Pharmaceutical Leak & Flow Testers | Leak Test For Blisters | TM Electronics

Pharmaceutical Leak & Flow Testers

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 to have your vocabulary refreshed, we strongly recommend that you take a few minutes and browse through our informational course, Leak, Flow and Package Testing 101.

Some basic definitions:

Pressure decay test: An inflation test in which a non-porous package or component is pressurized to a preset level. After the pressure has been stabilized, the decay in pressure over a preset time is evaluated to determine if a leak is present.

Vacuum decay test. Similar to the Pressure test, except a preset vacuum is established inside the package or component, and the decay in the vacuum is evaluated to determine if a leak is present.

Non-destructive testing: using specific instruments and fixtures, either pressure or vacuum testing can be conducted on non-porous packages without the product lose that accompanies destructive leak testing.

Leak and Flow Testers for Pharmaceutical Industry Use

We at TME understand that documentation issues related to CFR Part 11 are complex and critical, and have designed our TME Solution Leak and Flow Tester with this in mind. FDA regulations mandate process validation, "establishing documented evidence which provides a high degree of assurance."The TME Solution and the TME Solution-C Closed Chamber Test System have been designed with additional security levels that prevent any attempt to alter data. The TME Solution-C Non-Destructive Leak Test System can help you to avoid loss of good product during testing while providing high resolution, repeatable, sensitive test results for induction welded bottle seals, blister cards and other pharmaceutical packaging. Leak testers are also used to test the integrity of the blister packs, packed strips, small sachets containing tablets, liquids and so on. In addition to package testing, time and money can be lost if product is manufactured while there is a leak or occlusion in the process equipment such as a production pipe. TME leak testers and flow testers provide high performance, cost effective solutions when process elements are tested for leak and flow integrity.

Mass Flow Testers for Testing Production/Packaging Equipment Components

Mass flow testing uses intrinsic properties of air to directly measure the amount of air escaping a closed system. Depending on the size of the leak you are searching for (and the volume of your test object), mass flow leak testers 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 can both be configured to perform leak and flow tests.

Mass flow testing is also 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 Solution and the TME Worker can be programmed to perform flow tests for occlusions in your manufacturing and packaging process equipment.

The TME Worker Leak, Leak/Flow or Leak/Occlusion Tester is simple to operate, economical, sensitive and reliable. The TME Solution Leak or Leak/Flow Tester provides high resolution, great flexibility, multiple ports if needed, a statistics package to aid in your process validation and control, and additional layers of security protection. With our many years of experience in pharmaceutical industrial testing, our Applications Specialists can help you determine the best leak test system (leak tester, accessories and/or fixtures) for your application and assist in qualification and/or validation issues as well.

Contact TM Electronics PH: (508) 869-6400 (Toll Free USA 800-370-0501) or by email or by completing the request form to the right.

Pharmaceutical Leak & Flow Testers | Leak Test For Blisters | TM Electronics
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The TME Solution pharmaceutical leak or leak/flow tester provides multiple ports, high resolution, great flexibility and a statistics package to aid in your process validation and control, and additional layers of security protection. Call @ 1-800-370-0501 or Email:sales@tmelectronics.com.