The Machine is suitable for laboratory applications, statistical purposes as well as off-line testing.
The Measurement System comprises applying a pressure differential into an airtight Testing Group enclosing the Container (Patent No. 1225063 of 13-9-1988). The test objective is to detect Container leakages by measuring the reached pressure level as well as the pressure change over test time.
The Measurement System follows the approved industry standard “ASTM F2338-09”:
The Test method is a Recognised Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006 (Reference: Federal Register Notice FR Notice (list #014) [Docket No. 2004N-0226]
MAIN FEATURES
Fully automated test cycle sequencing with manual loading and unloading of Containers.
High leak detection sensitivity.
Fast, reliable and repeatable results.
Non-invasive and Non-destructive Test Method.
Compact and durable design.
Enhanced easy-to-use HMI integrated functions.
System autodiagnostics available.
Maintenance-free.
Easy to clean – no hidden corners.
Cost-effective solution.
Quick change over.
Low power consumption.
HMI Real Time display of Testing Cycle diagram.
Validation Package guarantees complete and efficient regulatory compliance.
