D012-057-2 MediTEST User Guide Page 1-1
1.1 INTENDED USE
The MediTEST is a series of non-destructive leak detectors for sealed flow wrapped flexible packs,
pouches or trays. They are intended for use in pharmaceutical, medical device and food production
environments. The instruments detect pinhole size leaks in the pack material where it has been
punctured, tracking leak paths in seal areas where the material may have become wrinkled and seals
or material that may be mechanically weak.
1.2 OPERATING PRINCIPLE
The pack under test is placed within the instrument's drawer unit. Custom made product nests may be
employed to contain and support the pack. The drawer is closed to form a gas tight seal. The test cycle
is initiated by pressing the start button.
During the test cycle, the air within the test chamber is evacuated. As the vacuum is applied, a
pressure difference is created between the inside of the pack and the vacuum chamber. This pressure
difference causes the pack to attempt to expand against the pressure plate situated above and in
contact with the pack. The pressure plate (and any nest) prevents the packs from expanding any
further, therefore the volume of the pack and its internal pressure will be held constant. As the vacuum
increases, the pressure difference increases and hence an increasing force generated between the
pressure plate (above) and the sensor platform (below). The evacuation is terminated at a
predetermined vacuum level.
Any change in the ratio of internal pack pressure to test chamber pressure, such as may be due to a
leak will result in a change in the force developed between the pressure plate and the sensor platform.
The initial force reading at the end of the evacuation phase, and any subsequent change thereof
during the test phase, form the basis of the leak detection principle.
INTRODUCTION
SECTION 1: INTRODUCTION
This section describes:
• What the MediTEST system should be used for
• The operating principle
• MediTEST unit features and benefits
