Pharmaceutical Package Leak Tester To Prevent Moisture Oxygen And Microorganisms
PLT-900 Packaging Leak Tester
Product introduction
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.
Features:
Comply with USP <1207>, ASTM F2338 standards and FDA standards.
Semi-automatic detection, suitable for small batch and multi-variety testing.
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.
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.
Application Area
Pharmaceutical industry
Medical device industry
Food and beverage industry
Environmental protection industry
Technical Parameters
|
Model |
PLT-900 |
|
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) |
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.