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
- 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
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.
His career-long water systems and contamination troubleshooting experience, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is in his 17th year on USP Expert Committees responsible for Pharmaceutical Water and has co-authored everything related to water in USP. He previously served for 18 years on the PhRMA Water Quality Committee who achievements included creating the Water Conductivity and TOC specifications used in USP Purified Water and Water for Injection and adopted world-wide.
Dr. Soli is a recognized global expert in contamination and biofilm control in the Biopharmaceutical, Medical Device, and Personal Care Product Industries and has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.