Bacterial endotoxin presents a risk to several classes of pharmaceutical product, with parenteral products at the greatest risk. Bacterial endotoxin is the lipopolysaccharide (LPS) component of the cell wall of Gram-negative bacteria. It is pyrogenic and it is a risk to patients who are administered intravenous and intramuscular preparations. The pathological effects of endotoxin, when injected, are a rapid increase in core body temperature followed by extremely rapid and severe shock. In some cases, death can occur.
This is the topic of a new paper by Tim Sandle.
The reference is:
Sandle, T. (2016) Control of WFI and Clean Steam Systems for Bacterial Endotoxins, Journal of GxP Compliance, 20 (4): 1-15
For further details, contact Tim Sandle
Posted by Dr. Tim Sandle