Ethylene oxide residue detection analyzer

Ethylene oxide residue detection analyzer
　　Ethylene oxide residue detection analyzerIt uses headspace gas chromatography to quantitatively determine the content of ethylene oxide (EO) in disinfected medical equipment. The instrument configuration is reasonable and the operation is simple. It is a practical detection instrument for medical equipment manufacturers, pharmaceutical factories, and hospitals. Ethylene oxide (EO) is commonly used for disinfection of disposable sterile medical devices due to its characteristics of low temperature and humidity, strong penetration, and low cost. However, it is a known carcinogen that is flammable and explosive, and has a certain inhibitory effect on the central nervous system. If the mass fraction is too high, it will have a certain impact on the storage and transportation of the product. Relevant regulations require regular testing during production and use.
GC2020 headspace gas chromatography application for residual detection of ethylene oxide
【 Reason for determination 】 Ethylene oxide (EO) is the simplest cyclic ether. At low temperatures, it is a colorless and easily flowing liquid with a boiling point of 10.4 ℃. Above this temperature, it is a colorless gas. EO liquid is volatile at room temperature and has an ether odor. It belongs to highly efficient sterilization agents and has the advantages of wide applicability, strong penetration, extensive sterilization, minimal damage to objects, reliable sterilization effect, and long shelf life. It is one of the most commonly used sterilization methods. But there are certain residues after sterilization with ethylene oxide, which are harmful to the human body, corrosive to the skin, eyes, respiratory tract, and can also cause liver and kidney damage and hemolysis
Exposure limit of ethylene oxide for medical devices:
Short term exposure (≤ 24 hours; average daily dose ≤ 20mg)
Long term exposure (≤ 30 days,>24 hours; average daily dose ≤ 2mg, in addition to the highest dose: ≤ 20mg in the first 24 hours, ≤ 60mg in the first 30 days)
Persistent exposure (>30 days; average daily dose ≤ 0.1mg, in addition to the highest dose: ≤ 20mg in the first 24 hours, ≤ 60mg in the first 30 days, and ≤ 2.5g throughout life)
According to the requirements of GB16886.7-2001 Biological Evaluation of Medical Devices Part 7: Residual Ethylene Oxide Sterilization, headspace gas chromatography principle is used for the separation and determination of volatile components in solid and liquid test samples. After preparing the solid or liquid test sample into the test solution, it is placed in a sealed small bottle and heated in a temperature controlled heating chamber until the volatile components in the test sample reach equilibrium in non gaseous and gaseous states. Then, a certain volume of headspace is automatically drawn into the chromatographic column by the sampler.
Zhongkepu GC2020 gas chromatograph and workstation, DK-16A automatic headspace sampler; FID detector; Electronic Analysis Day
Ping. Purity of ethylene oxide reference standard: 99%, high-purity nitrogen gas cylinder; AK-2 air generator; HK-3 hydrogen generator
Temperature of various parts of the instrument
a) Gasification chamber at 200 ℃
b) Testing room at 250 ℃
airflow rate
a）N2 15ml/min ～ 30 ml/min
b）H2 30 ml/min
c) Air 300 ml/min
【 Measurement Method 】
Take an appropriate amount of ethylene oxide standard and prepare six concentration standard solutions, each with 10ml, to prepare six concentration standard samples.
When the standard sample reaches gas-liquid equilibrium, different concentrations of liquid correspond to different concentrations of gas. Take the equilibrium gas, inject it into the sampler, and record the peak height (or area) of ethylene oxide.
Sample Preparation
The preparation of test samples should be carried out immediately after sampling, otherwise the test samples should be sealed in a metal container sealed with polytetrafluoroethylene for storage.
Cut the sample into 5mm long fragments, take 2.0g and place it in an extraction container, add 10ml of water, with a top space of 40m; the pressure inside the container is normal pressure, and place it in a constant temperature water bath at 60 ℃± 1 ℃ for 20 minutes.