Accurate Labelling of Medical Devices

Stringent quality regulations, traceability and GAMP standards are some challenges medical device manufacturers face. SP Automation & Robotics works with medical device manufacturers to provide bespoke, high-quality, and accurate solutions.   A project from a world leader in the medical device industry required a process to accurately label medical devices to within a tolerance of +/-0.1mm with a throughput of 100 parts per minute. In addition, full traceability of the devices through the machine was required, from initial input loading by reading individual 2D bar codes on the device and checking each label before applying it to the device.

The Challenge

The main objective was to provide a fully automatic labelling system that could apply labels at 100 parts per minute with an accuracy of +/- 0.1mm.

Standard labelling techniques were considered; however, the accuracy required on the device labels could not be achieved using existing off-the-shelf technology.

  • 100% tracking each device
  • 100% tracking of each label
  • Wrap-around label with no overlap
  • Folding of complex information label
  • Placement of round label on the round device to ensure concentric placement
  • Label placement to within +/-0.1 mm

The Solution

A labelling system was designed to place the canister cap, body, and bung labels onto the devices as they indexed through a series of operation stations. The system was based around 3 Beckhoff XTS systems used to carry and locate devices, with nine labelling heads (3 for each label) positioned along the 14m machine length. To compensate for inherent inaccuracies using standard label heads, the machine had to dynamically position each device to suit the label along the length of the machine. To overcome the inaccuracies of the position of the label on the reel, each label was inspected as it was transferred to an SP designed application head. A camera below inspected the label position on the head and adjusted the theta position. The Beckhoff XTS system was then used to position the device for accurate linear placement. Before being applied, each label’s 2D barcode was inspected.

 

At the end of the line, a six-axis robot was used to unload devices into a collator system that was then used to transfer the devices for final loading into trays.

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