| Intertek ASG Laboratory, Manchester, UK
Case Study:
Biopharmaceutical Manufacturing Contamination
Intertek ASG can offer micro elemental analysis on particulate materials existing below 10 microns in size. Using the combination of Scanning Electron Microscopy (SEM) interfaced with Energy Dispersive X-Ray Analysis (EDX), qualitative information can be obtained on the full elemental composition of an unknown species.
Identification of a Typical Plant Contaminant
Intertek ASG has successfully worked on the characterization of unknowns from a biopharmaceutical manufacturing plant.
A Q-tip cotton swab soaked in contaminated material was subjected to an array of analysis methods. An image of the swab was obtained using a high resolution SEM in backscatter electron detection mode (BSE) - see Figure 1. This type of detection is effective in showing differences in atomic number based on contrast effects.
Within the swab fibres very small particles can be seen to exist at less than 10 microns in size. Using EDX microanalysis each individual particle was separately probed with the focused electron beam. The resulting EDX spectra show the different elemental composition from each particle probed. Particle 1 shows high levels of aluminium and oxygen and is thought to be aluminium oxide (alumina). Particle 2 shows high levels of iron, chromium and nickel and is consistent with stainless steel.
This information was used by the customer to resolve the nature and origin of contamination within the manufacturing unit. 
|
