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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
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
Speaker Profile
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
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