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One of the most effective methods is ethylene oxide (EO) sterilization. Ethylene oxide is a colorless, odorless gas heavier than air, with exceptional biocidal properties. It destroys microorganisms by disrupting their DNA, preventing cell division and reproduction — effectively ensuring that they cannot survive. This makes EO sterilization one of the most reliable methods available, providing nearly 100% sterility assurance.

Another particularly useful feature of ethylene oxide sterilization is that the process does not affect the structure, color, or strength of the material from which the sterilized product is made, which is usually plastic; The packaging of the sterilized product also remains unaffected. This is possible thanks to the physical properties of EO, as well as the parameters of the sterilization process, which takes place at a relatively low temperature compared to other sterilization methods.

STERILISATION WITH ETHYLENE OXIDE

One of the most effective methods is ethylene oxide (EO) sterilization. Ethylene oxide is a colorless, odorless gas heavier than air, with exceptional biocidal properties. It destroys microorganisms by disrupting their DNA, preventing cell division and reproduction — effectively ensuring that they cannot survive. This makes EO sterilization one of the most reliable methods available, providing nearly 100% sterility assurance.

Another particularly useful feature of ethylene oxide sterilization is that the process does not affect the structure, color, or strength of the material from which the sterilized product is made, which is usually plastic; The packaging of the sterilized product also remains unaffected. This is possible thanks to the physical properties of EO, as well as the parameters of the sterilization process, which takes place at a relatively low temperature compared to other sterilization methods.

Description of the Sterilization Line

Sterilizers — the devices used for sterilization — are most commonly found in healthcare facilities, hospitals, and medical universities. These are usually small, single-chamber units capable of holding several cartons of items for sterilization.

In medical device manufacturing plants, however, sterilization is performed using large, multi-chamber EO sterilization lines, capable of holding several pallets of products. In such cases, we speak not of a sterilizer, but of a complete EO sterilization line.

An advanced sterilization line consists of several types of chambers, each serving a specific function — such as the pre-conditioning chamber, sterilization chamber, and degassing (aeration) chamber.

The goods are transported to the pre-conditioning chamber on plastic pallets because plastic does not absorb or release moisture. In the pre-conditioning chamber, the products are heated and humidified for several hours. This makes the spore forms of microorganisms susceptible to the effects of ethylene oxide. The high relative humidity of the air, products, and air also increases the degree of gas penetration, i.e., the ability to penetrate longer elements with small cross-sections, such as drains and pipes. After several hours of conditioning, the pallets with the goods are transferred to the next chamber.

The sterilizer chamber is the center of the sterilization line – inside this chamber, the sterilizing agent comes into contact with the product being sterilized. After the exposure time to the gas has elapsed, the collective packaging with the product is rinsed with an inert gas to remove the biocidal agent – ethylene oxide. An important aspect of ethylene oxide sterilization is that it takes place under variable pressure conditions – thanks to the drops and increases in pressure inside the sterilizer chamber, it is possible to force EO into every element of the sterilized product. Controlling the pressure values also allows for the thorough removal of EO from the sterilizer chamber after the sterilization process is complete.

The final stage of the ethylene oxide sterilization process is degassing, i.e., removing gas from the packaging. This significantly reduces the amount of gas residue, i.e., the amount of gas remaining in the product after exposure to ethylene oxide. Degassing can be performed in the sterilizer chamber or in a separate chamber.

Due to the toxic properties and extreme flammability of ethylene oxide, the sterilization line must also include devices designed to neutralize the gas removed from the chambers after the sterilization stage and during the degassing stage. The post-process gas is forced through a ventilation system into a buffer tank, which prevents overloading of the ethylene oxide neutralizing device.