It is designed to perform Leak Test upon container closure systems using.

DYE INGRESS METHOD

Solution Used - 0.1% concentration of Methylene Blue solution (in Purified Water) topped upto 50% volume of testing chamber

Leak Test is performed to identify the integrity of the containers
•    Vials
•    Ampoules
•    Cartridges
•    PFS
•    IV Bags

Overall dimension of our equipment is customized, based on the Number and volume of samples to be tested at a time (As per client requirement). Applied Test Methodology is Vacuum and Pressure.

    Applied Vacuum:650 mm Hg.
    Applied Pressure:750 mm Hg

Operating Environmental Conditions:
•    Temperature : 15o C to 50o C
•    Relative Humidity : 25% to 80%

Utility Requirements:
•    Power Supply: 1 Phase, 230 V ± 10 V, 50 ± 5 Hz
•    Loading of Samples into testing chamber - Manual.
•    Closing of lid - Manual
•    Leak Testing Cycle - Automatic

Sequence of Operation:
•    Vacuum
•    Retention
•    Vacuum Hold
•    Vacuum Vent
•    Pressurization
•    Stabilization
•    Pressure Holding
•    Air Vent
•    Atmospheric Hold

Key Features:
•    Uniform Mixing:Design is in line with cGMP requirements.
•    Adjustable Settings:In compliance with 21 CFR Part 11 requirements
•    User-Friendly Interface:Equipped with necessary Process Interlocks.
•    Safety Features:Multiple recipes can be created
•    Versatility:With IPC Model; Customized Reports (Including Trends) can be provided,Historical reports are stored (Test report, along with alarms and audit reports),Moreover, if need be data can be parallelly saved or stored in Client Server.
•    Robust Construction:Post completion of cycle, Pass / Fail report is generated automatically.