2003:8: Miller, Vander Wood
Microsc Microanal 9 (Suppl 2)
Pharmaceutical and biopharmaceutical companies are frequently faced with particulate problems observed during routine Quality Assurance inspection or products returned as customer complaints. Microanalysis is useful in characterizing the contaminants to determine the origin and whether they are related to a raw material, the manufacturing process, or another type of contaminant, including adulterants. This paper highlights selected case studies of how microanalysis is used to identify particulate materials in the pharmaceutical industry and solve process related problems in the biomedical industry.
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