Packaging Sealing Integrity Tester

To ensure the quality and safety of pharmaceuticals, seal integrity testing of pharmaceutical packaging is critical. This testing is designed to protect pharmaceutical products from contamination by preventing contaminants such as moisture, oxygen and microorganisms from entering the packaging. Packaging Sealing Integrity Tester is suitable for sealing integrity for all types of pharmaceutical packaging such as bottles, bags, boxes, ampoules, vials, refills, pre-filled injections (PFS), blow-fill-seal (BFS) and form-fill-seal (FFS). test.

Model:MFT-1000

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China Packaging Sealing Integrity Tester Supplier

Packaging Sealing Integrity Tester 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 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.

●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:

●Adpot automous optimization Linux system.

●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).

●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 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.

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	1.5μm ( for IV bag minimum 5μm)
Display method	10-inch touch color touch screen
Voltage	AC100V-240V, 50/60Hz, power ≤200W
Weight	Host: 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
Signal output	(4-20) mA, RS485, 12V alarm output
Dimension	430655420（height1）*330（height2)mm