Key: test item, instrument name, total nonvolatile migration, gravimeter, moisture permeameter
Product
Packaging Integrity Tester -Vacuum Decay Method
- 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.
- Vacuum decay Method.
-
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).
- Method: Vacuum decay method.
-
Technical Specifications
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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