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Introduction to Leak and Flow Testers
Leak testing as a science has come a long way from submerging your product in water and observing the bubbles that rise. If you are new to leak and flow testing, or if you feel that you would like your vocabulary refreshed, we strongly recommend that you take a few minutes and browse through our informational brochure, Leak and Flow Testing 101.
Leak and Flow Testers for Medical Devices
We at TME understand that implementing a leak test system for medical devices is more complex than at first glance, and have designed our TME Solution, TME Worker and other instruments with this in mind. For example, the design of a multi-lumen catheter must permit each lumen to be tested during its production. Any testing, therefore, should be conducted on each lumen of the catheter. An approach to leak testing suitable for leak testing blood bags, for example, could not be used if your product is a cannula or a catheter. Questions to consider when designing and implementing a leak tester system for your medical device or product include:
- Is the test object rigid or flexible? Would the flexible product need to be restrained?
- Can it be accessed for pressurization, or would a closed chamber test be more suitable?
- Is the internal volume of the test object large or small?
- Is there air available in the head space of filled blisters or bottles?
- Will a leak test suffice, or should your product be tested for occlusions as well?
- What kind of data analysis and documentation will be needed for validation and/or qualification issues?
Mass Flow Testers
Mass flow testing uses intrinsic properties of air to directly measure the amount of air escaping a closed system. In certain circumstances, either pressure decay or mass flow testers can be used for leak testing. Depending on the size of the leak you are searching for (and the volume of your product), mass flow leak testers can have several advantages, including speed of test (1-2 seconds, rather than the longer time required for the pressure decay fill, settle, test cycle). The mass flow test is not dependent on temperature or air density, which may be a difficulty for the pressure decay test. The TME Solution and the TME Worker are each configured to perform both leak and flow tests, as well as testing for occlusions.
Mass flow testing is a valid method for identifying occlusions in an open-ended test part. Any obstructions in the part will restrict the flow of air through the device, thereby causing the part to fail the test. The TME Worker can be configured as a one-port leak/occlusion tester and the TME Solution, with multiple test ports, can be configured to perform leak and occlusion tests on one to four test parts using only the test sequence you need, which is ideal for the testing of devices such as multi-lumen medical diagnostic catheters.
The TME Worker is a simple to operate, economical and reliable leak, leak/flow or leak/occlusion test instrument. The TME Solution Leak or Leak/Flow Tester provides multiple ports, high resolution, great flexibility and a statistics package to aid in your process validation and control. With our may years of experience in medical device testing, our Applications Specialists can help you determine the best leak test system (leak tester, accessories, and/or fixtures) for your medical device or product and assist in qualification and/or validation issues as well.