- Event Date: Wednesday, Nov. 18th, 2015
- Time: 2 pm Eastern Time
- Duration: 45 Minutes including Q&A
- Presenters: David Exline, Vice President, Rebekah Byrne, Laboratory Manager and Emily Landsperger, Scientist I at Gateway Analytical
- Host: Paige Cohen, Sales Development Associate
This webinar will offer attendees insight into the challenges faced attempting to size and count glass lamellae while differentiating them from other particulate present in the sample and the variety of methods investigated.
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
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.
Who Should Attend?
You should attend this webinar if you are involved in guaranteeing the quality and safety of parenteral drug products and are involved in glass delamination investigations.
David Exline, Vice President, Gateway Analytical
David Exline has more than 20 years of experience in managing and administering analytical laboratory and consulting services. David has specific expertise in applying chemical imaging methods such as Raman, UV-Vis and NIR techniques to solve the most difficult pharmaceutical and material science problems for Gateway Analytical customers. David is adept in numerous pharmaceutical-related services and testing methods including: materials characterization, particulate contamination analysis, particle sizing and high-resolution microscopy.
Rebekah Leigh Byrne, Laboratory Manager
Rebekah is the Laboratory Manager at Gateway Analytical and she has more than seven years of experience working under quality systems in both clinical and analytical laboratory settings, including cGMP and ISO environments. Rebekah worked as a genetics scientist for Perkin Elmer for two years before joining Gateway Analytical. She has worked specifically in materials characterization for more than four years, with a focus on both pharmaceutical forensics and criminal forensics.
Emily Landsperger, Scientist I
Emily is a scientist at Gateway Analytical whose primary focus is glass delamination examinations. Emily has more than three years of experience working under quality systems in both criminal forensic and analytical laboratory settings. Emily worked as a DNA analyst for the United States Army Criminal Investigation Laboratory while deployed in Afghanistan for two years before joining Gateway Analytical. Emily obtained her Bachelor’s degree in Biochemistry and Master’s degree in Forensic Science and Law from Duquesne University.