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.

We have many more resources on our website that you should check out

Our clients prefer to work with us because we are Experts in Vacuum Science and Technology. You should check out some of our other items we carry; click on the links below.

Vacuum Decay Leak Testing Systems
Vacuum Decay Leak Testing Systems are Instruments that detect and quantify a leak by measuring the drop in vacuum (pressure) inside the specimen. During a vacuum decay leak test, the specimen is placed into a vacuum chamber, the vacuum is pulled to a specified setpoint, and the drop in vacuum is monitored and recorded over time. If a leak in the specimen exists, the air will travel from a higher pressure (inside the specimen) to a lower pressure (vacuum chamber). As a results of the additional air, the vacuum levels will drop whereas a leak can be detected and quantified.
Piston Vacuum Pumps
Piston Vacuum Pumps are devices that generate a vacuum through the workings of an internal piston. Several advantages of a piston pump include, low maintenance, no oil mist emission since it’s an oil free vacuum pump – the shortcoming are not as high of vacuum levels and volumetric flow.
Our Work: Chamber for Vacuum Extrusion System
This is a custom acrylic vacuum chamber build for a high volume manufacturer of parts which are fabricated using vacuum extrusion techniques. The challenge was to build a vacuum chamber system which mated on two perpendicular surfaces; on the bottom and on the rear of the chamber. This was accomplished by incorporating a double gasket mechanism on the bottom and incorporating a clamping mechanism on the rear.
Related Articles: Piston Vacuum Pump: The Ultimate Guide to WOB-L and ROC-R Vacuum Pumps
This article is intended to be the Definitive Resource when it comes to Piston Vacuum Pumps. We know a thing or two about vacuum pumps because we work with them every day. In this article we will specifically talk about Piston Vacuum Pumps – the WOB-L and the ROC-R to be exact.