Test plan for sealing performance of medical infusion bag (mfy-01 sealing tester)

Abstract: the composite film formed by CO extrusion of polyolefin and polyamide resin is mostly used as packaging material for pharmaceutical infusion bags, which has the advantages of high health and safety, no precipitated particles, high barrier and not easy to break, but its sealing performance is the performance index of Zui affecting the quality of liquid medicine and destroying the sterile environment This paper uses mfy-01 sealing tester independently developed by Labthink Languang to test the sealing performance of infusion bags, and details the testing principle and detailed process of the tester, so as to provide reference for pharmaceutical enterprises and other industries in monitoring the sealing performance of infusion bags and other packaging Key words: infusion bag, medicine, medicine, soft plastic packaging, sealing performance, sealing tester, leakage, air leakage, bubble 1, significance Medical infusion bag includes PVC material and non PVC composite membrane material At present, most of the three-layer or five layer co extrusion composite membrane materials are non PVC composite membrane materials Its main materials are polypropylene (PP), polyethylene (PE), polyamide (PA) and a variety of elastic materials (SEBS) It is one of the current Zui safe infusion packaging materials, without any plasticizer, itself and liquid medicine There is no reaction and adsorption phenomenon between them It eliminates the problem of alkali evolution of the glass bottle It has good low temperature resistance and is a kind of material The good quality infusion bag should not be easy to break, it has high gas and water resistance, and the internal liquid medicine is not easy to deteriorate or leak, which can meet the high requirements of sterile environment However, the medical infusion bag is sealed by heat sealing In the process of heat sealing, improper setting of heat sealing parameters may lead to improper heat sealing or excessive heat sealing For example, too high heat sealing temperature may lead to fracture or air leakage of the edge sealing root, or the uneven surface of the heat sealing knife may lead to the edge sealing fold containing unsealed leakage points If the sealing of the infusion bag is not good, water vapor, oxygen and other gases in the external environment are easy to penetrate into the inside of the infusion bag, causing bacteria invasion, resulting in deterioration and oxidation of the liquid medicine, and even leakage in the process of transportation or use In this paper, a professional sealing performance tester is used to introduce the testing scheme of the sealing performance of infusion bags to the relevant pharmaceutical manufacturers Fig 1 packaging of medical infusion bag 2 At present, the sealing performance test of soft plastic packaging mainly refers to GB / T 15171-1994 test method for sealing performance of soft packaging, which is applicable to the sealing performance test of sealing soft packaging made of various materials 3 Test sample a brand of sodium chloride infusion bag packaging 4 In this paper, mfy-01 sealing tester developed by Labthink Languang is used to test the sealing performance of infusion bag samples Fig 2 test principle of mfy-01 sealing tester 4.1 Mfy-01 sealing tester determines the sealing performance of the sample by vacuuming the vacuum chamber to produce the internal and external pressure difference of the sample immersed in water, and observing the gas escaping from the sample; or, without adding water, by vacuuming the vacuum chamber to produce the internal and external pressure difference of the sample, observing the expansion of the sample and the recovery of the sample shape after the vacuum is released, so as to determine the sample's sealing performance Sealing performance and find out the leakage position of the sample accurately 4.2 scope of application this equipment is applicable to the sealing performance test of sealed products such as bags, bottles, tubes, cans and boxes made of glass, plastic and metal materials in pharmaceutical, food, medical equipment, daily chemical, automobile, electronic components, stationery and other industries, as well as the test of sealing performance of samples after drop, pressure, high temperature or cooking tests This equipment conforms to many national and international standards, such as GB / T 15171, ASTM d3078, etc 4.3 the vacuum degree of equipment parameter is 0-90 kPa There are three kinds of effective dimensions for the vacuum chamber: 270 mm (diameter) × 210 mm (height), 360 mm (diameter) × 585 mm (height) and 460 mm (diameter) × 330 mm (height) The system adopts digital preset test vacuum degree and vacuum holding time to ensure the accuracy of test data Automatic constant pressure air supply technology is adopted to further ensure that the test can be carried out under the preset vacuum conditions The professional software supports the functions of automatic back blow unloading and automatic end of test to ensure the smooth test process 5 Test step (1) put a proper amount of distilled water into the vacuum sealed tank (i.e vacuum chamber), and immerse the sample of infusion bag into the water At this time, the distance between the top of the sample and the water surface shall not be less than 25 mm (2) Cover the sealing cover to ensure that there is no air leakage around the sealing cover and the sealing tank is well sealed (3) The vacuum degree (i.e negative pressure value) and the holding time in the vacuum tank are set through the microcomputer operation interface (4) Open the vacuum pump, click the test key, and the test starts (5) Observe the leakage of the sample in the process of vacuumizing and pressure maintaining, and observe whether there are continuous bubbles (6) If there are continuous bubbles on the surface of the sample, record the pressure value and the position of bubbles when continuous bubbles appear (7) Close the vacuum pump, make the vacuum chamber open to the atmosphere, open the sealing cover, take out the sample, wipe the water on its surface, open the seal if necessary, and check whether there is test water penetrating into the sample (8) Turn off the power of the instrument 6 Results five samples of blister packaging were tested in this test, none of them had air leakage under Zui high negative pressure - 90 kPa, which had good sealing performance, and could ensure the quality of liquid medicine not affected by external bacteria or air 7 Conclusion the sealing property of the infusion bag is an important performance index of Zui, which can ensure that the liquid medicine is not polluted and does not deteriorate Mfy-01 sealing tester (Labthink) has the advantages of high accuracy, simple operation and tight sealing when monitoring this performance It can not only determine the position where the package is easy to leak, but also establish the quantitative limit of product quality, so as to assist the improvement of product packaging process In order to overcome the disadvantages of the traditional sealing tester, such as heavy workload of manually recording test results, the risk of recording errors, the difficulty of data storage, difficult to consult, poor traceability and so on, Labthink blue light improved and innovated on the basis of mfy-01 sealing tester, and developed i-process 6200 sealing tester and data processing system, which is specialized in the detection of sealing performance of products on the production site, can automatically judge 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, so as to facilitate the management and control of the sealing performance of products on the production site Figure 3 in addition to the sealing performance of i-process6200 sealing tester and data processing system, the heat sealing strength, puncture resistance, water vapor transmittance, oxygen transmittance and other performance of medical infusion bag are also important performance indicators of the product You can log in Jinan Languang company to check the corresponding testing equipment or call for consultation The more you understand, the more you trust! 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