Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
Why should you attend:
Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.
Who will benefit:
This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:
- Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
- Quality Assurance personnel responsible for water system deviation management and change control
- Regulatory and Compliance professionals responsible for FDA interactions
- Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
- Facility Engineers responsible for water system design or renovation
- Validation personnel for water system qualification
- Change Control personnel involved in water system changes and repairs
- Production Managers involved with water system use for manufacturing and cleaning
- Laboratory Managers and Supervisors responsible for lab water systems and other water sources
Day 1 Schedule
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
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
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?
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
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
Day 2 Schedule
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?
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
Microbial Enumeration Issues with High Purity Water Systems
- 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
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
What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues
- PW, WFI, Pure Steam micro specifications?
- <1231> Starting water issues
- <1231> Misunderstood issues clarified
- <1231> Microbiological test issues clarified
- <1231> Suggested micro test method
- <1231> Micro Specifications
- <1231> Alert and Action Levels and max's
- Recent/Upcoming USP water changes
- Discrepancies between pharmacopeia's
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Principal Consultant, Soli Pharma Solutions
Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.
He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.
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