3 Hours Virtual Seminar: Understanding and Controlling Biofilm - Preventing Water System Microbial Problems

T C Soli

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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 misapplied 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 have't already been covered by the presentation.

Course Objective

  • Poor microbial control in water systems is usually caused by a poor understanding of biofilm.                                                                        
  • Poor microbial control in water systems is usually related to poor system design, poor maintenance practices or poor process control levels that allow biofilm development.                                                                                
  • Poor microbial control in water systems will eventually lead to process or product microbial contamination, that may in turn lead to high product reject rates, product recalls, regulatory scrutiny, and financial losses due to potential injury litigation and damaged company image.                                                                                                       
  • Cheaply constructed water systems are probably more costly than more expensive water systems in the cost of ongoing maintenance, excursion investigations, and product losses.
  • Using good design and maintenance practices will eliminate water system biofilm problems, but do you know what those practices are?

Course Outline

  • Microbial control – where and why it matters
  • Biofilm basics and how it develops
  • Biofilm impact on “active” surfaces
  • Environmental resistances of biofilm
  • Biofilm impact on purification unit operations and how to control it
  • Good design practices to control biofilm
  • Good maintenance practices to control biofilm

Target Audience

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

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: T C Soli,

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc., and since becoming a full time consultant, 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, and has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time 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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