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<img style="width: 30%;" src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/20230831170031541.jpg" alt="iso 11135 for Eto sterilization" data-href="">
<h2> What is ISO 11135?</h2>
ISO 11135: 2014 specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and healthcare facility settings, and it acknowledges the similarities and differences between the two applications.
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<h2>Implementation of the Sterilization Process</h2>
Sterilization is carried out by eto sterilizer installed in a factory or sterilization station. Control system installed in another room. This control system controls the Sterilization process according to defined parameters and requirements.
<img style="width: 50%;" src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/20230831170200845.png" alt="Sterilizer Control System" data-href="">
<h2>&nbsp;</h2>
<h2>Gas Used in Sterilization Process</h2>
The gas used in Sterilization is either composed of pure Ethylene Oxide and nitrogen or mixtures of carbon dioxide (we suggest EO gas percent not less than 30%. or we should strengthen the chamber).
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<h2>About Ethylene Oxide Gas</h2>
It is highly toxic.
It is flammable.
It possesses the risk of explosion from 2.6% volume in air.
So we suggest handling, store and use EO gas with great care.&nbsp;
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<h2>Steps Involved in Sterilization Process</h2>
In ISO 11135 The ethylene oxide sterilization process into three stages:
1. Preconditioning (heating, humidification)
2. Sterilization(EO Injection, expose）
3. Aeration（EO removal, Air wash）
<img style="width: 50%;" src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/20230831170330520.png" alt="Eo" data-href="">
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Validation Of EO Sterilization In ISO-11135 &nbsp;
Process Validation consists of 3 stages.
<img style="width: 50%;" src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/20230831170427400.png" alt="IQ OQ PQ" data-href="">
Pls review this article to know more about <a title="Qualification Services" href="https://www.hzbocon.com/qualification-services">IQ, OQ, and PQ.</a>
PQ consists of two stages, MPQ and PPQ.
<img style="width: 30%;" src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/20230831170502444.png" alt="PQ" data-href="">
1.MPQ (Microbiological Performance Qualification
2. PPQ (Physical Performance Qualification

ISO-11135 For Eto Sterilization

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ISO 11135: 2014 specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and healthcare facility settings, and it acknowledges the similarities and differences between the two applications.

ISO-11135 For Eto Sterilization

Publish Time：2023-10-09