Magic 8 for Leak Testing Equipment
20 May 2008
When manufacturing for critical applications the consequences for component failure can come back to haunt the manufacturer in the form of expensive liability claims. Yet, says Richard Ray, senior engineer at Terumo Medical Corporation, armed with some advanced knowledge about what to look for in leak detection devices, test engineers can increase the odds that all products will roll off the production line with absolute quality assurance.
The Uson Vector is a multi-channel leak flow tester that cycles through simultaneous tests for increased throughput
Following an overhaul, in association with Suffolk based Uson, of test equipment at the company’s Elkton, Maryland plant, Ray has pinpointed eight things medical device manufacturing engineers need to know about leak testing equipment.
1) Insist on application specificity
A one-size-fits-all approach only succeeds at being universally mediocre. A leak tester supplier should consider each unique case, and then maximise the potential of the test equipment to fit that need through a redesign of the tester, or by reconfiguring it to integrate within the manufacturer's production system.
2) Look for equipment that automates the testing process
Test equipment must feature semi-automatic or fully automated leak detection systems that streamline product delivery, sealing, clamping, testing, and marking.
With continuously moving zones, assembly lines never stop. If it were a station with up to ten different ports to seal, there would never be enough time in the process allocation to do that. Here is where automated testers are a huge time-saver.
3) Examine ease of operation
A leak tester, no matter how capable its performance, is nothing if the human/machine interface lacks ready comprehension. Programming should be simplified by software with pre-formatted test configurations easily modified to each application.
Leak testers that work within the Windows environment also lend themselves toward instant, intuitive operation. Added features to look for include touch screen input, large graphical displays, selectable engineering units, built-in diagnostics and remote troubleshooting.
4) Check for fixings that fit your product
Partly a product of application specificity, the physical process of affixing the product to the leak tester is extremely important, as failures here can quickly undo all other attempts at accuracy and expediency.
Product variations, as well as specification changes and the introduction of new components all mandate changes in testing parameters. These accommodations save the expense of having to buy a totally new piece of equipment.
5) Hold out for options in output
When it comes to certifying a manufacturing process, there is nothing like a good paper trail. A complete leak detection system must include options for documenting the testing process.
A modular design suits future needs especially well, as users can choose only those features that may be needed for initial requirements, but later expand the same unit to add capabilities for more complicated applications easily and economically.
6) Consider repeatability
A test has no meaning unless it can be repeated with the same results.
Unlike reliance on the memory of an operator to initiate a sequence of tests, the automation of leak-detection actually improves repeatability because the testing process becomes non-subjective. Innate to some leak detection equipment is the ability to automatically compensate for temperature and humidity changes, which also helps assure consistent product quality.
7) Demand good support from the supplier
Look for a supplier that offers custom system design, installation and commissioning services. As well, some suppliers provide online tools to help test engineers dial in their testing parameters.
8) Seek system flexibility for future upgrades
Product variations, specification changes and the introduction of new components all mandate changes in testing parameters. A quality leak tester can accommodate such changes, saving the expense of having to buy a totally new piece of equipment.
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