Case Studies in Foreign Particulate Analysis

Authors & Contributors
David Exline

July 01, 2015

Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves.

Highlighted Topics

  • An overview of manual foreign particulate characterization
  • An overview of automated particulate characterizations
  • How manual analysis compares to automated technologies for particle identification
  • Commonly found sources of particulate contamination
  • Application and case study examples of both manual and automated particulate analyses

During this webinar, Gateway Analytical scientists will present an overview of manual (SEM-EDS, microscopy, FTIR, and Raman) and automated (automated SEM, CCSEM) methodologies for characterizing foreign particulate matter in pharmaceutical investigations and cleanliness studies. Several case study examples will be presented showing the various approaches to particulate identification and the utility of both types of analyses.