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Product Details:
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| Differential Pressure Resolution: | 0.1pa | Display Method: | 10-inch Touch Color Touch Screen |
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| Interface Ethernet: | USB RS485 | Temperature Range: | -20'C~+40'C |
| History Record: | ≥5 Years Storage | Weight: | 30 Kg |
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.
◎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, and 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, you only need to put in/take out the test sample manually.
◎Automatically test the flow rate and change the aperture size during the whole process.
◎Automatic leak rate calibration function.
◎Equipped with standard leaks (standard positive bottles, with third-party certification).
◎Four-level user authority management meets FDA 21CFR PART 11 requirements.
◎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 support services related to tightness testing, including positive bottle 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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Differential pressure sensor
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±2kpa, error≤0.5%F.S.
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Differential pressure resolution
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0.1pa
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Test pressure sensor
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Error≤±1%F.S.
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Test pressure range
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-0.1～0.2MPa/-0.1～0.7MPa/-0.1～1.0MPa
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Minimum detectable aperture
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2μm ( for IV bag minimum 5μm)
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Display method
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10-inch touch color touch screen
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Voltage
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AC100V-240V, 50/60Hz, power ≤200W
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Weight
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Host: about 30kg
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Audit trail
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≥5 years of storage Multiple event logs, which can be queried according to time
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Authority management
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Login with username and password, level 4 authority, meet FDA 21CFR PART 11 requirements
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Print function
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External micro printer
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History record
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≥5 years of storage
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Data backup
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Support U disk to export data
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Signal output
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(4-20) mA, RS485, 12V alarm output
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Interface
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Ethernet USB RS485
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Contact Person: Lisa Niu
Tel: 86-15699785629
