Abstract: The content of carbon dioxide and residual oxygen in medical air-filled packaging directly affects the shelf-stable effect of packaging. The GMP specification also makes corresponding requirements for the residual oxygen content in the container. In this paper, a test method for testing carbon dioxide and oxygen content in injection ampoules is introduced. A test method for detecting carbon dioxide content and residual oxygen content in medical inflatable packaging is introduced. The test principle and equipment CLASSIC 650 top air volume analysis are introduced. The description of the parameters of the instrument, the scope of application, and the test process provide a reference for enterprises to monitor the carbon dioxide and residual oxygen content in pharmaceutical packaging.
Key words: nitrogen content, residual oxygen, carbon dioxide content, pharmaceutical packaging, headspace analyzer, nitrogen-filled packaging, ampoule
1, meaning
There are many types and forms of pharmaceutical products. Most of the products are sensitive to oxygen, easily oxidized and deteriorated, and cause discoloration and odor. They not only affect the efficacy of the product, but also toxic and harmful substances generated by oxidation may even be life-threatening, but contain hydroxides. A drug such as a calcium salt easily absorbs carbon dioxide to form a carbonate. In order to minimize the amount of oxygen and carbon dioxide that the drug is exposed to, oxygen and carbon dioxide-sensitive drugs are usually packaged in a package such as vacuum or nitrogen-filled inert gas to reduce the oxygen and carbon dioxide content of the package. However, vacuum packaging and nitrogen-filled packaging cannot completely remove or replace the gas inside the package, and the packaging material has a certain gas permeability. Therefore, a certain amount of oxygen and carbon dioxide remain in the package, and the content of the gas component is not constant. It will increase with the storage time of the drug. By monitoring the residual oxygen content and carbon dioxide content in the package, it is not only one of the effective means to ensure the good quality of the drug, but also serves as the basis for determining the shelf life.
2, test samples
An ampule was packaged with a brand of injection solution as a test sample.
3, testing standards
At present, there is no method standard for the detection of gas content in packaging. The test standard for reference in this paper is GB/T 6285-2003 "Electrochemical method for the determination of trace oxygen in gas".
4, test equipment
The test equipment used in this test is the CLASSIC 650 top air body analyzer independently developed by Jinan Languang Electromechanical Technology Co., Ltd.
Figure 2 CLASSIC 650 top air body analyzer
4.1 Principle of the test
The sampling device is used to measure the oxygen content and the carbon dioxide content of the gas in the package by flowing the gas inside the package through the oxygen sensor and the carbon dioxide sensor disposed in the device. The sampling device of the device includes a sampling needle and a gas collecting device. For nitrogen-packed pharmaceutical products, the gases in the package are mainly nitrogen, oxygen and carbon dioxide. By testing the oxygen and carbon dioxide content, the nitrogen content can be obtained.
4.2 Equipment parameters
Oxygen measurement range is 0% ~ 21%, test accuracy is ± 0.2%; carbon dioxide measurement range is 2% ~ 100%, measurement accuracy is ± 0.2%; professional structure design and imported high-precision sensors to ensure test results Accuracy; configuration micro-printer, convenient for users to print test results at any time; PVC operation panel, menu interface, LCD liquid crystal display, convenient for users to operate and view results; system configuration of Chinese and English bilingual operating environment, to meet the needs of different language users .
4.3 Scope of application
The equipment is suitable for rapid and accurate detection and analysis of the content and mixing ratio of oxygen, carbon dioxide and other gases in the sample at the production site, warehouse, laboratory, etc. The detectable samples include sealed packaging bags, such as pharmaceutical packaging, coffee. Inflatable or modified atmosphere bags such as cheese, milk tea, milk powder, bread, soy flour, ready-to-eat food, etc.; packaging containers, such as ampoules, vials, filling coffee, filling milk powder, canned food, Tetra Pak packaging, beverages, etc.
5, the test process
5.1 Setting parameters Set the test parameters such as sampling time and analysis time on the device control panel.
5.2 Collecting Gas Place the sample of the ampoule to be tested in the gas collection device, carefully open the sample, and the gas in the bottle will be collected in the gas collection device.
5.3 Test Insert the sampling needle carefully into the gas collection device, click the test button, the test starts, the instrument draws the sample gas in the collection device and analyzes it. After the test, the device automatically displays the test result, ie oxygen content and carbon dioxide content.
6, test results
The ampoule sample tested in this test has an oxygen content of 0.96% and a carbon dioxide content of 0.08%. If the gas filled in the sample is high-purity nitrogen, the nitrogen content in the bottle is 98.96%.
7. Conclusion
The content of oxygen and carbon dioxide in the package is an important factor affecting the quality of the drug. The residual oxygen content is one of the basic requirements for GMP for inert gas packaging of sterile drugs. This paper tests the ampoule for injection packaging using CLASSIC 650 head air analyzer. The oxygen and carbon dioxide content in the bottle, and the nitrogen content is calculated. The whole test process is simple, the equipment is easy to operate, and the test results are accurate and reliable. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D, production and packaging testing services for packaging testing equipment. The existing equipment includes a barrier to the permeability of gases such as nitrogen, oxygen, carbon dioxide and water vapor. Sexual equipment, physical and mechanical equipment capable of testing tensile properties, heat sealing strength, puncture resistance, ampoules breaking force, sealing performance, torque, etc., can test solvent residue, non-volatiles and other sanitary performance testing equipment, understand related equipment and Service information, you can log in to view. The more you understand, the more you trust! Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
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