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Pharmaceutical &
Manufacturing Applications
Vacumn
Leak Inspection / Detection
Micro Leak Testing Of Vials, Ampoules, Filled And Sealed Bottles and
Pharmaceutical Packages - PTI's Inspection Systems utilizing differential
vacuum technology provides a non-invasive, non-destructive method of leak
detection for both off-line and 100% on-line applications.
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PTI-325 Leak Tester for Food And
Pharmaceutical Applocations
Applications
- Flexible, rigid and semi-rigid
packages
- Filled & sealed bottles and
containers
- Stand-up pouches
- Cups and trays with heat sealed lids
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Features and Benefits
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General
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Vacuum leak tester covering the full application range for bottles, vials,
cups, trays, pouches
and blisters.
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Vacuum leak tester covering the full application range for bottles, vials, cups, trays, pouches
and blisters.
Robust machine design for long term reliable operation
Quick and easy machine set-up – easily transportable
High quality commercially available components
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Tooling:
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Fast change-over for different packages with tooling
change.
Rrequirement only for rigid and flexible packages
(pouches)
Patented
flexible tooling that compensates for pouch size differences automatically
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Test Method:
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Non-invasive, non-destructive test method based on
vacuum decay detection - No sample preparation
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Test Vacuum Range:
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-up to –900 mb vacuum
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Test
sensitivity:
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*
Micro-leaks < 10 microns
Micro-leaks < 1 micron for rigid containers
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Dual
Transducer Technology
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Non-drift transducer technology for high resolution
measurement
of absolute pressure in mb AND differential pressure
in Pa, enabling detection of smallest possible leaks.
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Test
results:
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Quantified and conform to FDA's 21 CFR Part 11 requirements
Non-variable, 100% repeatable results
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Certification:
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CE Marking
Machine calibration certified to industry standards
Periodically
only due to non-drift transducer technology
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Validation:
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In accordance with FDA standards
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Program storage:
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Up to 30 different package set-ups
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Operation:
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User friendly Touch-screen operator panel
After entry
of 2 test parameters (test vacuum and time)
automatic setting of testing criteria based on “n”
test samples using
PTI’s Self-Teach Adaptive Algorithm Technology
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