Factors Affecting the Chemical Durability of Glass Used in the Pharmaceutical Industry

Delamination, or the generation of glass flakes in vials used to contain parenteral drug products, continues to be a persistent problem in the pharmaceutical industry. To understand all of the factors that might contribute to delamination, a statistical design of experiments was implemented to describe this loss of chemical integrity for glass vials. Phase I of this study focused on the effects of thermal exposure (prior to product filling) on the surface chemistry of glass vials. Even though such temperatures are below the glass transition temperature for the glass, and parenteral compounds are injected directly into the body, data must be collected to show that the glass was not phase separating. Phase II of these studies examined the combined effects of thermal exposure, glass chemistry, and exposure to pharmaceutically relevant molecules on glass delamination. A variety of tools was used to examine the glass and the solution contained in the vial including: scanning electron microscopy and dynamic secondary ion mass spectroscopy for the glass; and visual examination, pH measurements, laser particle counting, and inductively coupled plasma–optical emission spectrometry for the analysis of the solution. The combined results of phase I and II showed depyrogenation does not play a significant role in delamination. Terminal sterilization, glass chemistry, and solution chemistry are the key factors in the generation of glass flakes. Dissolution of silica may be an effective indicator that delamination will occur with a given liquid stored in glass. Finally, delamination should not be defined by the appearance of visible glass particulates. There is a mechanical component in the delamination process whereby the flakes must break away from the interior vial surface. Delamination should be defined by the observation of flakes on the interior surface of the vial, which can be detected by several other analytical techniques

Effects of Al:Si and (Al+Na):Si Ratios on the Static Corrosion of Sodium-Boroaluminosilicate Glasses

International audienceUnderstanding alteration mechanisms of borosilicate glasses in aqueous media is essential to nuclear waste performance assessments to ensure radioisotopes are contained for extended durations. Aluminum is typically added to glass compositions to reduce the extent of alteration. However, previous work on 7-day durability tests has suggested that Al has a non-linear relationship with extent of alteration. The effects of Al:Si and (Al+Na):Si substitutions on glass durability were evaluated using series of glasses based on the International Simple Glass corroded in static conditions up to 13 months in deionized water at 90 °C. The alteration behavior was determined by measurement of element release in solution. The ⁓7-day alteration trends across the series were consistent with predicted trends. The 13 month results indicated overall alteration decreased as Al:Si ratios increased and was unaffected by changes in (Al+Na):Si except for the glass with the highest (Al+Na):Si ratio (ISG-A23N), which completely altered within 14 days. Frequent sampling and in-situ Raman measurements revealed ISG-A23N experienced several distinguishable alteration rate regimes within 7 days, forming a ⁓100 µm alteration layer and a NaSiAlO4 zeolite