PK-VG

 

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).

SALIENT FEATURES

  • 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.

TECHNICAL SPECIFICATIONS

  • 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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