The method of verifying the barrier performance of medical plastic ampoules to external oxygen

Abstract: there are some easily oxidized components in medicine, so it is required that medical packaging should have high oxygen resistance In this paper, Jinan Languang ox2 / 230 oxygen permeability test system is used to test the external oxygen barrier performance of medical plastic ampoules, and the basic process of the test, the scope of application of the test equipment, equipment parameters and other contents are introduced, which can be used as a reference for enterprises in selecting oxygen permeability test equipment and test methods Key words: medicine packaging, medicine, plastic ampoule bottle, oxygen resistance, oxygen permeability, oxygen permeability test system 1 Meaning ampoule bottle is a small container used to contain injection solution or oral liquid, with a capacity of 1 ~ 25ml However, because glass ampoules are difficult for consumers to open and are prone to accidents, many pharmaceutical industries now use plastic ampoules, which are not only easy to use but also easy to open If the oxygen resistance of plastic ampoules is low, that is to say, the oxygen permeation is high, some components of drugs are easy to be oxidized under the action of oxygen, resulting in the discoloration of drugs and the decrease of drug efficacy Therefore, the oxygen resistance of plastic ampoules is one of the key performance indexes that should be considered when drug manufacturers select drug packaging materials Drug manufacturers should strengthen the monitoring of oxygen permeability of plastic ampoules Fig 1 ampoules for medical plastics 2 The test method for oxygen permeability of packaging containers in China is coulometer test method GB / T 31354-2014 test method for oxygen permeability of packages and containers coulometer test method was established in 2015 Since, it has stipulated the test method for oxygen permeability of packages and containers under steady-state conditions and the test method for oxygen permeability of plastic and composite packages and containers with a volume of less than 2L in dry environment 3 Test sample a plastic ampoule bottle provided by an enterprise 4 Test equipment: ox2 / 230 oxygen transmittance test system independently developed and designed by Jinan Languang Electromechanical Technology Co., Ltd Fig 2 ox2 / 230 oxygen transmittance test system 4.1 test principle ox2 / 230 uses the isobaric test principle (i.e Coulometric test principle) to clamp the pre-treated sample between the test chambers Oxygen or air flows on one side of the film and high-purity nitrogen flows on the other side of the film Oxygen molecules diffuse through the film to high-purity nitrogen in the other side and are carried to the sensor by the flowing nitrogen Through the analysis of the oxygen concentration measured by the sensor, parameters such as oxygen transmittance can be calculated For packaging containers, high-purity nitrogen flows in the container, and air or high-purity oxygen surrounds the outside of the container 4.2 scope of application (1) this equipment is applicable to the oxygen permeability test of containers, plastic films, sheets, paper, cardboard and composite materials Containers include bottles, bags, cans, boxes and barrels made of plastic, rubber, paper, paper plastic composite, glass, metal and other materials, such as Coke bottles, peanut oil barrels, Tetra Pak packaging, vacuum packaging bags, metal three piece cans, plastic cosmetics packaging, toothpaste hoses, jelly cups, yogurt cups, etc Film materials include various plastic film, plastic composite film, paper plastic composite film, coextrusion film, aluminum coating film, aluminum foil, aluminum foil composite film and other film-like materials Sheet materials include various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet, etc In addition, the special fixture of the equipment can also be used for the oxygen transmittance test of special packaging such as medical packaging, automobile fuel tank, battery plastic shell, plastic pipe, solar panel, etc (2) This equipment can meet many national and international standards, such as GB / T 31354, ISO 15105-2, GB / T 19789, ASTM d3985, ASTM f2622, ASTM f1307, ASTM f1927, JIS k7126-2, YBB 00082003 4.3 test range of equipment parameters: film test 0.01 ~ 6500 cm 3 / (M 2 · d), container test 0.0001 ~ 60 cm3 / PKG · D Number of samples: three identical or different samples can be tested at the same time Resolution: film 0.001 g / M 2 · 24 hours, container 0.00001 g / PKG · D Test temperature range: 15 ℃ ~ 55 ℃, temperature control accuracy ± 0.1 ℃ Test gas: O2, air (supplied by the user) The system Zui can support parallel connection of 10 instruments and establish a system for simultaneous test of 30 samples It can be combined with the water vapor transmittance test system to form a hybrid test system, which is controlled by a computer It can realize a convenient test mode of simultaneous measurement of oxygen and water vapor transmittance Support Lystem TM laboratory data sharing system, and manage test results and test reports in a unified way 5 The test process (1) fix the pinhole in the middle of the plastic tube on the special device of the test vessel with fast fixing adhesive, after sealing, connect it to the instrument, and then seal and bind the sample and the special device with sealing bag (2) Set the sample name, test temperature, test humidity and other parameters (3) Click the "start test" option (4) Start the air source, adjust the humidity and carrier gas flow (5) After the test, the instrument automatically calculates and displays the test results 6 The results showed that the oxygen permeability of the plastic ampoule was 0.1825 cm 3 / PKG · D 7 Conclusion the barrier performance of plastic ampoules is an important factor affecting the composition and color of drugs, especially the barrier performance of external oxygen The higher the barrier performance is, the smaller the oxygen permeability is, the longer the shelf life of drugs is Ox2 / 230 oxygen transmittance test system is a professional oxygen transmittance test instrument for film test and container test It has the advantages of simple operation, high test accuracy and high repeatability Jinan Languang has been committed to providing professional equipment and testing services for customers all over the world, and providing customers with a large number of references for packaging material performance data Languang is looking forward to technical exchanges and cooperation with users in various industries.