Leak and Pressure Testing

Leak and Pressure Testing

Our testing machines check the quality of medical plastic tubing products such as infusion and transfusion bags and sets. Our solutions cover leak, obstruction, and vacuum testings.

Our leak & pressure testing machines help medical device manufacturers to conduct non-destructive testing of their finished products.  These quality control activities are critical, given current regulations for medical devices.

Our testing solutions cover biomedical products, such as blood lines, infusion and transfusion bags and sets, breathing lines, and many other medical products.

Each of our machines undergoes quality and performance testing, as well as equipment calibration. Our calibration closely follows international standards requirements for metrological equipment. Thus, each device comes with a Calibration Certificate. 

Testing types available

Our machine can perform one or several testing types:

• Leak test: measures the loss or drop in pressure
• Vacuum Testing: uses a vacuum generator to detect leak testing 
• Single obstruction test: identifies the presence of a possible obstruction inside the circuit
• Multiple obstruction tests: determines the presence of more than one obstructions within the product to be tested

Phases of the leak testing

The leak test consists of several phases:

1. Pressurization: add compressed air into the product that needs testing
2. Stabilization: close the filling valve and, at the same time, monitor the pressure to detect any leaks
3. Test: detect and quantify any pressure drop inside the product. Then, reject the product if the measured pressure drop is higher than the set limit or “Leak Limit.”
4. Discharge: release out the air introduced into the product.

 Obstruction testing

Obstruction testing machines verify that the pressure of the circuit being tested remains within a predetermined range (minimum pressure – maximum pressure). If the parameters deviate from this range, there is an obstruction. There are two types of obstruction testing:

• Single obstruction testing
• Multiple obstruction testing

Range of test pressures

Test pressures range from 10.0 to 9000 hPa/mBar, depending on the machine.