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The impact of the glass material of ampoules on the quality of injectables

2025-12-16 09:28

【Article overview】The packaging process for injectables requires high-temperature sterilization, and injectables must withstand prolonged storage. Since ampoules used to contain injectable solutions come into direct contact with various types of pharmaceutical liquids, these two components can interact with each other, leading to phenomena that compromise the quality of the injectables, such as changes in pH, precipitation of active ingredients, discoloration, and flaking of the glass surface. Therefore, it is essential to understand the composition, types, and properties of ampoule glass materials in order to make the correct selection. The primary component of glass is silicon dioxide, which is relatively brittle and has a high melting point, making it unable to directly meet the basic requirements for ampoule production. For this reason, we often add sodium, potassium, calcium, magnesium, and aluminum to the basic glass matrix.

The packaging process for injectables requires high-temperature sterilization, and injectables are often stored for extended periods. Since the ampoules used to contain the injectable solutions come into direct contact with various types of pharmaceutical liquids, these two components can interact with each other, leading to phenomena that compromise the quality of the injectables, such as changes in pH, precipitation of active ingredients, discoloration, and flaking of the glass surface. Therefore, it is essential to understand the composition, types, and properties of ampoule glass materials in order to make the correct selection.

The primary component of glass is silicon dioxide, which has a relatively brittle texture and a high melting temperature, making it unable to 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 glass’s basic structure to modify its physicochemical properties. Currently, the commonly used low-borosilicate glass ampoules in China partially accommodate our country’s conditions—backward production equipment and processes, low costs, and high demand. However, the widespread use of these glass-based products has also hindered the development of pharmaceutical glass in China. Objectively speaking, low-borosilicate glass represents a transitional material that has reduced both the quality grade and various performance indicators compared to neutral borosilicate glass. Consequently, low-borosilicate glass ampoules are generally suitable only for containing ordinary antibiotic-controlled injections. In contrast, neutral borosilicate glass ampoules exhibit significantly superior chemical stability and resistance to rapid temperature changes. Taking chemical stability as an example, the particle-method water resistance of neutral borosilicate glass ampoules can reach Grade 1, whereas most low-borosilicate glass ampoules achieve only Grade 1 under the same particle-method test. Yet, when examined at the microscopic level, the amount of alkali leaching from low-borosilicate glass is considerably greater than that from neutral borosilicate glass. Thus, when used to contain strong acids, strong bases, or high-end pharmaceuticals, there is a substantial difference in chemical performance between these two types of glass ampoules.

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Low-borosilicate glass versus traditional materials: A comparative advantage analysis of ampoules for injection.

The impact of the glass material of ampoules on the quality of injectables

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