Sterilization Validation testing verifies the appropriate Sterility Assurance Level (SAL), drying time and thermofiltration of the medical device. The test determines relevant sterilization parameters for healthcare processing instructions. Based on the data obtained by the tests, the manufacturer will be able to provide approved sterilization parameters to healthcare institutions. EUROLABcan verify the following methods for sterilization; moist heat (gravity or pre-vacuum), ethylene oxide (EO) and dry heat.
EUROLABhas the equipment and qualified personnel to guide you through the process. Our experts will provide individualized advice and are here to help simplify complex regulatory and standards recommendations.
Steam Sterilization Sterility Assurance Level test: The test verifies recommended gravity and/or vacuum pre-steam sterilization parameters for the medical device. EUROLAB validates individual devices, implants, trays, kits or other reusable devices. Typically, the 10 6 Sterility Assurance Level (SAL) biological indicator is validated using the overfill method. In addition to SAL verification, drying time verification testing is recommended and internal temperature mapping may be appropriate. Drying time testing ensures that packaging and devices are not wet after the sterilization cycle. Moisture may compromise the sterile properties of the packaged device. Temperature mapping determines the temperature inside the enclosure device and displays the heating characteristics of the device.
EUROLAB, with its highly expert team and internationally accredited laboratories, Sterilization Validation Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
