Most people who design, maintain, and monitor WFI systems have heard of biofilm and know a little about endotoxin, but may not realize where it can come from in the water system, how to control those sources, or how to "clean up" endotoxin once it has contaminated water, APIs, or equipment. In spite of a superficial knowledge about the bacterial origin of endotoxin, they may not realize the diversity of its composition and potency from various bacterial sources, how it behaves in water, as well as the medical complications it causes, which is the reason behind the various endotoxin specifications for the compendial bulk and packaged waters or the molecular amplification mechanisms behind the relatively simple-to-run but exquisitely sensitive and easily compromised LAL test.

This presentation will cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water and possibly into finished products, and where to implement effective corrective actions.

Most people who design, maintain, and monitor WFI systems have heard of biofilm and know a little about endotoxin, but may not realize where it can come from in the water system, how to control those sources, or how to "clean up" endotoxin once it has contaminated water, APIs, or equipment. In spite of a superficial knowledge about the bacterial origin of endotoxin, they may not realize the diversity of its composition and potency from various bacterial sources, how it behaves in water, as well as the medical complications it causes, which is the reason behind the various endotoxin specifications for the compendial bulk and packaged waters or the molecular amplification mechanisms behind the relatively simple-to-run but exquisitely sensitive and easily compromised LAL test. This presentation will cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water and possibly into finished products, and where to implement effective corrective actions.