Pharmaceutical 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.
Pharmaceutical Package Testing
Package testing can be regarded as a two part process. Your package testing system should include both package integrity (leak) 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 and control.
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, and provides an extra layer of security to protect your data and help you meet the document security requirements of CFR Part 11.
Closed Chamber Package Testers
The Closed Chamber Test Method provides fast, non-destructive testing of sealed flexible packages, blister cards or induction welded bottle seals. 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.