Medical Device Product and Package Examination in a Large Vacuum Chamber

Medical Devices are products such as syringes, catheters, pacemakers, and other electronics fabricated for the therapeutic medical purposes. All Medical Devices produced and sold in the US must be regulatory compliant with the Food and Drug Administration (FDA). Failure to comply with the FDA can lead to severe consequences. If you were to ask me what the purpose of the FDA is in one sentence it would be: “The Purpose of the FDA is to protect the end user from harm”.

Regardless of your stance on regulation, whether we have too much or too little; there is one fact we can both agree upon: We want our medical devices to be quality products and thoroughly tested. No patient ever walked into the operating room and said: “Give me the crappiest Heart Lung Machine you got!”

This is why our medical device manufacturer came to us. Their mission is to help the healthcare industry to design and develop solutions to Medical Devices by offering Comprehensive Lifecycle Services To Support Regulatory Approvals and the maintenance of Medical Products.

We built a Fully transparent Acrylic Vacuum and Pressure Chamber with additional vacuum feedthroughs. Including having a fully functional Vacuum Chamber capable of medium vacuum levels about approximately 0.5 Torr, they also required a 5PSI Overpressure Option in order to pressurize several of their test specimen. A vacuum chamber having the inside dimensions of 24 inch cube (2 feet cube) is quite large and heavy. This is why we placed this chamber onto a table frame structure with 4 fully lockable swivel casters. This enables the medical device development engineers to move the chamber with ease from room to room.

The door to this chamber is a hinged door. It is clamped with swing thumb clamps during overpressure operations. On the Right wall, there are total of four vacuum feedthroughs. Two are a multipin, Type-D, 9 pin connectors. The third one is a 25 Amp, 1000 Volts, 4 pin vacuum power feedthrough, and the fourth one is a vacuum liquid feedthrough. All 4 feedthroughs can be operated at full vacuum without compromising the vacuum or pressure inside the chamber.

On the left wall, you see two valves and a vacuum gauge. Behind the valve port assembly is a pressure relief valve that will pop open at 10PSIG in the event where the operator forgot to turn off or down-regulate the overpressure for this vacuum/pressure chamber

Do you work with Medical Devices which are required to be Regulatory Compliant? If you are, Contact Us and find out how we can help you make better medical products.

Did you know that we carry a many more products?

We are an Engineering Excellence Company. You should check out some of our other items we carry; click on the links below.

Internal Pressurization ASTM F2096 Leak Testing Systems
Internal Pressurization (ASTM F2096) Leak Testing Systems are instruments that are used during the Quality Control process to discover leaks in sealed packages. As opposed to the vacuum bubble leak test, where the specimen is subjected to a vacuum, the internal pressurization integrity test creates a pressure difference and drives the air through a leak by internally pressurizing the specimen. Our Internal Pressurization Leak Testing Systems are designed and built to conform to the ASTM F2096 Protocol Standard.
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: Vacuum Levels of Acrylic Vacuum Chambers
In this article we will discuss the vacuum levels of an acrylic vacuum chamber. This article also covers the leak rate or the leak tightness of the acrylic chamber. Additionally, we are going to recommend a rule of thumb used for vacuum pump selection based on the size of the vacuum chamber.