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Control Measures for Chemical Performance of Tubular Glass vial

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[Abstract]:
Control Measures for Chemical Performance of Tubular Glass vial

Control Measures for Chemical Performance of Tubular Glass vial

 

    Tubular glass vials are the main inner packaging containers used in small doses (2 ml to 30 ml) of medicine in the world. Tubular glass vials are made by the glass tube after the flame processing, the main process has a burning mouth, burning bottom, annealing, inspection, packaging and so on.

    In the field of medicine, the chemical properties of tubular glass vials is an important factor in testing the quality level of glass vials. The chemical properties of regulated glass vials include particle water resistance, water resistance of the inner surface, acid resistance and alkali resistance. The specific requirements of these chemical performance indicators can be found in the Chinese standard document "YBB00292005-2-2015" or the ISO International Standards Organization "ISO8362-1".

   

    Taian Youlyy Industrial Co., Ltd has been continuously researching and improving various chemical properties of tubular glass vials. At present, it is mainly guaranteed by the following measures:

    1. The chemical properties of the glass tube itself directly determine the chemical properties of the controlled glass vial. Pharmaceutical glass tube scored as: soda-lime glass tube, low borosilicate glass tube, neutral borosilicate glass tube, high borosilicate glass tube. These glass tubes are classified according to the content of boron trioxide (B2O3), an important manufacturing component of the glass tube, and the content of boron trioxide determines the chemical properties of the glass tube. Within a certain range, the higher the content of boron dioxide, the better the chemical properties of the glass tube. However, after the content of boron trioxide reached a certain value (about 11.5%), the chemical properties of the glass tube decreased.

     

    The content of B2O3 in soda-lime glass tubes is generally below 4%, and the chemical properties of soda-lime glass tubes are the worst among all medical glass tubes.

    The content of B2O3 in low borosilicate glass tubes is generally between 5% and 7%, and its chemical properties are better than soda-lime glass tubes.

 

    The B2O3 content of the neutral borosilicate glass tube is generally between 8% and 11%, and its chemical properties are the best.

    The B2O3 content of high borosilicate glass tubes is generally between 12% and 14%, and its chemical properties are worse than that of neutral borosilicate glass tubes.

 

    If the situation request the chemical performance of tubular glass vials is very high (for high-risk drugs, high-required chemical reagents, etc.), neutral borosilicate glass tubes are the best choice, which can meet the requirements of pharmacopoeias of various countries for glass containers.

    If the situation has requirement for the chemical properties of tubular glass vials, but when they are applied to non-high-risk drugs and can meet the corresponding pharmacopoeia requirements, low-borosilicate glass tubes can be selected.

 

    2. Under the same glass tube conditions, the production process control of tubular glass vials is the main factor to ensure and improve the chemical performance of regulated glass vials. Different production processes determine the specific chemical performance indicators of tubular glass vials.

    During the firing process of the tubular glass vial, the glass temperature at the bottom and the mouth of the vial exceeds 700 degrees Celsius (the critical value of the softening temperature of medical glass). At this high temperature, alkaline substances are precipitated on the surface of the glass. These alkaline substances have relatively high activity, which reduce the chemical stability of the glass vial. In order to reduce the precipitation of alkaline substances, Taian Youlyy Industrial Co., Ltd strives to control the following process details:

 

    When firing a glass tube, the glass must be softened to make the mouth and bottom of the vial. If the temperature is too low, it cannot be formed. If the temperature is too high, more alkaline substances will be precipitated. To quantify and control the softening temperature and time of the glass tube, to maintain a lower temperature and a shorter time for the tubular glass vial to form, it can ensure that less alkaline substances are deposited on the glass surface.

    During the production process of tubular glass vials, it is inevitable that alkaline substances will precipitate on the glass surface. These alkaline substances will be fixed on the glass surface after the glass vial is annealed at high temperature (between 520 degrees Celsius and 600 degrees Celsius), and it is difficult to remove them. Therefore, cleaning some alkaline substances before the glass vial is annealed can improve the chemical stability of the glass vial.

 

    During the annealing process of tubular glass vials, the annealing temperature, heating time, holding time, and cooling time will affect the surface structure and surface precipitates of the glass.

    Taian Youlyy Industrial Co., Ltd summarizes years of production experience, quantifies various data, and controls the annealing process of glass vials within a reasonable temperature and a reasonable time range, thereby maximizing the chemical stability of the tubular glass vials .

 

    The improvement and perfection of technology is endless. Taian Youlyy Industrial Co., Ltd focuses on the production and development of tubular glass vials, focuses on improving the chemical stability of regulated glass vials, and strives to provide customers with high quality tubular glass vials.