Multi-layer co-extruded infusion bag for detecting nitrogen barrier performance

Abstract: In order to effectively reduce the oxygen content in the injection solution, some injection products use the nitrogen filling method, that is, to increase the nitrogen concentration in the infusion bag and reduce the internal oxygen concentration as much as possible so that the injection solution is in a low oxygen or anaerobic environment. This article uses the VAC-V2 differential pressure method gas permeability meter independently developed by Jinan Languang Electromechanical Technology Co., Ltd. to monitor the nitrogen barrier properties of multi-layer co-extruded infusion bags. Through the test principle and process of detailed test, how relevant the industry is Control medicinal soft plastic packaging barrier properties to provide reference.

Keywords: nitrogen barrier, nitrogen barrier, nitrogen permeability, nitrogen permeability, barrier properties, multi-layer co-extrusion, infusion bags, flexible plastic packaging, pharmaceuticals, injections, solutions, nitrogen filling, differential pressure method Differential Pressure Gas Permeameter

1 , the meaning

Infusion is a common disease treatment method. In the storage process of injection, if the storage is improper, there will be discoloration and precipitation of the liquid. The appearance of these phenomena and certain components in the liquid are easily oxidized. Big relationship. Some components of the liquid are sensitive to oxygen, such as vitamin C , metal ions, bromides, alcohols, aromatic amines, phenothiazines, etc., and are prone to oxidation reactions when they encounter oxygen, resulting in the color of the liquid. Changes occur, active ingredients change, and efficacy decreases. Therefore, lowering the oxygen content in the infusion bag when packaging and using the infusion bag with higher barrier property is an effective way to prevent the oxidation of the liquid medicine and maintain the efficacy of the liquid medicine.

In order to effectively reduce the oxygen content in the liquid, some injection products use a nitrogen filling method, that is, to increase the nitrogen concentration in the infusion bag and reduce the internal oxygen concentration as much as possible so that the injection is in a low oxygen or anaerobic environment. Therefore, in order to ensure that the nitrogen in the bag is not easy to dissipate and to maintain a high nitrogen and low oxygen environment, the infusion bag must have a high barrier to internal nitrogen, ie, the nitrogen gas transmission rate is low. This article uses the VAC-V2 differential pressure method gas permeability meter independently developed by Jinan Languang Electromechanical Co., Ltd. to test the nitrogen permeability rate of injection bags, and provides technical reference for pharmaceutical and other related industries by detailing the testing principle, steps and related technical standards.


Figure 1 nitrogen infusion bag

2 , testing standards

At present, the permeability test of soft plastic packaging nitrogen gas is only a principle method of differential pressure method. The corresponding differential pressure tester is to place the sample between the high and low pressure chambers, vacuum the low pressure chamber to the high pressure chamber. The nitrogen gas is filled with a certain pressure, and the nitrogen permeability of the sample is obtained by testing the change of the pressure in the low pressure chamber. This method has a wide measuring range and is suitable for the detection of low nitrogen gas permeability of high barrier materials.

At present, the national test method for nitrogen permeability ( 23 °C standard test environment) by the differential pressure method follows the national standard of GB 1038-2000 "Plastic film and sheet gas permeability test method differential pressure method".

3 , test sample

A multi-layer co-extruded infusion bag manufactured by a manufacturer is filled with nitrogen.

4 , test equipment

In this paper, Labthink blue light VAC-V2 pressure differential gas permeameter was used to test the permeability of the infusion bag sample to internal nitrogen.


Figure 2 VAC-V2 Differential Pressure Gas Permeameter

4.1 Test principle

This equipment is developed based on the design principle of differential pressure method. The test chamber of the device is divided into upper and lower two, the upper chamber is a high pressure chamber, the lower chamber is a low pressure chamber, and the sample is located between two test chambers. During the test, the sample is clamped between the two test chambers. First, the vacuum chamber is evacuated, and then the entire system is evacuated. When the specified vacuum degree is reached, the low pressure chamber is closed and a certain pressure is filled into the high pressure chamber. The test gas forms a constant pressure difference between the two test chambers ( that is, on both sides of the sample ) . Under the effect of pressure difference, the test gas will penetrate from the high-pressure chamber to the low-pressure chamber. Through the monitoring of the pressure inside the low-pressure chamber, Get the sample's barrier coefficient.

4.2 Scope of application

(1) This equipment is used to test the permeability, permeability coefficient, solubility coefficient, and diffusion coefficient of various inorganic gases at various temperatures.

Films: Film materials such as various plastic films, plastic composite films, paper-plastic composite films, co-extruded films, aluminized films, aluminum foils, and aluminum foil composite films. Sheets: 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 aerospace materials, paper and board, paint film, glass fiber cloth, fiberglass paper, cosmetics hose sheet, all kinds of rubber sheet and other materials permeability test.

(3) This equipment is suitable for testing the permeability of various gases, such as nitrogen, oxygen, carbon dioxide, helium, and air.

(4) The equipment meets a number of national and international standards such as ISO 15105-1 , ISO 2556 , GB/T 1038 , ASTM D1434 , JIS K7126-1 , YBB00082003 .

4.3 Equipment Parameters

The test range of the equipment is 0.05 ~ 50000 cm3/m2·24h·0.1MPa , and the vacuum resolution can reach 0.1 Pa . The device's temperature control range is 5 °C ~ 95 °C , temperature control accuracy is ± 0.1 °C ; humidity control range is 0%RH , 2%RH ~ 98.5%RH , 100%RH , humidity control accuracy of ± 1% RH , can Satisfy the test requirements under different test conditions of the sample. This device has three completely independent test chambers that can test three identical or different specimens at the same time. The device can be fitted with data at any temperature and easily obtain test results under extreme test conditions. After reforming, this device can also support the testing of toxic gases, flammable and explosive gases. The device provides a standard film for quick calibration to ensure the accuracy and versatility of the test data. This device supports the LystemTM laboratory data sharing system, which manages test results and test reports in a unified manner .

5 , the test process

The VAC-V2 is an automated tester. The test process is simple and easy to operate:

Connect the nitrogen gas source to the device port. Set the parameters, adjust the test temperature to 23 °C , and adjust the relative humidity to 0% RH . Open the device software, set the test parameters, and start the test. Test parameters include control parameters (test mode, upper chamber purge 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.


Figure 3 sample mounting process

6 , test results

Nitrogen permeation three samples (23 ℃, 0% RH) test results were 161.113 cm3 / m2 · 24h · 0.1MPa , 157.224 cm3 / m2 · 24h · 0.1MPa, 158.381 cm3 / m2 · 24h · 0.1MPa .

7. Conclusion

Nitrogen permeability is one of the important properties of a multi-layer co-extruded infusion bag in the form of a nitrogen-filled infusion bag. The longer the shelf life of an infusion bag with higher nitrogen barrier, the less susceptible it is to oxidative deterioration. The VAC-V2 pressure differential gas permeameter has high accuracy, repeatability, convenience, and high efficiency in testing nitrogen permeability of infusion bags and other flexible plastic packaging materials. At the same time, the instrument can also be used to test oxygen and carbon dioxide. Air permeability such as air. In addition to gas barrier properties, Labthink also provides testing equipment for the infusion bag's puncture force, puncture retention, and insertion point impermeability. Related test equipment can be found on the Jinan Languang website for specific information or Call for advice. Jinan Languang Electromechanical Technology Co., Ltd. is always committed to providing professional testing equipment and services to customers around the world. The more you understand, the more you trust! Labthink expects to enhance technology exchanges and cooperation with enterprises and institutions in the industry!

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