Water System Compliance - What Makes Water Systems Have Microbial Quality Problems

Most people who design, maintain, and monitor high purity water systems have heard of biofilm and a few "rules" about how to control and monitor it. Unfortunately, many of these "rules" such as flow rates, dead legs, surface smoothness and the like are either only half right or frankly wrong. Once there is an understanding of the basics of how biofilm really develops on surfaces and how that protects it, it is easier to see how it can impact the operability of various unit operations in a water system and why it is so hard to control and even to monitor accurately.

This presentation will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems. It will also cover the various principles or "rules" now used and why they may be mis-applied and often inappropriate, as well as what kinds of approaches do work to control it and monitor it. This presentation is also intended to be interactive to the extent that your specific questions can also be addressed if they haven't already been covered by the presentation.

Areas Covered in the seminar:

• Understand biofilm basics and how it develops.
• Understand the impact of biofilm on the commonly used purification unit operations.
• Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development.
• Understand the how, where, and why of microbial monitoring, action levels, etc.
• Debunk a few water system microbial control myths.
• Get answers to your own water system questions.

Who will benefit:

This webinar will be valuable for all companies that operate high purity water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees 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.

Instructor Profile:

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and has been consulting full time for 5 years, serving consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. Prior to consulting, he had 25 years of diverse "Big Pharma" operating company experience.

During his 30 year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for PDA and ISPE publications. He is currently Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>.

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