BRIEF INTRODUCTION

– 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:

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