Equipment Validation
Users can apply one of the following validation test methods to meet AS 2773 and AS 4187:
- TGA approved Soniclean's Ultrasonic Performance Meter
-
Aluminium foil. Watch our Soniclean instructional demonstration with validation.
For more information:
- Download and print the Foil Test and Instrument Cleaning info sheet
- Read and adapt Ultrasonics and the Foil Test
- Refer to information given in the Operating Procedures
Our Soniclean service team also performs validation consisting of the following identified stages:
- Installation Qualification (IQ)
- Operation Qualifications (OQ)
- Performance Qualification (PQ)
IQ is undertaken to demonstrate that Soniclean equipment and any ancillary items have been supplied and installed in accordance with our specifications. OQ is carried out to demonstrate the capability of the equipment to meet our original specifications.
PQ is performed after IQ and OQ or after repairs are carried out. It ensures the ultrasonic activity performance is consistent with the original production validation records. PQ makes use of the aluminium foil test, Soniclean’s TGA approved Ultrasonic Performance Meter and Soniclean’s SoniClip to validate cleaning performance inside and outside lumens of cannulated equipment.
Soniclean has not authorised any other third-party or service provider to undertake validation of Soniclean products and cannot be held liable for any malfunction or adverse cleaning results caused by a validation undertaken by a third-party. Book a service with Soniclean.