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.

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Our clients prefer to work with us because we are Experts in Custom Fabrication (especially Polymer Fabrication). There is a tremendous amount of valuable resources and information regarding vacuum systems and vacuum technology; check them out by clicking 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.
Vacuum Controller Instruments
Vacuum Controller Instruments are devices that measure and control for vacuum inside a vacuum chamber. A vacuum controller consists of a vacuum gauge, control system, and an Human Machine Interface; options include vacuum pump relays and Vacuum valves. A vacuum Controller will enable you to store products at a specified vacuum level or run a vacuum vs. time profile.
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This custom job was a modification to our standard acrylic vacuum chambers. When it comes to working with the Us Military, they want all specs to be met 110% and they want it yesterday. The military does not mess around which is why they came to us since we know how important it is to meet specs and ship fast.
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.