Microbiological contamination of raw materials for large-volume parenterals.

A wide range of raw materials used for the production of large-volume parenterals were tested for their content of bacteria, molds, yeasts, and endotoxins. All raw materials were relatively free of microorganisms, although some mannitol samples contained relatively high amounts of endotoxin. The low endotoxin content of the other raw materials did not require the use of depth filters to remove endotoxins to prepare pyrogen-free infusion fluids.