How to determine the residual gas content of vials
Abstract: In order to improve the quality of medicines such as powder injections and biological preparations packed in vials during the shelf life period, companies often fill the vials with a certain amount of nitrogen. The actual nitrogen and oxygen content of the vial packaging is The important factors affecting the quality of content are also an important performance indicator that pharmaceutical manufacturers are concerned about. In this paper, by using the Labthink blue light HGA-02 headspace gas analyzer to analyze the concentration of oxygen, carbon dioxide and nitrogen in the vial, the method and the test equipment for measuring the gas content in the vial were introduced. The nitrogen filling of the vial was monitored. The effect provides a reference.
Keywords: nitrogen content, oxygen content, residual oxygen content, carbon dioxide content, headspace gas analyzer, vial, pharmaceutical packaging, packaging container, nitrogen-filled packaging, pneumatic packaging
1 , the meaning
Xilin bottle is a kind of controlled or molded injection bottle, which is mainly divided into soda-lime glass and borosilicate glass, and has transparent, brown and other color classifications. It can be used for injections, vaccines, freeze-dried drugs, biological agents and other drugs. package of. When packaging medicines with vials, a certain amount of high-concentration nitrogen is often used to reduce the content of oxygen and water vapor in the vials and improve the shelf life of the drugs. However, during the inflating process or after the packaging is completed, the storage process is completed. Due to the limitation of the inflation process or the tightness of the package, the gas content in the vial finished product package, including nitrogen content, oxygen content, etc., is not static, and the gas composition in the bottle has the quality of the packaged drug. Importantly, therefore, it is of far-reaching significance to strengthen the monitoring of the contents of gas components or residual oxygen in vials.
Figure 1 Common vial
2 , the standard basis
At present, there are no corresponding standards for the analysis of the composition of the headspace gas in the packaging container and the analysis of the residual oxygen content in the country.
3 , test sample
A company's production of powder injection vials finished packaging.
4 , testing equipment
In this paper, the HGA-02 headspace gas analyzer independently developed by Jinan Languang Electromechanical Technology Co., Ltd. was used to analyze the content of gas components in the sample bottles.
Figure 2 HGA-02 headspace gas analyzer
4.1 Test principle
The device is equipped with a high-precision oxygen sensor and carbon dioxide sensor. During the test, the gas in the vial is first collected by a gas collection device, injected into the device, and then the oxygen content of the sample gas is analyzed by the gas sensor in the device. Carbon dioxide content, due to the gas in the vial is mainly nitrogen, oxygen, carbon dioxide, other gas content is negligible, so the total gas content of 100% minus the oxygen content, carbon dioxide content, you can get nitrogen content.
4.2 Scope of application
It is suitable for the rapid and accurate detection and analysis of the content and mixing ratio of oxygen, carbon dioxide and other gases in the production site, warehouse, laboratory and other occasions. The detectable samples include:
Sealed bags, such as pharmaceutical packaging, coffee, cheese, milk tea, milk powder, bread, bean flour, ready-to-eat foods, such as inflatable or modified atmosphere bags. Packaging containers, such as filling coffee, filling milk powder, cans, Tetra Pak packaging, beverages and other packaging containers. Ampoules, vials and other packaging.4.3 Equipment Parameters
The equipment is suitable for analysis of oxygen, carbon dioxide gas content or mixing ratio. Oxygen measurement range is 0 ~ 100% , when the oxygen content is 0% ~ 2% , the test accuracy is ± 0.3% (absolute), when the oxygen content is 2% ~ 100% , the measurement accuracy is ± 0.5% ( relative value). The CO2 measurement range is 0 to 100% and the measurement accuracy is ±0.5% . The use of professional structural design and import of high-precision sensors to ensure the accuracy of the test results. Configure a micro-printer to allow users to print test results at any time. PVC operation panel, menu-type interface, LCD display, user-friendly operation and viewing results. The system is configured with Chinese and English bilingual operating environment to meet the needs of users of different languages.5 , the test process
(1) Set test parameters such as sampling time and analysis time on the PVC panel of the headspace gas analyzer .
(2) Put the vial finished packaged sample into the gas collection device. Carefully remove the vial stopper and the gas in the bottle will be collected in the gas collection device.
(3) Carefully insert the needle into the gas collection device.
(4) Click the test button to start the test. The instrument draws the sample gas in the gas collection device and analyzes it. After the test is completed, the test result is automatically displayed, ie the oxygen content and the carbon dioxide gas content.
6 , test results
The vial finished product packaging samples were divided into three groups of samples. The results of gas content detection in the three groups of samples are shown in Table 1 .
Table 1 Record results of three groups of test results
Gas content /%
Sample 1
Sample 2
Sample 3
Oxygen content
1.91
2.03
1.98
Carbon dioxide content
0.12
0.11
0.14
Nitrogen content
97.97
97.86
97.88
7. Conclusion
The content of gas components in the vial has an important influence on the quality of the packaged drug. In this paper, the HGA-02 headspace gas analyzer was used to test the content of oxygen, carbon dioxide and nitrogen in the vial. The accuracy of the test results was good. With high accuracy and good repeatability, it can accurately reflect the content of gas components in the vial bottle. It has a guiding role for the company to improve the nitrogen filling process of the vial and improve the sealing performance of the vial. Labthink has always been dedicated to providing professional testing equipment and testing services to customers around the world. In addition to headspace gas analyzers, Labthink also provides you with water vapor transmission rate tester, oxygen permeability tester, and gas. Transmissivity tester, medical packaging performance tester, intelligent electronic tensile tester, torque meter, ink-combination fastness tester and many other testing equipments cover the drug packaging, food packaging, daily chemical packaging, printing, Adhesives, automobiles, petrochemicals, biotechnology, construction and new energy industries, etc. To understand the relevant testing equipment, you can visit the website of Jinan Languang Company to view or call for consultation. The more you understand, the more trust! Jinan Languang Electromechanical Technology Co., Ltd. is willing to take this opportunity to increase technical exchanges and cooperation with enterprises and institutions in the industry.
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