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.

Criterios aplicables:

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.