AAPS PharmSciTech

, Volume 15, Issue 6, pp 1398–1409 | Cite as

Glass Delamination: a Comparison of the Inner Surface Performance of Vials and Pre-filled Syringes

  • Jianxiu Zhao
  • Virginie Lavalley
  • Paolo Mangiagalli
  • Justin M. Wright
  • Theresa E. Bankston
Research Article

Abstract

The occurrence of glass delamination is a serious concern for parenteral drug products. Over the past several years, there has been a series of product recalls involving glass delamination in parenteral drugs stored in vials which has led to heightened industry and regulatory scrutiny. In this study, a two-pronged approach was employed to assess the inner surface durability of vials and pre-filled syringes. Non-siliconized syringes were used in order to directly compare glass to glass performance between vials and syringes. The vial and syringe performance was screened with pharmaceutically relevant formulation conditions. The influence of pH, buffer type, ionic strength, and glass type and source was evaluated. In addition, an aggressive but discriminating formulation condition (glutaric acid, pH 11) was used to ascertain the impact of syringe processing. Advanced analytical tools including inductively coupled plasma/mass spectrometry, scanning electron microscopy, atomic force microscopy, and dynamic secondary ion mass spectroscopy showed significant differences in glass performance between vials and syringes. Pre-filled syringes outperform vials for most tests and conditions. The manufacturing conditions for vials lead to glass defects, not found in pre-filled syringes, which result in a less chemically resistant surface. The screening methodology presented in this work can be applied to assess suitability of primary containers for specific drug applications.

Key words

borosilicate vials glass delamination glass corrosion hydrolytic resistance pre-filled syringes 

Notes

Acknowledgments

The authors gratefully acknowledge the support and effort of the following people: Changyun Xiong, Feng Zhang, Richard Evans, and Harry Sugg.

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • Jianxiu Zhao
    • 1
  • Virginie Lavalley
    • 2
  • Paolo Mangiagalli
    • 2
  • Justin M. Wright
    • 1
  • Theresa E. Bankston
    • 1
  1. 1.BD Medical—Pharmaceutical SystemsFranklin LakesUSA
  2. 2.BD Medical—Pharmaceutical SystemsCedex Pont de ClaixFrance

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