• Is designed to perform Leak Test upon container closure systems using DYE INGRESS METHOD
• Solution Used - 50 % volume of 0.1% Methylene Blue

Salient features:

• Leak Test is performed to identify Leaks and Seal Integrity (as applicable) for

           a.) Vials

           b.) Ampoules

           c.) Cartridges

           d.) PFS

           e.) Terminally Sterilized Infusion Bags

• Applied Test Methodology is

           a.) Vacuum Decay

           b.) Pressure Decay

           Applied Vacuum    :  650 mm Hg

           Applied Pressure   :  750 mm Hg

• Operating Conditions - Temperature : 15º C to 40º C

           Relative Humidity : 25% to 80%

• Utility Requirements:

           a.) Power Supply: 1 Phase, 230 V ± 10 V, 50 ± 5 Hz.

• Loading of Samples into Vessel - is Manual.
• Closing of Vessel - is also Manual.
• Leak Testing Process - is Automatic
• Overall dimension of our equipment is customized, based onthe No. of samples to be tested at a time (i.e., client requirement).
• Sequence of Operation:

           a.)Vacuum

           b.)Retenation

           c.)Vacuum Hold

           d.)Vacuum Vent

           e.)Pressurization

            f.)Stabilization

           g.)Pressure Holding

           h.)Air Vent

            i.)Atmospheric Hold

• Key Features:

           a.) Design is in line with GMP  requirements.

           b.) In compliance with 21 CFR Part 11 requirements.

           c.) Equipped with necessary Safety and Process Interlocks.

           d.) Multiple recipes can be created

           e.) With IPC Model; Customized Reports (Including Trends)can be provided.
                 Moreover, if need be data can be parallelly saved or stored in Client Server.

            f.) Test pass Or Test Fail report is automatically generated post completion of cycle.