Medical device manufacturing has a well deserved reputation for rigorous manufacturing and process control. There is no compromise on quality when people’s lives are at stake. This focus on quality control and assessment certainly applies to medical devices made from metal — for example, implants, replacement joints, endoscopes and cannulas, all of which are inserted into a patient’s body. So there are stringent demands on any cleaning processes and inspection of the completed part or component.
Manufacturing support materials such as oils, cooling lubricants, corrosion protection, drawing aids and temporary masking materials are used in the mechanical production of metal parts in medical device technology. Subsequent production steps, which require a high level of cleanliness to ensure high quality, can be severely compromised by any residual contamination. These include bonding and soldering processes in endoscope production as well as surface finishing or coating processes for implants and surgical instruments.
The SITA CleanoSpector fluorescence measuring device is used to detect filmic contaminants such as oils, cooling lubricants and release agents. With the SITA CleanoSpector, the cleanliness of the parts can be checked very quickly and at the push of a button, with a non-contact and non-destructive test. cleanliness test data can be recorded and managed with the SITA-ProcessLog software.
Process monitoring and documentation
The technology of fluorescence measurement using the CleanoSpector enables reliable monitoring and recording of part cleanliness after cleaning. In addition, as an initial check before cleaning, it can ensure that the degree of contamination of the parts remains within the permissible limits for which the cleaning process was specified and designed. Parameter deviations and cleaning system faults can be recognised in time and process reliability can be significantly increased.
The SITA CleanoSpector is easy to use and a reliable measuring device for the inspection of parts cleanliness in medical device technology. Due to its uncomplicated operation and the measurement accuracy, it is suitable for use in the laboratory as well as for use around the manufacturing processes.
