Glass Delamination Analysis Services Lab

Glass Delamination Analysis Services Lab

Watch our Glass Delamination Analysis Webinar

  • Glass delamination analysis
  • Validation and testing of product vials
  • USP <1660> testing support

In the pharmaceutical industry, glass delamination is defined as thin glass flakes shedding from the internal diameter of glass containers and vials. The flakes, also called “glass lamellae,” can be shed and suspended in parenteral drug products. This is a major concern in the pharmaceutical industry and has resulted in a number of recalls. Detecting glass lamellae is one of the key aspects of glass delamination analysis. USP laid out some analytical guidelines for pharmaceutical manufacturers and analytical laboratories on how to screen for glass delamination.

Evaluation of inner glass surface by USP

USP <1660> recommends three key parameters for screening glass delamination in drug vials. The parameters are the condition of the glass surface, the presence of extracted elements in solution, as well as the presence of visible and subvisible glass particles.

  • For glass surface analysis, the objective is to examine the degree of surface pitting and chemical composition as a function of depth. This part of the analysis can be accomplished by differential interference microscopy or electron microscopy and secondary ion mass spectrometry.
  • .
  • For extracted elements in solution, the objective is to measure the pH, conductivity of the solution, and the concentration of SiO2. This part of the analysis can be done by conductivity, pH measurement and inductively coupled plasma (ICP) with mass spectrometry (MS) or optical emission spectrometry (OES).
  • .
  • For visible and subvisible glass particles, the objective is to examine and record the number, size, shape and composition of the particles. This part of the study can be accomplished by a particle size analyzer or SEM-EDS.
Example of a delaminated glass vial surface analyzed by SEM-EDS
Example of a delaminated glass vial surface analyzed by SEM-EDS

Analytical approach for glass delamination analysis

MVA Scientific Consultants has customized a systematic approach for glass delamination analysis which includes special sample preparation, filtration, and examination by light microscopy, SEM-EDS and ICP-MS or ICP-OES.

glass delamination inspection flowchart

  • Glass container inspection – upon receiving the samples, the first step is to examine the glass containers with stereomicroscopy to document any visible defects.
  • .
  • Drug product removal – once observations are made, the next step is to filter the drug product from the container to isolate glass particles/lamellae.
  • .
  • Glass container preparation – glass containers come in all shapes and sizes; they need to be sectioned to expose the interior surface for analysis.
  • .
  • Microscopical inspection of sectioned containers – examine, document and photograph the interior surface of the container.
  • .
  • Analysis of glass container by SEM – analyze the sectioned glass container by SEM for surface delamination.
  • .
  • Analysis of drug product by ICP – analyze the drug product by ICP for elements associated with glass degradation.
High magnification SEM imaging showing the pits and surface structure of the interior glass surface
High magnification SEM imaging showing the pits and surface structure of the interior glass surface
Surface roughness profile of the glass interior showing the pits and delaminated area of the surface
Surface roughness profile of the glass interior showing the pits and delaminated area of the surface
Glass lamellae observed by light microscopy
Glass lamellae observed by light microscopy

For more info visit:
Looking at Glass Delamination of Drug Vials

.

Contact us at 1-877-896-8366 to learn more about how MVA can handle your specific glass delamination analysis and testing needs.