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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.
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. |
