Abstract: Water vapor transmission rate is one of the basic properties of pharmaceutical packaging, which has an important impact on the quality of the packaged pharmaceutical products. In this paper, the C390 water vapor transmission rate test system of the infrared detector method is used to test the water vapor transmission rate of a sample of aluminized composite film for pharmaceutical packaging, and the test principle, equipment parameters, application range and test process are adopted. The introduction of the content provides a reference for enterprises to monitor the water vapor transmission rate of plastic composite film for pharmaceutical packaging.
Key words: water vapor transmission rate, water vapor transmission rate test system, infrared detector method, moisture resistance, moisture resistance, pharmaceutical packaging, aluminized composite film
1, meaning
For most drugs, the moisture-proof work during storage and shelf life is one of the key measures to prevent drug failure and even produce toxic and harmful substances. The detection of water vapor transmission rate of packaging is an important part of drug moisture-proof work.
Common pharmaceutical packaging materials include plastic composite film, aluminized composite film, blister packaging, ampoules, plastic tubes, vials, etc., and their moisture barrier properties are not the same. Different drugs have different requirements on the moisture resistance of packaging materials. For example, granules, effervescent tablets, capsules, powder injections and other types of drugs require higher water vapor transmission rate of packaging materials, while liquid drugs, such as Injections, eye drops, etc. require low water vapor transmission rate of the packaging material. Therefore, by testing the water vapor transmission rate of the packaging material, it is necessary to select a packaging suitable for the pharmaceutical product to ensure that the quality of the pharmaceutical product is good during the shelf life. The basic requirements for moisture absorption and deterioration.
Figure 1 Soft plastic composite film material for pharmaceutical packaging
2, testing basis
The pharmaceutical packaging standard related to the water vapor transmission rate test of pharmaceutical packaging is YBB00092003-2015 "Water vapor transmission amount measurement method", which specifies four kinds of water vapor transmission rate test methods, respectively, cup method, Electrolytic analysis method, gravimetric method, infrared detector method, wherein the infrared detector method is the arbitration method, and the sample is tested according to the infrared detector method.
3, test samples
In this test, an aluminum-plated composite film material for pharmaceutical packaging was used as a test sample.
4, test equipment
In this paper, the C390 water vapor transmission rate test system is used as the test equipment to test the water vapor transmission rate of the sample. The equipment is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd.
Figure 2 C390 water vapor transmission rate test system
4.1 Principle of the test
The infrared detector method is based on the principle that infrared light can quantitatively absorb water molecules, and the water vapor transmission rate of the sample is obtained by testing the degree of attenuation of the infrared light after passing through the carrier gas containing water vapor. The specific implementation process is that after the sample is clamped in the test chamber of the device, the test chamber is divided into upper and lower test chambers. During the test, the upper chamber is filled with high-purity nitrogen gas with a certain humidity. The lower chamber is a low-humidity nitrogen gas. Under the action of the concentration difference, the water vapor permeates through the sample into the lower chamber, and the nitrogen gas is carried to the infrared detector for analysis, thereby obtaining the water vapor transmission rate of the sample.
4.2 Equipment parameters
When the test area of ​​the film sample is 50 cm2, 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 of the container sample The range is 0.00025 ~ 0.2 g / (pkg · d); the test temperature control range is 15 ° C ~ 55 ° C, the temperature control accuracy is ± 0.2 ° C; the humidity range is 5% RH ~ 90% RH, 100% RH, humidity control accuracy It is ±2% RH; the three test modes of artificial, proportional and cyclic provide suitable detection methods for materials with different barrier properties; using the second generation three-cavity integrated block, all three test chambers can be independently designed, and the test process is mutually No interference, the test results are displayed independently.
4.3 Scope of application
(1) This equipment is suitable for testing the water vapor transmission rate of packaging materials such as film, sheet, paper, cardboard and composite materials, containers and the like. The film includes various plastic film, paper-plastic composite film, aluminized film, aluminum foil, aluminum foil composite film, glass fiber aluminum foil paper composite film, etc.; sheet materials include various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet, etc.; paper, cardboard and composite materials including paper, cardboard, etc., such as cigarette coated aluminum paper, paper aluminum-plastic composite sheet, etc.; containers include plastic, rubber, paper Bottles, bags, cans, boxes, barrels made of paper-plastic composite, glass, metal, etc., such as tea aluminum cans, cola bottles, peanut oil barrels, Tetra Pak packaging, vacuum packaging bags, metal packaging bags, metal three-piece cans , plastic cosmetic hose packaging, toothpaste hose packaging, jelly cups, etc.
The device can also be used for testing the water vapor transmission rate of special packages such as solar back panels, liquid crystal display films, medical blister packs, pharmaceutical plastic bottles, sterile protective film, automobile fuel tanks, and battery plastic casings.
(2) This device complies with GB/T 31355, ISO 15106-2, ASTM F1249, GB/T 26253, TAPPI T557, JIS K7129, YBB00092003.
5, the test process
(1) Three specimens were cut from the surface of the specimen with a special sampler and adjusted for 4 h in an environment of 23 ± 2 ° C and 50 ± 10%.
(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 clamp device.
(3) Set the test temperature (38 ° C), test humidity (90%), sample name and other parameter information, click the test option, the test begins.
(4) Turn on the air supply, adjust the carrier gas flow, etc., so that the humidity in the test chamber reaches the set value. After the test, the device automatically calculates the water vapor transmission rate of the sample based on the test value.
6, test results
The water vapor transmission rates of the three samples tested in this paper were 0.73 g/(m2·24h), 0.77 g/(m2·24h), and 0.71 g/(m2·24h), respectively. The average value of the test results of the three samples was 0.74 g/(m2·24h).
7. Conclusion
The water vapor transmission rate of pharmaceutical packaging is an important factor affecting the moisture absorption and deterioration of the packaged drugs in the storage process. This paper introduces the use of infrared light by testing the water vapor transmission rate of aluminized composite membrane for a pharmaceutical packaging. The detector tests the water vapor transmission rate of the soft plastic packaging material. The human error is less in the whole test process, the equipment is intelligent, the operation is simple, the test results are reproducible, and the water vapor transmission rate of the sample is relatively uniform. . In addition to the water vapor transmission rate tested in this test, the oxygen barrier properties, interlaminar composite fastness, heat seal strength, sealing properties, friction coefficient, non-volatiles, solvent residues and other properties of the aluminized composite film will affect its properties. Use performance. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D, production and packaging testing services for packaging testing equipment. You can find out the relevant testing equipment and testing service information. You can log in and see, the more you understand, the more you trust! Labthink Languang looks forward to Enterprises and institutions in the industry to enhance technical communication and cooperation!
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