Tengzhou Hongxiang Analytical Instrument Co., Ltd
Home>Products>Detection and Analysis of Residual Ethylene Oxide in Medical Device Sterilizer by Gas Chromatography
Detection and Analysis of Residual Ethylene Oxide in Medical Device Sterilizer by Gas Chromatography
Detection and Analysis of Residual Ethylene Oxide in Medical Device Sterilizer by Gas Chromatography
Product details

Product Introduction:

Ethylene oxide (EO) is a commonly used sterilizing agent for medical devices, which has the characteristics of strong penetration ability and good sterilization effect. It is widely used in the disinfection of medical supplies (masks, gloves, plasma bags, disposable injection equipment, etc.). However, ethylene oxide itself is a toxic gas. If the sterilized product cannot fully evaporate the ethylene oxide gas and the residual toxicity reaches a certain level, it will pose a threat to the human body.

1.jpg

At present, the most effective method for detecting residual organic solvents in medical device epoxyethane and packaging materials is headspace gas chromatography. Our company producesEthylene oxide detectionSpecialized gas chromatographGC-7900giveHeadspace samplerAfter heating and equilibrating the tested sample (gas-liquid or gas-solid), the top gas is directly extracted and injected into the gas chromatograph. The composition and content of residual solvents are detected using a high-sensitivity hydrogen flame (FID) detector. The whole set of instruments is easy to operate, with good separation effect and high analysis efficiency, fully meeting the requirements of national testing standards. This instrument is particularly suitable for the analysis of volatile trace components, and its sensitivity for detecting ethylene oxide is more than 5 times that of similar products. It is an essential testing instrument for quality control of medical device sterilization. We have sufficient spare parts to promptly solve technical problems that arise during debugging and use. At the same time, the company has a group of experienced and excellent high-tech professionals who provide users with hardware configuration, instrument installation, debugging, application, and maintenance services.

5.jpg

2.jpg


headspace gas chromatographyGC-7900Product Introduction:
1. Large screen LCD Chinese display, real-time display of various temperatures and operating conditions, clear and intuitive content, truly realizing human-machine dialogue;
2. Power on self-test, wide range self diagnostic function, can accurately determine the fault location and alarm;
3. Six independent temperature control channels (vaporization chamber and capillary vaporization chamber can independently control temperature), with eight step programmed temperature rise function;
4. Overtemperature protection function: If any circuit exceeds the set temperature, the instrument will automatically power off and sound an alarm;
5. The unique vertical heating device makes sample vaporization more reliable, minimizes the heat radiation generated by the vaporization chamber, and ensures minimal temperature deviation inside the column box;
6. Intelligent fuzzy control rear door opening system, automatically tracks temperature and dynamically adjusts air door angle, truly achieving near room temperature operation
7. Configure a capillary split/non split injection device with filling column head injection and glass lining injection, equipped with diaphragm cleaning function, and capable of installing gas injectors;
8. High precision dual stable gas path, capable of installing four types of detectors simultaneously;
9. Used in conjunction with a headspace sampler to complete the analysis and detection of residual ethylene oxide (EO) in medical devices.

1Gas chromatograph GC-7900Temperature control index parameters:
1. Temperature control range: room temperature+5 ℃~400 ℃, increment 0.1 ℃
2. Temperature control accuracy: better than ± 0.01 ℃
Program heating: Eight step constant temperature time from 0 to 999min
Increment of 0.1 minutes, temperature increment of 0.1 ℃
Heating rate:
Maximum 40 ℃/min at 200 ℃
Maximum 20 ℃/min at 200 ℃

IIGas chromatograph GC-7900Detector indicator parameters:

Hydrogen Flame Detector (FID):
Sensitivity Mt ≤ 3 × 10-16g/s (n-hexadecane)
Noise ≤ 2 × 10-14A linear range ≥ 106

Gas chromatography method for residual detection of ethylene oxide:
1. Experimental equipment:
Gas chromatograph GC-7900 headspace sampler
2. Testing principle: At a certain temperature, extract the ethylene oxide (EO) contained in the sample with an extractant water, and determine the content of EO using headspace gas chromatography.
3. Standard storage solution preparation method (weighing method):
Take an externally dried 50ml volumetric flask, add about 30ml of water, add a stopper, weigh to the nearest 0.1mg. Inject about 0.6ml of ethylene oxide into the flask without a stopper, gently shake well, cover the flask with a stopper, weigh, and the difference between the two weighings is the weight of ethylene oxide contained in the solution. Add water to the mark and dilute the solution to 1 × 10-2g/L as the standard stock solution.
4. Testing method:
4.1 Take an appropriate amount of ethylene oxide standard solution and prepare six concentration standard solutions. Take 10ml each and 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.
4.3 Plot the peak height (or area) based on the peak height (or area) corresponding to different concentrations of standard solutions.


Configuration of ethylene oxide detection instrument:

name Model and configuration quantity
Gas chromatograph GC-7900 GC-7900 host 1 unit
FID detector
Capillary column sampler
chromatographic column Specialized capillary chromatography column 1 piece
workstation software N2000 1 set
Headspace sampler HS-9, 100 headspace bottles, using tools 1 unit
Gas source for chromatography LH-300 hydrogen generator 300ml/min 1 unit
LA-2L air generator 2000ml/min 1 unit
nitrogen cylinder 1 bottle
Standard sample EO standard solution 2 bottles
Starter Kits 1 set
Computer, printer self-provide

Online inquiry
  • Contacts
  • Company
  • Telephone
  • Email
  • WeChat
  • Verification Code
  • Message Content

Successful operation!

Successful operation!

Successful operation!