LEAK TESTING FOR MEDICAL TECHNOLOGY
Leak testing, which is part of manufacturing catheters, catheter balloons, luer connectors, dialyzers, IV bags, and respiratory gas filters in medical technology contexts, is a highly sensitive process with strict standards to meet.
From determining the lowest measurable leak rates and performing measuring instrument capability investigations to identifying required cycle times, we have developed a range of solutions with our finely honed expertise in leak testing. We have what it takes to support you from product and process development through high-volume production.
Because of their size, miniaturized valves made from silicone and other plastics are challenging to deal with in leak testing. Non-return valves, for instance, require not only leak testing but also opening pressure detection at minimum diameters.
For applications involving our ZEDcore modular measuring unit, we have developed an external valve block that minimizes the volume on the device side – allowing even the smallest volumes to be tested efficiently.
The entire ZED device family, which includes the ZEDbase+, comes with our modular ZEDcore measuring unit featuring highly sensitive sensor technology – allowing even the lowest leak rates to be detected reliably.
The structure and complexity of catheters make them challenging to deal with in leak testing. We test:
We have made the testing process even better with a customized pre-filling process that stabilizes the volume during the measurement time.
Handling flexible parts such as catheters requires intelligent solutions. Take advantage of our experience in manual and automated adaptations.
Bioprocess bag testing requires a reliable method of detecting low leak rates at very large volumes.
We have developed a special test bench that accelerates the filling process. It has been designed in line with customer requirements for use in cleanroom class 7 environments according to EN ISO 14644-1.
We use special test leaks to simulate certain hole sizes between 10 μm and 250 μm.
Our ZELTWANGER sensor technology is ideal for testing sensitive components such as respiratory gas filters.
Specialized high-precision sensor technology is essential for performing tests at very low levels of test pressure. This technology is included in the modular ZEDcore measuring unit, making it available for the entire family of devices to use.
LARGE NUMBER OF UNITS
Getting reliable results when performing quality assurance procedures on dialyzers and dialysis accessories requires high-precision sensor technology. A modular design allows this technology to be used with the entire family of devices, making it possible to cater to specific requirements.
Our multi-channel solutions – which include the ZEDflex – provide a flexible basis for optimizing test times in cases where testing processes are more complicated.
Covering everything from leak testing and flow testing to burst pressure testing, our wide-ranging expertise and many years of experience allow us to help our medical technology customers develop a complete process solution. We specialize in: