Quality Assurance

SEM image of multivitamin

SEM image of multivitamin particles

Microscopy techniques are used to determine the quality and integrity of manufactured products. Greater resolution is often required as particle sizes are shrinking. Particle size, shape, texture and distribution can be examined using scanning electron microscopy (SEM) and EDS analysis. Elements can be determined for a point, across a line, or mapped.

EDS line scan of a multivitamin

 Corresponding EDS line scan of multivitamin sample

Chemical Composition

The chemical composition of a mixed batch or foreign particulate matter may need to be determined. The Phenom ProX with energy-dispersive X-ray spectroscopy (EDS) can analyze the chemical composition of individual particles.

EDS Excipient with foreign particulate matter

 EDS elemental analysis of excipient with foreign particulate matter

Elemental Mapping shows the distribution of elements across a region of interest. Using automated image acquisition, an efficient collection of a large amount of data for statistical analysis is possible. 

Elemental mapping to show distribution of elements
Elemental mapping using Phenom ProX desktop SEM 

QC Example: Foreign Particulate Matter

Save time determining root cause of foreign or abnormal particulate matter. The Phenom desktop SEM provides an optical image to visually locate foreign material. SEM imaging quickly shows particle morphology and EDS provides elemental information.

 SEM and EDS QC example

The optical image (left) shows foreign particulate matter. The foreign particulate is brighter in the SEM image (center), indicating a heavier element. Elemental analysis (right) indicates the foreign particulate matter contains aluminum. 

Related Pages

Phenom SEM
Phenom SEM

Phenomenal SEM for most applications

EDS Mapping & Linescan
EDS Mapping & Linescan

Mapping & line scan software to reveal the distribution of elements

Quartz PCI/CFR
Quartz PCI/CFR

Bring your Phenom SEM into compliance with FDA 21 CFR Part 11


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