Scanning Electron Microscopy for Pharmaceutical Quality Assurance
The Phenom Desktop SEM is a powerful instrument capable of quickly producing actionable data for QA purposes within the pharmaceutical industry.
- The high-brightness CeB6 source produces beautiful SEM images while maintaining a very long service lifetime.
- The integrated navigation camera and motorized X/Y stage also allow for the seamless identification and investigation of foreign particulate at both low and high magnification.
- Chemical composition of materials can be inferred using the Phenom's back-scatter electron detector and quantified using the integrated energy dispersive X-ray spectrometer (EDS).
- Lastly, imaging systems can be coupled with Quartz PCI/CFR to ensure data generated is compliant with FDA 21 CFR Part 11.
Foreign Particle Investigations
The integrated navigation camera allows the SEM operator to identify the particulate on a SEM stub and then transition the sample into the SEM for imaging and elemental composition analysis. This whole process (including pulling vacuum) generally requires less than one minute to complete. The Phenom is the highest throughput electron microscope on the market.
Optical (right) and SEM images of a foreign particle extracted during quality testing
EDS spectroscopy can be used to determine the elemental composition of particulate.
SEM Analysis of Pharmaceutical Coatings.
Understanding the thickness, texture and chemical composition of tablet coatings is important when optimizing an array of different parameters including, swallowability, product stability and the controlled release properties of the active pharmaceutical ingredient (API).
Analysis of tablet cross-sections are a trivial experiment to perform with the Phenom SEM and will provide QA scientists with invaluable information regarding the efficacy of the coating process.
SEM comparison of tablet coatings