Supplement
bottle seals
Plastic Ampoules
Unit dose packages
Nutriceutical bottle seals
Blister packs
Pharmaceutical bottles
Process Tanks
Process Piping
Cosmetic jar closures
Pharmaceutical Tubes
Veterinary Medicine Containers
Vial packaging
Transdermal patch packaging
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Case
Studies:
Package
Testing of Sterilized, Sealed Foil Pouch
Testing Induction Welded Seals on
Solid Dose Pharmaceutical Bottles
Testing Process Piping to Avoid Leaks
that Impact Production
Package Testing of Sterilized,
Sealed Foil Pouch
The customer manufactures transdermal patches
which are then packaged in a foil pouch. His need
was to assure that the packaging would protect
the product inside from contamination. A seal
strength testing system was designed based on
the TME BT-1000 Automated Package Tester, the
patented TME Package-Port ™ entry system and
a restraining plate fixture. The interior of the
sealed pouch is accessed using an inflation and
sensor probe through an attached Package-Port.  The
pouch is placed in restraining plates to minimize
the internal volume and concentrate the test pressure
on the package seals in order to better identify
the weakest seal, and a burst test is performed. The
BT-1000 provides the test operator with a pressure
versus time plot of the burst test, and the burst
pressure value, a variable statistic, is included
in the Datalog for mean, standard deviation calculation
and control chart development.
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Testing Induction Welded Seals
on Solid Dose Pharmaceutical Bottles
The customer had previously been testing the induction
welds on sealed solid dose pharmaceutical bottles
by using the blue dye test, which he found to
be messy, slow, and operator dependent.  TME
designed a nondestructive, quantitative, non-operator
oriented test system for this primary pharmaceutical
container. The sealed bottle is placed in a custom
designed fixture in which a chamber surrounds
the cap area and creates an airtight seal above
the shoulder of the bottle. The head space inside
the chamber is pressurized, and the TME Solution-C
Leak Tester performs a pressure decay test that
will detect pinholes, cracks, seal and channel
leaks. Quick change, interchangeable fixture heads
were also provided to enable the test system to
accommodate bottles of various sizes and shapes.
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Testing
Process Tanks to Avoid Leaks that Impact
Production
The customer is a pharmaceutical manufacturer
who mixes solutions in large tanks. The tanks
range from 5 Liters to 250 liters. The customer's
engineers had developed a manual leak test that
would prevent a leaking tank from being used in
the manufacture, but the leak test took as long
as 30 minutes per tank to complete. A TME
Solution© Leak Tester with maximum pressure resolution was
able to perform the same test in as little as
60 seconds. It was also found that using the Memory
Reference Curve technology could bring the overall
test time down even more. The Memory Reference
Curve is a technology that allows the operator
to store the decay curve of a good unit in the
instrument's memory. The TME Solution© then
compares the pressure decay of the unit being
tested to the reference in its memory to determine
if the tested part has a leak. If the decay curve
of the part being tested drops faster than the
reference decay curve, the part is considered
a failure.
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