Glass: The best material for pharmaceutical packaging

Abstract

Glass is the most used material in pharmaceutical packaging, and the production volumes are continuously growing. The reasons why glass can be considered the best material for pharmaceutical containers are discussed. A current picture of this area, which was showcased during the Covid-19 pandemic, is provided. Borosilicate glass products, which are currently the most used among those described by the Pharmacopoeia, are mostly considered, but new glasses that may be introduced in the future are also mentioned. A short view on the evolution of this type of glass and the current market situation are provided. Particular emphasis is given to chemical durability. Glasses are generally considered inert from the chemical point of view, but this is not exactly true. Phenomena such as the release of elemental impurities into solution, buffer interaction, and delamination have caused much concern in the last decade or so, especially as the complexity and value of drugs has been increasing. These phenomena are described, and it is pointed out that, thanks to the increasing scientific knowledge and production technologies, these issues are now under control, and the products on the market are of very high quality and very reliable.

Insights on surface analysis techniques to study glass primary packaging

“…Indeed, the original molecule that generates the bulges could be an impurity from the original raw material, such as sodium tetraborate decahydrate. 32 Na + map confirmed the XPS results as this ion is mainly concentrated on the surface. It should be stated that in the collected data, other ion elements are present, not shown in this study, that can be extracted by a retrospective analysis, for example, Na 2 BO 3 H.…”

“…In other words, the surface composition can be inferred by considering that the spectrum acquired during ToF‐SIMS analysis is the result of the interaction of the primary ion beam and the molecules on the surface. Indeed, the original molecule that generates the bulges could be an impurity from the original raw material, such as sodium tetraborate decahydrate 32 …”

Surface Hardness and Abrasion Threshold of Chemically Strengthened Soda-Lime Silicate Glasses After Steam Processing

“…Thereby, IOX of smaller alkali species (Li + or Na + ) by larger ones (typically K + ) at a temperature below the glass transition T g creates a surface compressive layer [14], [15]. Regarding the length scale of diffusive exchange, chemical strengthening is suitable for thin glass products; it is commonly applied for display covers and bendable or flexible glass sheets [16], but has also been used in other applications such as pharmaceutical packaging [17], or smart window devices [18]. For benchmark aluminosilicate glasses, the surface compressive stress (CS) generated by IOX reaches a level of ~ 1 GPa.…”

Sterility of Ophthalmic Solutions as a Factor in the Evolution of Primary Packaging for Eye Drops: A Literature Review

“…Unfortunately, this increases the likelihood of Al contamination (23). Other considerations include the possibility of glass interaction with the buffer, delamination, and breakage (24)(25)(26). Differences in the glass vial manufacturing process, the nature of the dosage form, the presence or absence of an ammonium sulfate coating, storage time, and conditions, can all contribute to the likelihood of glass breakage.…”