Monitoring method for oxygen resistance of plastic bottles for drug packaging

Abstract: the oxygen resistance performance of plastic packaging container is an important performance index, which has an important impact on the quality of drugs packaged inside In this paper, the Labthink Languang ox2 / 230 oxygen transmittance tester is used to measure the oxygen permeability of polypropylene plastic bottles for drug packaging The process, principle and parameters of the test are described, so as to provide a reference for enterprises in selecting the test methods or equipment for similar packaging materials Key words: plastic bottle, container, oxygen resistance, oxygen permeability, isobaric method, oxygen permeability tester, drug packaging 1 Significance Plastic bottle packaging is an important part of the pharmaceutical packaging market It has the advantages of light weight, high strength, not easy to be damaged, good sealing performance, moisture-proof and sanitation Compared with glass containers, it can be directly used for pharmaceutical packaging without cleaning and drying There are many specifications of pharmaceutical plastic bottles, ranging from dozens of ml to thousands of ML, with various colors, shapes and categories With the increase of drug types and strict requirements for use, pharmaceutical packaging plastic bottles are developing in the direction of functionality and intelligence Fig 1 common plastic bottles for pharmaceutical packaging in various forms are polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), etc., which are widely used in the packaging of oral solid drugs and oral liquid drugs, such as tablets, capsules, granules, syrups, etc The performance of plastic bottles for drug packaging with different materials and structures is quite different, and oxygen resistance is one of them When plastic bottles are used for packaging drugs, they should be selected reasonably according to the composition and storage requirements of the drugs For drugs containing easily oxidized components such as ferrous salts, alcohols, ethers, aromatic amines, pyrazolone and thiophenazine, the packaging materials should be required to have high oxygen resistance If the oxygen resistance of plastic bottles is low, that is, the oxygen transmission is high, these components are easy to be in the oxygen Under the action of oxidation, the medicine will change color and reduce its efficacy Therefore, the oxygen resistance of plastic bottles for packaging is one of the key performance indexes to be considered when selecting drug packaging materials 2 There are two test methods for oxygen transmission of standard packaging materials: differential pressure method and constant pressure method (coulometric method) The test method for oxygen transmission of packaging containers is coulometric method for test methods of package and container permeability (GB / T 31354-2014) 3 Test sample the test sample in this paper is a plastic bottle for a tablet drug packaging 4 The testing equipment used in this test is the ox2 / 230 oxygen transmittance tester independently developed and designed by Jinan Languang Electromechanical Technology Co., Ltd Figure 2 ox2 / 230 oxygen transmittance tester 4.1 equipment principle ox2 / 230 The oxygen transmittance tester uses the principle of isobaric method to measure the permeability of oxygen The pre-treated sample is clamped between the test chamber Oxygen or air flows on one side of the film, while high-purity nitrogen flows on the other side of the film Oxygen molecules diffuse through the film to the high-purity nitrogen on 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, while air or high-purity oxygen surrounds the outside of the container 4.2 scope of application container: it is applicable to the oxygen permeability test of bottles, bags, cans, boxes and barrels made of plastic, rubber, paper plastic composite, glass, metal and other materials, such as Coke bottles, peanut oil barrels, Tetra Pak packaging, vacuum packaging bags, metal three cans, plastic cosmetics packaging, toothpaste hoses, jelly cups, yogurt cups, etc Film type: it is applicable to the oxygen permeability test of various plastic cover film, plastic composite film, paper plastic composite film, coextrusion film, aluminum coating film, aluminum foil, aluminum plastic composite film and other film materials Sheet type: it is suitable for oxygen permeability test of sheet materials such as engineering plastics, rubber, building materials, etc., such as PP sheet, PVC sheet, PVDC sheet, etc Standards: it can meet GB / T 31354, ISO 15105-2, GB / T 19789, ASTM d3985, ASTM f2622, ASTM f1307, ASTM f1927, JIS k7126-2, ybb00082003 and other national and international standards 4.3 equipment parameters the test range of container type sample is 0.0001 ~ 60cm 3 / (PKG · d), the resolution is 0.00001 cm3 / (PKG · d); the test range of thin film type sample is 0.01 ~ 6500 cm3 / (M 2 · d), the resolution is 0.001 cm3 / (M2 · D) Three identical or different samples can be tested at the same time The system Zui can support parallel connection of 10 instruments and establish a system for simultaneous test of 30 samples The temperature control range is 15 ~ 55 ℃, and the temperature control accuracy is ± 0.1 ℃ The humidity control range is 0% RH, 35% RH ~ 90% RH, and the humidity control accuracy is ± 1% RH Wide range, high precision temperature and humidity control range, both sides of the sample can be humidified to achieve the test under different temperature and humidity conditions The professional pressure compensation technology ensures the high accuracy and repeatability of the test results It can be combined with the water vapor transmittance test system to form a hybrid test system, which is controlled by a computer to realize the 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 Test process 5.1 seal the test sample on the container sealing device with quick fix adhesive, then seal the sample together with the container sealing device in the sealed aluminum foil bag, and then clamp the processed sample on the equipment, so that the outside of the sample flows high-purity oxygen, and the inside of the sample flows high-purity nitrogen 5.2 set parameters to set test temperature, sample humidity and other test parameters, select the test mode, click the test option, and the test starts By adjusting the humidity and carrier gas flow, the humidity in the test chamber can reach the set value 5.3 after the end of the test, the equipment displays the test results of the samples After purging the pipeline, turn off the equipment 6 Test results the oxygen permeability of the plastic bottle for drug packaging tested in this test is 1.0269 cm 3 / (PKG · d) 7 conclusion In the process of storage and circulation of drugs, the oxygen penetration of plastic bottles used for packaging is closely related to the quality of drugs Choosing high barrier packaging materials is an effective and green way to prevent the oxidation and discoloration of drugs Therefore, in the process of screening packaging materials, entering the factory and quality evaluation before using packaging materials, the detection of oxygen resistance of packaging materials should be strengthened It is particularly important The ox2 / 230 oxygen permeability tester has the advantages of high efficiency, high precision, accuracy and repeatability in the detection of oxygen resistance of packaging containers Besides packaging containers, it can also be used for the detection of oxygen permeability of packaging films, sheets and other samples Jinan Languang mechanical and Electrical Technology Co., Ltd is a high-tech enterprise specializing in the research, development and production of packaging material testing equipment In addition to the oxygen permeability testing equipment, it can also provide users with gas barrier testing equipment such as water vapor transmission, nitrogen transmission, carbon dioxide transmission, sulfur hexafluoride transmission excess, etc., such as sealing, heat sealing strength, smoothness, flexibility and rubbing resistance Physical and mechanical performance testing equipment such as sexuality, and sanitary performance testing equipment such as evaporation residue and solvent residue For relevant testing equipment or testing services, you can log in Jinan Languang company to check or call for consultation The more you understand, the more you trust! Labthink is willing to enhance technical exchanges and cooperation with enterprises and institutions in the industry.