Residual Ethylene Oxide Gas Chromatography System
Application
The system is suitable for the analysis of residual ethylene oxide in the following industries and products:
(1) Medical Device Industry: surgical instruments, catheters, syringes, implants, and other sterilized medical equipment — residual EO detection
(2) Pharmaceutical Industry: sterilized vials, ampoules, and packaging materials — EO residue quantification
(3) Hospital Sterilization Facilities: EO-sterilized medical consumables, hospital sterilization quality control — monitoring residual EO levels
(4) Quality Control Laboratories: medical product manufacturers, third-party testing labs — EO residue compliance testing
(5) Research and Development: development of new sterilization processes, optimization of EO sterilization protocols
(6) Regulatory Compliance Testing: submission of data for ISO, USP, Ph. Eur., JP, and national pharmacopoeial requirements
Standards
The instrument is compliant with and suitable for use with the following standards:
(1) ISO 10993-7:2021 – Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
(2) United States Pharmacopeia (USP) – relevant chapters for chromatography and biocompatibility testing
(3) European Pharmacopoeia (Ph. Eur.) – e.g., 2.2.28 Gas Chromatography for sterilizing agent residues
(4) Japanese Pharmacopoeia (JP) – residual solvent and sterilizing agent testing methods
(5) National Standards – e.g., GB/T 16886.7 (China) for EO residual testing
Features
(1) High Accuracy and Sensitivity: Detects trace levels of EO, ECH, and EG in ppm or µg/g ranges
(2) Compliance Assurance: Meets ISO 10993-7, USP, Ph. Eur., and other pharmacopoeial requirements
(3) Reliable Detection: Hydrogen Flame Ionization Detector (FID) ensures robust and consistent results
(4) Automated Sample Preparation: Optional headspace samplers improve reproducibility and operator safety
(5) Comprehensive Data Analysis: Advanced software provides chromatograms, quantitative results, and reporting
(6) Ensures Product Safety: Monitors residual toxins to protect patients and healthcare workers
(7) Modular Design: Six independent temperature-controlled zones, modular chambers for easy installation and replacement
(8) Precise EPC Electronic Flow Control: 18 gas channels independently controlled for flow and pressure
(9) Power-Off Protection: Automatic parameter memory and immunity to sudden power fluctuations
(10) Extensive Self-Diagnosis: Real-time fault detection with suggested solutions
(11) Fully Integrated Control Workstation: Three digital and three analog outputs for comprehensive control
Technical Parameters
| Item | Specification |
|---|---|
| Gas Flow Control | EPC electronic control, 18 independent channels |
| Injector | Up to 3 independently temperature-controlled injectors |
| Temperature Control Zones | 10 independent zones, including column, vaporization, FID, thermal conductivity, auxiliary 1 & 2 |
| Detector | Hydrogen Flame Ionization Detector (FID), high sensitivity |
| Power-Off Protection | Automatic parameter memorization, power fluctuation immunity |
| Self-Diagnosis | Real-time fault messages with solutions |
| Control Workstation | Fully integrated, 3 digital + 3 analog outputs |
| Safety | Automatic stop functions and modular design for easy replacement |
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