Abstract: The safety of pharmaceuticals is very important, so the performance requirements of the external packaging materials are also high, especially the oxygen barrier properties of the packaging materials to the outside world, which is the key performance to ensure that the drugs are not easily deteriorated. In this paper, the Labthink OX2/230 oxygen transmission rate tester is used as the testing equipment to test the oxygen transmission rate of the medicinal ointment aluminum tube, and the test process, test principle, equipment parameters and other information are described. Provide technical reference for monitoring the oxygen barrier properties of medicinal ointment aluminum tubes or screening test equipment. Key words: pharmaceutical packaging, ointment aluminum tube, container, oxygen barrier, oxygen transmission rate, isobaric method, oxygen transmission rate tester Meaning As drug safety becomes more and more concerned, pharmaceutical companies are increasingly demanding packaging. Pharmaceutical packaging is developed according to demand, from the initial paper packaging to the current plastic packaging, metal packaging, for example, for all types of creams, gels, ointments, medicinal aluminum tube packaging, it has corrosion resistance, no leakage, airtight Excellent character, strong barrier, easy to use and green. The aluminum tube has high oxygen barrier performance. If the oxygen barrier of the aluminum tube of the ointment is low, that is, the oxygen permeation amount is high, the anaerobic component contained in the medicine is easily oxidized under the action of oxygen, resulting in discoloration of the ointment and medicine. Reduced efficiency. Therefore, pharmaceutical companies should strengthen the key monitoring of the oxygen barrier properties of ointment aluminum tubes. Figure 1 medicinal ointment aluminum tube packaging 2. Standard The method for detecting the oxygen permeation of packaging containers is GB/T 31354-2014 "Coulomb Test Method for Permeability Test Method for Packages and Containers". 3. Test sample A pharmaceutical ointment aluminum tube provided by a pharmaceutical company. 4. Test equipment The testing equipment used in this paper is the independent research and development design of OX2/230 oxygen transmission rate tester for Jinan Languang Electromechanical Technology Co., Ltd. Figure 2 OX2/230 oxygen transmission rate tester 4.1 Equipment principle The OX2/230 oxygen transmission rate tester uses the isostatic test principle. For the packaging container, high-purity nitrogen flows in the container, air or high-purity oxygen surrounds the outside of the container, and oxygen molecules diffuse through the container to the container. The internal high-purity nitrogen gas is carried to the sensor by the flowing nitrogen. By analyzing the oxygen concentration measured by the sensor, parameters such as oxygen transmission rate are calculated. 4.2 Scope of application Container: Suitable for oxygen transmission rate (quantity) test of tubes, bottles, bags, cans, boxes and barrels made of plastic, rubber, paper, paper-plastic composite, glass, metal, etc., such as medicinal ointment aluminum tube , Coke bottle, peanut oil barrel, Tetra Pak packaging, vacuum packaging bags, metal three cans, plastic cosmetic packaging, toothpaste hose, jelly cup, yogurt cup, etc. Film type: It is suitable for oxygen transmission rate (quantity) test of various plastic film, plastic composite film, paper-plastic composite film, aluminized film, aluminum foil and other film materials. Sheet type: It is suitable for oxygen transmission rate (quantity) test of various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet and so on. It meets many national and international standards such as GB/T 31354, ISO 15105-2, GB/T 19789, ASTM D3985, ASTM F2622, ASTM F1307, ASTM F1927, JIS K7126-2, YBB 00082003. 4.3 Equipment parameters The test range of the container sample is 0.0001 ~ 60 cm3 / (pkg · d), the resolution is 0.00001 cm3 / (pkg · d); the test range of the film sample is 0.01 ~ 6500 cm3 / (m2 · d), The expandable test range is 0.07 ~ 65000 cm3/(m2·d) with a resolution of 0.001 cm3/(m2·d). The test temperature control range is 15 ~ 55 °C, and the temperature control accuracy is ±0.1 °C. The test humidity control range is 0% RH, 35% RH ~ 90% RH, and the humidity control accuracy is ±1% RH. Wide range, high precision temperature and humidity control range, both sides of the sample can be humidified to achieve the test under different temperature and humidity conditions. The three test chambers can be independently tested, the test process does not interfere with each other, and the test results are displayed independently. The system can support up to 10 instruments in parallel connection, and establish an efficient system for simultaneous testing of 30 samples. It can be combined with the water vapor transmission rate test system to form a hybrid test system, which is controlled by a computer to achieve an efficient and convenient test method for simultaneous oxygen and water vapor transmission rate testing. Support LystemTM laboratory data sharing system to manage test results and test reports. 5. Test process (1) Cut the bottom seal of the aluminum tube of the medicinal ointment, seal the test sample on the container test special tray device with quick-solid glue, and then seal the sample together with the tray device in a sealed aluminum foil bag, using the pipeline It is connected to the device so that the outside of the sample flows with high purity oxygen, and the inside of the sample flows with high purity nitrogen. (2) Set the sample name, test temperature, test humidity and other parameters, select the test mode, and start the test. (3) After the test is over, the device displays the test results of the sample. 6. Test results The overall oxygen transmission rate of the aluminum ointment package for the test ointment was 0.0034 cm3/(pkg·d). 7. Conclusion OX2/230 Oxygen Permeability Tester is a test equipment for testing the oxygen barrier of packaging containers. It has the advantages of high test efficiency, high precision of test results, good accuracy and repeatability, and can be used in addition to packaging containers. Oxygen transmission rate of samples such as packaging films and sheets. As a leader in the development and manufacturing of packaging inspection equipment, Labthink is committed to providing professional, high-end packaging inspection equipment and testing services to customers around the world, as well as providing customers with a large number of packaging material performance data references. For related testing equipment and testing services, you can log in to view. The more you understand, the more trust! Jinan Languang Electromechanical Technology Co., Ltd. is willing to enhance technical exchanges and cooperation with enterprises and institutions in the industry. Jiangmen Merit Metal Electric Appliance Co.,Ltd. , https://www.meritbbq.com
