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

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Beijing Puri Analytical Instrument Co., Ltd. is a professional manufacturer and seller of chromatographs (gas chromatographs, liquid chromatographs) and accessories, providing you with cost-effective gas chromatograph, liquid chromatograph, headspace sampler, Gas generators to save time and efficiency in your analysis. Beijing Purui Analytical Instruments Co., Ltd. is a professional chromatograph (gas chromatograph, liquid chromatograph) and accessories manufacturer and distributor, providing you with a cost-effective gas chromatograph. , liquid chromatograph, headspace sampler, gas generator, make your analysis work time-saving and efficient 1, method reference standards and scope of application, this method refers to GB/T16886.7-2001 for medical supplies Among the bacteria, the residue in gauze and plastic medical products, especially the sterilization of medical devices, the application of ethylene oxide sterilization is more and more widely used. The quality of ethylene oxide has a significant effect on the sterilization effect, and the residual ethylene oxide in the sterilized articles is also harmful to the health of patients and medical personnel. For medical devices used for extracorporeal circulation, ethylene oxide is highly toxic to humans and animals, similar to ammonia. Ethylene oxide is corrosive to the eyes and respiratory tract, which can cause vomiting, nausea, diarrhea, headache, central inhibition, dyspnea, pulmonary edema, liver and kidney damage and hemolysis. Excessive skin contact with ethylene oxide liquid or solution produces a burning sensation, blisters, dermatitis, etc., and may cause a systemic reaction if absorbed through the skin.

1. Method reference standard and scope of application. This method refers to GB/T16886.7-2001 for sterilization of medical supplies, residues in gauze and plastic medical products, especially sterilization of medical devices, epoxy Ethane sterilization is becoming more and more widely used. The quality of ethylene oxide has a significant effect on the sterilization effect, and the residual ethylene oxide in the sterilized articles is also harmful to the health of patients and medical personnel. For medical devices used for extracorporeal circulation, ethylene oxide is highly toxic to humans and animals, similar to ammonia. Ethylene oxide is corrosive to the eyes and respiratory tract, which can cause vomiting, nausea, diarrhea, headache, central inhibition, dyspnea, pulmonary edema, liver and kidney damage and hemolysis. Excessive skin contact with ethylene oxide liquid or solution produces a burning sensation, blisters, dermatitis, etc., and may cause a systemic reaction if absorbed through the skin.

2, method principle, the method uses headspace gas chromatography, a chromatographic technique for adding a headspace sampler in front of the gas chromatograph inlet, GC7800 gas chromatograph developed by Beijing Purui Analytical Instrument Co., Ltd. An instrument that combines a headspace sampler with a gas chromatograph. It uses the sample to be tested (gas-liquid and gas-solid) to heat balance, and then takes its volatile gas portion into the gas chromatograph. It is specially designed for the analysis of volatile trace components, such as many volatile organic solvents such as methanol and ethanol; floral aromas and perfumes in different seasons, Chinese herbal medicines with volatile components, vegetables and condiments with special odors, etc. It can be used for quantitative analysis. The solution for detecting residual solvents in medical products is to use a headspace sampler to separate the capillary column, and the hydrogen flame detector to detect the residual solvent content. The method is simple in operation, good in effect, high in efficiency, and is a medical device. The necessary testing program for bacterial quality control.

2, method principle, the method uses headspace gas chromatography, a chromatographic technique for adding a headspace sampler in front of the gas chromatograph inlet, GC7800 gas chromatograph developed by Beijing Purui Analytical Instrument Co., Ltd. An instrument that combines a headspace sampler with a gas chromatograph. It uses the sample to be tested (gas-liquid and gas-solid) to heat balance, and then takes its volatile gas portion into the gas chromatograph. It is specially designed for the analysis of volatile trace components, such as many volatile organic solvents such as methanol and ethanol; floral aromas and perfumes in different seasons, Chinese herbal medicines with volatile components, vegetables and condiments with special odors, etc. It can be used for quantitative analysis. The solution for detecting residual solvents in medical products is to use a headspace sampler to separate the capillary column, and the hydrogen flame detector to detect the residual solvent content. The method is simple in operation, good in effect, high in efficiency, and is a medical device. The necessary testing program for bacterial quality control.

3, instrument introduction, using single-chip and integrated circuit control, Chinese interface, operating parameters keyboard settings. The instrument has power-down protection and file storage. Large screen LCD display. At the same time, the instrument has a stopwatch timing function. Double column double pneumatic structure for multiple inspection and injection combinations. A variety of detectors (TCD, FID, ECD, FPD and NPD) can be configured according to user analysis requirements, and up to three detectors can be installed at the same time. The detector and its control components are in a plug-and-play control mode. Constant temperature and temperature programmed operation is available. With over temperature protection. The column chamber is equipped with a flexible rear door automatic temperature control system. It can realize the near-room temperature operation in the true sense, and the fifth-order program temperature rises. The sample introduction system can be equipped with a variety of sample introduction devices such as packed column head injection, glass liner rapid injection, capillary column split/splitless injection with diaphragm cleaning function, and capillary injection system with microcomputer automatic control. Electromagnetic switching valve for split/splitless injection operation. The gas injector can be configured. The carrier gas path has a low pressure and gas shutoff protection function. Preset standby temperature control port for easy expansion. 3, instrument introduction, using single-chip and integrated circuit control, Chinese interface, operating parameters keyboard settings. The instrument has power-down protection and file storage. Large screen LCD display. At the same time, the instrument has a stopwatch timing function. Double column double pneumatic structure for multiple inspection and injection combinations. A variety of detectors (TCD, FID, ECD, FPD and NPD) can be configured according to user analysis requirements, and up to three detectors can be installed at the same time. The detector and its control components are in a plug-and-play control mode. Constant temperature and temperature programmed operation is available. With over temperature protection. The column chamber is equipped with a flexible rear door automatic temperature control system. It can realize the near-room temperature operation in the true sense, and the fifth-order program temperature rises. The sample introduction system can be equipped with a variety of sample introduction devices such as packed column head injection, glass liner rapid injection, capillary column split/splitless injection with diaphragm cleaning function, and capillary injection system with microcomputer automatic control. Electromagnetic switching valve for split/splitless injection operation. The gas injector can be configured. The carrier gas path has a low pressure and gas shutoff protection function. Preset standby temperature control port for easy expansion. Main technical indicators: 1), temperature control, column room: temperature control range: room temperature 3-400 °C, temperature control accuracy: better than ± 0.1 °C main technical indicators: 1), temperature control, column room: temperature control range: room temperature 3-400 ° C, temperature control accuracy: better than ± 0.1 ° C five-step rise, six-way temperature control. 2), flame ionization detector FID, detection limit Mt ≤ 1.0 × 10-11g / s (benzene) fifth-order rise, six-way temperature control. 2), flame ionization detector FID, detection limit Mt ≤ 1.0 × 10-11g / s (benzene) 4, instrument configuration 4, instrument configuration GC7800 host, (FID detector) Column: SE-54 capillary column 30 * 0.32.*0.5 Column and reagent, ethylene oxide standard PR3000 chromatography workstation (including computer) 1mL glass syringe 2, headspace sampler headspace bottle 20ml (with plug) 100 hydrogen nitrogen oxygen generator top Air pressure clamp pliers 1 GC7800 mainframe, (FID detector) Column: SE-54 capillary column 30*0.32.*0.5 Column and reagent, ethylene oxide standard PR3000 chromatography workstation (including computer) 1mL glass syringe 2 Branch, headspace sampler headspace bottle 20ml (with plug) 100 hydrogen nitrogen and oxygen integrated generator head air capping pliers 1