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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Portable Vacuum Chamber and Pump Systems
We carry a wide range of portable vacuum chamber and pump systems. A Portable Vacuum Chamber and Pump system is placed onto a frame structure and lockable swivel casters which enable you to move your vacuum chamber and pump system around your facility. Our portable vacuum systems are very popular among businesses that are constantly growing, evolving, or sharing. Our portable vacuum systems are moved with ease from location to location.
Power Vacuum Feedthroughs
Power vacuum feedthroughs are hermetically sealed off the shelf components used to transfer electrical power from the outside of the vacuum chamber into the inside of the vacuum chamber without compromising the vacuum. One example application would be powering an electronic device inside the vacuum chamber
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: Dry and Wet Vacuum Leak Quality Testing of Sachets Filled with Powder or Liquid
This article will talk about how to test the seal integrity of food bars. You will understand what you will need to do in order to ensure good seal quality. This article covers the seal integrity testing of Breakfast bars, Chocolate candy bars, Crisped rice bars, Energy bars, Granola bars, Health bars, Protein bars, Fruit and Nut Bars, Meal Replacement Bars or any other food bar sealed with a flow wrapper.