The manufacture of pharmaceuticals can be a complex process, involving various raw materials, numerous steps of production, and many stages where failure can occur. One type of failure encountered in the production of a drug product is unintentional introduction of foreign particulate into a drug product. Having an understanding of process, raw materials, and various steps of production can help to identify potential sources for contaminants.
A pharmaceutical manufacturer, through visual inspection, identified a dark particle within a parenteral drug product. The company isolated the material, and sent it to Gateway Analytical for not only identification, but also, comparison to probable sources from the filling room. These materials include a liner from a cart, a sample of the flooring, and plastic cap. Initially, microscopy (optical and fluorescence) of the materials in question was performed.
Gateway Analytical had the ability to not only aid in the identification of foreign particulate,
but also to help identify likely sources for those contaminants.