GXP

Addressing Bacterial Endotoxin Contamination Incidences in WFI Systems: A Review of Case Studies

Endotoxin refers to a component of the outer cell membrane of Gram-negative bacteria. The endotoxin complex contains many cell wall components including phospholipids, lipoproteins, and lipopolysaccharides. Lipopolysaccharide is a hydrophobic molecule and the biologically active portion of naturally occurring endotoxin complexes (1.) One portion of liposaccharide called Lipid A can exert a powerful biological response modifier that can stimulate the mammalian immune system, triggering a pyrogenic response (fever) or endotoxic shock (2.) The pathological effects of endotoxin, when injected, are...

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