Medical Package Testers | Medical Device Package Testing ISO 11607 | TM Electronics

Medical: Package Testers

Introduction to Package Testers

We at TME know that it is just as important to test your packaging as it is to test your product. If you are new to package testing or would like your vocabulary refreshed, we encourage you to browse our informational course, Leak, Flow and Package Testing 101.

Implications of ISO-11607 for Medical Packaging

The standard ISO 11607 "Packaging for Terminally Sterilized Medical Packaging" provides guidance on the design, manufacture and evaluation of medical device packages. According to ISO-11607, your package testing system must include both package integrity testing and seal strength testing, two complementary but very different procedures. Both testing modes are important in your final package analysis. The TM Electronics BT-1000 Automated Package Tester provides seal strength and package integrity testing in one instrument, and also provides the documentation necessary for your packaging process validation. We meet or exceed medical device package testing to help you ensure that quality of your medical devices!

Inflation Seal Strength Testers

Inflation seal strength testing includes burst, creep and creep-to-failure testing. Inflation tests are applicable to most materials (porous and non-porous) and most package forms such as pouches, header bags, lidded trays, flexible or rigid blisters and laminated or rolled tubes. The TM Electronics BT-1000 provides graphs of individual tests of your products. The pressure at which the package bursts is a variable statistic that can be utilized to document process development and process control through the use of tools such as upper and lower control limits, all part of the statistics package that is standard on the TME BT-1000.

Inflation Package Integrity (Leak) Testers

Package integrity testing is purely a measure of the package's sterile barrier - a "leak test" of the whole package. Pressure decay testing is very effective in determining leaks in flexible packages that have non-porous material surfaces and seals. The TM Electronics BT-1000, which is capable of performing both seal strength and package leak tests, has a resolution of 0.02psi. The TME SOLUTION© leak test instrument can be configured to do a leak test of a package with a resolution as high as 0.0001 psi.

Non-Destructive Package Testers

The Closed Chamber Test Method provides fast, non-destructive testing of sealed flexible packages. The TME SOLUTION-C Test System is comprised of the TME Solution™ leak test instrument and a chamber fixture custom designed for your package. The chamber fixture enclosing your package is pressurized (or evacuated for a vacuum test), stabilized and tested for pressure (or vacuum) decay that would indicate leakage from the test item.

Restraining Plate Package Testing

Seal strength values are related to the package size, geometry, and materials. For example, pouches with a long side seal will generally fail on the long seal unless a heater failure has occurred on the shorter seal or chevron. Unsupported tray lid seals may fail at points only relative to their geometry. Very flexible package materials may deform with pressurization to an extent that makes seal testing difficult. To address these problems, it may be advisable to use restraining plates for your inflation testing. Restraining plate fixtures are available from TM Electronics designed to accommodate different sizes of package.

Medical Package Testers | Medical Device Package Testing ISO 11607 | TM Electronics
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TM Electronics provides smart, fast, reliable medical package testers for inflation seal strength testing, package integrity testing, non-destructive package testing & restraining plate package testing for the medical packaging industries. Call @ 1-800-370-0501 or