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Application of standard for medicinal glass bottles
- May 14, 2018 -

Various types of products, different materials to form a vertical and horizontal interwoven standardization system for all types of drugs to choose a scientific, reasonable and appropriate glass containers provide a sufficient basis and conditions.

The selection and application of medicinal glass bottles by different dosage forms, different kinds of drugs and different grades should follow the following principles:

Chemical stability

Good chemical stability principles Glass containers for all types of drugs should have good compatibility with drugs, that is, to ensure that in the production, storage and use of drugs can not be due to the chemical properties of glass containers unstable, the mutual chemical reaction between certain substances caused by the mutation or failure of drugs. For example, blood preparations, vaccines and other high-grade drugs must choose borosilicate glass material glass containers, all kinds of strong acid, strong alkali water needle preparation, especially strong alkali water injection should also choose borosilicate glass material glass containers. China's large number of low boron-silicon glass ampoules used in the preparation of water needle is not appropriate, this type of glass material to gradually to 5.

0 Glass material transition, as soon as possible in line with international standards to ensure that its products in the use of the drug is not off the film, not cloudy, not degenerate. For the general powder injection, oral agent and infusion and other drugs, the use of low borosilicate glass or neutral treatment of sodium-calcium glass can still meet its chemical stability requirements.

The degree of erosion of the glass is generally more liquid than solid, alkaline is greater than acid, especially the water injection of strong alkali to medicinal glass bottles of chemical performance requirements.

Anti-temperature and rapid degeneration

Good and suitable resistance to temperature and rapid degeneration Different dosage forms of drugs in the production of high-temperature drying, sterilization or low-temperature freeze-dry process, which requires a good glass container to resist the drastic changes in temperature and not burst the ability. The temperature-resistance of glass is mainly related to thermal expansion coefficient, the lower the coefficient of thermal expansion, the stronger the ability of resisting temperature change. For example, many high-grade vaccine preparations, biological agents and lyophilized preparations should generally choose 3. 3 Borosilicate glass or 5. 0 Borosilicate Glass. Domestic production of low borosilicate glass to withstand the drastic changes in temperature difference, often prone to burst, the bottle off the bottom and other phenomena. 3 of China. 3 Borosilicate Glass has a great development, this kind of glass is especially suitable for lyophilized preparation, because its resistance to temperature is better than 5. 0 Borosilicate Glass.