Abstract : Medicinal infusion bags mostly use polyolefin and polyamide resin co-extruded composite films as packaging materials. They have high hygienic safety, no precipitated particles, high barrier properties, and are not easily broken, but they are sealed. Good or bad is the performance index that affects the quality of the liquid and destroys the sterile environment. This article uses Labthink blue light independent research and development MFY-01 sealing tester to test the infusion bag sealing performance, and detailed this instrument's test principle and the test detailed process, thus for the pharmaceutical industry and other industries in the infusion bag and other packaging sealing performance Monitoring provides reference. Keywords : Infusion bag, medicinal, flexible plastic packaging, sealing performance, sealing tester, leak, leak, bubble 1 , the meaning Medicinal infusion bags include polyvinyl chloride ( PVC ) and non- PVC composite membranes. Currently, most of them are three-layer or five-layer coextrusion composite membranes made of non- PVC composite membranes. The main materials are polypropylene ( PP) and polyethylene. ( PE) , Polyamide ( PA ), and various elastic materials ( SEBS ) are one of the safest infusion packaging materials at present, and do not contain any plasticizer. There is no reaction or adsorption between itself and the liquid. Alkaline problem of glass bottles, good low temperature resistance, is a high quality material. Good quality medical infusion bags should not be easily broken, their gas barrier properties and water resistance are high, the internal liquids are not easily degraded or leaked, and they can meet the highly demanding sterile environment. However, medical infusion bags rely on heat sealing to seal the edges around them. In the process of heat sealing, the improper setting of the heat sealing parameters causes the heat sealing to be incomplete or the heat sealing is excessive. For example, the heat sealing temperature is too high to cause edge sealing. The root is easily broken or leaks, or the surface of the heat-sealing knife is uneven, resulting in the edge seal fold containing an unsealed leak point. If the infusion bag is poorly sealed, water, oxygen, and other gases in the external environment can easily permeate into the infusion bag, causing bacterial intrusion, resulting in deterioration and oxidation of the liquid and even leakage during transportation or use. This article uses a professional sealing performance tester to introduce relevant pharmaceutical production companies to test solutions for infusion bag sealing performance. Figure 1 Medicinal infusion bag packaging 2 , standard At present, the sealing performance test of soft plastic packaging mainly refers to GB/T 15171-1994 Test Method for the Sealing Performance of Flexible Packages , which is applicable to the sealing performance test of sealed flexible packages made of various materials. 3 , test sample A brand of infusion bag finished product packaging. 4 , test equipment This article uses Labthink blue light independent research and development MFY-01 sealing tester to test the infusion bag sample sealing performance. Figure 2 MFY-01 Seal Tester 4.1 Test principle The MFY-01 Sealing Tester vacuums the vacuum chamber to generate a differential pressure between the inside and outside of the sample immersed in the water and observes the escape of gas in the sample to determine the sealing performance of the sample; or in the absence of water. The vacuum chamber is evacuated to produce a differential pressure between the inside and outside of the sample, and the expansion of the sample and the recovery of the shape of the sample after releasing the vacuum are observed to determine the sealing performance of the sample and accurately find the location where the sample is liable to leak. 4.2 Scope of application 4.3 Equipment Parameters 5 , test steps (1) Put a proper amount of distilled water in a vacuum sealed tank (ie, a vacuum chamber) and immerse the infusion bag sample in water. At this point, the distance between the top of the sample and the surface of the water must not be less than 25 mm . (2) Cover the seal cap to ensure that the periphery of the seal cap does not leak gas and the sealed canister is well sealed. (3) Set the test parameters, such as vacuum degree (negative pressure value) and holding pressure time in the vacuum tank, through the interface of the microcomputer. (4) Open the vacuum pump and click the test button to start the test. (5) Observe the leakage of the sample during the vacuum and pressure holding process, and observe whether there is continuous bubble generation. (6) If there is a continuous bubble on the surface of the sample, record the pressure at the time of the continuous bubble and the position of the bubble. (7) Close the vacuum pump, open the vacuum chamber to the atmosphere, open the sealing cover, remove the sample, wipe off the water on the surface, and if necessary, open the inside of the sample to check if the test water penetrates into the sample. (8) Turn off the instrument. 6 , test results A total of five blister packaging samples were tested in this test. They did not exhibit leakage at the maximum negative pressure of -90 KPa . They have good sealing properties and can ensure that the quality of the liquid is not affected by external bacteria or air. 7. Conclusion The sealability of the medical infusion bag is the most important performance index to ensure that the liquid is not contaminated and does not deteriorate. When monitoring this performance, MFY-01 Sealing Tester ( Labthink ) has the advantages of high accuracy, easy operation, and tight sealing. It can not only determine the location where the leakage is easy to occur in packaging, but also establish the quantitative limit of product quality. As a result, the product packaging process is improved. In order to overcome heavy workload conventional sealing tester manually record the test results, there is a risk of transcription errors, data storage difficulties, easy inspection, defects and poor traceability, Labthink blue light on the basis of improvement and innovation MFY-01 on seal tester, Developed the i-Process 6200 sealing tester and data processing system. The system is professionally used to test the sealing performance of production products on the spot. It can automatically determine whether the test results are qualified or not, and the test data can be automatically uploaded to the data management center for data. Management and storage make it easy for users to manage and control the sealing performance of product packaging at the production site. Figure 3 i-Process6200 Seal Tester and Data Processing System In addition to the sealing performance, the properties such as heat-sealing strength, anti-puncture force, water vapor transmission rate, and oxygen permeability of medical infusion bags are also important performance indicators of the products. You can visit the website of Jinan Languang Company for the corresponding testing equipment. Check or call for advice. The more you understand, the more trust! Labthink expects to enhance technology exchanges and cooperation with enterprises and institutions in the industry! 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Medicinal infusion bag sealing performance test program
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