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Ethylene Oxide and Ethylene Chlorohydrin Analysis and Importance in Medical Materials and Related Products

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  • Ethylene Oxide and Ethylene Chlorohydrin Analysis and Importance in Medical Materials and Related Products

Ethylene oxide is a toxic substance. Flammable and heavier than air.

During World War II it was used for sterilization. One of the most preferred sterilization methods in today's medical production is sterilization with ethylene oxide. The exposure times of the products to ethylene oxide gas may vary. The capacity of the sterilizer used during this period, the purity of ethylene oxide, the raw material and structure of the sterilized product are effective. During the exposure time it is desirable to monitor a stable condition in the temperature and humidity of the cabinet. Excessive fluctuations will also cause the device to suffer during validation. After exposure, rinsing is carried out and ethylene oxide is removed.

Ethylene chlorhydrin is a flammable liquid which is irritating to the body surfaces, shows acute toxicity and is rapidly absorbed through the skin in amounts that are toxic. Ethylene oxide appears as a by-product during sterilization.

The conditions for the removal of ethylene oxide after exposure are important for the limit values ​​mentioned in ISO 10993-7 and indicated in the table below. Therefore, the final sample to reach the consumer after the production stage of ethylene oxide and ethylene chloride analysis should be done by checking.

Table Summary of acceptable limits for EO and ECH (limits for each device)

Device Category Ethylene Oxide Ethylene chlorohydrin
Limited (4 mg9 mg
Long term (> 24 h > 30 days 60 mg/30 days 60 mg/30 days
Permanent (>30 gün) 2,5 g/ life long 10 g/ life long
TTolerable Contact limit(TCL) 10 μg / cm2 or negligible irritation 5 mg / cm2 or negligible irritation
Lens in the eye 0,5 μg/lens/day 1,25 μg/lens 4 × EO limit recommended
Blood cell separator (Apheresis) 10 mg 22 mg
Blood Oxygenator 20 mg 45 mg
Cardiopulmonary bypass devices 60 mg 9 mg



Devices of blood purification (hemodializers)




4,6 mg




4,6 mg

Healthy skin in contact with surgical cover 10 μg / cm2 or negligible irritation 5 mg/cm2 veya ihmal edile5 mg / cm2 or negligible irritationbilir tahriş


We are accredited for the analysis of ETHYLENE OXIDE AND ETHYLENE CHLORHYDRINE in medical materials and related products. You can contact us for more information.

Büşra Gökdemir

Chemical Engineer

Saniter Chemistry Laboratory Head

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