BRIEF INTRODUCTION

– 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]

SALIENT  FEATURES

• 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.

TECHNICAL SPECIFICATIONS

• Application: Doy Pack, Ready Meals , Stick Packs .
• Container Filling: Closed, Empty, Filled.
• Container Content: Liquid, Powder, Semi-solid, Solid.
• Machine Type: Laboratory Leak Tester.
• Testing Methods:
• Max speed: Cpm
• Min Container Dimension: 8 x 8 x 5 (LxWxH)
• Max Container Dimension: 250 x 250 x 300 (LxWxH)
• Testing Heads Number: