Solution to the detection of oxygen resistance of infusion bag packaging

Abstract: some components in the solution are sensitive to oxygen, easy to be oxidized and affect the efficacy Taking the three-layer coextrusion infusion bag as an example, this paper uses the vac-v2 differential pressure gas permeameter independently developed by Jinan Languang Electromechanical Technology Co., Ltd to test its oxygen permeability, and briefly introduces the test principle, equipment parameters and other information of the equipment, describes the basic process of the test, and provides a reference for enterprises to solve the problem of how to control the oxygen resistance of pharmaceutical soft plastic packaging Key words: oxygen resistance, oxygen permeability, infusion bag, medical packaging, oxygen permeability tester, oxygenation 1, meaning infusion are common disease treatment methods In the storage process of injection, if the storage is improper, the liquid will change color and precipitate, which is closely related to the oxidation of some components in the liquid Some components in the liquid medicine are sensitive to oxygen, such as vitamin C, metal ions, bromides, alcohols, aromatic amines, phenothiazines, etc when encountering oxygen, they are prone to oxidation reaction, resulting in changes in the color of the liquid medicine, changes in the effective components, and reduced efficacy Therefore, it is an effective way to reduce the oxygen content in the infusion bag and select the infusion bag with high oxygen resistance to prevent the solution from oxidation and maintain the efficacy of the solution Fig 1 infusion bag 2 At present, the reference standards for oxygen permeability of medical packaging mainly include GB / T 1038-2000 test methods for gas permeability of plastic film and sheet - differential pressure method and ybb00082003 test method for gas permeability Among them, the reference standard for oxygen transmission of infusion bag is ybb00082003 gas transmission measurement method, which stipulates two detection methods, i.e equal pressure method and differential pressure method In this paper, the differential pressure method is used for the test 3 The test sample is a three-layer co extrusion infusion bag produced by a manufacturer 4 In this paper, we use Labthink blue light vac-v2 differential pressure gas osmometer to test the oxygen permeability of infusion bag samples Fig 2 4.1 test principle of vac-v2 pressure difference gas permeameter this equipment is developed based on the design principle of pressure difference method The test chamber of the equipment is divided into upper chamber and lower chamber The upper chamber is high pressure chamber and the lower chamber is low pressure chamber The sample is located between the two test chambers During the test, place the sample between two test chambers and clamp it First vacuum the low-pressure chamber, and then vacuum the whole system When the specified vacuum degree is reached, the low-pressure chamber is closed, and a certain pressure of test gas is filled into the high-pressure chamber to make the two test chambers (i.e two sides of the sample) Under the action of pressure difference, the test gas will permeate from the high pressure chamber to the low pressure chamber By monitoring the pressure in the low pressure chamber, the barrier coefficient of the sample is obtained 4.2 scope of application (1) this equipment is mainly used for testing gas transmittance, permeability coefficient, solubility coefficient and diffusion coefficient of various film and sheet samples at various temperatures Film type: such as all kinds of 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: such as various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet (2) The equipment can also be extended to the air permeability test of aerospace materials, paper and cardboard, paint film, fiberglass cloth, fiberglass paper, cosmetic hose sheet, various rubber sheets and other materials (3) This equipment is suitable for the transmittance test of various gases, such as oxygen, carbon dioxide, nitrogen, helium, air, etc (4) This equipment meets many national and international standards, such as ISO 15105-1, ISO 2556, GB / T 1038, ASTM d1434, JIS k7126-1, ybb00082003 4.3 test range of equipment parameter equipment is 0.05 ~ 50000 cm 3 / M 2 · 24 h · 0.1MPa, and vacuum resolution can reach 0.1pA The temperature control range of the equipment is 5 ℃ ~ 95 ℃, and the temperature control accuracy is ± 0.1 ℃; the humidity control range is 0% RH, 2% RH ~ 98.5% RH, 100% RH, and the humidity control accuracy is ± 1% RH, which can meet the test requirements under different test conditions The equipment has three completely independent test chambers, which can test three identical or different samples at the same time The equipment can be used for data fitting at any temperature, and the test results under extreme test conditions can be easily obtained After reform, the equipment can also support the testing of toxic gas, flammable and explosive gas This equipment provides standard membrane for rapid calibration to ensure the accuracy and universality of test data This equipment supports Lystem TM laboratory data sharing system, and manages test results and test reports in a unified way 5 During the test (1) three pieces of 97 mm diameter sample were cut from the surface of the infusion bag with a sample cutter (2) Apply a layer of vacuum grease evenly around the three sample cavities of the equipment Pay attention that the vacuum grease cannot contaminate the test area, and then place a filter paper with a diameter of 65 mm in the test area (3) Clamp 3 pieces of samples to 3 test chambers respectively Fig 3 sample clamping process (4) set the test temperature, humidity, sample thickness and other parameter information, open the vacuum pump, water bath temperature control device, click the start test option to start the test (5) The instrument automatically calculates the test results according to the monitoring of the pressure in the low-pressure chamber 6 Test results considering the humidity of the storage environment of the infusion bag is large, the test conditions for the oxygen transmission of the infusion bag are 23 ℃ and 50% RH The results of oxygen permeability of the three samples were 855.465 cm 3 / M 2 · 24h · 0.1MPa, 861.379 cm3 / m2 · 24h · 0.1MPa and 859.619 cm3 / m2 · 24h · 0.1MPa, respectively 7 Conclusion oxygen permeation is an important performance index of infusion bag, and its value is very important to the quality of medicine Vac-v2 differential pressure gas permeameter has the advantages of accurate test results, high measurement accuracy and high automation of the equipment in the measurement of oxygen permeability At the same time, the equipment can also be used in the measurement of air, nitrogen, carbon dioxide, helium and other gas permeability, with a wide range of applications In addition to oxygen permeability, it is also necessary to test the water vapor permeability, puncture force, retention of puncture device and impermeability of insertion point of infusion bag For relevant test equipment, you can visit Languang company or call for consultation Jinan Languang mechanical and Electrical Technology Co., Ltd has always been committed to providing professional testing equipment and services for customers around the world The more we understand, the more we trust! 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