PK-VG

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Off-Line Leak Testing Machine into Pucks


• The Machine is designed for Non-Destructive Integrity Testing of Containers with pharmaceutical products.
• The Containers to be tested are hold into dedicated Pucks.
• The Machine is suitable for 100% in-line and off-line testing at high production speed.
• 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":
> “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
> The Test method is a Recognised Consensus Standard by the United States Food and Drug Administration (FDA),
• Containers and Package System that can be non-destructively tested by ASTM F2338-09 include: Rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; flexible, nonporous packages.
• The Machine is designed and manufactured for installation in clean areas for less critical phases of sterile product fabrication (Class C and D).
 


Technical Specifications

Tested Container Vials, Monobloc , PFS Nest, Pouches, MDPI , MDI , IV Bags , Flowrapped Device , FFS , BFS , Carpule, Pre Filled Syringes , Bottles, Ampoules .
Container Filling Filled.
Container Content Lyophilised, Liquid, Powder, Semi-solid, Solid.
Machine Type Rotative Leak Tester
Testing Methods Vacuum Decay.
Max speed Data available upon request
Min Container Dimension Data available upon request
Max Container Dimension Data available upon request
Testing Heads Number Data available upon request
Technical data may be changed without notice

• High leak detection sensitivity.
• Fast, reliable and repeatable results.
• Non-invasive and Non-destructive Test Method.
• Enhanced easy-to-use HMI integrated functions.
• System autodiagnostics available.
• Easy to clean – no hidden corners.
• Ease of maintenance: free access to all moving parts.
• Cost-effective solution.
• Quick change over.
• Storage, maintenance, and download of historical data (production, raw data, events, alarms).
• HMI Real Time display of Testing Cycle diagram.
• Computerized system is designed to comply with FDA 21 CFR Part 11 and EU Annex 11.
• Validation Package guarantees complete and efficient regulatory compliance.