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.

You may be interested in some of our other items

Our clients prefer to work with us because we are Experts in Custom Fabrication (especially Polymer Fabrication). You should check out some of our other items we carry; click on the links below.

Pressure Decay Leak Testing Systems
Pressure Decay Leak Testing Systems are instruments that detect and quantify a leak by measuring the pressure drop over specified amount of time. Any specimen that is inflated will stay inflated if it is leak tight. On the other hand, of a leak exists in the inflated specimen, air will escape through the orifice and decrease the pressure inside the specimen. The higher the pressure drop, the high the leak.
Liquid and Gas Vacuum Feedthroughs
A Liquid and Gas Vacuum Feedthroughs are tubes that will allow you to run liquid or gas into your vacuum chamber without contaminating the vacuum levels or vacuum chamber in general. Say you are looking to run a coolant into the vacuum chamber and cool a component you are testing. You can simply install a liquid and gas vacuum feedthrough are run your coolant towards your test specimen.
Our Work: Vacuum Storage of Pharmaceutical Products and Medical Supplies
A pharmaceutical manufacturer contacted us to build them a large vacuum storage system for their pharmaceutical products. They were looking for as much footprint as possible which is why they got a two-chamber system from us. They needed a total of 6 shelves per chamber including trays. Finally, they were looking to have both chambers to be placed on a table frame assembly with lockable swivel casters. What you are seeing is a two chamber system, each chamber is our 20 inch cube acrylic vacuum chamber, front load hinged door. Each chamber can be accesses independently while the other is under vacuum. The trays can be easily loaded and unloaded. This whole system can also be moved to anywhere in their facility.
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