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Recently, problems related to product quality of pharmaceuticals and medical devices have arisen. 80% of the problems are caused by contamination. We investigate the causes of contamination using our foreign matter retrieving technique by micromanipulator system and high-sensitivity composition analysis by scanning infrared microprobe system (IRμs/SIRM) and electron probe X-ray microanalyzer (EPMA).

Features 1. Only micro foreign matter is retrieved from a sample matrix and analyzed. 2. Micro foreign matter having a particle size of approx. 10μm can be analyzed. 3. Foreign matter included in liquid preparations and emulsions can be analyzed.   Retrieval of foreign matter by micromanipulator Before retrieval After retrieval Optical microphotograph of foreign matter   Example of analysis by EPMA and IRμs/SIRM   It was revealed that the main components of the   micro foreign matter were amide compounds (nylon, etc.). EPMA spectra

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