- General Details
Laboratory High Voltage Leak Detection Equipment
This compact bench top equipment is designed to perform the Container Closure Integrity of sealed containers filled with parenteral sterile liquid drugs.
The equipment is fitted with a motorized plate enabling the container rotation around its axis during inspection; this system allows to wet the internal surface of the container with the liquid product thus and assures the proper detection capability.
HV lab is configurable to handle a wide range of container sizes and types.
- High Voltage Leak Detection system is a proprietary technology of Xepics
- Full scan of the container surface, inspection of 100% critical areas
- Quick inspection time (20-200msec)
- Applicable to glass and plastic containers
- Original electrodes system configuration for Your Product Type and Size
- HMI and Control System compliant with FDA 21 CFR P11 and EU GMP Annex 11 requirements
Non destructive investigation of the closure integrity of glass and plastic packages containing a wide range of drug products:
- Biological and biosimilar
- Highly viscous and concentrated, large molecules
- Suspensions and emulsions
- Monoclonal antibodies, live cells
- WFI and water-based solutions with an electrical conductivity level in the order of micro Siemens/cm
- Techical Info
Specifications Containers to be processed Ampoule, Vial, Cartridge, Bottle, Prefilled Syringe, Blow Fill Seal, Form Fill Seal Container content Liquid Container material Glass, plastic Container sizes 8 to 80 mm in diameter, 35 to 185 mm in height Fill volume 1 to 1000ml Measurement time 10-200 milliseconds Max Voltage applied 20 kV Minimum liquid conductivity In the range of micro Siemens/cm (as a function of product and package features)
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