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홈페이지사례 연구Kestrel Ensures Blood Processing Medical Devices are in Specification

Kestrel Ensures Blood Processing Medical Devices are in Specification

By1월 16, 2019사례 연구

Kestrel Ensures Blood Processing Medical Devices are in Specification


Gambro BCT are using a Kestrel non-contact measuring system to measure and inspect a wide range of medical device components as well as mould tools used in their manufacture.

Gambro BCT is a global leader in automated blood collection technologies. The UK headquarters in Gloucester is the European production centre for blood component technology disposables. These devices are used in the innovative new OrbiSac system, a machine developed to extract platelets from blood products. Platelets are increasingly in demand for donation to patients who are suffering from a variety of illnesses where these repair cells have been destroyed by disease or treatment.

 

 

Critical Devices

The disposable device used in the OrbiSac system is a complex assembly of several PVC tubes and soft PVC collection bags, assembled using precisely toleranced and quality controlled components. Whenever a platelet donor gives blood, a new, sterile collection system must be used. Due to the critical nature of the device, quality and functionality must be guaranteed with each device being carefully controlled and inspected during manufacture.

The Kestrel system is operated within the ENISO 14664-1 Class 8 standard clean room. The regular task that falls on the Kestrel is the accurate gauging of PVC tubing used within the disposable device. 1km reels of PVC tubing are delivered to Gloucester, where every batch is then sampled for accurate inner diameter (ID) and outer diameter (OD). A slice of tubing is examined on the Kestrel’s XY stage, allowing extremely accurate measurement of the diameter.

Adrian Mann, Senior Engineer commented that “the Kestrel offers significant benefits over conventional contact gauging methods. The PVC tubes are quite flexible so accurate, repeatable gauging is very difficult when using a number of inspectors”. The Kestrel is connected to a QC200 microprocessor, so operators follow a basic operating procedure and input points on the tube diameter using the simple to use keypad. Adrian continues “…for basic inspections, the system couldn’t be simpler. The operators multi-task throughout the production cell. This way, I don’t need to have a specialist engineer to carry out the measurements.”

 

 

Flexibility, Accuracy and Ergonomics

To ensure the best possible seal in the collection bags, an RF (radio frequency) welding technique is used. This provides a strong, water tight seal that is stronger than the bag itself. A secondary measurement task for the Kestrel is the gauging of the RF brass mould tools. These measurements allow the Kestrel to demonstrate its flexibility and accuracy, by allowing an engineer to measure the precise features of the brass mould tool against the original engineering drawing. Because of the true optical image used by Kestrel, edges and features are clearly contrasted in the viewing head, allowing edges to be precisely located despite being brass against brass.

Another advantage of the ergonomically optimised system is the large eye relief distance offered by the display head. The Gambro operators must wear eye protection to guard against any possible risk of solvent splashes. Kestrel allows safety glasses or prescription glasses to be worn, unlike conventional microscope eyepieces. This means that not only is the unit comfortable to use, operator safety is also assured.

Adrian Mann concludes “I’m very happy with my choice of measuring system; Kestrel has provided a flexible solution that is popular with the operators. Not only is it compact and simple to use, but it’s also very good value for money!”