Glass delamination is a phenomenon which can occur in parenteral drugs stored in glass containers. By interaction of the drug product with the vial surface, the glass surface will sometimes break down, causing the layers to separate; ultimately this results in the presence of small glass flakes, known as lamellae, in the drug solution. The USP has issued guidance under General Chapter 1660 – “Evaluation of the Inner Surface Durability of Glass Containers,” outlining recommended parameters and methods to test the durability of the inner surface of glass containers. One of the recommendations is counting and sizing glass lamellae using a “Particle Size Analyzer.” Typical particle analyzers can only speak to an entire population and cannot verify that the particles being counted are or are not chemically or morphologically consistent with glass lamellae. An automated method with the ability to accurately count and size glass lamellae, along with verifying the flakes as being consistent with glass material, could save analysis time and reduce the degree of human error, as well as providing a more accurate measurement of the degree of delamination occurring in a sample.
During this webinar we will discuss the variety of methods that have been investigated in an attempt to identify an automated protocol for the specific (chemical and/or morphological) counting and sizing of glass lamellae in parenteral drug solutions.
Topics Covered Will Include
- An overview of glass delamination and glass lamellae morphology
- Automated SEM-EDS and LIBS Technologies and their unique capabilities
- How automated SEM-EDS and LIBS compare to particle size analyzers
- The challenges encountered in counting and sizing glass lamellae using an automated system
- Case study examples of automated vs. manual counting and sizing of glass lamellae