Test method for moisture resistance of soft plastic packaging of pharmaceutical granules

Abstract: the granule drugs are sensitive to the external water vapor, and the packaging is required to have high moisture resistance In this paper, the packaging roll film of a certain brand cold granules is taken as the test object, and the W3 / 031 water vapor transmittance tester independently developed by Jinan Languang mechanical and Electrical Technology Co., Ltd is used as the test equipment The test process and the test principle of the equipment, equipment parameters, etc are analyzed, so as to provide a test method of water vapor transmittance of soft plastic packaging for enterprises Key words: dampproof, dampproof, water vapor transmission rate, granules, drugs, soft plastic packaging, caking, moldy 1 Zui's remarkable characteristics in the deterioration of significant granules are viscidity, caking, moldy, abnormal odor, etc the occurrence of these problems is related to the increase of water content in drugs The water content of the granules is low, the surface area is large and the water absorption is strong If they are not stored properly, the above deterioration will occur Therefore, to improve the storage environment and reduce the humidity of the storage environment is an effective way to prevent the deterioration of drugs and extend the shelf life, which requires that the packaging materials of the drugs have low water vapor permeability, good moisture resistance and moisture resistance 2 At present, the common packaging materials that directly contact with the powder drugs are plastic composite film, aluminum coated composite film, aluminum plastic composite film, etc after the drugs are put into the packaging bag, they are put into the paper packaging box for transportation and sales Fig 1 at present, the test methods for the water vapor transmission rate of common drug packaging roll film, packaging bag and packaging box in China are weighing method (cup method), electrolysis method, humidity method and infrared method sensor The reference method standards are respectively GB 1037-1988 test methods for water vapor permeability of plastic film and sheet cup method and GB / T 16928-1997 Test methods for packaging materials -- moisture permeability, GB / T 21529-2008 determination of water vapor transmission of plastic film and sheet -- Electrolytic sensor method, GB / T 30412-2013 determination of water vapor transmission of plastic film and sheet -- humidity sensor method (issued, implemented on December 1, 2014), GB / T 26253-2010 Plastics film and sheeting - Determination of water vapor transmittance - infrared detector method The reference standard in this paper is GB 1037-1988 test method for water vapor permeability of plastic films and sheets cup method 3 The test sample is a plastic composite film for packaging a brand of cold particles 4 The testing equipment used in this paper is Labthink blue light W3 / 031 water vapor transmittance tester Fig 2 test principle of W3 / 031 water vapor transmissivity tester During the test, the sample is clamped in the moisture permeable cup, and a certain humidity difference is formed on both sides of the sample Under the effect of the humidity difference, the water vapor will permeate from the high humidity side to the low humidity side By measuring the weight of the moisture permeable cup with the change of time, the parameters such as the water vapor transmittance of the sample can be obtained 4.2 scope of application (1) this equipment is applicable to the test of water vapor transmission of film, sheet, paper, paperboard, textile, non-woven cloth and other materials Film type: all kinds of plastic film, plastic composite film, paper plastic composite film, geomembrane, coextrusion film, aluminized film, aluminum foil, aluminum plastic composite film, waterproof and breathable film and other film-like materials Sheet materials: various engineering plastics, rubber, building materials, insulation materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet, nylon sheet, etc (2) the equipment can also be extended to the test of the sample's inverted cup method and the water vapor transmission rate of the liquid crystal display screen, the solar panel, the aseptic protective film and the beauty mask (3) the equipment meets a number of national and international standards, such as GB 1037, GB / T 16928, ISO 2528, ASTM E96, ASTM D1653, TAPPI t464, DIN 53122-1, JIS z0208, ybb00092003, etc 4.3 the test range of equipment parameter equipment is 0.1 ~ 10000 g / M 2 · 24h, and the resolution is 0.01 g / m2 · 24h The temperature control range of the equipment is 15 ℃ ~ 55 ℃, the temperature control accuracy is ± 0.1 ℃, the humidity control range is 10% RH ~ 98% RH, and the humidity control accuracy is ± 1% RH The equipment is equipped with three moisture cups, which can be tested independently The system adopts the intermittent weighing method that meets the standard requirements, and ensures the constant humidity difference between the inside and outside of the moisture permeable cup through the standard purging wind speed The equipment provides two fast calibration methods of standard membrane and standard weight to ensure the accuracy and universality of test data The equipment supports the comparison of test results The user sets the standard value and error range before the test After the test, the system automatically judges whether the test results are within the standard error range, and informs the user intuitively It supports Lystem TM laboratory data sharing system Test data and equipment information can be reported simply by setting and operation, and it is easy to realize centralized and systematic management of laboratory test data 5 During the test (1), cut 3 pieces of 74 mm diameter sample from the sample surface (2) clamp the test pieces in three moisture cups respectively, and then put them on the moisture cup bracket inside the equipment respectively, and close the test chamber door Fig 3 sample clamping process (3) set the test temperature, humidity, sample thickness and other parameter information in the special software system of equipment configuration, click the test option, and the test starts (4) the equipment automatically calculates the water vapor transmittance of the sample according to the monitoring results 6 The results showed that the water vapor transmittance of the three samples were 1.095 g / m 2.24h, 0.918 g / m2.24h and 0.961 g / m2.24h respectively 7 Conclusion in order to prevent the deterioration of pharmaceutical granules, the packaging materials should have low water vapor transmittance This paper tested the packaging materials of a cold granule by W3 / 031 water vapor transmittance tester The test results have good repeatability, high precision and can show the moisture resistance of the packaging materials Water vapor transmittance tester is a practical testing equipment Jinan Languang mechanical and Electrical Technology Co., Ltd has always been committed to providing professional testing equipment and services for customers around the world To learn about Labthink Languang's testing equipment or services, you can visit Jinan Languang company or call directly for consultation Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry! 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