Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

Why Should You Attend:

Many water systems have been designed and are monitored using a set of rules taken out of context and in fact may be downright wrong or at least misguided -- what the author calls "Water System Myths".

Is your water system one of them? If it is, what can you do to make sure the system operates as intended, in spite of its non-optimal design? What can you do to optimize the testing? Attend this webinar and find out how we got into this predicament and what we can do to get out of it and begin building and operating efficient and effective water systems.

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your own "rules of thumb" are actually based on “ Water System Mythology ”!

Areas Covered in the Seminar:

• Why water myths develop.
  • Impact of c-GMPs
  • Well-meaning but misguided precedents
  • Scientifically unchallenged traditions and benchmarking
  • Rule-hungry culture
• Water System Microbial Control Myths.
  • WFI from RO
  • Turbulent Flow and Flow Rate
  • Dead Leg Rules
  • Smooth Surfaces
  • In-Line Sterilizing Filters
  • Ozone
• Microbial Enumeration Myths.
  • Referee Methods
  • Thermopiles in Hot Systems
  • R2A, 35°C, 5 days
  • Test Filter Membrane Rating
  • Compendial Action Levels
  • TOC and Endotoxin as Microbial Count Correlates

Who Will Benefit:

This webinar will be valuable for all companies that operate WFI or Purified 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:

• Validation managers and personnel
• Engineers involved in water system design and installation
• Utility operators and their managers involved in maintaining and sanitizing water systems
• QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
• QA managers and personnel involved in investigations of excursions and preparing CAPAs
• QC laboratory managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
• Consultants and Troubleshooters

Instructor Profile:

Dr. Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP’s Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE’s Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.