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
© 1994 | Saniter Gıda – Çevre Bilimi Gözetim Ve Mühendislik Hiz. Tur. Tic. A.Ş.
