Powder medicine aluminum-plastic composite film for external oxygen barrier detection
Abstract: Some components in pharmaceuticals are prone to oxidative deterioration due to oxygen, so pharmaceutical packaging should have good oxygen barrier properties. In this paper, Labthink VAC-V2 differential pressure gas permeation instrument is used to test the barrier properties of aluminum-plastic composite film samples for powder pharmaceutical packaging to external oxygen, and the test process, test principle and equipment parameters are detailed. It can be referred to through the performance test equipment and test methods.
Key words: pharmaceutical, aluminum-plastic composite film, oxidative deterioration, oxygen transmission performance, oxygen transmission rate, barrier property, gas permeation meter
1. Status
The safety of the drug itself is very important, so the performance requirements of its packaging materials are also high, especially the barrier properties of the package to the outside oxygen, and the lower oxygen transmission rate can effectively prevent the oxidative deterioration of the drug. The packaging materials of powder medicines are commonly used in plastic composite film, aluminum-plated composite film, aluminum-plastic composite film, etc. Among them, aluminum-plastic composite film packaging not only has high barrier performance, but also makes the pharmaceutical packaging have a beautiful appearance, but aluminum The aluminum foil layer in the plastic composite film is easy to have 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 greatly affected.
This paper introduces the monitoring scheme of oxygen barrier of aluminum-plastic composite film packaging of powder medicine, and explains that oxygen barrier performance is an important factor affecting the quality of drug shelf life. If the package has poor oxygen barrier properties, the product will have excessive oxygen transmission rate during the long-term circulation and storage process after leaving the factory, which may cause problems such as oxidative deterioration and lower drug efficacy. Therefore, pharmaceutical companies should strengthen the regular monitoring of the oxygen barrier properties of packaging.
Figure 1 Powder pharmaceutical aluminum-plastic composite film packaging
2, testing standards
The domestic oxygen permeability test methods for composite film and sheet packaging include differential pressure method and coulometric method (isostatic method). The reference method standards are GB/T 1038 "plastic film and sheet gas permeability test method". Differential Pressure Method and GB/T 19789 "Packaging Material Plastic Film and Sheet Oxidation Permeability Test Coulomb Test Method". The reference standard in this paper is GB/T 1038.
3, test samples
A powder medicine aluminum-plastic composite film package provided by a pharmaceutical company.
4, test equipment
Jinan Languang Electromechanical Technology Co., Ltd. independently developed the VAC-V2 differential pressure gas permeation instrument.
Figure 2 VAC-V2 differential pressure gas permeation meter
4.1 Test principle
The VAC-V2 adopts the differential pressure test principle, and the pre-treated sample is placed between the upper and lower test chambers and clamped. First, vacuum treatment is performed on the low pressure chamber (lower chamber), and then the whole system is evacuated; when the specified degree of vacuum is reached, the lower chamber of the test is closed, and the test gas of a certain pressure is filled into the high pressure chamber (upper chamber), and the test gas is ensured. A constant pressure difference (adjustable) is formed on both sides of the sample; thus, the gas will permeate from the high pressure side to the low pressure side under the action of the pressure difference gradient, and the pressure of the low pressure side is monitored and processed, thereby obtaining the test samples. Item barrier parameter.
4.2 Scope of application
(1) This equipment is suitable for testing the transmission rate of packaging gases such as plastic film, sheet, paper, cardboard and composite materials, cosmetic hose sheets and various rubber sheets.
Film type: gas permeability test of film materials such as various plastic film, plastic composite film, paper-plastic composite film, co-extruded film, aluminized film, aluminum foil, aluminum foil composite film, etc.
Sheet type: Gas permeability test of various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet, etc.
(2) This equipment is suitable for the permeability test of various gases, such as oxygen, carbon dioxide, nitrogen, air, helium, etc., as well as the barrier properties of various films for flammable and explosive gases.
(3) This equipment can meet a number of national and international standards, such as ISO 15105-1, ISO 2556, GB/T 1038, ASTM D1434, JIS K7126-1, YBB 00082003.
4.3 Equipment parameters
Test range: 0.05 ~ 50000 cm3 / m2 · 24h · 0.1MPa.
Number of samples: 3 pieces (data are independent)
Test temperature range: 5 ° C ~ 95 ° C, temperature control accuracy ± 0.1 ° C; test humidity range: 0% RH, 2% RH ~ 98.5% RH, 100% RH, temperature control accuracy ± 1% RH.
Support for testing of toxic gases and flammable and explosive gases (required restructuring).
Data fitting at any temperature can be performed to easily obtain test results under extreme conditions.
Support LystemTM laboratory data sharing system to manage test results and test reports.
5, the test process
(1) Cut 3 pieces of the Φ97 mm sample with a sampler.
(2) Three samples were clamped to the three test chambers of the device.
(3) Set the sample name, sample thickness, test temperature, test humidity and other parameters.
(4) Start the vacuum pump and click the “Start Test†option. The test starts and the instrument automatically calculates and displays the test results.
6, test results
The oxygen transmission rates of the three samples tested in this paper were: 0.0942 cm3/(m2·24h·0.1 MPa), 0.0728 cm3/(m2·24h·0.1 MPa), and 0.0584 cm3/(m2·24h·0.1 MPa).
7. Conclusion
VAC-V2 differential pressure gas permeation instrument is an oxygen transmission rate test instrument specially used for packaging of medicines, foods, daily chemicals and other products. The equipment is simple in operation, high in test accuracy and good in repeatability, and can reflect the powder medicine aluminum. Plastic composite film packaging barrier to external oxygen. In addition, we should strengthen the inspection of key items such as sealing performance and heat seal strength. Labthink has been committed to providing professional testing services and equipment to customers around the world. It has provided tens of thousands of times to customers around the world for many years. Oxygen barrier testing service. Learn more about the relevant instrumentation information, you can log in to view specific information. Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry.
Eyebrow Tools,Eyebrow Clip,Stainless Steel Eyebrow Clip,Fashion Eyebrow Clip
Yangjiang Etina Houseware Co., Ltd. , https://www.jmstjsrobot.com