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.

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). What are you building? Take a look at the links below and discover some of the cool things we make.

Vacuum Oven Systems
Vacuum Ovens are vacuum chambers and ovens combined in one system. Vacuum ovens are necessary during processes which require the specimen to be subjected to a hypobaric and hyperthermal environment. Our Vacuum Oven Systems enable to you run a complete vacuum vs time and temperature vs time profile. We also carry portable vacuum oven systems and custom vacuum oven systems.
Altitude Simulation Controller Instruments
An Altitude simulation Controller is type of vacuum controller that simulates a certain altitude because altitude can be derived from vacuum levels. An altitude simulation controller will enable you to hold your vacuum level at a certain altitude equivalent of testing, run an altitude vs time profile, or rate of change of altitude vs. time. Further options include a vacuum pump relay that will control when the vacuum pump turns on and a vacuum valve.
Our Work: Research, Development, and Testing of Weather Balloons inside a Clear Vacuum Chamber
A wonderful company (more like one of the best companies in the world) which is currently involved with the research, development, and testing of high-altitude weather balloons, had a need for a vacuum chamber capable of achieving about 100 micro Torr (Micron) of ultimate Pressure for their testing environment. Fortunately, acrylic vacuum chambers are the perfect choice when it comes to Low, Rough, and Medium Vacuum.
Related Articles: Force Decay Leak Testing
Force Decay Leak Testing is a very popular quantitative leak testing method used to quality test package and product integrity due to its ability to detect small leaks which cannot be seen through visual inspection. In this method, the test specimen is internally inflated by either internal pressurization or vacuum force. The inflated test specimen will, in turn, apply a force on a pressure transducer. Finally, the change in force applied by the inflated specimen over a specified time is observed.