Advanced surface techniques meet chemical analysis: Shedding light on parenteral containers

The pharmaceutical industry relies on secure and effective packaging to ensure the integrity, safety, and efficacy of its products, and glass containers have long been a staple in pharmaceutical packaging. In this study, advanced glass surface analysis techniques: dynamic secondary ion mass spectrometry (D-SIMS) and x-ray photoelectron spectroscopy (XPS), were used in tandem with more consolidated chemical functional methods for pharmaceutical products. The aim is to characterize the inner vial surface after the converting process and under stress conditions. Different vials, obtained from distinct converting process parameters, have been investigated by XPS and SIMS to evaluate at nanoscale level the surface composition. Afterward, the evaluation of vial quality attributes was performed using chemical durability testing platform: hydrolytic and corrosion resistance and pH shift estimation. The purpose is to correlate chemical and physical properties to better define the risk evaluation in assessing common failure modes of pharmaceutical containers.