Low vapour transmission pouches used for IVD or other moisture sensitive products, including dressings which should be kept moist, can be quality controlled by vacuum decay leak testing. The foil pouch is placed into specially designed tooling. Closing the chamber automatically starts the leak test cycle. A vacuum is drawn in a slave chamber. The vacuum is then dumped to the test chamber. As the volume of each chamber is known the resulting pressure will also be known. Any variation from this pressure will be a result of leakage from the test pack.
This type of system is typically calibrated with a specifically manufactured reference leak and validated using perforations of known size.
This method is often not suitable for pouches filled with a gloopy fluid which can mask leaks or enter the leak test machine electronics.
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Medical Device Testing Equipment and Information
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