LDEC
Container Closure Integrity Tester-DHS 640 Vacuum decay integrity tester
Container Closure Integrity Tester-DHS 640 Vacuum decay integrity tester
DHS640 is a vacuum decay method container closure integrity tester with dual sensor and dual cycle detection technology. The method complies with USP1207, Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Drug Injectable Agents and Technical Guidelines for Study of Sealing of Chemical Drug Injectable Agent Packaging System.
The tester host is connected to a specially designed chamber that accommodates the packaging under test. The packaging is placed in the experimental chamber requiring vacuum extraction, where the chamber is evacuated. By detecting the differential pressure (pa) during the pressure-holding phase of the container, the system monitors potential leaks and determines product compliance based on method-developed thresholds. This configuration can detect packaging leaks as small as 1μm. Furthermore, its dual-cycle detection mode enables simultaneous micro-leak detection and large-leak detection capabilities.
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model |
DHS 640 |
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Technical parameters |
Suitable packaging |
Vials, ampoules, pre-filled syringes, cartridges, infusion bottles/bags, BFS, eye drops, etc |
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Applicable products |
Freeze-dried, powder, solution, etc |
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Purpose of testing |
Prevent microbial invasion risk |
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test method |
Vacuum attenuation (optional pressure/vacuum attenuation dual mode) |
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Test principles |
Dual sensor double cycle differential pressure detection |
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testing standard |
ASTM F2338-09 (Vacuum attenuation); ASTM F2095 (Pressure attenuation) |
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detection sensitivity |
Maximum 0.01sccm (equivalent aperture about 1 μm) |
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Test chamber |
Custom cavities are available according to user specifications, which can be made of 316L or plexiglass |
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detection result |
Qualification/Non-qualification; Quantitative mbar Pa |
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software |
It has permission management, audit log and automatic data storage functions, which meet the requirements of 21CFR Part 11 |
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System validation |
IQ/OQ/PQ, method development and method validation |
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option |
3Q verification/minimal flowmeter (mass flow) |
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language |
Chinese/English |
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Power/Power |
100-240V AC/50W |
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air supply |
Vacuum is below 1mbar |
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Environmental requirements |
working temperature |
+10℃~+45℃ |
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Storage temperature |
0℃~+60℃ |
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Mainframe size (L*W*H) |
420*420*380mm |
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Host weight |
25kg /55 lbs |
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noise level |
< 53db |
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