Compliance FDA 21 part 11 Packaging leak tester for pharmaceuticals

Category:Pharmaceutical Packaging Machinery > Packaging Testing Equipment
Product Name:Compliance FDA 21 part 11 Packaging leak tester for pharmaceuticals
Price(USD):45880
Company:Beijing Neuronbc Laboratories Co., Ltd.

Basic Info
  • Factory Location: Beijing China

    Main Sales Markets: Central/South America,Asia,Middle East,Africa

  • Monthly Production Capacity: 100units/month

    Packaging Information: wooden case

  • Delivery Lead Time: 1-4 weeks

    Sample Provided: no

    Payment Terms: T/T

    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:

    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)

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