Water System Biofilm Control and Microbial Monitoring Myths 2019

Key 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 EMEA 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
• Consultants and Troubleshooters