SterisolutionsA leader in sterilisation
Sterisolutions is an independent Ethylene Oxide sterilisation plant and holds and Maintains ISO 13485 as well as ISO 11135 Certified.
Consistently high standards
Top management has ensured that customer requirements, needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving safe sterilisation of medical devices and customer satisfaction.
A quality management system
SteriSolutions has established, documented, implemented and is maintaining and continually improving a quality management system in accordance with the requirements of ISO 13485. This includes:
- 4 preconditioning rooms as well as storage space for sterilised products
- The EtO steriliser is 22m3 in size and approximately 60 cycles are run per month
- All staff are continuously trained and maintain a high level of competence and safety, this includes the use of PPE equipment.
- The sterilisation plant and process has been completely validated and custom validations can be done as requested
- Sterisolutions has all the equipment required for loading, unloading and handling as well as for quality controlling each and every run. All parameters for each run are logged and remotely monitored real time.
- A complete Certificate of Conformance is provided for each run
- Sterisolutions can provide a validated and efficient Ethylene Oxide Sterilisation service to clients