Testing for Glass Flakes in Pharmaceutical Vials
Kristie J. Diebold, McCrone Associates, Inc., Westmont, Illinois
Pharmaceutical Technology - September 21, 2011
The drug industry has used glass vials for a long time, and most industry professionals assume that these containers are safe. Yet glass vials can pose contamination risks that often are invisible to the naked eye. Glass flaking or delamination, for example, is a serious concern. It can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. More significantly, if glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.
What causes glass delamination?
Glass delamination occurs when top layers of a glass surface separate and flake off, typically at a scale invisible to the naked eye. Chemicals from the product solution or manufacturing process can cause the glass surface of the vial to delaminate or discolor. This effect can occur at any point during the vial’s life: during manufacturing, heat treatment, sterilization, or stability testing.
Most pharmaceutical quality-control departments are not equipped to investigate the problem of glass delamination. Instead, they often turn to independent laboratories for their analytical expertise and capabilities.