Water System Biofilm Control and Microbial Monitoring Myths

Product Id : 600874

Globalcompliancepanel

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

Overview:

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 "rules of thumb" are actually quite wrong!

Areas Covered in the Session:
  • 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
    • Thermophiles 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
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and is a consultant serving consumer products and FDA-regulated industries with training and contamination troubleshooting expertise covering water systems, sterile and non-sterile products and processes, and microbiological laboratory operations. Prior to full time consulting starting in 2004, he had 25 years of pharmaceutical operating company experience. He has lectured extensively at conferences and webinars, authored numerous papers and written several book chapters related to water system microbiology and biofilm control for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters during which he completely rewrote USP Chapter <1231> which many consider to be USP's "pharmaceutical water bible".


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