcomputer bending stiffness tes...
	G631A electric shoe stripping testing machine	Upper peeling strength tester is suitable for testing the peeling strength between the sole and the upper of the shoe, the principle is to load the...

Похожие товары

	pH-2398 pH/EC/ORP/Temperature multi-parameter Water Quality Tester	Продавец: Коллирон электроникс лимитед	Feature Large display screen, capable of simultaneously measuring water quality pH, redox potent...
	ORP-2026S Waterproof Soil ORP and Temperature Meter	Продавец: Коллирон электроникс лимитед	范围 ORP -999～999mV Temp 0～50℃ 分辨率 ORP 1mV...
	TDS-2616 Waterproof EC/TDS/Temperature Meter	Продавец: Коллирон электроникс лимитед	Range EC ～19.9mS TDS Temp 0～50℃ R...
	EC-98330 CF ECOstick - Nutrient Tester	Продавец: Коллирон электроникс лимитед	Ideal for hydroponics and agriculture applications, theNutrient Tester accurately measures the el...
	PH-808 Waterproof Soil PH Meter	Продавец: Коллирон электроникс лимитед	Model PH-808 Range PH ～14.00PH Temp 0～50℃ ...