Product Details
Product Description
Product Description
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.
1. Features:
◎Comply with USP , 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 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.
2. Advantage function:
◎Automatically test the flow rate and change the aperture size during the whole process.
◎Automatic leak flow calibration function.
◎Equipped with standard leaks (standard positive 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.
3. Specifications:
Differential pressure sensor
| ±2kpa, error≤0.5%F.S.
|
Differential pressure resolution
| 0.1pa
|
Test pressure sensor
| Error≤±1%F.S.
|
Test pressure range
| -0.1～0.2Mpa /-0.1～0.7MPa/-0.1～1.0Mpa（operational）
|
Minimum detectable aperture
| 2μm ( for IV bag minimum 5μm)
|
Display method
| 10-inch touch color touch screen
|
Voltage
| AC100V-240V, 50/60Hz, power ≤200W
|
Weight
| Host: about 30kg
|
Audit trail
| <=5 years of storage Multiple event logs, which can be queried according to time
|
Authority management
| Login with username and password, level 4 authority, meet FDA 21CFR PART 11 requirements
|
Print function
| Built in printer
|
History record
| <=5 years storage
|
Data backup
| Support U disk to export data
|
Interface
| Ethernet USB RS485(operational)
|
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