Monitoring method for oxygen barrier performance of plastic bottles for pharmaceutical packaging

Abstract: The oxygen barrier properties of pharmaceutical plastic packaging containers are an important performance indicator and have an important impact on the quality of the drugs packaged inside. In this paper, Labthink OX2 / 230 Oxygen permeability tester to test equipment, the test drug packaging oxygen permeation amount polypropylene plastic bottles, and the test process, test principle, device parameters and other information has been described, so that It provides a reference for enterprises to use oxygen barrier performance testing methods or test equipment for similar packaging materials.

Keywords: plastic bottles, containers, oxygen barrier, oxygen permeation, isobaric pressure, oxygen transmission rate tester, pharmaceutical 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 break, good sealing performance, moisture resistance, sanitation, etc. Compared with glass containers, it can be used directly without cleaning or drying. Packaging of medicines. There are many specifications for medicinal plastic bottles, ranging from a few dozen milliliters to as large as a thousand milliliters, various colors, different shapes, and a wide variety of products. With the increasing variety of drugs and strict requirements for use, pharmaceutical packaging plastic bottles are functioning. The direction of development and intelligence.

Figure 1 various forms of medicinal plastic bottles

Common plastic bottles for pharmaceutical packaging are made of polyethylene (PE) , polypropylene (PP) , and polyethylene terephthalate (PET) . They are widely used in the packaging of oral solid medicines and oral liquid medicines. Tablets, capsules, granules, syrups, and the like. The performance of plastic bottles for pharmaceutical packaging with different material structures is quite different, and oxygen barrier is one of them. Plastic bottles should be reasonably selected according to the composition and storage requirements of the drug when used for packaging medicines, such as oxidized components containing ferrous salts, alcohols, ethers, aromatic amines, pyrazolones, phenothiazines, etc. The drug should require the packaging material to have a high oxygen barrier property. If the oxygen barrier of the plastic bottle is low, that is, the oxygen permeation amount is high, these components are easily oxidized under the action of oxygen, resulting in discoloration of the drug and efficacy. reduce. Therefore, the oxygen barrier property of plastic bottles for packaging is one of the performance indicators that should be considered when selecting pharmaceutical packaging materials.

2. Standard

There are two methods for detecting oxygen permeation of packaging materials: differential pressure method and isobaric method ( Cullen coulometric method ) . The method for detecting the oxygen permeation of packaging containers is GB/T 31354-2014 "Packaging and container permeability test method Coulomb" Measurement method.

3. Test sample

The sample sample tested in this paper is a plastic bottle for packaging a tablet drug.

4. Test equipment

The testing equipment used in this test is the independent research and development design of OX2/230 oxygen transmission rate tester by Jinan Languang Electromechanical Technology Co., Ltd.

Figure 2 OX2/230 oxygen transmission rate tester

4.1 Equipment Principle

The OX2/230 oxygen transmission rate tester uses the isostatic test principle to clamp pre-treated samples between test chambers. Oxygen or air flows on one side of the membrane. High-purity nitrogen is on the other side of the membrane. Flowing, oxygen molecules diffuse through the membrane to the other side of the high purity nitrogen and are carried to the sensor by the flowing nitrogen. By analyzing the oxygen concentration measured by the sensor, parameters such as oxygen transmission rate are calculated. For packaging containers, high purity nitrogen flows through the container, and air or high purity oxygen surrounds the outside of the container.

4.2 Scope of application

  • Containers: Suitable for oxygen transmission rate testing of bottles, bags, cans, boxes and barrels made of plastic, rubber, paper, paper-plastic composite, glass, metal, etc., such as Coke bottles, peanut oil barrels, Tetra Pak, Vacuum packaging bags, metal cans, plastic cosmetic packaging, toothpaste hoses, jelly cups, yogurt cups, etc.
  • Film type: It is suitable for oxygen transmission rate test of film materials such as plastic cover film, plastic composite film, paper-plastic composite film, co-extruded film, aluminized film, aluminum foil, aluminum-plastic composite film.
  • Sheet type: It is suitable for oxygen transmission rate test of sheet materials such as PP , PVC sheet and PVDC sheet.
  • Standard: meet the GB / T 31354, a number of national and international standards ISO 15105-2, GB / T 19789, ASTM D3985, ASTM F2622, ASTM F1307, ASTM F1927, JIS K7126-2, YBB00082003 like.

4.3 Equipment parameters

  • The test range of the container sample is 0.0001 ~ 60 cm 3 / (pkg · d) , the resolution is 0.00001 cm 3 / (pkg · d) ; the test range of the film sample is 0.01 ~ 6500 cm 3 / (m 2 · d) with a resolution of 0.001 cm 3 /(m 2 ·d) .
  • Three identical or different samples can be tested at the same time . The system can support parallel connection of 10 instruments and establish an efficient system for simultaneous testing of 30 samples.
  • The test temperature control range is 15 ~ 55 °C , and the temperature control accuracy is ±0.1 °C.
  • The test 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.
  • Professional pressure compensation technology guarantees high precision and repeatability of test results.
  • It can be combined with the water vapor transmission rate test system to form a hybrid test system, which is controlled by a computer to achieve simultaneous oxygen and water vapor transmission rate testing.
  • Support Lystem TM laboratory data sharing system to manage test results and test reports.

5. Test process

5.1 loading

The test sample is sealed on the container sealing device with quick-setting glue, and then the sample is sealed together with the container sealing device in a sealed aluminum foil bag, and the processed sample is clamped to the device, so that the outside of the sample flows with high purity. Oxygen, the inside of the sample flows with high purity nitrogen.

5.2 Setting parameters

Set the test parameters such as test temperature and sample humidity, select the test mode, click the test option, and the test starts. The humidity in the test chamber is brought to a set value by adjusting the humidity and the carrier gas flow rate.

5.3 End of test

After the test is over, the device displays the test results for the sample. After purging the tubing, turn off the device.

6. Test results

The oxygen permeability of the plastic bottle sample for drug packaging tested in this test was 1.0269 cm 3 /(pkg·d) .

7. Conclusion

In the process of storing and distributing medicines, the oxygen permeation of the plastic bottles used in packaging is closely related to the quality of the medicines. The use of high-barrier packaging materials is an effective and green way to prevent oxidation and discoloration of the medicines, so whether it is in the screening package. It is especially important to strengthen the detection of oxygen barrier properties of the packaging materials during the quality evaluation process before the packaging materials are put into the factory and the packaging materials are used. The OX2/230 Oxygen Permeability Tester has the advantages of high test efficiency, high precision of test results, accuracy and repeatability in detecting the oxygen barrier properties of packaging containers. It can also be used for packaging films and sheets in addition to packaging containers. The oxygen permeation amount of the sample is detected. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in the R&D and production of packaging materials testing equipment. In addition to oxygen permeation detection equipment, it can also provide users with water vapor transmission, nitrogen permeation, carbon dioxide transmission, and six. Gas barrier testing equipment such as sulfur fluoride permeability, physical and mechanical properties testing equipment such as sealing property, heat seal strength, smoothness, flexibility, and stagnation resistance, and hygienic performance testing equipment such as evaporation residue and solvent residue, etc. For testing equipment or testing services, you can visit Jinan Languang Company or call us . The more you understand, the more you trust! Labthink is willing to promote technical exchanges and cooperation with enterprises and institutions in the industry.

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