• The Machine is designed for Non-Destructive Integrity Testing of Containers with pharmaceutical products.
• The Machine is suitable for 100% 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), 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

• Containers automated loading and unloading.
• High leak detection sensitivity.
• Fast, reliable and repeatable results.
• Non-invasive and Non-destructive Test Method.
• Enhanced easy-to-use HMI integrated functions.
• System auto-diagnostics 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.
• Computerised system is designed to comply with FDA 21 CFR Part 11 and EU Annex 11.
• Validation Package guarantees complete and efficient regulatory compliance.

TECHNICAL DESCRIPTION

• Tested Container: Vials, Ampoules .
• Container Filling: Filled
• Container Content: Lyophilised, Liquid, Powder, Semi-solid.
• Machine Type: Rotative Leak Tester
• Testing Methods: Vacuum Decay, Pressure Decay.
• Max speed: 400
• Min Container Dimension: 10 x 10 x 35 mm (LxWxH)
• Max Container Dimension: 25 x 25 x 138 mm (LxWxH)
• Testing Heads Number: 18 to 36