Sterilization is essential for professionals in the medical sector. Strict standards (ISO 11135 and ISO 11137) govern each step of the treatment for sterilization and its validation.
For complete validation of the sterilization of medical devices, the operation must be conducted by an expert.
Medical equipment requires the utmost rigor in its sterilization. Adhering to French and European standards necessitates following a strict sterilization protocol. These standards define the steps of the sterilization process, whether it is carried out by radiation or by ethylene oxide.
These two processes fundamentally differ. Widely used, sterilization by ionization allows for the treatment of large volumes while achieving a very high-quality result. Its use at the end of the logistics chain also saves time and reduces storage costs, as products are available immediately after sterilization.
The validation of these two sterilization methods is subject to a strict regulatory framework.
The ISO 11137 standard related to radiation sterilization governs both microbial determination tests and the processes to be implemented to establish the sterilizing dose.
By defining minimum and maximum doses to be applied during the process, it helps eliminate the microbial load of the device without altering its characteristics.
On the other hand, ISO 11135 pertains to EO sterilization and its various phases. By combining installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), one ensures the consistency of cycle parameters over time.
Founded in 1993, IONISOS is the direct successor of the Lyon Atomic Application Center, a pioneer in the treatment by ionizing radiation established in 1956. For 29 years, we have been serving industrial clients in the medical sector and all activities subject to strict sterilization requirements (pharmaceutical, cosmetic, food industry…).
This expertise has made us a European leader in sterilization. We continually work to improve our know-how and carry out sterilization in state-of-the-art centers in France and Europe.
We aim to guarantee our clients flawless quality for the sterilization of their medical equipment and products. To achieve this, we offer a customized process that ensures effectiveness and safety. We rigorously apply current standards to
In order to choose the most appropriate method for your products and advise you throughout the process, a dedicated contact person will oversee your file. Control at each stage ensures optimal quality and safety for your products, whatever your needs.
Would you like to start a partnership with IONISOS? We are here to assist you with any inquiries.