Glass is the favorite material for parenteral packaging because of its physico-chemical properties. Type I borosilicate glass is worldwide use at this scope, but it may have some issues related to breakage, corrosion and delamination that might compromise the drug quality, safety and efficacy. These issues can be mitigated and avoided starting from the appropriate selection of the most suitable raw material at the early stage of the glass container design. In this study, Type I borosilicate glass vials manufactured using two glass tubes having different chemical compositions, were studied and compared in terms of their resistance to corrosion. Testing design was applied with the aim to select the best practice approach comparing different storage simulation conditions: ageing treatment through autoclaving and stability testing (real-time and accelerated). Clear differences were found between the different glass types in terms of hydrolytic and corrosion resistance that highlighted the relation between chemical composition and glass chemical durability. Non-negligible differences were also observed using different storage conditions.

During the forming process of a vial by tubing glass, temperatures of up to 1200°C are applied to adjust the glass viscosity. This process causes the release of volatile components such as alkali borates. Consequently, the percentage of sodium and boron measured on the inner surface of the vial can be higher than that measured on the corresponding glass tube. This study aimed to characterize the inner surface of two different borosilicate glass tubes of type I before and after the vial forming process at the nanoscale level. Quantitative elemental analysis of the surface along the vertical axis of glass tubes and vials was performed by X‐ray photoelectron spectroscopy, whereas the topographical investigation was carried out by scanning electron microscopy (SEM). In the near‐bottom region of a vial, which is usually the area most prone to corrosion, the SEM micrographs showed the appearance of bulges on the surface. The latter were then analyzed by time‐of‐flight secondary ion mass spectrometry to characterize their molecular composition. The purpose of this work is to identify possible new strategies for faster identification of factors that eventually influence chemical resistance of pharmaceutical glasses and to provide useful information needed to improve industrial processes.

The use of glass for pharmaceutical new applications such as high-technology drugs, requires the strictest container inertness. A common theme of paramount importance in glass container integrity preservation is the detailed mechanism driving the sudden failure due the crack propagation. Using a combination of discrete element method (DEM) and finite element method (FEM), a stress map for glass cartridges packed into an accumulation table and transported by a conveyor belt at a fixed velocity is obtained under realistic conditions. The DEM calculation provides a full description of the dynamics of the cartridges, as approximated by an equivalent sphere, as well as the statistics of the multiple collisions. The FEM calculation exploits this input to provide the maximum principal stress of different pairs as a function of time. Our analysis shows that, during their transportation on the conveyor belt, the cartridges are subject to several shocks of varying intensities. Under these conditions, a crack may originate inside the cartridge in the area of maximal tensile stress, and propagate outward. Estimated stresses are found in good agreement with real systems.

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