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Leak Detection Systems |
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Integrity testing of pharmaceutical packages,
e.g. plastic containers, has always been an important
phase of the manufacturing process. |
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Current FDA guidelines require validation
for container closure integrity tests. EU GMP guidelines
stipulate "Plastic ampoules should be subject
to 100% integrity testing". |
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For smaller quantities, rommelag® offers a simple
vacuum test chamber for integrity testing. Once the vacuum
chamber has been loaded manually, a two-step vacuum cycle
is performed. Subsequent to unloading, the ampoules are
inspected visually by personnel. |
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rommelag®'s high voltage leak detector represents
a testing method at high capacity, without risk of contamination
of product and does not require human intervention. This
HVLD leak detector operates based on the high voltage
test method and the electrical conductivity of the fill
product packaged in a non-conductive plastic ampoule.
It is designed for fully-automatic in-line leak testing. |
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If any leak is present, the discharge
current will flow through the pinhole into the container
and the detection of this current will automatically
cause the container to be rejected.
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The machines consist of the following
basic components: Ampoule feeding systems to the leak
detector, transport system with product holders, switch
for ampoule separation, inspection electrode(s), ampoule
discharge system, machine guards, ozone exhaust system,
electrical panel with all electrical inspection devices,
PLC and colour monitor.
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Both testing methods are non-destructive
procedures. |
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Production of leak detectors is also subject
to the process in accordance with our quality control
management system to DIN EN ISO 9001:2000 standard. |
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Please click on your preferred topic on
the right for further information. |
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