– 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]