EO gas chromatograph

EO gas chromatograph
EO gas chromatography uses ethylene oxide (EO) for sterilization of medical devices, which has the advantages of low cost, good sterilization effect, minimal damage to medical devices, and ensuring that the expected functions of medical devices are not affected. However, although EO can efficiently sterilize medical products, the residual EO on medical products can also cause a certain degree of toxicity to users and patients' bodies while killing microorganisms.
Ethylene oxide (EO) is a combustible gas that can irritate the surface of the body and cause strong reactions. In many cases, ethylene oxide (EO) is mutagenic, toxic and teratogenic to fetuses, has side effects on the function of Zhaowan, and can damage many organ systems in the body. In animal cancer research, inhalation of ethylene oxide (EO) can cause several vegetational changes, including leukemia, brain tumors, and breast tumors. When ingested or injected subcutaneously with ethylene oxide (EO), tumors only form at the contact site.
Therefore, Tengzhou Huapu quantitatively determines the residual ethylene oxide (EO) in medical devices. The EO detection solution is to use headspace gas chromatography to quantitatively determine the EO content in disinfected medical equipment. The instrument configuration of this solution is reasonable. Simple operation is a practical testing solution for medical equipment manufacturers and hospitals.
Detection solution:
The principle of residual ethylene oxide (EO) detection in disinfection equipment is to extract the ethylene oxide contained in the sample with water at a certain temperature, and determine the content of ethylene oxide using headspace gas chromatography.
2. Gas chromatograph conditions for residual ethylene oxide (EO) detection in disinfection equipment, hydrogen flame identification device: sensitivity not less than 2X 10-11g/s (benzene, carbon disulfide (CS2))
Chromatographic column: The chromatographic column used should be able to separate impurities and epoxyethane * in the sample, and have a certain degree of water resistance.
Complete set of equipment for residual determination of ethylene oxide in medical devices:
1 HP-2013 gas chromatograph: FID, capillary injection system, packed column injection system, eighth order programmed temperature rise, intelligent back door.
1 headspace sampler: including forceps and headspace vial.
1 chromatography workstation: N3000 (computer, printer self equipped)
1 capillary chromatography column: 30M * 0.32mm * 0.5um
Hydrogen air generator
headspace sampler
Instrument Introduction
The sampling pump is matched with the injection valve for negative pressure sampling, precise quantification, and high sensitivity
The temperature of the injection valve and sample transfer pipeline can be set to avoid sample condensation
Sampling pipeline and injection valve quantitative tube with blowback function to prevent cross contamination
Microcomputer control, membrane keyboard input parameter values
Can connect various models of gas chromatographs at home and abroad
The function of synchronously starting data processing software
Technical parameters:
Heating range of headspace bottle: above room temperature to 150 ℃, set in increments of 1 ℃
Temperature control range of injection valve: above room temperature to 150 ℃, set in increments of 1 ℃
Temperature control range of sample transfer pipeline: above room temperature to 150 ℃, set in increments of 1 ℃
Injection valve quantitative tube volume: 1ml
Headspace bottle number: 6
Headspace bottle specification: 10ml 20ml
The detection method for ethylene oxide can meet the requirements of YY 0334-2002
References
GB/T 14233.2-1993 Methods for inspection of medical infusion, transfusion, and injection equipment - Part 2: Biological test methods
GB/T 16886.7-2001 Biological Evaluation of Medical Devices Part 7: Residual Ethylene Oxide Sterilization
GB 18278-200。 Requirements for sterilization confirmation and routine control of healthcare products - Industrial wet heat sterilization
GB 18279-2000 Confirmation and Routine Control of Ethylene Oxide Sterilization for Medical Devices
GB 18280-2000 Requirements for Sterilization Confirmation and Routine Control of Healthcare Products - Radiation