Section 1. Hazards and Limitations of Ethylene Oxide
Ethylene oxide is a flammable gas that can irritate the skin and cause a severe reaction. In many cases, it exhibits mutagenic, teratogenic, and embryotoxic properties, adversely affects testicular function, and can cause damage to multiple organ systems within the body. In animal carcinogenic studies, inhalation of EO can lead to several tumorigenic changes, including leukemia, brain tumors, and breast tumors, while ingestion or subcutaneous injection of EO forms tumors only at the site of contact. In 1994, the International Agency for Research on Cancer (IARC) reclassified EO as a human carcinogen (Group 1) based on its mechanism of action.
Section II: Scope of Inspection
Shandong LuChuang Analytical Instrument Co., Ltd. introduces the Ethylene Oxide Residue Rapid Determination Instrument, primarily used for quick testing of disposable medical masks, gloves, protective suits, and packaging materials for medical supplies. The product is easy to operate, with reliable results, and has been on the market for many years, receiving positive feedback and good reputation among customers. Suitable for users in various medical device industries, pharmaceutical factories, drug inspection, commodity inspection, and quality control departments.
Section 3: Testing Indicators: Ethylene Oxide (EO)
Section 4. Reagents: Ethylene Oxide (EO) Standard Solution
Five: Flowchart of residual ethylene oxide analysis in medical equipment using a gas chromatography (GC) analyzer: Sample Preparation - Headspace Sampler Injection - GC Analysis - Chromatography Workstation - Data Output (Residual Content)
Section 6: Analytical requirements are proposed for the环氧乙烷 (EO) residue limits according to GB/T16886.7-2015, the 7th part of the Medical Device Biological Evaluation, and ISO 10993-7.
Section 7: Ethylene Oxide Determination Conditions in Medical Devices
Chromatographic Column: 30m x 0.32mm x 0.5μm
Chromatography Column Temperature: 80℃
Vaporization chamber: 150℃
FID：200℃
Headspace sampler: Sample heated to 80°C, valve box to 60°C, pipeline to 100°C.
Appendix 1: Standard Curve Solution Concentration: 1 to 10 ug/mL
Appendix 2: Sample Processing: Test components on the product with high residual content of ethylene oxide (EO) in contact with the human body. Cut into 5mm fragments, weigh 1.0g and place it in a 20mL extraction container. Precisely add 5mL of water, seal, and balance at 60℃ for 40 minutes.
The GC-9870 high-end gas chromatograph is an upgraded and replaced product based on our GC-9860, featuring a majestic appearance and a well-designed structure. It also incorporates our independently developed bilingual display technology, significantly enhancing its automation level and overall performance. The high-stability, high-sensitivity microcurrent amplification technology significantly improves the detection limit of the FID, while the new thermal conductivity detector has a sensitivity 5 times higher. It narrows the gap between domestic and imported models, meeting the needs of the petrochemical, food, environmental protection, disease control, scientific research institutions, and quality inspection departments.
Key Technical Specifications
● English/Chinese switchable display technology, 5.7-inch LCD large screen (320*240). Up to 20 display interfaces, abundant information, capable of storing 20 sets of chromatographic analysis data, and can be accessed at any time.
Industrial design exterior, innovative, stylish, and practical, with a reasonable structure and comfortable operation.
● Gas shut-off protection function, protecting chromatographic columns, thermal conductivity cells, electron capture detectors, and more.
● The eight-stage linear programming temperature ramp function and the intelligent double-side door design truly achieve near-ambient temperature control with a temperature accuracy of ±0.1℃ to meet wide-range analysis requirements.
● Enhanced over-temperature thermal protection and platinum resistance open circuit/short circuit alarm function ensure the instrument is not damaged.
● Self-diagnosis function with fault Chinese prompts, conveniently informing users of the cause and location of the problem.
The FLASH memory system ensures data protection without reliance on batteries.
The microcomputer-controlled FID detector features an automatic ignition function.
● High-precision voltage and current stabilization mode ensures precise and stable airflow, achieving a multi-channel air path control system.
● High-performance capillary vaporization chamber, achieving a true分流/不分流injection system.
● Can install 1-4 detectors simultaneously. Operates in dual FID, dual TCD, dual ECD, or dual NPD configurations. The TCD features dual-column post-complementary gas, allowing for use with single, dual, or capillary columns.
● Capable of simultaneously installing and operating 1-3 capillary columns and running 3 detectors at once. One instrument is equivalent to 3 (shared column chamber). Or dual FID with dual capillary. Dual TCD with dual capillary. Both TCDs work simultaneously without interference, with separate carrier gases. It eliminates the cumbersome process of replacing chromatography columns and detectors.
● The detector can be used in series or parallel configurations, with intelligent automatic switching controlled by events.
● The instrument can be equipped with a variety of sample introduction methods, including a conversion furnace, pyrolysis desorption instrument, automatic sampler, automatic headspace sampler, and a pyrolyzer. It can be set to automatically sample at scheduled intervals, enabling automatic on-line analysis.
● The instrument is particularly suitable for various enterprises, technical supervision bureaus, environmental monitoring, health and epidemic prevention, universities and colleges, scientific research departments, and other sectors.
Equipped with a variety of detectors, including FID, TCD, ECD, and FPD.
Technical Specifications
●Dimensions: 520×480×500mm (Length×Height×Width)
●Pole Box Dimensions: 260×250×150mm (Length×Height×Depth)
● Chromatography Column Mounting Span: 152.4mm (6-inch Standard Interface)
● Chromatography Column: Outer Diameter 3 ~ 5mm (Metallic or Glass Column)
● Instrument Weight: 50 Kg
● High Power: 2500W
● Voltage: 220 ± 10%
●Column box temperature control range: Room temperature + 5℃ - 400℃ (adjustable in increments of 1℃)
● Temperature Accuracy: Not more than ±0.1℃
● Temperature Gradient: ±1% (Temperature Range: 100℃-350℃) Programmed Temperature Increase
● Heating Rate: 0.1-50℃/min (adjustable with increments of 0.1℃)
● Time Setting: 6000 (min)
● Program Steps: 8 Steps
Detector Technical Specifications
Hydrogen Flame Ionization Detector (FID)
● Detection Limit: Mt ≤ 2×10^-12 g/s (n-hexadecane)
Noise: ≤2×10^-14A (0.02mv)
Drift: ≤1.5×10^-13A/30min (0.15mV/0.5h)
● Linear Range: ≥107
● High operating temperature: ≤450℃
Thermal Conductivity Detector (TCD)
● Sensitivity: S≥10000 mV.ml/mg (n-hexadecane)
Noise: ≤20μV
● Baseline Drift: ≤150μv/30min
Electron Capture Detector (ECD)
● Detection Limit: ≤1×10^-14 g/ml
● Linear Range: 104
Source of Radiation: 63Ni
Flame Photometric Detector (FPD)
Detection Limit: (P) ≤ 1×10^-12 g/s; (S) ≤ 1×10^-12 g/s
● Linear Range: 105 (P) 103 (S)
Nitrogen-Phosphorus Detector (NPD)
● Detection Limit: (N) ≤ 5×10^-13 g/s; (S) ≤ 5×10^-13 g/s
