Foreign Particle Analysis with the Scanning Electron Microscopy (SEM)
Minimizing foreign particulate contamination in both tablet based and parenteral (injectable) drug compounds is a major concern in the pharmaceutical industry. FDA regulations require that all foreign particles are thoroughly investigated in order to locate their origin. Shape, size, color and chemical composition are all important characteristics that must be quantified during this investigation.
The Phenom Desktop SEM is uniquely capable of addressing virtually all of the above listed concerns. Particle shape, size and color can be visualized with both the integrated optical microscope (capable of bright and dark field imaging) and the electron microscope. Further, the staging of the SEM is calibrated and indexed with a high enough degree of accuracy that images individually acquired with each microscope can be correlated by position. Chemical composition can often be inferred using the SEMs back-scatter electron detector and it can be quantified using energy dispersive X-ray spectroscopy (EDS).
Optical, SEM images and an EDS spectrum of a foreign particle extracted during quality testing.
Using the Phenom SEMs integrated optical camera a white particle is easily identified on the SEM stub. High resolution SEM images shows the particle to be comprised of small crystals consistent in morphology to gypsum.
EDS analysis confirms that the chemical composition is also consistent with gypsum
Additionally, Phenom SEMs can all be equipped with the Quartz PCI/CFR software which helps microscopists working in pharmaceutical quality assurance labs comply with FDA 21 CFR Part 11 requirements for electronic record keeping.