Medical devices manufactured in standard manufacturing conditions in accordance with ISO 13485 requirements can contain micro organisms prior to the sterilization process during the production phases. Medical devices and equipment in the production phase are not called sterile until they arrive in the sterilization process.
The medical devices and equipment that have undergone the sterilization process must not contain living microorganisms. ,
The aim of sterilization is to neutralize microbiological contaminators and thus sterilize the non-sterile medical device.
ISO 11135 Sterilization of medical materials – Ethylene oxide – The standard of requirements for the development, validity and routine control of medical devices determines the requirements of sterilization with Ethylene Oxide.
The service provided during the validation process is the process of valiing the sterilization of the medical device sterilised in accordance with ISO 11135 standard and does not contain any micro organisms after sterilization.
Etilen oxide sterilization validation work is carried out with the following steps;
- Preparation of validation protocol
- Biological load (bioburden) study of the product
- 1 partial, 3 halves, 2 consecutive full loops,
- During these cycles, temperature-humidity monitoring and recording the results with a number of independent dataloggers in accordance with the standards,
- Sterility analysis of biological indicators placed in the device with the products during cycles,
- Sterility analysis of products representing the difficult condition after half cycles,
- Performing package performance and residue analysis after 2 consecutive full cycles,
- The preparation of the validation report tells the whole process along with the results.