Abstract: The oxygen content in the package is an important factor affecting the effectiveness of the vaccine. This paper takes the test process of residual oxygen content in vaccine packaging as an example. Through the description of the test principle, equipment parameters and scope of application, test process, etc., a test method for the content of gas components in vaccine packaging is introduced.
Keywords: vaccine, medicine, headspace, residual oxygen content, oxygen content, headspace analyzer, vial, ampoule
1, meaning
A vaccine is a biological preparation that is inoculated into the human or animal body in order to prevent or control infectious diseases. The pathogenic bacteria characteristic of the vaccine can stimulate the body's immune system to produce corresponding protective substances. When the human body comes into contact with microorganisms such as viruses and bacteria containing the pathogen, the human body can use existing or produce more protective substances to resist. Invasion of microorganisms. Whether the vaccine can stimulate the body to produce a corresponding immune response determines the injection effect of the vaccine, which puts high requirements on the production, packaging, cryogenic storage and transportation of the vaccine. In addition, in order to ensure the active ingredient of the vaccine, the inside of the package is usually filled with high-purity nitrogen to displace the oxygen inside the package, preventing oxygen from irreversibly damaging the active ingredients of the vaccine. However, due to the difference in barrier properties and tightness of the package, after the vaccine is stored for a period of time, the gas content inside the package, especially the oxygen content, is likely to change. Therefore, strengthening the monitoring of the oxygen content inside the package is of great significance to ensure the injection effect of the vaccine.
Figure 1 Common packaging forms for vaccines
2, test samples
In this test, the finished vaccine packaged in ampoules was used as a test sample to test the residual oxygen content.
3. Test basis
At present, the test method standards related to the residual oxygen test in medical packaging have not been released in China. This test is based on years of testing experience and existing reasonable testing equipment.
4, test equipment
In this paper, the HGA-02 top air analyzer is used as the test equipment to test the oxygen content in the sample. The equipment is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd.
Figure 2 HGA-02 top air body analyzer
4.1 Principle of the test
The device quantitatively absorbs the gas inside the package through the configured sampling device, and sends it to the gas sensor disposed inside the device, and then uses the gas sensor to accurately test the gas content in the package. The device is equipped with an oxygen sensor and a carbon dioxide sensor to accurately measure the oxygen and carbon dioxide content in the package. For food and medicine, the common filling gas for packaging is mainly oxygen, carbon dioxide and nitrogen. Therefore, it can be calculated through the device. The amount of nitrogen in the package.
4.2 Scope of application
This equipment is suitable for testing the content of oxygen and carbon dioxide in the hollow packaging containers such as sealed bags, bottles, cans, etc., such as coffee, cheese, milk tea, milk powder, bread, soy flour, ready-to-eat food, medicine and other sealed bags. Or container. This equipment is not only suitable for use in laboratories, but also for the rapid and accurate evaluation of gas component content and proportion in warehouses, production lines and other occasions.
4.3 Equipment parameters
The measurement range of oxygen is 0 ~ 100%. When the measured value is 0% ~ 2%, the measurement accuracy is ±0.1% (absolute value); when the measured value is 2% ~ 100%, the measurement accuracy is ±0.5% (relative value) The measurement range of carbon dioxide is 0 ~ 100%, the measurement accuracy is ± 2%; the oxygen and carbon dioxide sensors are imported components to ensure the test accuracy of the equipment; the micro printer is convenient for users to print test results at any time; portable design and Power and battery dual power supply mode, convenient for users to use in the laboratory or production site; support Lystem TM laboratory data sharing system, unified management test results and test reports.
5, the test process
(1) Parameter setting
Set parameter information such as sampling time and analysis time from the control panel of the device.
(2) Gas collection
Due to the small amount of gas in the tested ampoules, 5 bottles of samples were randomly selected in this test and placed in a gas collection device to collect gas.
(3) Testing
Carefully insert the needle into the gas collection device, click on the test option, the test begins, the device automatically completes the sampling, analysis process, and displays the test results after the test.
6, test results
The oxygen content of the vaccine sample packaged in the ampoules tested in this test was 0.43%.
7. Conclusion
In addition to factors such as production process, packaging materials, transportation and storage environment, the residual oxygen content in the packaging is an important factor affecting whether the vaccine can achieve the expected preventive effect. In this paper, the HGA-02 head air analyzer is used to test the oxygen content in the vaccine sample packaged in the ampoule. The test process is simple, the equipment is easy to operate, the degree of intelligence is high, the human interference factor is small, and the test result is accurate and reliable. Accurate and efficient testing of residual oxygen in the vaccine package. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D, production and packaging inspection services for packaging inspection equipment. The existing equipment includes water vapor transmission rate tester, gas permeability tester, oxygen permeability tester, and intelligent Electronic tensile testing machine, heat sealing tester, heat sealing and hot adhesion tester, heat shrink tester, seal tester, pendulum impact tester, friction tester, migration and non-volatile tester, etc. . The more you understand, the more you trust! Labthink is looking forward to enhancing technical communication and cooperation with enterprises and institutions in the industry.
Flavonoids Powder,Pueraria Mirifica Powder,Mulberry Leaf Extract,Citrus Aurantium Extract
Shaanxi Changsheng Industrial Co., Ltd. , https://www.sxcsmalehealth.com