Webinar 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 payment)
SPEAKER: T.C. Soli,
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. (www.solipharmasol.com), 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 31+ year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter which many consider to be USP’s “pharmaceutical water bible”.
