This is a 3 module Webinar to be presented over a 6 hr period including a 1 hr break about half-way. 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 taken out of original contexts and 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 they are protected by the nature of that growth, it is easier to see how biofilm 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 after it is established. The key to biofilm control is to always keep it from getting out-of-control.
This webinar will review what biofilm is and how it grows, discuss specifically how it negatively affects just about every kind of unit operation used in today's water systems and how routine maintenance activities of those unit ops help to control it. It will also discuss how routine sanitization, with specific sanitizer examples, picks up where routine maintenance leaves off in controlling biofilm development, with discussions regarding mechanisms and relative efficacies of various sanitization approaches. But this webinar does not stop here. Controlling biofilm development is a big part of having a successful water system, but there are many other compliance issues that also put water systems in regulatory cross-hairs during an inspection. So this webinar will also address the regulatory issues and pitfalls that are often the focus of a water system inspection with advice on how to prepare for them. 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 3 presentations.
Module 1-Essentials of Water System Biofilm Control by Design & Operation
Module 2-Successful Water System Sanitization
Module 3-Guarding Against Common Pharmaceutical Water System Inspection Pitfalls
This webinar will be valuable for all companies that operate high purity water systems, particularly for those in FDA and EMA 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
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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>.