Ever since Uson first developed the leak testing technology for the US space agency NASA (National Aeronautics and Space Administration) in 1963, the medical device industry has been using the same dry air leak testing technology. As the European Sales Manager of the company, I regularly run into manufacturing engineers and other support staff throughout Europe who do not clearly understand the basic principles of leak detection for the medical device industry. As a result, they continue to run compromised assembly lines.
I recently saw a test station using a leak tester that was ideal for leak testing a single lumen catheter but was very inefficient when it came to testing multi-lumen catheters. What was really needed for this 4-lumen application was a 4-channel concurrent tester that is capable of switching between occlusion and leak testing on all four channels at once. Such a test process is much safer as each assembly is tested to the same pre-programmed rigorous test regime without the risk of a channel being missed, and you get the benefit of a much faster test.