Packaging Leak Tester

PLT-1000 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, 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.

Advantage function

Adopt 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.

Application Area

Pharmaceutical industry
Medical device industry
Food and beverage industry
Environmental protection industry

Technical Parameters

Model	PLT-1000
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	>=300000 storage
Data backup	Support U disk to export data
Interface	Ethernet USB RS485(operational)