Ethylene Oxide Sterilization: Uses and Limitations

Ethylene Oxide Sterilization: Uses and Limitations

Among the disinfection techniques applicable to medical and pharmaceutical products, the use of gas remains the most commonly employed method.

IONISOS, an expert in industrial sterilization, presents the process of ethylene oxide sterilization, its uses, and its limitations.

Ethylene Oxide, a Sterilization Agent

Sterilization using ethylene oxide (EtO) has significant advantages when it comes to medical equipment. This agent effectively eliminates microorganisms at relatively low temperatures (30 to 60°C at most). This technique is recommended for heat-sensitive equipment and those that cannot undergo ionization processes.

The operation proceeds as follows:

  • Based on the type of product and its characteristics, preliminary tests determine the duration and temperature of sterilization, gas concentration, and the humidity level to achieve effective results without damaging the equipment;
  • The equipment to be sterilized is first preheated and humidified;
  • It is then placed in a chamber where it is exposed to ethylene oxide for several hours;
  • Finally, the product is placed in a chamber to eliminate most of the residual ethylene oxide and may be stored for several hours or days to allow for the removal of gaseous residues down to a legally acceptable level.

Once verified, the equipment can be shipped and is immediately usable.

The Advantages and Constraints of Gas Sterilization

Ethylene oxide is widely used for industrial sterilization in the pharmaceutical, medical, and cosmetic sectors. Its high toxicity to living organisms makes it an effective and reliable tool for sterilizing equipment as well as for treating archives, for example.

It also has the advantage of being compatible with a wide range of materials and is suitable for products that cannot withstand high-temperature sterilization. Finally, ethylene oxide can penetrate into the smallest crevices of the items to be sterilized. This characteristic makes its use possible on already packaged materials.

Regarding the disadvantages, there is little to criticize about the gas sterilization method:

  • It should be reserved for solid products, with packaging that is permeable to gas;
  • The toxicity of the gas necessitates a desorption period—also called degassing—of 24 to 48 hours to eliminate residual ethylene oxide, as well as strict implementation protocols.

To address this last point, IONISOS develops customized sterilization cycles, reducing the gas concentration to a minimum. Residues are therefore minimal, which decreases the duration of degassing and makes your products operational more quickly.

IONISOS, Your Partner in Industrial Sterilization

Working with IONISOS guarantees you tailored support with a dedicated contact person, excellent responsiveness, and on-site controls thanks to our integrated laboratory.

Our company specializes in EtO sterilization, as well as ionization (beta and gamma). Founded in 1956, the original company merged in 1993 to become IONISOS. We currently operate in about ten specialized treatment centers across France and Europe.

By the end of this year (2022), we will open a new EtO treatment site in Kleve, Germany. Spanning 6,600 m², fully automated cells will transport the products to be sterilized to the treatment chambers, followed by aeration chambers. This will enhance our responsiveness and allow us to handle larger volumes.

Contact us today and take advantage of our expertise!