– 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).
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- 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.
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- Application: Doy Pack .
- Container Filling:Filled.
- Container Content: Liquid, Powder, Semi-solid, Solid.
- Machine Type: Rotative Leak Tester.
- Testing Methods:
- Max speed: Cpm
- Min Container Dimension: 5 x 5 x 20 (LxWxH)
- Max Container Dimension: 50 x 80 x 120 (LxWxH)
- Testing Heads Number: