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| Salient Features: |
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- 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 instructions
- Should incorporate necessary accessories and sufficient spare parts
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