Integrity Tester

Packaging Leak Tester MFT-1000

It is suitable for sealing integrity testing of pharmaceutical packaging to prevent moisture, oxygen, and microorganisms from contaminating products.
Medicines: bottled, bagged, boxed, ampoules, vials, cartridges, prefilled needles (PFS), (BFS), (FFS), etc.
Spray cans: plunger spray cans; bag-lined spray cans; "energy jacket" spray cans; flexible tube spray cans.

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导言
Characteristics

Comply with USP <1207>, ASTM F2338 standards and FDA standards
Non-destructive non-destructive testing, high accuracy, repeatability, sensitivity
The leak rate can be automatically converted into defect aperture µm
Database storage of test results for easy quality management
Semi-automatic detection, suitable for small batch and multi-variety testing
The instrument is used for vacuum pressure, pressure decay difference detection
Database storage of test results for easy quality management
Touch-type man-machine interface, simple and quick operation: after setting/selecting the test program, only need to manually put in/take out the test sample

Advantage Function

Adpot automous optimization Linux system
Automatic leak flow calibration function
With audit trail function
Split design, the test chamber is located above the host, and various test chambers can be provided according to different product types
The test cavity is customized according to customer needs to ensure that the test cavity is fully matched with the customer’s product, and rapid and sensitive testing
Automatically test the flow rate and change the aperture size during the whole process
Equipped with standard leaks (standard leak bottles, with third-party certification)
Four-level user authority management meets FDA 21CFR PART 11 requirements
We also provide users with supporting services related to tightness testing, including positive bottle(mould) production, standard leak rate/annual leak verification, new sample mold customization, sample methodological parameter development and verification, etc

Parameters

Differential Pressure Sensor±2kpa, error≤0.5%F.S.
Differential Pressure Resolution0.1pa
Test Pressure SensorError≤±1%F.S.
Test Pressure Range-0.1~0.2Mpa /-0.1~0.7MPa/-0.1~ 1.0Mpa (operational)
Minimum Detectable Aperture2µm (for IV bag minimum 5µm)
Display Method10-inch touch color touch screen
VoltageAC100V-240V, 50/60Hz, power ≤200W
WeightHost: about 30kg
Audit Trail>=5 years of storage Multiple event logs, which can be queried according to time
Authority ManagementLogin with username and password, level 4 authority, meet FDA 21CFR PART 11 requirements
Print FunctionBuilt in printer
History Record>=300000 storage
Data BackupSupport U disk to export data
InterfaceEthernet USB RS485 (operational)

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