title: Nondestructive detection of glass vial inner surface morphology with differential interference contrast microscopy.
abstract: 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.
authors.affiliation: Department of Process and Product Development, Amgen Inc., Thousand Oaks, California 91320-1799, USA. zwen@amgen.com
authors.forename: Zai-Qing
authors.initials: ZQ
authors.lastname: Wen
authors.forename: Gianni
authors.initials: G
authors.lastname: Torraca
authors.forename: Peter
authors.initials: P
authors.lastname: Masatani
authors.forename: Christopher
authors.initials: C
authors.lastname: Sloey
authors.forename: Joseph
authors.initials: J
authors.lastname: Phillips
mesh_terms: D004349:Drug Packaging; D005898:Glass; D008857:Microscopy, Interference / Q000379:methods*; D012995:Solubility; D013499:Surface Properties