Monitoring method of water vapor transmittance of aluminized composite film for pharmaceutical packaging

Abstract: water vapor transmittance is one of the basic properties of drug packaging, which has an important impact on the quality of the packaged pharmaceutical products In this paper, the c390 water vapor transmission test system based on the principle of infrared detector is used to test the water vapor transmission of a kind of aluminum-plated composite film sample for drug packaging Through the introduction of the test principle, equipment parameters, application scope and test process, the reference is provided for the enterprise to monitor the water vapor transmission of the plastic composite film for drug packaging Key words: water vapor transmittance, water vapor transmittance test system, infrared detector method, moisture resistance, moisture resistance, drug packaging, aluminized composite film 1, significance For most drugs, the moisture-proof work during storage and shelf life is one of the key measures to prevent the failure of drugs and even the generation of toxic and harmful substances The detection of water vapor transmission rate of packaging is an important part of drug moisture-proof work The common packaging materials of drugs are plastic composite film, aluminized composite film, blister packaging, ampoule bottle, plastic tube, vials, etc their moisture resistance performance is not the same Different drugs also have different requirements on the moisture resistance of packaging materials For example, the water vapor transmission of packaging materials is required to be higher for the types of drugs such as granules, effervescent tablets, capsules and powder injections, while the water vapor transmission of packaging materials is required to be lower for the types of liquid drugs such as injections and eyedrops Therefore, through the detection of the water vapor transmission of packaging materials, suitable drugs are selected The packaging of is the basic requirement to ensure the good quality of drugs within the shelf life and not to absorb moisture Fig 1 soft plastic composite membrane materials for drug packaging 2 The test basis is the method of water vapor transmission measurement (ybb0009203-2015), which is related to the water vapor transmission test of drug packaging 4 There are three methods to measure the water vapor transmittance, which are cup method, electrolytic analysis method, gravimetric method and infrared detector method The infrared detector method is arbitration method In this paper, the samples are tested according to the infrared detector method 3 The test sample this test uses a kind of aluminum-plated composite film material for drug packaging as the test sample 4 In this paper, c390 water vapor transmission test system is used as the test equipment to test the water vapor transmission of the sample, which is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd Fig 2 c390 water vapor transmission test system 4.1 test principle infrared detector method is based on the principle that infrared light can absorb water molecules quantitatively The water vapor transmission of the sample can be obtained by testing the attenuation degree of infrared light after passing through the carrier gas containing water vapor The specific realization process is that after the sample is clamped in the test chamber of the equipment, the test chamber is divided into two test chambers: upper chamber and lower chamber During the test, the upper chamber is filled with high-purity nitrogen with a certain humidity, and the lower chamber is filled with low humidity nitrogen Under the effect of concentration difference, water vapor penetrates the sample from the upper chamber into the lower chamber, and carries the nitrogen to the infrared detector for analysis Water vapor transmittance to sample 4.2 equipment parameters when the test area of thin film sample is 50 cm 2, the test range is 0.05 ~ 40 g / (M2 · 24h), when the test area is 7 cm2, the test range is 0.35 ~ 280 g / (M2 · 24h); the test range of container sample is 0.00025 ~ 0.2 g / (PKG · d); the test temperature control range is 15 ℃ ~ 55 ℃, the temperature control accuracy is ± 0.2 ℃; the humidity range is 5% RH ~ 90% RH 100% RH, humidity control accuracy of ± 2% RH; artificial, proportional and cyclic three test modes provide suitable detection methods for materials with different barrier properties; using the second generation of three chamber integrated block, the three test chambers can be designed independently, the test process does not interfere with each other, and the test results are displayed independently 4.3 scope of application (1) this equipment is applicable to the test of water vapor transmission of film, sheet, paper, cardboard, composite materials, containers and other packaging Among them, film category includes various plastic films, paper plastic composite films, aluminized films, aluminum foil, aluminum foil composite films, glass fiber aluminum foil composite films, etc.; sheet category includes various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC, etc Sheet, etc.; paper, paperboard and its composite materials include paper, paperboard, etc., such as cigarette pack aluminum coated paper, paper aluminum plastic composite sheet, etc.; container includes bottles, bags, cans, boxes and barrels made of plastic, rubber, paper, paper plastic composite, glass, metal and other materials, such as tea aluminum cans, coke bottles, peanut oil barrels, Tetra Pak packaging, vacuum packaging bags, metal packaging bags, three pieces of metal Can, plastic cosmetic hose packaging, toothpaste hose packaging, jelly cup, etc The equipment can also be extended to test the water vapor transmission rate of special packaging such as solar back panel, liquid crystal display film, medical bubble cover, pharmaceutical plastic bottle, sterile protective film, automobile oil tank, battery plastic shell, etc （2） This equipment conforms to GB/T 31355, ISO 15106-2, ASTM F1249, GB/T 26253, TAPPI T557, JIS K7129 and YBB00092003 5 During the test (1) three samples were cut from the surface of the sample with a special sampler, and the condition was adjusted at 23 ± 2 ℃ and 50 ± 10% for 4 hours (2) Apply a layer of vacuum grease around the test chamber of the equipment, clamp the sample on the surface of the test chamber, and clamp it with the sample clamping device (3) Set the test temperature (38 ℃), test humidity (90%), sample name and other parameter information Click the test option to start the test (4) Open the air source and adjust the carrier gas flow to make the humidity in the test chamber reach the set value After the test, the equipment automatically calculates the water vapor transmittance of the sample according to the test value 6 Results the water vapor transmittance of the three samples was 0.73 g / (M 2 · 24h), 0.77 g / (M2 · 24h) and 0.71 g / (M2 · 24h) The average value of the three samples was 0.74 g / (M2 · 24h) 7 Conclusion The water vapor permeability of drug packaging is an important factor that affects whether the packaged drugs are easy to absorb moisture and deteriorate in the storage process This paper introduces the method of measuring the water vapor permeability of soft plastic packaging materials by using infrared detector through the test of the water vapor permeability of aluminum-plated composite film for a drug packaging In the whole test process, there is less interference of human factors, and the intelligent degree of the equipment High efficiency, simple operation, good repeatability of test results and uniform water vapor transmittance of the sample In addition to the water vapor transmittance tested in this test, the oxygen resistance, interlayer composite fastness, heat sealing strength, sealing performance, friction coefficient, non-volatile matter, solvent residue and other properties of the aluminized composite film will affect its service performance Jinan Languang mechanical and Electrical Technology Co., Ltd is a high-tech enterprise specializing in the research and development of packaging testing equipment, production and packaging testing services! 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