Package Seal Integrity Test-Vacuum Attenuation Method
Date:
2024-10-10
Source:
Package Seal Integrity Test-Vacuum Attenuation Method
1. Introduction
Packaging seal integrity testing is an important means to ensure product quality and shelf life. Among the many test methods, the vacuum decay method is favored because of its simple operation and accurate results. This paper will introduce the principle, operation process and matters needing attention of vacuum attenuation method in detail.
Principle of 2. Vacuum Attenuation Method
The vacuum decay method is a test method to evaluate the integrity of the package seal by monitoring the pressure change in the package. During the test, the test sample is placed in a closed environment, and the air in the environment is extracted to form a vacuum inside the package. With the increase of the vacuum degree, the pressure difference between the inside and outside of the package increases gradually. If there is a small defect in the package, the air will penetrate from the defect, causing the internal pressure to rise gradually. By monitoring the pressure change, the seal integrity of the package can be judged.
3. operation process
1. Prepare samples: Select representative packaging samples to ensure that the number of samples is sufficient for statistical analysis.
2. Create a vacuum environment: Put the sample into the vacuum decay test equipment and close the sealing door.
3. Start the test: start the vacuum pump, extract the air in the environment, observe and record the pressure change.
4. Data recording: In the set time period, the pressure value in the package is recorded regularly.
5. Result analysis: According to the pressure change curve, judge the sealing integrity of the package.
4. considerations
1. Environmental factors: The test environment should be stable to avoid external interference affecting the test results.
2. Equipment calibration: to ensure that the test equipment performance is good, regular calibration.
3. Sample handling: The selected samples should be representative to avoid deviation of test results.
4. Operating specifications: Operators should follow the standardized operating procedures to ensure the safety of the testing process.
5. Conclusion
The vacuum decay method is an effective method for testing the integrity of packaging seals. By monitoring the pressure change, the small defects of the packaging can be found in time, which provides strong support for the quality control in the production process. In actual operation, it is necessary to pay attention to environmental factors, equipment calibration, sample handling and operation specifications to ensure the accuracy of test results.
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The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.
The "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly issued by the China Vaccine Industry Association and the China Standardization Association, was developed and drafted with the participation of Huaren Pharmaceutical Clinvantage. It is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.