Residual Ethylene Oxide Gas Chromatography System

The Residual Ethylene Oxide Gas Chromatography System is a professional analytical instrument designed for the detection and quantification of residual ethylene oxide (EO) and its related compounds (ethylene chlorohydrin, ECH; ethylene glycol, EG) in medical products. It provides high sensitivity, accuracy, and compliance with international and national standards, ensuring the safety of sterilized medical devices and related products.

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

Accessories

(1) Gas chromatograph column(s) suitable for EO/ECH/EG detection

(2) Headspace sampler (optional, automated)

(3) Injector liners and septa

(4) Hydrogen and air supply lines with regulators

(5) Data acquisition software with quantitative analysis module

(6) Calibration gas kits

(7) Operation manual

(8) Maintenance toolkit

(9) Power cable

Test Procedures

(1) Prepare sample according to the target product type and standard requirements

(2) Load sample into headspace vial or GC injector system

(3) Configure the GC method parameters including temperature zones, flow rates, and detector settings

(4) Start automated or manual analysis

(5) Acquire chromatograms and record quantitative residual EO, ECH, and EG values

(6) Verify results against pharmacopoeial limits (ISO 10993-7, USP, Ph. Eur.)

(7) Clean injector, column, and sampling system after testing

Maintenance Information

(1) Regularly clean injector, column, and detector chambers

(2) Replace septa, liners, and GC columns as recommended

(3) Verify calibration with standard gases before each batch of testing

(4) Maintain gas supply lines and regulators for consistent flow

(5) Keep software, logs, and calibration records updated for compliance documentation

(6) Store instrument in a clean, dry laboratory environment

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