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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Force Decay Leak Testing Systems
Force Decay Leak Testing Systems are instruments that detect and quantify leaks in a test specimen through measuring the drop in force an inflated specimen applied onto a pressure transducer. The specimen is placed into a vacuum chamber, a vacuum is pulled, and the test sample inflates. As the test sample inflates, it applied a specific force onto the force transducer. This force is measured and recorded over time. If a leak exists, the specimen will deflate and lose pressure, as a result, the force it applies onto the force transducer will decrease. This in turn will enable for detection and quantification of a leak in the specimen.
Rotary Vane Vacuum Pumps
Rotary Vane Vacuum Pumps are the most widely used vacuum pump in the industry. When it comes to performance at a reasonable price, rotary vane vacuum pumps are the way to go. Many Rotary Vane Pumps can achieve 2 to 5 milliTorr vacuum rating at a good volumetric flowrate (2 to 20 CFM) at a very reasonable price (hundreds to a few thousand dollars)
Our Work: Bubble Leak Testing System with a Dry off Sink used for Leak Testing Large Bags
How do you leak test Large Food Bags? This is the same question a Large Food and Beverage Processor had asked themselves because they had need for a bubble leak testing system which could be used to detect presence of leaks in their large bags. Their requirements were to test several sized bags with the largest bag being 24 inches Wide by 12 inch Deep by 9 inches High. In addition to the bubble leak testing system, they also needed a way to dry the bags after the test.
Related Articles: Anatomy of the Pressure Decay, Vacuum Decay, and Force Decay Curve
How do you know that you have a good part during your leak test? In order to understand your leak test, you must first understand the Test Decay Curve and what it tells you about your test specimen. There is a certain way that a test specimen behaves during the leak test.