The impact of ampoule glass material on the quality of injectables.
Release time:
2025-01-03
The packaging process of injectables requires high-temperature sterilization, and the injectables must undergo long-term storage.
The packaging process of injectables requires high-temperature sterilization, and the injectables must undergo long-term storage. The ampoules containing the injectable solution come into direct contact with different types of drug solutions, which can mutually affect each other, leading to changes in pH, precipitation, discoloration, and flaking, all of which can impact the quality of the injectables. Therefore, it is necessary to understand the composition, types, and properties of ampoule glass materials to select them correctly.
The main component of glass is silica, which is relatively brittle and has a high melting temperature, and cannot directly meet the basic requirements for ampoule production. Therefore, we often add oxides of elements such as sodium, potassium, calcium, magnesium, aluminum, iron, and boron to the basic framework of glass to alter its physicochemical properties. Currently, the commonly used low borosilicate glass ampoules in the country somewhat adapt to the backward production equipment and processes, low cost, and high demand in our national conditions. However, the widespread application of this type of glass material also hinders the development of pharmaceutical glass in our country. Objectively speaking, low borosilicate glass is a transitional material that reduces the quality level and various performance indicators of neutral borosilicate glass, so low borosilicate glass ampoules can generally only be used for ordinary antibiotic controlled injectables. In comparison, neutral borosilicate glass ampoules have significantly better chemical stability and resistance to sudden temperature changes than the former. For example, in terms of chemical stability, the water resistance of neutral borosilicate glass ampoules can reach level 1, while the water resistance of low borosilicate glass ampoules is mostly level 1. However, when viewed microscopically, the amount of alkali precipitation is much larger than that of neutral borosilicate glass. Therefore, when used to contain strong acids, strong bases, and high-quality pharmaceuticals, there is a significant difference in the chemical properties of ampoules made from these two types of glass.
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The impact of ampoule glass material on the quality of injectables.
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