Glass containers intended for pharmaceutical purposes are engineered to be in direct interaction with medicinal products. The types of glass employed for these containers fall into two categories: borosilicate glass, also known as neutral glass, and soda-lime-silica glass. Borosilicate glass boasts a composition rich in boric oxide, aluminum oxide, and alkali or alkaline earth oxides, contributing to its exceptional hydrolytic resistance and formidable resilience against thermal shocks. This type of glass is recognized as Type I due to its characteristics.
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On the other hand, soda-lime-silica glass, a variant of silica glass, predominantly comprises alkaline metal oxides, especially sodium oxide, and alkaline earth oxides, namely calcium oxide. The inherent chemical makeup of this glass grants it a moderate level of hydrolytic resistance, categorizing it as Type III. However, treating the internal surface of soda-lime-silica glass containers enhances their hydrolytic resistance, lifting them to a Type II classification.
1. Hydrolytic resistance test
i. Glass Grains test ' used to distinguish Type I glass from Type II and Type III glass
ii. Surface Glass Test ' used to distinguish Type I and Type II glass containers from Type III glass container. It is based on hydrolytic resistance of the inner surfaces of glass containers.
iii. Surface Etching Test/Comparison of Glass Grains Test and Surface Glass Test data ' this is to determine whether high hydrolytic resistance of Type I or Type II glass containers are due to inner surface treatment or due to the chemical composition of the glass containers
1. Light/spectral transmission for coloured glass containers
2. Arsenic release ' used to detect the presence of arsenic in aqueous parenteral preparations
There are various factors that influence selection process of glass containers as primary packages. These factors include:
· Limit of alkalinity and hydrolytic resistance of the glass container
· Thermal expansion properties of the glass container (freeze-drying)
· Sensitivity of the glass container to barium or calcium ions
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· Glass containers are mainly used in packaging liquid preparations due to their rigidity and their superior protective qualities
· Its high transparency allows easy inspection of its contents.
· It offers better protection because it is relatively impermeable to air and moisture.
· It is chemically resistance to most medicinal products.
· Coloured glass (amber glass and red coloured glass) can protect its content from ultraviolet rays and certain wavelengths.
· Glass containers can be easily sterilized using heat.
· Glass containers are expensive to manufacture
· They are fragile and relatively heavy
· During heat sterilization, some types of glass containers have the tendency of shedding some part of the silica into the formulation.
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