Identification of Foreign Particulate Matter Using Automated Raman & Automated SEM-EDS
By: Angela Flowers, Emily Landsperger, Rebekah Byrne, and Dave Exline, Gateway Analytical
Foreign particulate matter in drug products is a common problem in the pharmaceutical industry that can have major impacts on pharmaceutical companies, from both financial and safety aspects. While manual particulate characterization is best suited for many investigations, automated Raman and automated Scanning Electron Microscopy/Electron Dispersive Spectroscopy (SEM-EDS) analyses can offer additional insight and investigative solutions to contamination issues, including foreign particulate matter. Automated Raman and automated SEM-EDS analyses offer the ability to establish the size and chemical composition of hundreds of particles in a sample, whether the chemical makeup is metallic, organic or inorganic.1
The Single Particle Explorer (SPE)-raman.ID system completes optical analysis (particle count, size and shape) on particles 2 μm and greater, along with Raman spectroscopic analysis to gain a chemical identification on the particles, as shown in Figure 1. The SPE also provides automated database searching, as shown in Figure 2, along with the ability for manual confirmation of specific particles.
Automated SEM-EDS is a complementary technique to automated Raman spectroscopy, which can classify particles (most commonly metallic and inorganic) 1 μm and greater. This analysis provides elemental composition of each particle, as shown in Figure 3. The SEM system also has the ability to acquire high resolution and high magnification images when necessary, as shown in Figure 4.
The combination of the automated Raman and automated SEM-EDS analysis techniques allows a comprehensive understanding of the composition of the many different particle types in a sample population as a whole; this includes organic, inorganic, and metallic particles. Automated analyses, such as those described here, provide a more practical approach to identification of a large population of small particulates, than does traditional, manual foreign particulate matter identification. Click here for a case study.
References
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SPE Operators Guide raman.ID+metal.ID. (2013) RapID Particle System GmgH. Edition 1.8
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