Force decay Testing of Medical Devices using Custom Vacuum Chambers

Force decay Testing of Medical Devices using Custom Vacuum Chambers
Force decay Testing of Medical Devices using Custom Vacuum Chambers
Medical Devices are subject to much regulatory scrutiny and compliance and therefore must perform as intended and as specified. Furthermore, device or product failure is not an option when it comes to medical devices. This is why performance and product quality are of utmost importance.

A medical device manufacturer, and we are talking about the largest medical device manufacturer in the work, reached out to us looking for a non-destructive leak testing solution to their surgical balloons. These balloon type of catheters are devices which are inserted into the veins or arteries of a patient and ran towards a target location. Once this balloon type device reaches it’s destination, the balloon is inflated causing an expansion of whatever needs to be expanded on that location. Sometimes it is a mesh which is inserted and expanded into arteries in order to open up a clogged artery and improve blook flow. Other times, it is something else. As you can see, it is critical that the balloon does not leak, because a leaking balloon will put the patient at risk as air will be filling the vanes of the patient and therefore putting them at great risk. Some approaches have mitigated the risk of balloon failure by inflating the balloon with saline solution which would not put the patient at risk if balloon failure occurs. However, there is still of risk of debris being deposited and left in patient vanes.

We design a custom vacuum chamber to accommodate various sized balloon our client was making. We also ran a vacuum feedthrough into the chamber which was connected to the force transducer present at the balloon testing site. When a vacuum is pulled, the balloon will inflate and apply force to the pressure transducer. This force will be measured and a leak rate will be calculated based on the decay in force over specified testing time. A larger vacuum chamber enables multiple testing specimen to be tested simultaneously eliminating the risk of production delays. The force decay leak test was only one of the many tests this medical device was subjected to during it fabrication process. We do talk about our other leak testing methods in other articles. If you are looking for a force decay leak tester that will help you produce medical devices with the highest degree of performance and quality, please check out our leak testing systems to explore ways how our products can help you.

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Vacuum Bubble Emission ASTM 3078 Leak Testing Systems
Bubble Emission (ASTM 3078) Leak Testing Systems are instruments that are used during the Quality Control process discover and locate leaks or seal integrity failures. Leaks are detected by submerging the specimen into a tank of water, applying a vacuum, and inspecting the submersed specimen for bubble emission. Our Bubble Leak Testing Systems are designed and built to conform to the ASTM D3078 protocol standard.
Viewport Vacuum Feedthroughs
Viewports Vacuum Feedthroughs are windows that enable you to look into the inside of your vacuum chamber. If you are using a metallic vacuum chamber with a metallic lid, you will not be able to view the interior of your vacuum chamber unless you have a viewport. Viewports also enable a different electromagnetic spectrum of light to passthroughs.
Our Work: Custom Vacuum Chamber with Blank Plate
You are looking at our standard Acrylic Vacuum Chamber, Hinged Door with Clamps. There is only one difference; this vacuum chamber has a blank acrylic plate that is connected to and aluminum plate which in turn is anchored to the side wall of the acrylic vacuum chamber. This blank plate is there to enable our client to add vacuum feedthroughs to the side wall in the future
Related Articles: Force Decay Leak Testing
Force Decay Leak Testing is a very popular quantitative leak testing method used to quality test package and product integrity due to its ability to detect small leaks which cannot be seen through visual inspection. In this method, the test specimen is internally inflated by either internal pressurization or vacuum force. The inflated test specimen will, in turn, apply a force on a pressure transducer. Finally, the change in force applied by the inflated specimen over a specified time is observed.