Dr. Brandon Aldinger presented "Applying Glass Fractography to the Evaluation of Novel Glass Parenteral Packaging Technologies" recently at the Parenteral Packaging Conference in Copenhagen, Denmark and this course is a recorded version of the same presentation.
Following the astounding success of chemically strengthened smartphone screens, pharmaceutical vial manufacturers have developed several advanced glass technologies designed to reduce breakage during filling and handling. These technologies include novel glass compositions, such as aluminosilicates and fused silica, as well as vial treatments such as chemical strengthening and friction-reducing coatings.
But how would a glass manufacturer optimize vial enhancement technologies? How can a pharma company assess whether or not the higher-cost vials are likely to reduce breakage on their filling line?
Strength testing, in isolation, provides raw quantitative data that appear definitive, but may actually be misleading. It can also be unclear how strength data collected under laboratory conditions would apply to disparate filling line processes such as depyrogenation, capping, or lyophilization.
In this talk, we will:
• Demonstrate inadequacy of destructive strength test data alone to evaluate vial performance
• Provide criteria for selection of test methods: strength testing (i.e. Instron), internal pressure, impact, and thermal shock
• Show the importance of fracture analysis in interpretation of test results, yielding insights into technology development, line handling, and flaw severity