Monitoring scheme for nitrogen barrier of multi-layer co extrusion infusion bag

Abstract: in order to effectively reduce the oxygen content in the injection, some injection products adopt the method of filling nitrogen, that is, to increase the nitrogen concentration in the infusion bag, to reduce the internal oxygen concentration as much as possible, so that the injection is in a low oxygen or oxygen free environment In this paper, the vac-v2 differential pressure gas permeameter independently developed by Jinan Languang Electromechanical Technology Co., Ltd is used to monitor the nitrogen barrier of multi-layer co extrusion infusion bag The test principle and process are described in detail to provide a reference for the relevant industries on how to strictly control the barrier of pharmaceutical soft plastic packaging Key words: nitrogen barrier, nitrogen resistance, nitrogen permeability, nitrogen permeability, barrier, multi-layer co extrusion, infusion bag, soft plastic packaging, medicine, injection, drug solution, nitrogen filling, differential pressure method, differential pressure method gas permeameter 1, significance Infusion is a common way of disease treatment In the storage process of injection, if the storage is not proper, there will be discoloration, precipitation and other phenomena, which are closely related to the oxidation of some components in the solution 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 during packaging and select the infusion bag with high barrier to prevent the solution from oxidation and maintain the efficacy of the solution In order to effectively reduce the oxygen content in the solution, some injection products adopt the method of nitrogen filling, that is, to increase the nitrogen concentration in the infusion bag, to reduce the internal oxygen concentration as much as possible, so that the injection is in a low oxygen or oxygen free environment Therefore, in order to ensure that the nitrogen in the bag is not easy to lose and maintain the environment of high nitrogen and low oxygen, the infusion bag must have a high barrier to the internal nitrogen, that is, the nitrogen permeability is low In this paper, the vac-v2 differential pressure gas permeameter independently developed by Jinan Languang mechanical and Electrical Co., Ltd is used to test the nitrogen permeability of the injection bag The test principle, steps and relevant technical standards are described in detail to provide technical reference for the pharmaceutical industry and other related industries Fig 1 nitrogen filled infusion bag 2 At present, there is only a principle method of differential pressure method in the barrier test of nitrogen in soft plastic packaging The corresponding differential pressure method tester is to place the sample between the high and low pressure chambers, vacuumize the low pressure chamber, and fill a certain pressure of nitrogen into the high pressure chamber Through the measurement of the pressure change in the low pressure chamber, the nitrogen transmittance of the sample is obtained This method has a wide measurement range and is suitable for the detection of high barrier materials and low nitrogen transmittance At present, the test of nitrogen transmittance (standard test environment at 23 ℃) by differential pressure method in China complies with the national standard of GB 1038-2000 test methods for gas permeability of plastic films and sheets - differential pressure method 3 The nitrogen filled packaging of multi-layer coextrusion infusion bag produced by a manufacturer was tested 4 This paper uses Labthink blue light vac-v2 differential pressure gas permeation instrument to test the permeability of the infusion bag sample to the internal nitrogen 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 the transmittance, permeability coefficient, solubility coefficient and diffusion coefficient of various inorganic gases under various temperatures of various films and sheet samples 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 nitrogen, oxygen, carbon dioxide, 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 Vac-v2 is an automatic test instrument in the test process, which is convenient and easy to operate: connect the nitrogen gas source to the equipment port Set parameters, adjust the test temperature to 23 ℃, and adjust the relative humidity to 0% RH Open the equipment software, set the test parameters and start the test Test parameters include control parameters (test mode, upper chamber purging time, upper chamber pressure, test time, degassing time, etc.) and sample parameters (number, type, area, thickness, etc.) End of test, data processing Turn off the air supply and power supply Fig 3 sample clamping process 6 Test results the test results of nitrogen transmittance (23 ℃, 0% RH) of three samples are 161.113 cm 3 / M 2 · 24h · 0.1MPa, 157.224 cm 3 / m2 · 24h · 0.1MPa, 158.381 cm 3 / m2 · 24h · 0.1MPa, respectively 7 Conclusion nitrogen permeability is one of the important properties of multi-layer co extrusion infusion bag with nitrogen filling form The longer the shelf life of infusion bag with higher nitrogen resistance is, the less likely it is to be oxidized The vac-v2 pressure difference gas permeameter has the characteristics of high degree, good repeatability and convenience in testing the nitrogen permeability of infusion bag, and it can also be used to test the gas permeability of oxygen, carbon dioxide and air In addition to gas barrier, Labthink Languang can also provide testing equipment for the puncture force of infusion bag, the retention of puncture device and the impermeability of insertion point For relevant testing equipment, you can log in Jinan Languang company to check specific information or call for consultation Jinan Languang mechanical and Electrical Technology Co., Ltd has always been committed to providing professional 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