Measuring Medical Devices with OGP UK- Syringe Special

With the evolution of advanced multi-sensor metrology capabilities at its peak, this technology is fast becoming a popular measurement solution for increasingly complex components within the medical manufacturing industry. As the preferred quality control technology, it allows medical manufacturing companies to develop and improve the quality of specialist devices.

On one end of the spectrum medical devices can require highly customised forms, such as hip ball joints or knee cap replacements, because they have to mimic organic curves in order to mate perfectly with real bones. At the other end of the medical device spectrum however, are plastic syringe bodies that appear as a simple metrology task, when in reality they require a number of varied dimensional measurements. A custom solution has proven to be the best measurement method for batches of medical device parts, especially plastic syringe bodies like this. As a minimum, the length and outside diameter of each of the tubular syringes is measured.

measuring medical devices


Also see: Make Better Medical Devices with OGP UK Multi Sensor Metrology

This is easily accomplished by using a fixture to secure the syringe horizontally across the multi-sensor metrology system stage, backlighting it, and utilising video sensor technology to measure the edges defining its outer diameter and length in order to determine the distance between those edges.

Syringe bodies can be measured one at a time, but this is time-consuming and throughput is minimal, or they can be more efficiently measured when mounted in a multi-part fixture, which better supports production volumes and lowers cost per syringe. This solution successfully allows for the efficient measurement of the outer cylinder of the syringe, whereas the equally important diameter measurement cannot be gathered using video technology while the syringe body is horizontal.

One method would be to re-mount the syringes vertically in a separate fixture, however that would cost not only additional parts, but extra expenditure as well as add more time to the process. Another solution is to implement a rotary indexer, mounting each syringe individually. The rotary indexer would allow for the length and outside diameter to be measured while the syringe body is fixed to one position, then it would enable the imagining and measurement of important diameters by rotating the syringe 90 degrees. Although this would automate the measurement process it is inefficient because each syringe body must be loaded, unloaded, and measured individually, whilst indexer rotation is also time-consuming for the entire process.

A specially designed multi-part fixture is an ideal solution for this measurement problem. A 45 degree mirror offers direct imaging and measurement of part diameters when the syringe bodies are horizontally mounted relative to the video optics on the XY plane. Through fixturing a number of syringe bodies beside one another the video optics can carry out all measurements with its quick XY positioning.

Once a part routine has been created for one syringe, it can easily be applied to other routines, thereby increasing throughput speed as well as avoiding part deformation of the soft plastic bodies due to the nature of video measurement as non-contact technology.

The custom video measurement method will work dependent on the strength of the video sensor optics, especially if they have long enough working distance to focus on the part after reflecting the imaging path. This type of fixture, as an optical technique will work well with a TTL laser sensor for more thorough data point collection accuracy and, much like optical sensors, would require a long working distance alongside minimal beam triangulation. OGP’s TeleStar TTL laser sensor fulfils these requirements offering an optimal metrology sensor for syringe bodies.

The documentation required by medical device manufacturers to accompany parts and devices produced for the medical industry should demonstrate controlled manufacturing processes, including inspection operations and equipment used in quality control as well as monitoring.

Multi-sensor measurement systems enable the verification of medical devices, collecting part dimension data and ensuring the part meets the design specification. Manufacturers then use this information to improve the accuracy of the part. There is currently a myriad of medical devices that are measured on OGP UK multi-sensor metrology systems, enabling this advanced technology to maximise medical devices and part performance. The outcome not only affects the health of medical device manufacturers’ balance sheets, but ultimately, the health of the patient too.

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