The ISO 11135 standard encompasses the requirements for ethylene oxide sterilization of medical devices in both industry and healthcare settings. It details the various parameters to consider for this process and provides guidelines for establishing its validation.
Are you considering ethylene oxide sterilization for your products? IONISOS, your sterilization provider in France and Europe, presents the different validation methods related to this standard, along with its services.
The sterilization of medical devices using ethylene oxide (also known as EO, EtO, or OE) differs from ionizing radiation treatment in its core principle, which involves exposing products to gas within a vacuum-sealed chamber.
For this reason, the requirements and guidelines governing the process, its validation, and routine controls are consolidated into a specific standard: the ISO 11135 standard.
EtO sterilization is based on various cycle parameters (temperature, humidity, gas concentration, exposure time…) that are adjusted according to product characteristics to ensure sterility.
The standard incorporates European and French regulatory texts regarding the sterility of medical devices and reiterates the obligations of manufacturers and operators in this area.
It outlines all parameters of the validation dossier, defines the methods for validating the process in compliance with the standard, and specifies monitoring measures, routine controls, and release criteria to be followed.
The steps of EtO sterilization validation are outlined in detail in the standard’s text.
For clarity and conciseness, we provide a brief overview here.
The validation process is divided into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
1. Installation Qualification: The goal is to demonstrate that the equipment and all logistical resources used for the treatment comply with the standards and are suited to their intended use.
2. Operational Qualification: This aims to prove that the equipment can apply the EtO treatment while meeting the defined parameters.
3. Performance Qualification: This phase must demonstrate that the equipment can consistently meet predefined criteria, ensuring that the products are perfectly sterile without altering their appearance or characteristics.
This step is conducted in two distinct phases: the microbiological PQ, to ensure the required sterility assurance level, and the physical PQ, which verifies the reproducibility of the process and the consistency of the installation throughout the treatment. The process must be validated through at least three consecutive cycles to be considered reproducible.
The first two steps of the validation are performed by the sterilization company before treating medical devices.
Several laboratory tests are conducted during the validation process: microbial load tests, biological indicator cultures, tests to verify biological indicator populations, and sterility checks.
The process is then revalidated every two years to confirm that no changes affect the treatment. If modifications are made to the product or its packaging in the meantime, or to the service provider’s equipment, a full validation or reduced PQ may be conducted.
With over 60 years of sterilization expertise, the IONISOS group has been offering ethylene oxide treatment services to healthcare professionals since 2004.
Our four EO sterilization sites are located in Loiret and Rhône, France, as well as in Monza and Reggiolo, Italy. All our facilities are certified to ensure full compliance with the ISO 11135 standard.
Our expertise and experience in the industry allow us to offer a premium, flexible service tailored to your needs and to current regulations.
We develop customized cycles suited to your products. For transparency and quality commitment, we always provide results through a service agreement after completing Installation Qualification and Operational Qualification. This ensures that you receive perfectly sterile products in line with ISO 11135 standards.
Our processing capacity allows us to sterilize your products promptly, optimize the aeration phase, and conduct all chemical and microbiological tests in our analysis laboratory.
Finally, choosing IONISOS also means getting a tailored support service with a dedicated contact person who will oversee all your orders and provide expert advice, regardless of the sterilization method used.
Any questions? Need a quote? Our team is here to assist and advise you.