Process Solution

TRACEABILITY STATION

TECHNICAL HIGHLIGHTS:

  • Semi-automated table top stations
  • Small footprint (57x50x57 cm³)
  • Modular design
  • Presence control
  • Part assembly surveillance
  • Assembly inspection
  • MES controlled process
  • Suitable for medical products
  • Cleanroom class ISO 8
  • Intuitive HMI design

The IMSTec Traceability Station is a semi-automated system for single part traceability through an assembly and laser welding process of medical parts. Hardware control ensures that only one part per type is in circulation. A camera setup with image processing algorithm serves as quality control gate. All collected data is archived in an integrated MES system.

 

 

DESCRIPTION:

IMSTec’s traceability system consists of several stations around a laser welding setup (provided by the customer). Single components and mounted assemblies are sorted into trays in order to ensure full traceability. Input and output stations allow only one part at a time in the process. An inspection station controls the two main parameters that are relevant for the quality of the parts. The included MES system collects all data and saves them on a data base.

 

Components of heart pacemakers need to be separated before they are assembled. For the IMSTec traceability station the single part traceability is ensured by camera systems within all loading stations. The operator is requested to load one part to a blister tray with several nests. Only one nest is accessible at this process step. After insertion the image processing algorithm verifies that only one part of the correct sample type is present within the nest. Filled trays are then transferred to kitting where an operator removes single parts from two output stations (same principle as the loading station) to fit them together. The parts are then welded together with a welding laser. At the inspection station an image processing algorithm inspects the weld points and measures the run-out of every single sample. Defective parts are collected in a waste bin; a metal detector within the bin verifies that the part is actually scrapped. Another loading station is used to sort the assembled parts into a final blister tray.


On every workplace a batch reader ensures that only authorized personnel are working on the process. Every blister tray contains a barcode to guarantee traceability. The trays are locked and can only be unlocked within a loading or unloading station. All data (operator ID, station ID, inspection results, measurements…) are sent to the central MES system for archive.


Housings around all stations protect the operator from moving parts and prevent the process samples from unintended access by the user. A transparent window on the front side of the loading and unloading stations allows observation of the process.