Oxygen Permeation Testing of Medical Packaging
Added: (Fri Apr 17 2020)
Pressbox (Press Release) -
Oxygen Permeation Testing of Medical Packaging
Abstract: some components of medical packaging are prone to deterioration when encountering oxygen. Therefore, this packaging should have effective oxygen barrier performance. In this paper, Labthink’sVAC-V2 Differential Pressure Gas Permeability Tester is used to test the barrier performance of aluminum-plastic composite film samples for medical packaging in relation to oxygen transmission rate. The test process, test principle, equipment parameters, etc. are described in detail. This can be used as a reference for organizations selecting oxygen permeability test equipment and methods.
Keywords: medicine, aluminum-plastic composite film, oxidation deterioration, oxygen transmission rate, oxygen permeability, barrier performance, gas permeability tester
Given the high safety standards for medical packaging, oxygen transmission rate is a key factor for quality control. Low oxygen permeability can effectively prevent the oxidation and deterioration of medicine and medical devices. The common packaging materials of powder medicine include plastic composite film, aluminum-plated composite film, and aluminum-plastic composite film. The aluminum-plastic composite film packaging generally has an effective barrier performance. However, the aluminum foil layer in the aluminum-plastic composite film can crease easily in the process of packaging, filling drugs, and heat sealing. The barrier effectiveness of the composite film might worsen because of these processes and the overall sealing property of the finished product packaging could be affected.
This paper introduces the quality control method for the oxygen resistance of the aluminum plastic composite film packaging and reinforces that oxygen resistance is an important factor affecting the shelf life quality of the medicine. If the oxygen resistance of the package is poor, the contents will oxidize quicker and the efficacy will be reduced during long-term storage.
Figure1Powder 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 Labthink Instruments Co., Ltd.
Figure2 VAC-V2 Differential Pressure Gas Permeability Tester
Test Principle:
VAV-V2 adopts the principle of differential pressure test method which 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 sideto 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 Results:
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:
The VAC-V2 Gas Permeability Tester, utilizing the differential pressure method, is effective in reflecting the oxygen barrier performance of powder medicine aluminum plastic composite membrane packaging.Labthink Instruments Co., Ltd, provides 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