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.
- Comply with USP <1207>, ASTM F2338 standards and FDA standards
- Semi-automatic detection, suitable for small batch and multi-variety testing ；
- Non-destructive non-destructive testing, high accuracy, repeatability, sensitivity；
- The instrument is used for vacuum pressure ,pressure decay difference detection；
- The leak rate can be automatically converted into defect aperture μm；
- Database storage of test results for easy quality management；
- 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
Pharmaceutical industry
Medical device industry
Food and beverage industry
Environmental protection industry
- ◆ 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
- ◆ 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 timeRT 11
- ◆ 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(customization)
- ◆ Dimension430*655*420（height1）*330（height2)mm
- ◆ weight51kg
Advantage function:
◎Adpot automous optimization Linux system
◎Automatically test the flow rate and change the aperture size during the whole process.
◎Automatic leak flow calibration function.
◎Equipped with standard leaks (standard leak bottles, with third-party certification).
◎Four-level user authority management meets FDA 21CFR PART 11 requirements.
◎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.
◎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.
◎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.
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