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]
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.
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.