Moisture resistance monitoring and solution for medicinal aluminum-plastic composite film materials
Abstract: The drug is easy to absorb water and deliquesce, so its packaging material should have high moisture resistance, and the lower the water vapor transmission rate, the higher the moisture resistance of the packaging material and the good protection of the drug. In order to ensure the quality of the drug and extend the shelf life, the aluminum-plastic composite film material is often used, but the quality problem of the humidity resistance is seriously degraded due to its imperfection resistance, and further verification by the water vapor transmission rate test device is required. This article describes in detail the medicinal aluminum-plastic composite film test and how to monitor the moisture resistance of the packaging materials before and after the sputum, providing technical reference for users in various industries.
Key words: pharmaceuticals, aluminum-plastic composite film, antimony properties, moisture barrier, moisture permeability, water vapor barrier, water vapor transmission rate, deliquescent deterioration
Test significance:
The safety of the drug itself is very important, so the performance requirements of the external packaging materials are also high, especially the barrier property of the packaging material to the external water vapor, which can effectively prevent the drug from being deliquescent. In addition to the packaging of traditional Chinese medicine decoction pieces and low-grade granules, most of the medicinal composite membranes are mainly composite membrane materials containing pure aluminum foil . The aluminum-plastic composite membrane packaging can be used as a powder medicine outer packaging bag or blister packaging bottom material, in addition to allowing pharmaceutical packaging. With an aesthetic appearance and good texture, the important advantage of Zui is its high barrier. As a metal material, aluminum foil has high density, excellent moisture resistance and gas barrier properties (including oxygen barrier properties), and its barrier properties are unmatched by any other polymer materials and metal evaporation films. The barrier property of the aluminum-plastic composite film composited with aluminum foil and other plastic film is basically determined by the aluminum foil layer, but this is to ensure that the aluminum foil has no pinholes or the pinhole size is small enough compared with the thickness of other composite layers. . The plastic film layer in the composite film also participates in gas permeation, and has a certain effect on the overall barrier property of the composite film, but it does not play a decisive role unless the pinhole size of the aluminum foil is sufficiently large compared with the thickness of other composite layers, the composite film The barrier properties will be significantly affected by the thickness of the plastic film layer and its barrier properties. In addition, the aluminum foil layer in the aluminum-plastic composite film is prone to a certain degree of crease in the process of packaging molding, filling medicine, heat sealing, transportation and sales, so that the barrier property of the composite film is deteriorated, and the overall sealing property of the finished packaging is affected. Great impact.
The barrier properties of packaging materials to water vapor are generally characterized by water vapor transmission rate. The lower the value, the better the moisture barrier property, and the more difficult the product is deliquescent. Therefore, the water vapor transmission rate of the aluminum-plastic composite film is an important part of the monitoring of the packaging material, and whether the aluminum-plastic composite film is resistant to cockroaches, whether the water vapor transmission rate after the enthalpy changes significantly reflects the fact that the aluminum-plastic composite film is actually Whether the barrier property during use is an important performance index for the quality of the drug, this performance can be judged by detecting the water vapor transmission rate of the aluminum-plastic composite film before and after the enthalpy. The above test needs to use the æ‰æ“ tester to carry out the pre-simulation æ‰æ“ process, and then use the high-precision moisture permeability tester to detect the water vapor transmission rate of the enamel aluminum-plastic composite film.
Detection method:
The tamper resistance test of flexible composite membranes is in accordance with ASTM F392 , Test Method for Flexural Durability of Flexible Barrier Materials , and is compounded under standard atmospheric conditions ( 23 °C and 50% relative humidity) using a special helium tester. The film is reciprocated and repeatedly twisted, and the condition, the number of times, and the severity of the flaw vary depending on the material of the sample to be tested and the actual use process, but the frequency is fixed at a speed of 45 times / min. We will use the FDT-02 æ‰æ“ tester independently developed by Labthink to test the medicinal aluminum-plastic composite film samples in combination with the above standards.
Common soft plastic packaging moisture resistance test methods are divided into weighing method (also known as cup method) and sensor method, wherein the sensor method is divided into electrolysis method, humidity method and infrared method. As a basic method, the weighing method is widely used for the detection of water vapor transmission rate of medicinal packaging materials. By accurately weighing a certain temperature and humidity environment, the sample is clamped with sample after reaching the water vapor transmission equilibrium. The water vapor transmission rate of the sample was calculated by changing the mass before and after the moisture permeable cup.
At present, the domestic weighing method tests the water vapor transmission rate test in accordance with GB 1037-1988 "plastic film and sheet water vapor test method cup method" this national standard. We will use the W3/060 water vapor transmission rate test system independently developed by Labthink to test the water vapor transmission rate of high barrier aluminum-plastic composite film samples in combination with the above standards.
