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Research ArticleResearch

Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials

Serena Panighello and Odra Pinato
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 185-200; DOI: https://doi.org/10.5731/pdajpst.2019.010066
Serena Panighello
SG Lab Analytics, Nuova Ompi, Piombino Dese, Italy
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  • For correspondence: serena.panighello@stevanatogroup.com
Odra Pinato
SG Lab Analytics, Nuova Ompi, Piombino Dese, Italy
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Abstract

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.

  • Glass primary packaging
  • Surface chemistry
  • Glass corrosion
  • Glass delamination
  • Stability studies
  • Hydrolytic resistance
  • © PDA, Inc. 2020
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PDA Journal of Pharmaceutical Science and Technology: 74 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
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Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
Serena Panighello, Odra Pinato
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 185-200; DOI: 10.5731/pdajpst.2019.010066

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Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
Serena Panighello, Odra Pinato
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 185-200; DOI: 10.5731/pdajpst.2019.010066
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  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
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Keywords

  • Glass primary packaging
  • Surface chemistry
  • Glass corrosion
  • Glass delamination
  • Stability studies
  • Hydrolytic resistance

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