Moisture resistance monitoring and solution of medical aluminum plastic composite membrane materials

Abstract: the medicine is easy to absorb water and deliquesce, so its packing material should have high moisture resistance The lower the water vapor transmittance is, the higher the moisture resistance of the packing material is, and it has good protection for the medicine Currently, in order to ensure the quality of drugs and extend the shelf life, aluminum-plastic composite membrane materials are often used However, due to its poor kneading resistance, it is easy to have the quality problem of serious decline in moisture resistance, which needs to be further verified by water vapor transmission test equipment This paper introduces in detail the rubbing test of medical aluminum-plastic composite membrane and how to monitor the moisture resistance of packaging materials before and after rubbing, so as to provide technical reference for users in various industries Key words: drugs, aluminum-plastic composite film, kneading performance, moisture resistance, moisture permeability, water vapor barrier, water vapor transmittance, deliquescence deterioration test significance: the safety of drugs is very important, so the performance requirements of external packaging materials are also high, especially the barrier performance of packaging materials to external water vapor, which can effectively prevent drugs from deliquescence In addition to the packaging of traditional Chinese medicine pieces and low-grade granules, most of the pharmaceutical composite films are made of composite film materials containing pure aluminum foil Aluminum plastic composite film packaging can be used as the bottom plate material of powder medicine outer packaging bag or blister packaging In addition to making the medicine packaging beautiful and good texture, Zui has an important advantage of high barrier As a kind of metal material, aluminum foil has excellent moisture resistance and gas resistance (including oxygen resistance) due to its high density Its barrier performance is incomparable with any other polymer material and metal evaporated film The barrier property of aluminum-plastic composite film composed of aluminum foil and other plastic films is basically determined by the aluminum foil layer, but it is only when there is no pinhole in the aluminum foil or the pinhole size is small enough compared with the thickness of other composite layers The plastic film in the composite film is also involved in gas transmission, which also plays a certain role in the overall barrier of the composite film, but does not play a decisive role, unless the pinhole size of aluminum foil is large enough compared with the thickness of other composite layers, the barrier of the composite film will be significantly affected by the thickness of the plastic film and its barrier performance In addition, the aluminum foil layer in the aluminum-plastic composite film is easy to crease in the process of packaging, filling medicine, heat sealing, transportation and sales, which makes the barrier of the composite film worse, and the overall sealing of the finished product packaging is greatly affected The barrier performance of packaging materials to water vapor is generally characterized by water vapor transmittance The lower the value, the better the moisture resistance, and the less likely the drug is to deliquesce Therefore, the water vapor transmission of the aluminum-plastic composite membrane is an important part of the package material monitoring Whether the aluminum-plastic composite membrane is resistant to rubbing and whether the water vapor transmission changes significantly after rubbing is also an important performance index to truly reflect whether the barrier of the aluminum-plastic composite membrane can meet the requirements of the drug quality in the actual use process This performance can be tested by testing the aluminum-plastic composite membrane before and after rubbing The water vapor transmissivity of For the above test, the kneading tester shall be used to simulate the kneading process in the early stage, and then the high-precision moisture permeability tester shall be used to test the water vapor transmission rate of the rubbed aluminum-plastic composite membrane Test method: the rubbing resistance of flexible composite membrane shall be tested in accordance with ASTM f392 test method for flexural durability of flexible barrier materials Special rubbing tester shall be used under standard atmospheric pressure (23 ℃ and 50%) Relative humidity) the composite membrane is kneaded up and down and repeatedly twisted The kneading conditions, times and intensity of kneading vary according to the material of the tested sample and the actual use process, but the frequency is fixed at 45 times / min We will use fdt-02 kneading tester independently developed by Labthink Languang company to knead the samples of medical aluminum-plastic composite membrane according to the above standards The common test methods for moisture resistance of soft plastic packaging are weighing method (also known as cup method) and sensor method, among which sensor method is divided into electrolysis method, humidity method and infrared method As a basic method, weighing method is widely used in the detection of water vapor transmission rate of medical packaging materials By weighing the mass change of the sample before and after the water vapor transmission balance is reached under certain temperature and humidity environment, the water vapor transmission rate of the sample can be calculated At present, the test of water vapor transmission by weighing method in China follows the national standard of GB 1037-1988 test method for water vapor permeability of plastic film and sheet - cup method We will use the W3 / 060 water vapor transmission test system independently developed by Labthink Languang company to test the water vapor transmission of high barrier aluminum-plastic composite membrane samples in combination with the above standards 1 The fdt-02 kneading tester developed and produced by