1 , test equipment
The FDT-02 æ‰æ“ tester developed by Labthink has five standard test modes. The four sample stations can easily realize combined test under different conditions, and can realize fast switching between long and short strokes. The instrument meets ASTM F392 foreign standards and can be used for testing the anti-cracking properties of flexible films, composite films, aluminum-plastic composite films, aluminized films, coating films, etc. in various applications. Behaviors such as sputum and crushing damage during transportation and the like. After the end of the test, the resistance of the material is judged by detecting the change in the number of pinholes before or after the test or the change in the barrier properties.
W3/060 water vapor transmission rate test system, six-chamber independent, ultra-high test accuracy, can test six identical or different samples at the same time, temperature control range is 15 °C ~ 55 °C , humidity control range is 10% RH ~ 98 %RH , water vapor transmission rate test range (0.1 ~ 10,000) g / m 2 · 24h , system Zui can support 10 instruments in parallel connection, establish 60 high-efficiency system for simultaneous testing of samples. The instrument meets various national and international standards of GB 1037 , GB/T 16928 , ASTM E96 , ASTM D1653 , TAPPI T464 , ISO 2528 , DIN 53122-1 , JIS Z0208 , YBB 00092003 , and can meet various plastics under different temperature and humidity environments. Water vapor barrier test of film and sheet of film, composite film, paper-plastic composite film, co-extruded film, aluminized film, aluminum foil, aluminum-plastic composite film, waterproof breathable film, etc.
2. Preparation of samples 　　
The aluminum-plastic composite film sample was subjected to 270 repeated æ‰æ“ times in C mode for 6 minutes using the FDT-02 æ‰æ“ tester. The sample after sputum and the intact sample were placed in a 23 ° C environment and placed in a desiccator. Adjust the state for 48 hours. After taking out the two samples before and after the sputum, cut each sample from straight
3. Test conditions
Location: Jinan Languang Packaging Safety Testing Center Test Temperature and Humidity: 38 ° C, 90% RH
Test method: weighing method (ie cup method)
4. Test procedure
4.1 Test principle
W3/060 adopts the principle of wetting cup weighing method. Under certain temperature, the specific humidity difference is formed on both sides of the sample. The water vapor passes through the sample in the moisture permeable cup and enters the dry side. The amount of change in the weight of the moisture permeable cup over time is determined by parameters such as the water vapor transmission rate of the sample.
4.2 sample clamping
Add a certain volume of distilled water to the moisture permeable cup (generally between 1/2 and 2/3 of the height of the permeable cup ), prevent water from overflowing when moving or taking it; place a black rubber flat washer in the cup after adding water. , then gently put the composite film sample (do not let the sample wet, do not fold the sample to ensure complete expansion); put the sample, then place a black rubber flat washer; then put the white PTFE seal Close the lid and tighten it tightly; check if the white ring and the black ring are tightly pressed after tightening to ensure a good fit between the moisture permeable cup and the screw cap of the lid.
4.3 Detection process
W3/060 automated test, the test process is simple:
- Place the moisture permeable cup with the sample clamped into the instrument as soon as possible, place it on the cup holder according to the sample number, close the test chamber door, and fasten the door buckle.
- The test conditions were set to standard conditions, i.e., the test temperature was 38 ° C and the relative humidity was 90% RH .
- Open the device 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.
Water vapor transmission rate is not kneaded with plastic composite film of the sample after rubbing were 0.0259 g / m 2 · 24h, 2.5037 g / m 2 · 24h, the relative deviation between test results for each sample 3 specimens are Less than 10% , the relative average deviation is less than 5% . Therefore, the difference in moisture resistance between the aluminum-plastic composite film with poor quality is large, and the water vapor transmission rate is likely to increase after the formation of the finished product package, which leads to the quality problem of deliquescence of the drug.
to sum up:
When the water vapor transmission rate of the medicinal aluminum-plastic composite film is tested by the W3/060 water vapor transmission rate test system, high-accuracy and parallel data test results can be obtained, which truly reflect the barrier properties of the medicinal aluminum-plastic composite film. When it is not possible to judge whether the crease of the aluminum-plastic composite film on the surface after the tampering causes a fatal change in the moisture repellency, it is necessary to verify it by means of a reasonable water vapor detecting device in combination with a krypton tester. The testing equipment and testing standards used in this test are also applicable to the water vapor transmission rate test of materials such as aluminum-plastic composite film and plastic composite film for other purposes. Labthink has been committed to providing professional testing services and equipment to customers around the world. Over the years, it has provided tens of thousands of moisture-proof testing services to customers around the world, providing customers with reliable data support and solutions. Learn more testing instruments concerning the information, you can visit Labthink view specific information or call us directly. Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry.
Copyright statement: Article Copyright Jinan Languang Electromechanical Technology Co., Ltd., reprinted without permission!
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