Water System Biofilm Control and Microbial Monitoring Myths

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Category water System design, Laboratory Managers, EMEA Inspectors, Validation Managers

Deadline: March 04, 2019 | Date: March 05, 2019

Venue/Country: Online, U.S.A

Updated: 2019-01-31 18:12:29 (GMT+9)

Call For Papers - CFP

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.