Parenteral Solutions: Nature of Particulate Matter

An investigation on the level and nature of particulate contamination in 36 large volume injectable solutions produced in Italy was performed, using Scanning Electron Microscopic (SEM) and X-ray microanalitic (EDS) techniques. Wide variability of the contaminant level, even within each individual batch, was observed. About 20% of the samples revealed a considerable amount of contaminants greater than 20 μm. Fibers of presumably textiles, cellulose or plastic materials were detected. Other particulate matter, from manifacturing and packaging processes, were observed.