LF-SMH

BenchTop Multi-Head Leak Testing Machine


• 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]


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Technical Specifications

Tested Container Vials, Pouches, MDPI , MDI , IV Bags , Flowrapped Device , Bottles.
Container Filling Closed, Empty, Filled.
Container Content Liquid, Powder, Semi-solid.
Machine Type Laboratory Leak Tester
Testing Methods Vacuum Decay.
Max speed 20
Min Container Dimension 8 x 8 x 5 (LxWxH)
Max Container Dimension 86 x 86 x 170 (LxWxH)
Testing Heads Number Data available upon request
Technical data may be changed without notice

• Fully automated test cycle sequencing with Containers manual loading and unloading.
• High leak detection sensitivity.
• Fast, reliable and repeatable results.
• Non-invasive and Non-destructive Test Method.
• Compact and robust 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.
• Storage, maintenance, and download of historical data (production, raw data, events, alarms).
• HMI Real Time display of Testing Cycle diagram.
• Computerised system is designed to comply with FDA 21 CFR Part 11 and EU Annex 11.
• Validation Package guarantees complete and efficient regulatory compliance.
 

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