Labthink Languang has five standard test modes, four sample stations can easily realize the combined test under different conditions, and can realize the fast switching between long and short strokes The instrument meets the foreign standards of ASTM f392 It can be used to test the rubbing resistance of flexible film, composite film, aluminum-plastic composite film, aluminized film, coating film and other materials under various uses, and simulate the rubbing and bending damage of film in the process of production, processing and transportation After the kneading test, the anti kneading property of the material is judged by the change of the number of pinholes before and after the test sample or the change of the barrier property W3 / 060 water vapor transmittance test system, six chambers are independent, ultra-high test accuracy, can test six identical or different samples at the same time, the temperature control range is 15 ℃ ~ 55 ℃, the humidity control range is 10% RH ~ 98% RH, the water vapor transmittance test range is (0.1 ~ 10, 000) g / M 2 · 24h, the system Zui can support parallel connection of 10 instruments, and establish a system for simultaneous test of 60 samples The instrument meets the requirements of GB 1037, GB / T 16928, ASTM e66, ASTM D1653, TAPPI t464, ISO 2528, DIN 53122-1, JIS z0208, YBB 00092003 A variety of national and international standards can meet the water vapor barrier test of various plastic films, composite films, paper plastic composite films, coextrusion films, aluminized films, aluminum foil, aluminum plastic composite films, waterproof and breathable films and sheets under different temperature and humidity environment 2 The preparation of the sample uses fdt-02 kneading tester to knead the aluminum-plastic composite membrane sample for 270 times in 6 minutes in C mode Place the kneaded sample and the intact sample in 23 ℃ environment and put them in the dryer for 48 hours After taking out the two samples before and after rubbing, cut them straight from each sample 3 Test condition location: Jinan Languang packaging safety testing center test temperature and humidity: 38 ℃, 90% RH test method: weighing method (i.e cup method) 4 Test step 4.1 test principle W3 / 060 According to the measuring principle of the weight method of the moisture permeable cup, under a certain temperature, a specific humidity difference is formed on both sides of the sample, and the water vapor enters the dry side through the sample in the moisture permeable cup By measuring the change of the weight of the moisture permeable cup with time, the water vapor transmittance and other parameters of the sample are obtained 4.2 add a certain volume of distilled water (generally 1 / 2 and 2 / 3 of the water adding height in the water permeable cup) into the water permeable cup by clamping the sample When moving or taking, prevent the water from overflowing; after adding water, place the black rubber flat washer in the cup, and then put the composite membrane sample gently (do not let the sample get wet, do not fold the sample, and ensure to fully unfold); after placing the sample, place a black rubber flat washer; then put the white polytetrafluoroethylene sealing ring, cover the cup cover, and tighten; after tightening, check the white ring and Check whether the black circle is tightly pressed to ensure that the screw opening of the water permeable cup and the cup cover are in good agreement 4.3 W3 / 060 automatic test is simple: put the moisture permeable cup with the sample in the instrument as soon as possible, put it on the cup bracket according to the sample number, close the test chamber door and fasten the door buckle Set the test conditions as standard conditions, i.e the test temperature is 38 ℃, and the relative humidity is 90% RH Open the equipment software, set the test parameters and start the test Test parameters include control parameters (test mode, number of cycles, test interval, etc.) and sample parameters (name, number, material type, area, thickness, etc.) End of test, data processing Turn off the power The water vapor transmittance of the samples without kneading and kneading were 0.0259 g / M 2 · 24h and 2.5037 g / m2 · 24h, respectively The relative deviation of the test results among the three samples of each sample was less than 10%, and the relative average deviation was less than 5% Therefore, the moisture resistance of aluminum-plastic composite film with poor quality before and after rubbing is quite different In the later stage, the water vapor permeability of the finished product packaging is likely to increase significantly, leading to the quality problem of the drug deliquescence and deterioration Conclusion: when W3 / 060 water vapor transmission test system is used to test the water vapor transmission of medical aluminum-plastic composite membrane, the test results with high accuracy and parallel data can be obtained, which truly reflects the barrier performance of medical aluminum-plastic composite membrane When it is impossible to judge whether the crease on the surface of the aluminum-plastic composite film after being rubbed will make the moisture resistance change fatally, it needs to be verified with a reasonable water vapor detection device and a kneading tester The testing equipment and standards used in this test are also applicable to the water vapor transmission test of other materials such as aluminum plastic composite film and plastic composite film Labthink Languang has been committed to providing professional testing services and equipment for customers around the world Over the years, it has provided tens of thousands of moisture resistance testing services for customers around the world, providing customers with reliable data support and solutions For more information about related testing instruments, you can log in Jinan Languang to check the specific information or call directly for consultation Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry Copyright notice: All rights reserved Jinan Languang mechanical and Electrical Technology Co., Ltd no reprint without permission!