The laws of physics that determine the best match leak test methods have not changed. What has changed is the technology available - both the leak testers and the automation for full or semi-automated test and assembly machinery - that makes one or another leak tester the best match technology. This article reviews five factors that need to be considered to ensure the best choice is made.
Many in the medical device industry are unwilling to trade up to faster and more accurate leak test technology given the pain and costs of redoing process validations required by the FDA. While that is always a factor, reputable leak tester manufacturers have worked with device manufacturers to validate leak test assemblies or leak detectors used in cleanroom environments many times and can be called upon to minimize the time required for validations.
Furthermore, the calculation of return-on-investments for newer leak detectors is a relatively straightforward proposition. In fact, reputable manufacturers of leak test systems should keep customers apprised of technology options as part of the cradle-to-grave support to which they are entitled.
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