Understanding and Controlling Endotoxin in Water Systems

Why Should You Attend:

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.

Areas Covered in the Webinar:

• Where does endotoxin come from?
• What are the properties of endotoxin?
• How do you get rid of it?
• How do you detect it?
• What assay controls are used?
• What are the endotoxin specs for water?
• How do you control it?

Who Will Benefit:

This webinar will be valuable for all companies that operate Water for Injection(s) or "endotoxin-controlled" water systems, particularly for those in FDA and EMA regulated industries, including APIs, Medical Devices, and Diagnostics, Pharmaceuticals, and Biologics fields. The attendees who will benefit include:

• Engineers involved in water system design
• Utility operators and their managers involved in maintaining water systems
• QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels
• QA managers and personnel involved in investigations of excursions and preparing CAPAs
• QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
• Validation managers and personnel
• Consultants and troubleshooters

T.C Soli
President, Soli Pharma Solutions, Inc.

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc., and since becoming a full time consultant in 2004, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations. He has served as a pharmaceutical expert witness in several water-related product contamination litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience. During his 39 year career he has lectured extensively at conferences, authored numerous papers and several book and industry guide chapters related to water system microbiology for PDA and ISPE publications. He is in his 18th year as a volunteer and member of USP Expert Committees associated with pharmaceutical water and has co-authored everything currently written in USP regarding water, including all the water monographs and associated test and informational chapters.

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