PLASMA STERILIZER (HYDROGEN PEROXIDE) MPS SERIES
MIXTA
MIXTA performs sterilization validation followed ISO 1437.
ISO 1437:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of sterilization process for medical devices.
The purpose of validation is to demonstrate that the sterilization process established in process definition can be delivered effectively and reproducibly to the sterilization load. Validation consists of a number identified stages, installation qualification, operational qualification and performance qualification.
- Installation qualification is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with the specification.
- Operational qualification is carried out either with unloaded equipment or using appropriate test material to demonstrate the capability of the equipment to deliver the sterilization process that has been defined.
- Performance qualification is the stage of validation that uses product to demonstrate that equipment consistently operates in accordance with predetermined criteria and the process produces product that is sterile meets the specified requirements.