Automatic Filter Integrity Tester
FTtester
This FTtester is an easy to use, easy to validate, highly accurate, automatic integritytester for the regulated biopharmaceutical industry.
For production operators, supervisors, and validation managers who need to performon-site filter integrity tests, It is a premium instrument providing the highest level ofconfidence in the regulated biopharmaceutical industry.
Users can conduct bubble point, forward flow and water immersion tests onmembrane and cartridge. It displays the record data by graph to show the changes ofthe detection time with gas flow.
High performance CPU
High performance CPU can calculate the curve inflectionpoint accurately and quicklyto prevent the misjudgement by calculation error.
Touch mode design
10.4 inches(264mm) color touch screen, simple, intuitive and reliable operation.
Strong data storage
Great storage capabilities, data can be queried by each testing point, also can beoutput by USB flash disk.
User authorization management system
Users rights menagement system to prevent misuse, password level is divided intothe operator---supervisor---administrator.
Quick detection
Stop detecting immediately once the bubble point is qualified and then print thequalified results which can save time and extent the life of the filter.
Splash and dust proof technology
Splash and dust proof technology specifically designed for the cleanroomenvironment, IP54 splash-proof rating.
Humanized software updates
Specially designed software input interface for software updates.
Pefect validation service
Well validation support to provide you with a comprehensive validation service.
Wide detection range
Detection range is wide. It can detect the filters in different nominal accurancy from0.02 micron to 1micron.
Rapid repair design
Reasonable struction make it easy for maintenance. Internal modular design andspecificcally design of a detection window to make it easy for rapid repair.
Self-test function
Turn on FTtester each time, it will self-test which can prevent false-positive results andimprove the trace ability of deviation.
Simple appearance
Simple appearance make it easy to clean, fully considered in the condition of Class Bonline use, entirely suitable for surface disinfection.
Small volume, light weight and low consumption are easy to carry.
Inner stylus printer
Built-in stylus printer can print out the test results, history datas and real-time curvedatas quickly, and the printed result can be stored for long time.
Belgium Staubli quick connector
Imported well known brand of the quick connector, security, stability and never leak.
Automatic control on preventing gas return
External solenoid valve, automation control to prevent the gas return, ensure pollution-free for the filters and the FTtester.
Built-in recipe mode
Built-in recipe mode to avoid repeating input parameters when detect each time, andit can improve people's work efficiency.
Main Parameter
Power supply: AC 110V/AC220V, 50hz/60hz Power: 70W
Insurance fusing: <1.6A Repeat error: ≤3%
Detection accuracy: ±3% or ±5‰ F.S, refer to the bigger one.
Detection range:
a. Forward flow: 0.1-200ml/min
b. Water immersion: 0.05-50ml/min
c. Bubble point: 700-6000mbar
Sensitivity:
a. Foward flow: 0.1ml/min
b. Water immersion: 0.01ml/min
c. Bubble point: 50mbar
Dimension(LxWxH): 400x300x190mm
Meet following requirement
GMP(Good automated manufacturing practice)
Electronic records with 21CFR11
Calibration with 21CFR820.72
With extensive qualifivation documents, including guides of installation qualification and operation qualification(IQ/OQ)
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