Key: test item, instrument name, total nonvolatile migration, gravimeter, moisture permeameter

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Packaging Integrity Tester -Vacuum Decay Method

SPT-401
Focusing on packaging and material testing technology, we are committed to quality control in industries such as healthcare, pharmaceuticals, food, packaging, textiles, and new materials. Our products are widely used in enterprises, testing institutions, universities, and research institutes.
  • Description
  • Applications
  • Standard
  • Features
  • Parameter
  • Configuration
  • Video
  • PDF Download
    • Commodity name: Packaging Integrity Tester -Vacuum Decay Method

    SPT-401

    Product Function:

    Non-destructively test the leak rate and leakage aperture of flexible and rigid packaging components.

    Compliant Standards:

    ASTM F2338, recommended methods in USP1207, "Technical Guidelines for the Study of the Sealing Integrity of Chemical Injection Packaging Systems", and General Rule 4501 Vacuum Decay Inspection Method in "Guiding Principles for the Study of the Sealing Integrity of Drug Packaging Systems".

    Working Principle:

    • Vacuum decay Method.
    • Sample Installation: Place the packaging and its fixture inside the test chamber, then close and seal the test chamber cover.
    • Gross Leak Detection: Evacuate the space between the packaging, test chamber and fixture for a certain period of time. After that, close the valve and monitor the pressure change in this space. Compare it with the standard sample to evaluate whether there is a gross leak.
    • Small Leak Detection: When there is no gross leak in the packaging, the instrument automatically evacuates the space again. Close the valve, and the sensor monitors the pressure change in the space over time. Compare it with the standard sample to calculate the leakage rate and leakage aperture of the packaging, and evaluate the integrity of the packaging.

    Technical Features

    • Method: Vacuum decay method.
    • Non-destructive Testing: It can test the leakage rate and leakage aperture of flexible and rigid packages without damaging the samples.
    • Extensive Testing: It can evaluate gross leaks, medium leaks, small leaks and micro - leaks of packages. Test fixtures for accommodating packages can be customized.
    • Calibration Modes: Positive control samples, flow rate calibration, negative control samples.
    • Positive Control Samples: 2um, 5um, 10um (other specifications can be ordered according to requirements).
    • Intelligent and Automatic: Select the test mode, start with one - click, and the test is fully automatic. It can automatically determine whether it is qualified or unqualified according to the preset limits.
    • Monitoring and Measurement: Real - time monitoring and recording throughout the process. It is graphically presented, with full - process and all - element recording, and data will not be lost in case of power failure.
    • Data Security: The "GMP Computerized System" software module is optional, which has functions such as user and permission management, and audit trail.
    • Fault Diagnosis: Self - check at startup to avoid continuous testing in case of malfunctions.
    • Working Environment: Room temperature, no need for a constant temperature and humidity environment (reducing the use cost).

    Technical Specifications

    Name

    Range

    Error

    Detectable Leak Diameter

    0.5um~50um,>50 um;

    0.5um or 5% mv,max

    Leakage Rate Range

    2.8x10-5 to 1 std·cm3/s 

    2.8x10-5 std·cm3/s  

    Vacuum Sensor

    0.1 to 1333 .33 Pa

    0.5 Pa

    Absolute Pressure Sensor

    0 ~0.15 MPa.

    0.5 KPa

    Vacuum Degree

    For micro - leak detection, the vacuum pressure in the test chamber < 20 Pa

    Test Efficiency

    Gross leak detection (single cycle) < 1min; Medium, small and micro - leak detection > 1 min

    Calibrated Flow Rate

    0 - 2 cc/min (automatically controlled), repeatability < 0.5%*FS

    Linearity R2

    >0.995

    Monitoring Method

    Computer + Color Touch Screen

    Calibration Modes

    1. Positive control sample; 2. Flow rate calibration; 3. Negative control sample.

    Dimensions of Main Unit

    330(L)*450(B)*380(H)mm     

    Weight

    appr 18kg

    Power Supply

    AC220V /110V ;50/60Hz,≤800 W

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Standard Configuration

    No.

    Name

    Model/Specification/Brand

    Quantity

    Remarks

    1

    Test Main Unit

    SPT - 401

    1 set

    Vacuum decay method

    2

    Computer

    Dell

    1 set

    Including main unit, display, mouse, and keyboard

    3

    Communication Cable

    RS232

    1 set

     

    4

    Professional Testing Software

    SPT series

    1 set

    Including GMP software module

    5

    Vacuum Pump

    VRD - 4

    1 set

    -

    6

    Sample Testing Fixture

    /

    1 set

    Customized according to specifications

    7

    Negative Control Sample

     

    1 piece

    Customized and calibrated according to specifications

    8

    Positive Control Samples

    (2, 5, 10)um

    1 piece each

    For calibration

    9

    3Q Validation Service

    /

    1

    Vacuum decay method

    Items to be Prepared by the User: Laboratory table, power distribution

     

  • Product Functions

    Non-destructively test the leak rate and leakage aperture of flexible and rigid packaging components.

