Water System Mythology: Common False Beliefs for Microbial Control and Monitoring 2019

Topics

• Water System Microbial Control Myths
  • Turbulent Flow and Flow Rate
  • WFI from RO
  • Smooth Surfaces
  • Dead Leg Rules
  • Ozone
  • In-Line Sterilizing Filters
• Why water myths develop
  • Well-meaning but misguided precedents
  • Impact of c-GMPs
  • Rule-hungry culture
  • Scientifically unchallenged traditions and benchmarking
• Microbial Enumeration Myths
  • Thermophiles in Hot Systems
  • Referee Methods
  • Test Filter Membrane Rating
  • R2A, 35°C, 5 days
  • TOC and Endotoxin as Microbial Count Correlates
  • Compendial Action Levels

Who should Attend

• Engineers Involved in Water System Design and Installation
• Validation Managers and Personnel
• QA Managers and Regulatory Affairs Personnel involved in Defending Water System operations and Quality Data to FDA and EMA Inspectors and Outside Auditors
• Utility Operators and their Managers involved in Maintaining and Sanitizing Water Systems
• QC Laboratory Managers and Personnel involved in Sampling, Testing, and Trending Chem and micro data from water systems
• QA Managers and Personnel Involved in Investigations of Excursions and Preparing CAPAs
• Suppliers of Water System Equipment
• Consultants and Troubleshooters
• Suppliers of Microbial Testing Equipment and Growth Media
• Suppliers of Water System Sanitization Processes and Chemicals