The machine incorporates leak detection technology and software, developed by Sepha that is utilized on a daily basis by top global pharma companies to leak test flexible packaging and ensure product packaging integrity.
· Non-destructive seal integrity and leak detection device
· No tooling required, making it highly flexible across several pack types and sizes
· Capable of detecting weak seals, channel leaks and holes down to 10μm (pack dependent)
· Table top device
· Capable of handling non-porous packages up to 100mm x 200mm x 250mm
· Easy operator use via touch screen interface and easy load chamber
· Capable of storing multiple test methods for up to 30,000 product types
· User defined password protection ensuring multiple operator use
· Fully validated system
· Production of objective and repeatable results
· Test results can be printed, exported via USB (x2) or integrated into local quality control system via Ethernet cable
· Fast, efficient test speed
· Audit data available and fully 21 CFR part 11 compliant.
· Active Directory and OPC connectivity available on request
· How does Force Decay testing work?
A flexible package is placed within a tool set which comprises of a strain gauge load cell, which in turn is housed within a vacuum test chamber. Vacuum is applied to the test chamber and under this vacuum the flexible package will expand and generate an expansive force in response to the vacuum.
The strain gauge load cell measures the expansive force over time to determine if the package has a gross leak, micron leak or has no leaks.
· If there is a gross leak, no expansive force is measured.
· If there is a micron leak, an expansive force is initially measured but will start to reduce over time as the pack lets air escape into the vacuum chamber.
· If the pack is good it will expand under vacuum and remain inflated and in turn generate a constant force measurement over time.
· To ensure the integrity of the pack is not affected or does not burst, a force reaction/restraining plate is used to prevent full expansion.