ESCA depth profiling studies of borosilicate glass containers

Area of Science:

• Materials Science
• Analytical Chemistry
• Surface Science

Background:

• Borosilicate glass containers are widely used in pharmaceutical and chemical industries.
• Understanding surface composition is crucial for container integrity and preventing extractable contamination.
• Existing analytical methods may not fully capture surface and near-surface changes.

Purpose of the Study:

• To investigate the surface and near-surface composition of borosilicate glass containers using ESCA depth profiling.
• To differentiate between untreated and (NH4)2SO4 treated containers.
• To assess the impact of processing and aqueous media exposure on container surfaces.

Main Methods:

• Utilized Electron Spectroscopy for Chemical Analysis (ESCA) combined with Ar+ ion milling for depth profiling.
• Analyzed elemental composition (Na, Ba, O, B, Si, Al, C) at various depths (0.01-0.30 micron).
• Examined untreated, (NH4)2SO4 treated vials and ampoules, including those exposed to H2O, pH 8, and pH 10 buffers.

Main Results:

• ESCA depth profiling successfully distinguished treated from untreated borosilicate glass containers.
• Untreated containers showed significant surface compositional changes after washing, sterilizing, and prolonged aqueous exposure (pH 8).
• Both treated and untreated containers exposed to pH 10 media exhibited glass dissolution; treated samples were generally stable.

Conclusions:

• ESCA depth profiling is effective for characterizing borosilicate glass container surfaces and detecting treatment effects.
• Surface and near-surface composition significantly influences the extractable behavior of glass containers.
• Understanding these compositional changes is vital for ensuring container performance and product safety.