Bonfiglioli Engineering S.r.l.

Model LF-SMH - Benchtop Multi Head Leak Testing Machine

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The Machine is suitable for laboratory applications, statistical purposes as well as off-line testing. 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': 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].

  • Fully automated test cycle sequencing with Containers manual loading and unloading.
  • High leak detection sensitivity.
  • Fast, reliable and repeatable results.
  • Non-invasive and Non-destructive Test Method.
  • Compact and robust design.
  • Enhanced easy-to-use HMI integrated functions.
  • System autodiagnostics available.
  • Maintenance-free.
  • Easy to clean – no hidden corners.
  • Cost-effective solution.
  • Quick change over.
  • Low power consumption.
  • 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.

  • Tested Container: Ampoules, BFS, Bottles, Carpoules, FFS, Flowrapped Device, Pouches, Pre Filled Syringes, Stick Packs, Vials
  • Container Filling: Empty, Filled, Closed
  • Container Content: Liquid, Solid, Lyophilized, Powder, Semi-Solid
  • Machine Type: Laboratory
  • Testing Methods: Leak Testing
  • Max speed: 20 Cpm
  • Min Container Dimension: 8 x 8 x 5 (LxWxH)
  • Max Container Dimension: 86 x 86 x 170 (LxWxH)
  • Testing Heads Number: from 5 to 5

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