High Speed Ampoule & Vial Leak Test Machine

High Speed Ampoule & Vial Leak Test Machine

  • 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

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