Nondestructive detection of glass vial inner surface morphology with differential interference contrast microscopy

J Pharm Sci. 2012 Apr;101(4):1378-84. doi: 10.1002/jps.23048. Epub 2012 Jan 10.


Glass particles generated by glass dissolution and delamination of the glass container for pharmaceutical products have become a major issue in the pharmaceutical industry. The observation of glass particles in certain injectable drugs, including several protein therapeutics, has recently resulted in a number of product recalls. Glass vial surface properties have been suggested to play a critical role in glass dissolution and delamination. Surface characterization of glass container, therefore, is important to evaluate the quality of the glass container. In this work, we demonstrate that differential interference contrast (DIC) microscopy is a powerful, effective, and convenient technique to examine the inner surface morphology of glass vials nondestructively. DIC microscopy does not require the cutting of the glass vial for scanning the inner surface and has sufficient spatial resolution to reveal glass pitting, phase separation, delamination scars, and other defects. Typical surface morphology of pharmaceutical glass vials with different alkalinity are compared and discussed.

MeSH terms

  • Drug Packaging*
  • Glass
  • Microscopy, Interference / methods*
  • Solubility
  • Surface Properties