Compliance FDA 21 part 11 Packaging leak tester for pharmaceuticals

Packaging Leak Tester

MFT-1000

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.

1. 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.

◎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.

2. Advantage function:

◎Adpot 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.

 3. Specifications: