– The Machine is designed for Non-Destructive Integrity Testing of Containers with pharmaceutical products.
– The Containers to be tested are hold into dedicated Pucks.
– The Machine is suitable for 100% in-line and 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),
– Containers and Package System that can be non-destructively tested by ASTM F2338-09 include: Rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; flexible, nonporous packages.
– The Machine is designed and manufactured for installation in
clean areas for less critical phases of sterile product fabrication
(Class C and D).