Does ethylene glycol leave a residue?
The main side effect of using EO as a sterilization agent is that it can leave a residue on the devices being processed. Ethylene Glycol (EG) – the residue that may form when EO comes into contact with water.
What is EtO residual testing?
Ethylene Oxide (EO) Residuals Analysis is used in the identification and quantification of ethylene oxide, ethylene chlorohydrin, and ethylene glycol by gas chromatography. This test helps manufacturers demonstrate the safety of products sterilized by EO by determining compliance with accepted residual limits.
What is EtO analysis?
Ethylene oxide residuals analysis is used to identify and qualify ethylene oxide, ethylene chlorohydrin and ethylene glycol by gas chromatography. The technique helps manufacturers to demonstrate the safety of products sterilised by ethylene oxide by determining compliance with accepted residual limits.
How do you test for residual ethylene oxide?
Ethylene Oxide Residual Testing
- Gas Chromatography with Solid-Phase Micro Extraction.
- Gas Chromatography using headspace sampling for ethylene oxide (ETO)
- Gas Chromatography water extracts for ethylene oxide (ETO)
- Gas Chromatography water extracts for ethylene chlorohydrin (ECH) and ethylene glycol (EG)
Is ETO sterilization banned?
Sept. 25, 2019 — In 2005, the U.S. Environmental Protection Agency considered banning ethylene oxide in new sterilizing facilities because of the cancer risk it posed to residents who lived around the plants.
Can you smell ethylene oxide?
Ethylene oxide (EtO) is a flammable, colorless gas at temperatures above 51.3 ºF (10.7 ºC) that smells like ether at toxic levels.
Is EtO sterilization banned?
What is EtO sterilization process?
ETO should be considered a known human carcinogen. The basic ETO sterilization cycle consists of five stages (i.e., preconditioning and humidification, gas introduction, exposure, evacuation, and air washes) and takes approximately 2 1/2 hrs excluding aeration time.
How long does EtO sterilization take?
approximately 2 1/2 hrs
ETO should be considered a known human carcinogen. The basic ETO sterilization cycle consists of five stages (i.e., preconditioning and humidification, gas introduction, exposure, evacuation, and air washes) and takes approximately 2 1/2 hrs excluding aeration time.
What is the residue of ethylene chlorohydrin?
Ethylene Oxide (EO) – the residue that may remain after processing has been completed Ethylene Chlorohydrin (ECH) – the residue that may form when EO comes into contact with free chloride ions Ethylene Glycol (EG) – the residue that may form when EO comes into contact with water
Are there any residue issues with ethylene oxide?
The good news is that most residue issues can be overcome with a few simple changes to the existing sterilization parameters if an ethylene oxide process is currently in place. For new device manufacturers, residue issues can likely be eliminated up front by considering the following methods while developing the sterilization parameters.
What to do about ethylene oxide residue after sterilization?
If residue issues are currently a problem or may present a challenge to a new device, consult with a sterilization provider to discuss minimizing the effects of the ethylene oxide sterilization process. In addition, the test methods for analyzing EO residues will vary depending on the device.
Are there no exposure limits for ethylene glycol?
Per the AAMI 10993-7 standard, “No exposure limits are set for ethylene glycol because risk assessment indicated that when EO residues are controlled, it is unlikely that biologically significant residues of EG would be present.”