Withstand high voltage up to 750V (IEC/EN standard)
UL 94V-2 or UL 94V-0 flame retardant housing
Anti-falling screws
Optional wire protection
1~12 poles, dividable as requested
Maximum wiring capacity of 4 mm2
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Gas Chromatography for the Detection of Ethylene Oxide in Medical Products (Gas Chromatography)
**Tech Detail Main**
Beijing Puri Analytical Instrument Co., Ltd. is a leading manufacturer and supplier of chromatographs (gas chromatographs, liquid chromatographs) and related accessories. We provide cost-effective gas and liquid chromatography systems, headspace samplers, and gas generators to enhance the efficiency and accuracy of your analytical work. Our products are designed for a wide range of applications, including medical device testing, pharmaceutical analysis, and environmental monitoring.
This method refers to GB/T 16886.7-2001 for the detection of residual ethylene oxide in medical supplies, particularly in gauze and plastic medical products. Ethylene oxide sterilization is widely used in the medical industry, but its quality significantly affects the sterilization outcome. Residual ethylene oxide can be harmful to both patients and healthcare workers. For devices used in extracorporeal circulation, ethylene oxide is highly toxic, similar to ammonia, and can cause serious health effects such as eye irritation, respiratory issues, vomiting, nausea, and even organ damage. Prolonged skin contact may lead to burns, blisters, and systemic reactions if absorbed through the skin.
The method employs headspace gas chromatography, using a headspace sampler combined with a GC7800 gas chromatograph developed by Beijing Puri Analytical Instruments. This system is ideal for analyzing volatile trace components like solvents, fragrances, and herbal compounds. It separates volatile substances from the sample and detects them using a hydrogen flame ionization detector (FID). The process is efficient, accurate, and essential for ensuring the safety of medical devices by controlling bacterial contamination and residual solvents.
The GC7800 instrument features a single-chip microcontroller, a Chinese interface, and easy-to-use keyboard settings. It includes power-down protection, file storage, and a large LCD display. The device also offers a stopwatch function, double-column structure, and multiple detector options (TCD, FID, ECD, FPD, NPD), allowing up to three detectors to be installed simultaneously. It supports constant temperature and programmed temperature operations, with over-temperature protection and an automatic rear door temperature control system. The sample introduction system is flexible, supporting packed columns, glass liners, capillary injections, and more. The carrier gas path has low-pressure and gas shutoff protection, and it includes a preset standby temperature control port for future expansion.
Key technical specifications include:
- Column oven temperature range: 3°C to 400°C, with ±0.1°C accuracy.
- Flame ionization detector (FID) with a detection limit of ≤1.0×10â»Â¹Â¹g/s (benzene).
- Five-step temperature programming and six-way temperature control.
The instrument comes with the following configuration:
- GC7800 main unit with FID detector
- SE-54 capillary column (30m × 0.32mm × 0.5μm)
- Ethylene oxide standard solution
- PR3000 chromatography workstation (including computer)
- 1mL glass syringe
- Headspace sampler and 20ml headspace vials with caps
- Hydrogen, nitrogen, and oxygen generator
- Air pressure clamp pliers
This comprehensive setup ensures precise and reliable analysis of residual solvents, making it an essential tool for quality control in the medical and pharmaceutical industries.