Gas Chromatography for the Detection of Ethylene Oxide in Medical Products (Gas Chromatography)

Single chip microcomputer STM32L151CCU6

0603 pink

Probe domestic switch needle KG-300K, needle head diameter is 3.0mm, normally open switch needle

Beijing Purui Analytical Instrument Co., Ltd. is a professional manufacturer and supplier of chromatographs (gas chromatographs and liquid chromatographs) and their accessories. We provide cost-effective gas chromatography systems, liquid chromatography instruments, headspace samplers, and gas generators to enhance efficiency and accuracy in your analytical work. As a leading provider in the field, we focus on delivering high-quality solutions tailored for medical device testing and chemical analysis.

This method follows the GB/T16886.7-2001 standard for the detection of residual ethylene oxide in medical supplies, particularly in gauze and plastic medical products. Ethylene oxide sterilization is widely used in medical devices, but its quality directly affects sterilization effectiveness. Residual ethylene oxide can be harmful to both patients and healthcare professionals. For devices used in extracorporeal circulation, ethylene oxide is highly toxic, similar to ammonia, and can cause severe damage to the eyes, respiratory system, and skin. Prolonged exposure may lead to serious health issues such as vomiting, headaches, pulmonary edema, and organ damage.

The method utilizes headspace gas chromatography, where a headspace sampler is integrated with a gas chromatograph. The GC7800 model from Beijing Purui Analytical Instruments combines both components into one system. It works by heating the sample to equilibrium and then analyzing the volatile portion using a capillary column and a hydrogen flame detector. This technique is ideal for detecting trace amounts of volatile solvents, such as methanol, ethanol, and other organic compounds found in medical products. The process is efficient, accurate, and essential for bacterial quality control in medical devices.

The instrument features advanced single-chip microcontroller technology with a Chinese interface and keyboard settings for user-friendly operation. It includes power-down protection, file storage, and a large LCD display. A built-in stopwatch function enhances usability. The double-column, dual-pneumatic structure allows for multiple injection configurations. Users can choose from various detectors, including TCD, FID, ECD, FPD, and NPD, with up to three detectors installed simultaneously. The system supports temperature programming, over-temperature protection, and a flexible rear door temperature control system for near-room temperature operations. The sample introduction system offers options like packed column injection, glass liner injection, and capillary split/splitless injection with diaphragm cleaning functions.

The GC7800 gas chromatograph comes with an FID detector, SE-54 capillary column (30 m × 0.32 mm × 0.5 μm), reagents, and ethylene oxide standards. It also includes a PR3000 chromatography workstation with a computer, 1 mL glass syringe, headspace sampler, 20 mL headspace vials with caps, and a hydrogen/nitrogen/oxygen generator. Additional tools such as air pressure clamps and pliers are included for convenience. The system ensures precise and reliable results, making it an essential tool for laboratories focused on medical and chemical analysis.