Water Systems 2012 - The A to Z’s of Microbial Control, Montoring, Validation and Trouble Shooting of Pharmaceutical Water Systems

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. 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".
Lecture 1: What Makes Water Systems Have Microbial Quality Problems
? Understand biofilm basics and how it develops
? Understand the impact of biofilm on the commonly used purification unit operations
? Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
? Understand the how, where, and why of microbial monitoring, action levels, etc.
? Debunk a few water system myths
? Get answers to your own water system questions
Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality
? Material and construction limitations
? Continuous vs intermittent sanitization
? The importance of biofilm removal
? How sanitants work (or don't work)
? When to sanitize
? Troubleshooting sanitization problems
Lecture 3: Water System Validation by Logic Instead of Tradition
? Why validate a water system?
? Basic ground rules for water systems before you validate them
? Micro Test Method "validation"
? Minimum validation expectations
? How to figure out what you should validate
? What happens after the honeymoon is over
? Is validation ever really over?
? Special considerations for lab water systems
? Are packaged waters a viable option?
Lecture 4: Implementing Changes to a Validated System
? Purpose of a Change Control program - a help, not a hindrance
? When is a change major vs minor, requiring full vs limited re-qualification?
? What about water use during re-qualifications?
? FDA validation expectations
? Reliance on logic and common sense and the disservice of precedent and paradigms
? Additional useful tips
Lecture 5: Reducing Water Microbial Excursions & Improving Investigations
? What are excursions?
? Water system dilemma: process control or quality control (utility or raw material), or both
? Intended roles of Alert/Action Levels and Specifications
? Investigation, necessary and often fruitless
? Excursion responses and impact
? Criticality of valves, hoses, & outlet flushing
? Diagnosing the source of the problem
? Minimizing unnecessary excursion responses through best practices
Lecture 6: Understanding and Controlling Endotoxin
? Where does endotoxin come from?
? What are the properties of endotoxin?
? How do you get rid of it?
? How do you detect it?
? What assay controls are used?
? What are the endotoxin specs for water?
? How do you control it?
Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
? Water harmonization that has occurred
? Water Micro TM "Dis-Harmonization"
? A little about Biofilm
? Biofilm diversity in water systems
? Micro TM options and evaluation protocol
? The good and bad of Micro harmonization
? Where RMMs can fit in
? Parting wisdom
Lecture 8: Microbial Enumeration Issues with High Purity Water Systems
? Biofilm enumeration issues (planktonic vs surface)
? Traditional cultivative approach issues
? Validation of your test method
? Alternative TM choices (advantages/disadvantages)
? Significance of water isolates
? Sampling issues
? Establishing Alert/Action Levels and Water Specs and defending them to FDA
Lecture 9: Water System Investigation "How-To's" and Example Case Studies
? Gathering and assessing existing data and symptoms
? Considering user opinions
? Investigation approach elements
? Recognizing red herrings/false positives
? Recognizing possible root causes
? Water system contamination case studies
? Parting kernels of water system wisdom
Lecture 10: What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues
? PW, WFI, Pure Steam micro specifications?
? Starting water issues
? Misunderstood issues clarified
? Microbiological test issues clarified
? Suggested micro test method
? Micro Specifications
? Alert and Action Levels and max,s
? Recent/Upcoming USP water changes
? Discrepancies between pharmacopeias
? New water initiatives - need your input/feedback