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]
- 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.
- 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