Abstract: Powder injection is sensitive to water vapor, so good sealing performance is one of the basic requirements for powder injection packaging. In this paper, powder packaging Vial an enterprise for example, using Labthink PARAM MFY-01 seal test the sealing performance test apparatus, and test information describing the principle, the basic process and equipment parameters test equipment for monitoring enterprise The sealing performance of the vial powder injection provides a reference. Key words: vial, sealing performance, seal tester, powder injection, agglomeration, negative pressure method 1 , meaning Powder injection is a common pharmaceutical dosage form. After mixing with a drug and a reagent, it is sterilized and dried to form a powdered medicine, and then packaged. Before use, it is necessary to add water for injection or other reagents to dissolve it. Powder injection is divided into aseptic powder and lyophilized powder according to different production principles. Commonly used packaging containers include vials, ampoules, and straight tube bottles. The powder injection should be loose before use, and there should be no yellowing, agglomeration, or powder sticking on the bottle wall, and no abnormal phenomenon such as liquefaction can occur. The occurrence of the above phenomenon is related to the increase of moisture content in the powder injection. The good sealing performance of the powder injection packaging container is one of the effective measures for preventing the above problems of the powder injection agent. If the sealing property of the packaging container is poor, the water vapor in the environment is easy to penetrate into the interior of the container, causing the powder injection to absorb moisture, and the above occurs. Yellowing, wall hanging, adhesion, melting, etc., and even mildew. Therefore, it is of great significance to strengthen the monitoring of the sealing properties of powder injection packaging containers. 2 , testing basis At present, the testing standards related to the sealing performance of powder injection packaging containers have not been issued in China. The testing process of this paper is based on the standard of negative pressure method commonly used in the sealing test GB/T 15171-1994 . 3 , test samples The samples tested in this paper are vials for powder injection packaging. The vials are mostly made of borosilicate glass and soda lime glass, which are commonly used in the packaging of vaccines, biological agents, powder injections and the like. 4 , test equipment The testing equipment used in this verification process is the MFY-01 sealing tester independently developed by Jinan Languang Electromechanical Technology Co., Ltd. , which is commonly used for the testing of the sealing performance of flexible packaging parts. 4.1 Test principle The MFY-01 seal tester is based on the principle of negative pressure method. The sample to be tested is placed in the water of the sealed can, and a vacuum is applied to the sealed can to make a certain pressure difference between the inside and the outside of the sample. If the sealing of the sample is not strict, the internal gas will be in a pressure difference. Under the action, it overflows from the inside of the sample, which appears as continuous bubbles on the surface of the sample. Therefore, the tightness of the sample can be judged by observing whether or not continuous bubbles appear on the surface of the sample. 4.2 Equipment parameters The degree of vacuum control range is 0 ~ -90KPa , the test accuracy is 1 level, and the effective size of the vacuum chamber is 270 mm ( diameter ) × 210 mm ( height ) , 360 mm ( diameter ) × 585 mm ( height ) , 460 mm ( Diameter ) × 330 mm ( height ) 3 types to choose from, the system uses digital preset test vacuum and vacuum hold time to ensure the accuracy of test data, automatic constant pressure air supply further ensures that the test can be under preset vacuum conditions The professional software supports the functions of automatic backflushing and unloading and automatic end of the test to ensure the smooth progress of the test. 4.3 Scope of application The device is suitable for testing the overall sealing performance of seals such as glass, plastic composite, paper-plastic composite material, metal material, plastic material, etc., and conforms to GB/T. National and international standards such as 15171 and ASTM D3078 . 5 , the test process (1) Place the sample of the vial to be tested in the water of the vacuum chamber of the tester. (2) Apply a layer of water to the seal around the seal tester and close the seal to prevent air leakage during the test. (3) Set the test parameters such as test vacuum degree and vacuum degree retention time, press the test button lightly, and the test starts. (4) During the vacuuming or pressure maintenance of the equipment, carefully observe whether there are continuous bubbles around the bottle cap of the vial. If there is continuous bubble, immediately press the stop button, the device stops vacuuming, and the sample is generated. The pressure value at the time of air leakage is such that if the sample does not show continuous bubbles and the sample does not infiltrate moisture, the sealing property of the sample is good. 6 , test results When the device showed a negative pressure value of -59.1KPa , the sample of the vial powder sample tested in this paper showed continuous bubbles between the bottle body and the aluminum foil cover, indicating that the sealing between the bottle body and the aluminum foil cover was poor. 7 , conclusion Xilin bottle powder injection should have good sealing performance to prevent water vapor and oxygen from entering the bottle, causing deliquescence and even oxidation failure of powder medicine. In this paper , the sealing performance of the sample of the vial is tested by the MFY-01 seal tester. The equipment is easy to operate and the test efficiency is high. The test results can truly reflect the advantages and disadvantages of the sample sealing performance and the weak seal. Labthink is a high-tech enterprise specializing in R&D, production and supply of packaging inspection equipment. It is committed to providing sophisticated, high-end and practical packaging inspection equipment and accurate, efficient and intimate packaging inspection services to customers around the world. The packaging performance testing equipment currently involved includes barrier performance, impact resistance, heat sealing performance, composite fastness, smoothness, adhesive performance, sealing performance, hygienic performance, etc., corresponding testing equipment and testing services, Jinan Languang Electromechanical Technology Co., Ltd. is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!