In any research effort, sometimes an unexpected result can occur. In a large team effort, this unexpected result may be due to factors beyond the expertise of the team. Applying outside expert analysis can clarify the issue.
At the end of an extensive processing of a component of a medical device, in the research stage, black spots appeared. The questions were where did they come from and how do we prevent them.
The first step was to identify the black specs using a combination of micro-infrared spectroscopy and scanning electron microscopy with energy dispersive spectroscopy. These two tools determined that the black specs were associated with higher levels of an organic on the surface of the sample. The problem was that the contaminant found should not have been on the surface in the first place and there was no evidence of contamination until the end of an extensive process when the spots showed up.
Working as part of the client’s team, we designed an experiment to map the surface of the incoming raw materials. Then maintaining the original coordinate system, we sent the sample back to the customer for the next step in the processing. This approach continued through each step in the process. The key here was to understand the material distribution and to not further contaminate the sample.
Using this back and forth technique, the client’s experience with his material and Analytical Answers, Inc. experience in analysis and problem solving showed that the contaminant entered the process in the first step. Then because of the mechanical treatment of the sample, it was spread on the surface producing local “hot spots” which in the final processing step produced the black spots.