About the Kahma Group

Select Page

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), ISO 11135 (Sterilization of health-care products: Ethylene oxide – 

Requirements for the development, validation and routine control of a sterilisation process for medical devices) a quality management system in accordance with the standard requirements and ISO 10993-7: Biological evaluation of medical devices — Part 7: Ethylene oxide sterilisation residuals.


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.
  • Installation of four preconditioning rooms ensures customer product is pre-conditioned to the required temperature before EO sterilisation commences.
  • Our Ethylene Oxide steriliser is thirty cubic meters in size, one of the largest in South Africa.
  • 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.

our service

  • Steri Solutions SA can provide a validated and efficient Ethylene Oxide Sterilisation service its customers.
  • All parameters for each run are logged and remotely monitored real time.
  • Our 96-hour turnaround times ensure that the EO sterilisation process was completed satisfactorily, which is then accompanied by Certificate of Conformance (CoC).