ABSTRACT
This chapter provides the role of endotoxins in the validation of pure water systems. Endotoxin is a potential water contaminant of major interest to manufacturers of parenteral solutions and medical devices. Water for Injection (WFI), when suitably packaged and sterilized, is Sterile Water for Injection or Sterile Water for Irrigation. WFI is also used in the preparation of parenteral drugs. These waters have the most strict endotoxin limit for large volume parenterals. The US Pharmacopeia Bacterial Endotoxins Test replaced the Pyrogen Test and in 1983 became the official test for endotoxins in water. Endotoxins are pyrogens, substances that will cause a fever if they are introduced into blood or cerebrospinal fluid. Lipopolysaccharide is the biochemical class name for endotoxin molecule. Endotoxins are shed into water during bacterial growth or remain as part of the cell debris when bacteria die.
