Leakage Tester for Flexible PVC Bags
Salient Features:
• The Leakage Tester is intended for testing the leakage of sterile solutions filled in flexible PVC bags after autoclaving
• Should be suitable for 100% testing of leakage with capacity of at least 1400bags/hour
• Should be suitable to test the leakage of at least 6 PVC bags containing around 1020 ml capacity at a time
• Should have display system for results and control of parameters
• Should be suitable for integration to production line such as inspection instrument
• Should be pressure based system for testing and monitoring of leakage of filled PVC bags
• Leak Measurement by Differential Pressure Decay or similar mechanism
• Pressure Range: 0.1 – 10 bar
• Unit Adjustable (Bar, Kpa, Mpa, PSI)
• Leak range – 500 to +500PZ — 1000 to +1000Pa — 5000 to 5000Pa
• Maximum Resolution 1 Pa
• Linearity <0.5% of full Scale
• Accuracy 0.5% of measured Value +2 digit
• Should be fitted with containing mechanism for holding leaked solution
• Should be easy for use, cleaning and maintenance
• Should be compact in size with overall dimension be specified
• Minimum and maximum operating pressures should be specified
• The machine should not pollute the environment during operation
• Should be designed according to GMP guidelines and the manufacturer of the machine should be ISO certified.
• English language written original brochures of the machine and other relevant documents which indicates important specification must be submitted with the technical proposal (offer)
• The winning supplier must submit at least two original copies of English language written erection, Operation, maintenance, manuals (including electrical and electronics wiring diagram) and spare parts catalogue.
• Training possibility should be clearly specified with the offer
• All necessary machine validation and qualification (DQ,IQ & OQ) should be included
• Power requirements: 220v, 50 Hz or 380v, 50 Hz.
• Overall size should be specified
• Media of communication should be English
• Should be supplied with Test certificate, Calibration certificate, Installation and operating instruction.
• Should incorporate necessary accessories and sufficient spare parts.
