The Machine is designed for Non-Destructive Integrity Testing of Containers and it is suitable for laboratory applications, statistical purposes as well as off-line testing.
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.
Vials, Pre Filled Syringes, Pouches, PFS Nest, Monobloc, IV Bags, Flowrapped Device, FFS, Carpule, Bottles, BFS, Ampoules, Liquid Forms,
upon packaging/container specific features evaluation
|Container Filling||Filled, Empty, Closed|
|Container Content||Solid, Semi-solid, Powder, Lyophilised, Liquid|
|Machine Type||Laboratory Leak Tester|
|Technical operations||Vacuum Decay, Pressure Decay|
|Max speed||4 cpm|
|Min Container Dimension||8 x 8 x 5 mm|
|Max Container Dimension||250 x 250 x 300 mm|
|Technical data may be changed without notice|
Extensive pharmaceutical product testing experience goes into every LF-S11 equipment.
Some of these features are: