OVERVIEW
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.
FEATURES
◎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.
SPECIFICATION
| 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 |
| 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 | External micro printer |
| History record | ≥5 years of storage |
| Data backup | Support U disk to export data |
| Signal output | (4-20) mA, RS485, 12V alarm output |
| Interface | Ethernet USB RS485 |
