Sterile vial package tightness determining apparatus, has spacer provided with different characteristics, thickness and diameter for introducing distance between stopper positions so that leakage is generated to guide test gas to tester

摘要

The apparatus has a mechanical retainer for fixing a test vial, and a container for restricting a test area from environment and atmosphere. The test vial is arranged within the container, where a test gas e.g. helium, flows through the container. A spacer is provided with different characteristics, thickness and diameters for introducing a distance between a definite stopper position and a variable stopper position so that a leakage is generated for guiding the test gas from an inner area of the vial to a leakage tester. Independent claims are also included for the following: (1) a method for selective optimization of production of package components for an application in primary package (2) a method for determining package tightness depending on stopper seat height.