• Series 20 Standard Leak Testing Fixture
• Series 40 Standard Leak Testing Fixture
• Twin Station Series 40 Standard Leak Testing Fixture
• Series 40 Standard Leak Test Machine with Interchangeable Fixtures

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leak test facility

for small medical device

The facility is designed to leak test a sealed medical device. The test is to a limit which is intended to ensure that no inward leakage will occur at pressures up to 0.5 bar differential. An air leakage limit of the order of 20 mm3/sec is considered to meet this requirement and the actual equipment is set to operate below this value.

The medical devices are sealed with an enclosed internal volume, therefore the test method is to enclose the capsule in a pressurised chamber and measure any pressure decay due to leakage in the capsule. this is done using the standard air decay sequence of a nolek TS600 leak test instrument. However, in order to check for gross leaks (which would equalise pressure internally and therefore invalidate the test) a dosing system is added to the basic instrument (the new designation being TS624)

The test fixture is a simple bench mounting unit with a slide in drawer containing the lower half of the test chamber. The upper half is clamped by a pneumatic cylinder which can only operate when the drawer is fully closed. Once the drawer is closed, an interlock valve is operated which allows a pneumatic signal from the instruments auto connector output to operate the cylinder via a pilot operated valve.

TQC welcomes the opportunity to design and manufacture complete medical leak test systems to client specifications, whether you have a simple bench top application or a more complex automated leak test requirement. Contact our engineers to advise you on your automation project.