world class quality standards
Steri Solutions SA has established, documented, implemented and is committed to continuously maintaining and improving the effectiveness of their ISO 13485 (Medical devices: Quality management systems – Requirements for regulatory purposes)
and ISO 11135 (Sterilization of health-care products: Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices) a quality management system in accordance with the standard requirements.
our state of the art facility includes
- Steri Solutions SA has all the equipment required for loading, off-loading and handling as well as for quality controlling each and every run.
- Four preconditioning rooms for conditioning the product to the required temperature before sterilisation.
- Our Ethylene Oxide steriliser is 22 cubic meters in size.
- The sterilisation plant and process has been completely validated and custom validations can be done as requested.
- We have adequate storage space for sterilised products.
- All staff are continuously trained and maintain a high level of competence and safety, this includes the use of the correct PPE equipment for our application.
- Steri Solutions SA can provide a validated and efficient Ethylene Oxide Sterilisation service to clients.
- All parameters for each run are logged and remotely monitored real time.
- An approved Certificate of Conformance is provided for each run.