Water System Validation in Pharmaceuticals Industry 2017

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries

OVERVIEW:

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

AGENDA:

Day One

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

Day Two

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

• 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?
• <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

SPEAKER:

Teri C. Soli, Ph.D. Principal Consultant, Soli Pharma Solutions

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering training, auditing, and troubleshooting expertise covering water systems, contamination control, sterilization, aseptic processing, and microbiological laboratories. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

Dr. Soli's career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

He is beginning his fourth 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide as well as coauthor USP's comprehensive "water bible', Chapter <1231> "Water for Pharmaceutical Purposes". As a recognized global expert in contamination and biofilm control in the pharmaceutical setting and accomplished presenter, Dr. Soli speaks at numerous conferences and webinars. He has authored numerous articles in Pharmacopeial Forum and other publications as well as chapters in books and industry guides published by PDA and ISPE.

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