Validation of Sterilisability of Medical Devices with Moist Heat

For validating sterilization processes of medical devices with moist heat according to DIN EN 17665-1, SMP GmbH operates steam sterilizers according to DIN EN 285 and DIN EN 13060 and has the technical equipment for quality assurance measures and monitoring of these processes.

The inactivation efficiency of the heat-resistant Geobacillus stearothermophilus spores used to validate the sterility of a medical device is examined in the internal microbiological laboratory.

Low-Temperature Sterilization (H₂O₂)

In cooperation with certified partners, we offer the examination of industrial and clinical sterilization processes with ethylene oxide, hydrogen peroxide, or formaldehyde.

Newly developed sterilization methods are also inspected and evaluated by SMP GmbH according to ISO 14937.

Drying

After the sterilization process, the verification of drying of the packaged medical devices according to EN 285 and EN 868-8 is carried out.

Validation of Packaging Processes and Sterile Barrier Systems

DIN EN ISO 11607 and the mutual guideline of DGKH, DGSV and AKI for Sterile Packaging require quality assured and validated processes and the use of certified materials for packages of sterile medical devices.

We examine the leak tightness of packaging materials, their influence on the sterilization success and the storability of sterilized packaging which include sterilization containers and their filters, transparent sterile pouches (hot-sealed Foil-Paper-Pouches) and non-woven fabrics.