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
在线联系供应商
Other supplier products
 |
Shoe heat insulation testing machine -- sand bath | The sand bath component of the shoe heat insulation testing machine is primarily used to test the heat insulation or thermal insulation performance... |
 |
Luggage Walked Wear Test Machine | This product is used for suitcases, bags, strollers with wheels… Through the test mileage and test speed, to check the heat resistance, rupt... |
 |
Konan Tester | Product Description Conforms to the UN Recommendations on the Transport of Dangerous Goods - Manual of Tests and Criteria 11.5.1 Test 1(b): Kernan... |
 |
Particle Strength Tester | Standard ASTM D4179: Standard Test Method for Single-Pellet Pressure Resistance of Catalysts and Catalyst Carriers ASTM D6175: Standard Test Me... |
 |
Torsional Fatigue Tester | Standard YY/T 0857-2011 (China): Specifies torsional fatigue testing protocols for spinal pedicle screw-rod systems, including load ratios, freque... |
Same products
 |
Air Permeability Tester STD- F8 | 卖方: Standard International Group (HK) Limited | The Air Permeability Tester is designed to quickly and accurately measure the breathability and p... |
 |
Surface Performance Tester STD-FB4 - A | 卖方: Standard International Group (HK) Limited | Introduction TheSurface Tester analyzes finger movements-particularly, strokes-performed by arti... |
 |
Compression Tester STD - FB3 - A | 卖方: Standard International Group (HK) Limited | TheCompression Tester analyzes hand movements-particularly, pushing with a finger-performed by ar... |
 |
Single - Strand Bending Tester STD - FB2 - SH | 卖方: Standard International Group (HK) Limited | Standards ASTM A370. ASTM A416. ISO6934.4 The Single Fiber Bending Tester makes it possible to ... |
 |
Bending Tester STD- FB2 - S | 卖方: Standard International Group (HK) Limited | Compliance Standards ASTM D790 (Plastics Flexural Properties) ISO 178 (Flexural Strength of Rig... |
