Presented at: 2014 AAPS Conference
Authors: Angela Flowers, Rebekah Byrne, Emily Landsperger, David Exline
Release Date: November 2014
Overview
Glass delamination if not discovered early can be big problem for pharmaceutical manufacturers. It has the potential to cause costly product recalls and investigations. Because of this, the FDA highly recommends that manufacturers perform stability studies to evaluate the interaction of the drug formulation with the glass vial in addition to pretesting analysis on smaller batches of the product before going into full production.