Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
More Trainings by this Expert
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:
Who Will Benefit:
- 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
- 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 EMA 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
- Suppliers of Water System Equipment
- Suppliers of Water System Sanitization Processes and Chemicals
- Suppliers of Microbial Testing Equipment and Growth Media
T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. and for the past 16 years has offered troubleshooting consulting and training services covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 42 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Catalytica Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
He has served the past 20 years as a member of USP Expert Committees responsible for everything related to high purity water in USP/NF. He continues to serve USP with his water expertise in the role of Expert Advisor. He is an Approved USP Instructor, and in addition to this Pharmaceutical Water course, has given multiple webinars for Compliance4All as well as the USP Education Department. He previously served for 18 years on the PhRMA Water Quality Committee whose achievements included creating the Water Conductivity and TOC specifications used in USP Purified Water and Water for Injection since 1996 (USP 23, Supplement 5) and since adopted world-wide.
Dr. Soli is a recognized global expert consultant, speaker, and trainer in contamination and biofilm control in the Biopharmaceutical, Medical Device, Personal Care Product, and Beverage Industries and has coauthored 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.