    Compliance Standards

    ASTM F2338, recommended methods in USP1207, "Technical Guidelines for the Study of the Sealing Integrity of Chemical Injection Packaging Systems", and General Rule 4501 Vacuum Decay Inspection Method in "Guiding Principles for the Study of the Sealing Integrity of Drug Packaging Systems".

    Working Principle

    • Vacuum decay Method.
    • Sample Installation: Place the packaging and its fixture inside the test chamber, then close and seal the test chamber cover.
    • Gross Leak Detection: Evacuate the space between the packaging, test chamber and fixture for a certain period of time. After that, close the valve and monitor the pressure change in this space. Compare it with the standard sample to evaluate whether there is a gross leak.
    • Small Leak Detection: When there is no gross leak in the packaging, the instrument automatically evacuates the space again. Close the valve, and the sensor monitors the pressure change in the space over time. Compare it with the standard sample to calculate the leakage rate and leakage aperture of the packaging, and evaluate the integrity of the packaging.
  • Technical Features

    • Method: Vacuum decay method.
    • Non-destructive Testing: It can test the leakage rate and leakage aperture of flexible and rigid packages without damaging the samples.
    • Extensive Testing: It can evaluate gross leaks, medium leaks, small leaks and micro - leaks of packages. Test fixtures for accommodating packages can be customized.
    • Calibration Modes: Positive control samples, flow rate calibration, negative control samples.
    • Positive Control Samples: 2um, 5um, 10um (other specifications can be ordered according to requirements).
    • Intelligent and Automatic: Select the test mode, start with one - click, and the test is fully automatic. It can automatically determine whether it is qualified or unqualified according to the preset limits.
    • Monitoring and Measurement: Real - time monitoring and recording throughout the process. It is graphically presented, with full - process and all - element recording, and data will not be lost in case of power failure.
    • Data Security: The "GMP Computerized System" software module is optional, which has functions such as user and permission management, and audit trail.
    • Fault Diagnosis: Self - check at startup to avoid continuous testing in case of malfunctions.
    • Working Environment: Room temperature, no need for a constant temperature and humidity environment (reducing the use cost).
  • Technical Specifications

    Name

    Range

    名称

    Error

    Detectable Leak Diameter

    0.5um~50um,>50 um;

    最小漏径

    0.5um或5% mv,max

    Leakage Rate Range

    2.8x10-5~1 std·cm3/s 

    2.8x10-5 std·cm3/s  

    Vacuum Sensor

    0.1~1333 .33 Pa

    0.5 Pa

    Absolute Pressure Sensor

    0 ~0.15 MPa.

    0.5 KPa

    Vacuum Degree

    For micro - leak detection, the vacuum pressure in the test chamber < 20 Pa

    Test Efficiency

    Gross leak detection (single cycle) < 1min; Medium, small and micro - leak detection > 1 min

    Calibrated Flow Rate

    0 - 2 cc/min (automatically controlled), repeatability < 0.5%*FS

    Linearity R2

    >0.995

    Monitoring Method

    Computer + Color Touch Screen

    Calibration Modes

    1. Positive control sample; 2. Flow rate calibration; 3. Negative control sample.

    Dimensions of Main Unit

    330(L)*450(B)*380(H)mm     

    Weight

    ~18 kg

    Power Supply

    AC220V /110V ;50/60Hz,≤800 W

     

     

     

     

     

     

     

     

     

     

     

     

     

  • Standard Configuration

    No.

    Name

    Model/Specification/Brand

    Quantity

    Remarks

    1

    Test Main Unit

    SPT - 401

    1 set

    Vacuum decay method

    2

    Computer

    Dell

    1 set

    Including main unit, display, mouse, and keyboard

    3

    Communication Cable

    RS232

    1 set

     

    4

    Professional Testing Software

    SPT series

    1 set

    Including GMP software module

    5

    Vacuum Pump

    VRD - 4

    1 set

    -

    6

    Sample Testing Fixture

    /

    1 set

    Customized according to specifications

    7

    Negative Control Sample

     

    1 piece

    Customized and calibrated according to specifications

    8

    Positive Control Samples

    (2, 5, 10)um

    1 piece each

    For calibration

    13

    3Q Validation Service

    /

    1

    Vacuum decay method

    Items to be Prepared by the User: Laboratory table, power distribution

     

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