EO Sterilization Services

Ethylene Oxide Sterilization process

It is one of the most effective sterilization process at low temperature, and has more than 60 years of existence in the medical and pharmaceutical fields. Nowadays, the ETO sterilization process has been developed until reaching a high level of performance and efficiency. It is now a well proven technology for thermo-sensitive products, unable to be sterilized by others traditional sterilization methods like steam or dry heat process.

That chemical sterilization process is based on a large gas diffusion (ethylene oxide or EO) able to annihilate the micro-organisms, is a low temperature sterilization method as it is usually used up to 60ºC. Thanks to this important advantage, delicate products can be treated like syringes, latex gloves, catheters, etc.

It is necessary to highlight that such a sterilization process requires a specific know-how. More details about our EtO services expertise proposed.

What is the ethylene oxide (EO)?

The Ethylene Oxide is a colorless and odorless gas, which the chemical properties allow:

• An excellent propagation into the porous materials.
• A high diffusion and absorption on the thermo-sensitive products (mainly plastics).
• A preservation of the material characteristics.

Thanks to those specifications, Ethylene Oxide (ETO/EO) gas is able to:

• Spread into creases and difficult access to be sterilized.
• Sterilize between 30ºC and 60ºC (low temperature) ensuring neither deformation nor destruction of the sterilized elements.
• Go across wrapping membranes that contain the product.

For the Ethylene Oxide sterilization (ETO), different EO mixture could be used:

*Ethylene Oxide with CO2: the EO is mixed with X% of CO2, due to their mixable properties. The pressure inside the sterilizers will be higher in order to maintain a correct EO concentration.

*100% Ethylene Oxide: that mixture allows to work at a lower pressure inside the sterilizer.

Generally, the use of one or the other mixture depends on the gas availability in every country.

How does the Ethylene Oxide (EO / ETO) sterilization process work?

This gas is toxic, inflammable and explosive. That’s why it is important to handle the process under precaution, working with sterilization equipment that can ensure the personal and installation safety, as well as the environment concerns.

For these reasons, special attentions should be taken for ethylene Oxide cycle development. Always looking for the best relation between the following variables: Gas concentration, humidity, temperature and exposure time.

The Key parameters of this sterilization process

During the whole process, there are key parameters that must be controlled until the end of the cycle, which also allow the process optimization:

• Gas concentration.
• Chamber temperature.
• Relative humidity.
• Exposure time.

What material can be used with EO process ?

That sterilization process is used in the medical and pharmaceutical fields. The elements that use to be sterilized with Ethylene Oxide are all the materials that can’t be sterilized by traditional methods. In other words, all the thermo-sensitive material.

Some examples of those materials: Wrapping, plastic products, raw materials, surgical, medical and optical instrumentation, prosthesis, syringes, …. That is perfect for medical device sterilization and the sterilization of pharmaceutical products.

The ETO sterilization is nowadays, without any doubt, one of the most effective sterilization method for thermo-sensitive products, and takes importance where traditional methods are limited. In other word, this method is one of the most sought for medical device treatment.

What are the advantages of Ethylene Oxide (EO / ETO) sterilization?

• High efficiency as antivirus, bactericide and fungicide.
• Ideal for thermo-sensitive materials, thanks to the low temperature sterilization cycle, ensuring neither deformation nor destruction of the load.
• High diffusion coefficient in wrapping, creases, basically in any difficult access area.
• Process that doesn’t alter physical qualities of the sterilized product.

Additional Information

Medical Devices that Require ETO Sterilization

In addition to the high level of efficacy that ETO provides, it is highly compatible with a wide variety of medical device materials of various construction, enabling medical device companies to manufacture many devices that would not be possible without ETO. The high level of performance and effectiveness of medical devices when sterilized by ETO is well understood. If ETO could not be used for sterilization of healthcare products, there would certainly be significant, and likely disastrous, adverse public health consequences. Elimination of this sterilization technology would introduce the real risks of increased morbidity and mortality.

Strict government regulation controls ETO use in the U.S. FDA and other global regulators play an important role in ensuring that manufacturers’ sterilization methods are properly validated. FDA regulations, guidance and harmonized international standards include provisions that address the use of ETO and other Sterilants for medical devices. Manufacturers must conduct exhaustive studies to demonstrate that the required sterility assurance levels are achieved by the process and to confirm that exposure to the sterilization process does not adversely affect the device’s performance, safety or effectiveness.

Manufacturers must comply with FDA’s Quality Systems Regulation (QSR) relative to the methods used in, and facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. This includes the use of contract sterilization firms, as the contract sterilizers are considered vendors and part of the regulated manufacturing process.

Key Facts

• Approximately 50 percent of all medical device types are sterilized using ETO, totaling more than 20 billion devices annually.
• Most surgeries involve at least one device that has been sterilized by ETO.
• As part of FDA’s Quality System regulation and other global requirements, manufacturers must validate that their sterilization processes are in compliance with international standards.
• To achieve device sterility, many medical devices rely on ETO. Eliminating or severely restricting the use of ETO could put patients at risk by threatening the health care supply chain.
• Medical devices that require ETO sterilization include heart valves, pacemakers, surgical kits, gowns, drapes, ventilators, syringes, and catheters.

Feature	Benefit	Net Gain
Lower Cost	Lower price	$ Savings
Not residuals	Product immediately useable processing Safer product international acceptability Bl’s not required	Simplified inventory management No OSHA concerns No EPA/Environmental concerns NO false positives $ Savings
Faster turnaround	Reduced inventory	Consistent quality Environmentally friendly
Simple, Clean, on-off technology	Processing consistency No carcinogens	Time Savings
Greater flexibility	Ability to handle any shipment size Ability to process mixed product loads	Simplified scheduling
No expensive breathable packaging required	Packaging flexibility	$ Savings
No re-sourcing required	No radioactive Cobalt Re supply downtime	Uninterrupted processing capability