Source: Link Testing Instruments Co.,Ltd.
The safety of the drug itself is very important, so the performance requirements of its outer packaging materials are also high, especially the barrier performance of the packaging to external oxygen, and the lower oxygen transmission rate can effectively prevent the oxidative deterioration of the drug. The common packaging materials for powder drugs are plastic composite film, aluminized composite film, aluminum-plastic composite film, etc. Among them, aluminum-plastic composite film packaging not only has high barrier properties, but also can make drug packaging have a beautiful appearance, but the aluminum foil layer in the plastic composite film is prone to creases to a certain extent during the process of packaging, filling, heat sealing, transportation and sales, which makes the barrier property of the composite film worse, and the overall sealing of the finished product package is greatly affected.
In this article, by introducing the monitoring plan of the oxygen barrier property of the powder medicine aluminum-plastic composite film packaging, it is explained that the oxygen barrier property is an important factor affecting the quality of the drug shelf life. If the oxygen barrier property of the package is poor, the long-term circulation and storage of the product after leaving the factory will cause problems such as oxidative deterioration and reduced efficacy of the drug due to the excessive oxygen transmission rate of the package. Therefore, pharmaceutical companies should strengthen regular monitoring of the oxygen barrier properties of packaging.
Test Standards and Instruments
The chinese oxygen permeability test methods for composite film and sheet packaging include differential pressure method and coulomb counter method (isobaric method). Differential pressure method" and GB/T 19789 "Packaging material plastic film and sheet oxidative permeability test Coulomb meter detection method". The reference standard in this article is GB/T 1038.
This test uses the GTC-203H differential pressure gas permeameter independently developed and designed by Link Testing Instruments Co., Ltd.
Test principle: GTC-203H adopts the test principle of differential pressure method, and the pre-treated sample is placed between the upper and lower test chambers and clamped. First, vacuum the low-pressure chamber (lower chamber), and then evacuate the entire system; when the specified vacuum degree is reached, close the lower test chamber, fill the high-pressure chamber (upper chamber) with a certain pressure of test gas, and ensure that the A constant pressure difference (adjustable) is formed on both sides of the sample; in this way, the gas will infiltrate from the high pressure side to the low pressure side under the action of the pressure difference gradient. Item barrier parameter will be obtained.
Test samples and test procedures
Test sample: powder medicine aluminum-plastic composite film packaging provided by a pharmaceutical company.
(1) Use a sampler to cut out 3 pieces of samples with a size of Φ97 mm.
(2) Clamp 3 samples on the 3 test chambers of the equipment respectively.
(3) Set parameters such as sample name, sample thickness, test temperature, and test humidity.
(4) Start the vacuum pump, click the "Start Test" option, the test starts, and the instrument automatically calculates and displays the test results.
Test Results and Analysis
The oxygen transmission rates of the three samples tested this time are: 0.0942 cm3/(m2·24h·0.1MPa), 0.0728 cm3/(m2·24h·0.1MPa), 0.0584 cm3/(m2·24h·0.1MPa) .
GTC-203H Differential Pressure Gas Permeability Tester is a professional oxygen transmission rate tester used for the packaging of medicines, food, daily chemicals and other products. The equipment is simple to operate, has high test accuracy and good repeatability. The barrier properties of plastic composite film packaging to external oxygen. In addition, the inspection of key items such as the overall sealing performance and heat sealing strength of the packaging should also be strengthened.
For more details please visit www.linktesting.org