Oxygen Permeation Test of aluminum plastic composited medicine packaging

Abstract: some components of medicine are prone to oxidation deterioration when encountering oxygen, so medicine packaging should have good oxygen barrier performance. In this paper, Labthink VAC-V2 Differential Pressure Gas Permeability Tester is used to test the barrier performance of aluminum-plastic composite film samples for powder medicine packaging to oxygen. The test process, test principle, equipment parameters and other contents are described in detail, which can be used as a reference for enterprises in selecting oxygen permeability test equipment and test methods.

Keywords: medicine, aluminum-plastic composite film, oxidation deterioration, oxygen transmission rate, oxygen permeability, barrier performance, gas permeability tester

The safety of medicine itself is important, therefore the performance requirements of the packaging materials are also high, especially the barrier performance of the packaging to oxygen. The low oxygen permeability can effectively prevent the oxidation and deterioration of medicine. The common packaging materials of powder medicine are plastic composite film, aluminum-plated composite film, aluminum-plastic composite film, among which the aluminum-plastic composite film packaging not only has high barrier performance, but also have good appearance as the medicine package, but the aluminum foil layer in the aluminum-plastic composite film is easy to have a certain degree of crease in the process of packaging, filling drugs, heat sealing, transportation and sales, the barrier property of the composite film might be worsen because of these processes, and the overall sealing property of the finished product packaging would greatly affected.

This paper introduces the quality control method of the oxygen resistance of the powder medicine aluminum plastic composite film packaging, and expounds that the oxygen resistance is an important factor affecting the shelf life quality of the medicine. If the package is poor in oxygen resistance, the product will be oxidized and deteriorated and the efficacy will be reduced during the long-term circulation and storage. Therefore, pharmaceutical enterprises should strengthen the regular quality control of the oxygen barrier performance of packaging.

Figure1 Powder medicine aluminum-plastic composite film packaging

The domestic test methods for oxygen permeability of composite film and sheet packaging are differential pressure method and coulometer method (isobaric method). The reference method standards are ISO 2556 – Plastics — Determination of the gas transmission rate of films and thin sheets under atmospheric pressure — Manometric method and Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting Using a Coulometric sensor. This paper uses the method in ISO 2556.

Sample

Aluminum plastic composite film packaging for powder medicine provided by a pharmaceutical enterprise.

Test Instrument

VAC-V2 Differential Pressure Gas Permeability Tester independently developed and designed by Jinan Labthink Instruments Co., Ltd.

Figure2 VAC-V2 Differential Pressure Gas Permeability Tester

Test principle

VAV-V2 adopts the principle of differential pressure test method, places the pre-treated sample between the upper and lower test chambers and clamps it. First, vacuum the low-pressure chamber (lower chamber), and then vacuum the whole system; when the specified vacuum degree is reached, close the lower chamber for testing, fill the high-pressure chamber (upper chamber) with a certain pressure of test gas, and ensure that a constant pressure difference (adjustable) is formed on both sides of the sample; in this way, the gas will permeate from the high-pressure side to the low-pressure side under the effect of the pressure difference. Monitor the pressure of the low pressure side, so as to obtain the barrier parameters of the tested sample.

Test Procedure

(1) Cut 3 specimens of Φ 97 mm from the samples.

(2) 3 test specimens are clamped on three test chambers of the equipment.

(3) Set the sample name, sample thickness, test temperature, test humidity and other parameters.

(4) Start the vacuum pump, click the “start test” option, the test starts, and the instrument automatically calculates and displays the test results.

Test result

The oxygen transmission rate of the three samples were 0.0942 cm³/(m²·24h·0.1MPa), 0.0728 cm³/(m²·24h·0.1MPa) and 0.0584 cm³/(m²·24h·0.1MPa).

Conclusion

VAC-V2 Differential Pressure gas Permeability Tester is specialized in the packaging of medicine, food, daily chemical products and other products. It has the advantages of simple operation, high testing accuracy and good repeatability, and can reflect the oxygen barrier performance of powder medicine aluminum plastic composite membrane packaging. In addition, we should also strengthen the inspection of key items such as the overall sealing performance and heat sealing strength of the package

Jinan Labthink Instruments Co., Ltd, is dedicated to providing customers with packaging testing solutions and helping the manufacturers to reach their goals of quality and safety assurance through improvement of packaging testing techniques and development of high-end packaging testing instruments. For more information please visit www.labthink.com