NIE Lei, FAN Xu. Test and Study on Inner Surface Tolerance of Drug Packaging Materials for Glass Injection[J]. Analysis and Testing Technology and Instruments, 2022, 28(2): 210-221. DOI: 10.16495/j.1006-3757.2022.02.016
Citation: NIE Lei, FAN Xu. Test and Study on Inner Surface Tolerance of Drug Packaging Materials for Glass Injection[J]. Analysis and Testing Technology and Instruments, 2022, 28(2): 210-221. DOI: 10.16495/j.1006-3757.2022.02.016

Test and Study on Inner Surface Tolerance of Drug Packaging Materials for Glass Injection

  • In order to screen out a fast and effective method for the detection of glass flake, a test method for the tolerance of the inner surface of glass has been initially established for the reference of drug research and development personnel. Visual inspection, methylene blue staining test, insoluble particles, scanning electron microscope and ion detection were used to investigate the inner surface tolerance of drug packaging materials for glass injection from different angles. The inner surface tolerance of glass ampoules was stronger than that of glass injection bottles, the inner surface tolerance of medium borosilicate glass ampoules was better than that of low borosilicate glass ampoules, and the inner surface tolerance of sodium calcium glass infusion bottles was the worst. The corrosion ability of NaOH solution to glass containers was much stronger than the other four corrosion solutions, and the higher the concentration of NaOH, the stronger the corrosion ability. Five different detection methods were used for the investigation. From the different angles, it was found that the shape and material of glass, the property, concentration and time of the corrosion solution affected the tolerance of the inner surface of glass. The five methods have their own advantages and disadvantages, which can be used for reference and selection by drug developers when screening glass packaging materials in the early stage of drug development.
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