Ethylene Oxide (EO) GC-9870 Gas Chromatograph

I. Hazards and Limitations of Ethylene Oxide

Ethylene oxide is a flammable gas that can irritate the skin and cause a strong reaction. In many cases, it exhibits mutagenic, fetal toxic, and teratogenic properties, has adverse effects on testicular function, and can damage multiple organ systems within the body. In animal carcinogenic studies, inhalation of EO can produce several tumorigenic changes, including leukemia, brain tumors, and breast tumors, while ingestion or subcutaneous injection of EO only forms tumors 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 Instruments 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, has been on the market for many years, and has received positive feedback and good reputation from customers. Suitable for users in various medical device, pharmaceutical, drug inspection, commodity inspection, and quality control sectors.

Section 3: Inspection Criteria

Ethylene Oxide (EO)

Reagents

Ethylene Oxide (EO) Standard Solution

V. Flowchart of Gas Chromatography Analysis Process for Ethylene Oxide Residue in Medical Equipment

Sample Preparation – Headspace Sampler Injection – GC Analysis – Chromatography Workstation – Data Output (Residual Content)

Section 6: Meet the analysis requirements proposed by the national standards

Complies with the National Standard GB/T16886.7-2015 for Biocompatibility Evaluation of Medical Devices, Part 7, and the ISO 10993-7 requirements for the residual limit of ethylene oxide (EO), with analytical requirements specified.

Chapter 7: Determination Conditions for Ethylene Oxide in Medical Devices

Chromatography Column: 30m x 0.32mm x 0.5μm

Chromatography Column Temperature: 80℃

Vaporizing chamber: 150℃

FID：200℃

Headspace Sampler: Sample heated to 80°C, valve box to 60°C, and piping to 100°C.

Appendix 1: Standard Curve Solution Concentration: 1 to 10 ug/mL

Appendix 2: Sample Processing - Test components with high relative residual content of 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 equilibrate at 60°C for 40 minutes.

The GC-9870 high-end gas chromatograph is an upgraded and modernized version of our GC-9860, featuring a sophisticated appearance and a well-designed structure. It is equipped with 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 FID, while the new thermal conductivity detector offers a 5-fold increase in sensitivity. This 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

● Switchable Chinese and English 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 with a novel and elegant appearance, aesthetically pleasing and practical, with a reasonable structure and comfortable operation.

● Gas cutoff 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 rear door design truly achieve near room temperature control, with a temperature control accuracy of ±0.1℃ to meet wide range analysis requirements.

● Enhanced over-temperature thermal protection and platinum resistance open circuit/short circuit alarm functions ensure the instrument is not damaged.

● Self-diagnostic function with fault prompts in Chinese, conveniently informing users of the cause and location of the issue.

The adopted 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 multi-channel airway control system.

● High-performance capillary vaporization chamber, achieving a true分流/不分流injection system.

● Can install 1-4 detectors simultaneously. Can operate in dual FID, dual TCD, dual ECD, or dual NPD modes. The TCD features dual-column post-complementary gas, allowing for use with a single, dual, or毛细管 column.

● The system can simultaneously install and operate 1-3 capillary columns and run 3 detectors concurrently. One instrument is equivalent to 3 (shared column chamber). Alternatively, dual FID with dual capillary. Dual TCD with dual capillary. The dual TCDs operate simultaneously without interference, with separate carrier gases. This eliminates the麻烦 of changing chromatography columns and detectors.

● Achievable series and parallel operation of detectors, with intelligent automatic switching via event control.

● The instrument can be equipped with various sampling methods, including conversion furnace, pyrolysis desorption instrument, automatic sampler, automatic headspace sampler, and pyrolyzer. It is capable of timed automatic sampling to achieve on-line analysis.

● The instrument is particularly suitable for various enterprises, technical supervision departments, environmental monitoring, health and epidemic prevention, universities and colleges, scientific research, and other sectors.

Equipped with a variety of detectors, including FID, TCD, ECD, and FPD.

Technical Specifications

● Dimensions: 520×480×500mm (Length x Height x Width)

Column box dimensions: 260×250×150mm (Length×Height×Depth)

● Chromatography Column Mounting Span: 152.4mm (6-inch Standard Interface)

● Chromatography Column: External Diameter of Filling Column 3～5mm (Metallic or Glass Column)

● Instrument Weight: 50 Kg

● High Power: 2500W

● Voltage: 220 ± 10%

● Column cabinet temperature range: Room temperature +5℃ - 400℃ (adjustable with a 1℃ increment)

● Temperature Accuracy: Not greater than ±0.1℃

● Temperature Gradient: ±1% (Temperature Range: 100℃-350℃) Programmed Heating

● Heating Rate: 0.1-50℃/min (adjustable with 0.1℃ increments)

● Time Setting: 6000 (min)

● Program Stage: 8 stages

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: ≥10^7

● 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: 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