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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 brochure, Package Testing
201.
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.
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.
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