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<h1>Ethylene Oxide Sterilization for Medical Devices</h1>
<p>Sterilization is the process of removing, killing, or deactivating all forms of life, including microorganisms or microbes that have the potential to reproduce. Sterile products that undergo sterilization are often chemically or heat sterilized after being placed in their final packaging. The chemical or heat sterilization process after final product packaging is known as terminal sterilization.</p>
<h2>What is Ethylene Oxide and Sterilization by Ethylene Oxide?</h2>
<p>Ethylene oxide (EO) is a gas commonly used to sterilize medical devices and products chemically. Ethylene oxide is a potent and highly penetrating alkylating agent, making it an extremely effective sterilizing agent. However, at certain levels, ethylene oxide is also capable of causing cancer. Sterilization by ethylene oxide kills microorganisms through exposure to ethylene oxide gas under vacuum and humidity. EO is used either as 100% EO or in combination with carbon dioxide.</p>
<h2>What Items Can be Sterilized by Ethylene Oxide?</h2>
<p>Standard devices and materials sterilized with ethylene oxide are plastic materials (such as plastic devices), gowning materials, heat-labile equipment, and powders. Materials that can be moist heat sterilized can also be sterilized via ethylene oxide. However, if all materials in your device or product are easily sterilized via moist heat, moist heat is the cheaper and easier sterilization option.</p>
<h2>How is Sterilization by Ethylene Oxide Performed?</h2>
<p>A typical ethylene oxide sterilization cycle involves loading items into an ethylene oxide sterilization chamber, applying a vacuum, filling the chamber to the desired relative humidity, adding an appropriate concentration of EO gas, and allowing items to rest in the EO gas under vacuum and humidity for the desired exposure time. Afterward, the gas is slowly and safely evacuated from the EO sterilization chamber, and the sterilized items are given ample aeration time to support EO off-gassing. The exposure time for most EO sterilizations is relatively long (around 6 hours), and the gas aeration period is also lengthy, up to 24 hours or more.</p>
<h2>Factors That Affect EO Sterilization and Lethality</h2>
<p>Several factors affect EO sterilization and lethality, including gas concentration (ranges from 400 to 1200 milligrams per liter), temperature (most EO cycles range from 50◦C to 60◦C), relative humidity (traditionally ranges from 35% to 80% relative humidity), and exposure time (varies based on materials used, gas concentration, temperature, and relative humidity).</p>
<p>Ethylene oxide sterilization is a powerful and reliable solution for ensuring that medical devices and equipment are safe for use by healthcare professionals and patients. However, it's important to understand the risks and limitations associated with this method of sterilization. If you have any questions or concerns, please don't hesitate to contact us.</p>

Ethylene Oxide Sterilization For Medical Devices

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Ethylene Oxide Sterilization for Medical Devices

Ethylene Oxide Sterilization For Medical Devices

Publish Time：2024-06-14