Full Day Virtual Seminar: Understanding and Effectively Controlling Biofilm in Pharmaceutical Water Systems

Why Should You Attend:

This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control.  It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA.

Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you.

Duration:

6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule.

Agenda (times Eastern)

• 10:00am (7am Pacific)-11:30 Module 1: Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)
• 11:30-1:00pm Module 2: Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)
• 1:00-2:00 Lunch hour
• 2:00-3:30 Module 3: Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement (1:30)
• 3:30-3:45 Afternoon break
• 3:45-5:15 Module 4: Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)
• 5:15-5:30 Q&A

Syllabus:

1. Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)

Interactive discussion that presents the basics of biofilm development and the mechanisms behind its detrimental effects on water systems and why it is so hard to control

• Common biofilm examples
• Biofilm basics and how it develops
• Biofilm organism types in high purity water
• Biofilm impact on “active” surfaces
• Environmental resistances of biofilm
• Biofilm impact on purification unit operations
• Debunk a few water system myths

2. Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)

Interactive discussion that presents the reasons why sanitizations sometimes fail, the properties of commonly used sanitants, their relative efficacy, and how to use them.

• 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

3. Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement (1:30)

Interactive discussion of the fundamentals of water system validation with emphasis on what must be done in advance before validation commences as well as the typical content of each stage in the process, how lab water system validation can (and usually should be) different from manufacturing water systems, and whether using packaged waters is a reasonable alternative to a water system for a small volume user.  This module also presents the basics of Pure Steam systems validation and what attributes are appropriate to validate

• Why validate a water system?
• What you should know and do before you validate
• Figuring out what you should validate
• Validation elements and phases
• Minimum validation expectations
• What happens after the honeymoon is over
• Is validation ever really over?
• Special considerations for lab water systems
• Packaged water options
• Pure Steam specification & validation considerations
• Pure Steam testing & troubleshooting considerations

4. Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)

Interactive discussion of how the use of more thorough sampling directions, appropriately set microbial control levels and specifications, and appropriate test controls and environmental monitoring during testing and sampling will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

• 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

Who Will Benefit:

• Engineers responsible for water system design and fabrication
• Maintenance personnel responsible for water system maintenance and sanitization
• Microbiological personnel involved in collecting and testing water system samples
• Validation personnel involved in writing and executing water system validation protocols
• Quality Assurance professionals involved in deviation investigations and oversight/approval of all other water system activities as well as those involved in defending water system issues to regulatory investigators who may or may not be water experts themselves
• Regulatory Affairs professionals involved in describing water and water systems in regulatory filings and also those involved with regulatory inspections
• Managers and supervisors of all these disciplines who need to understand what makes water systems unique design, control, monitoring, validation, and investigative challenges.

Instructor Profile:

Dr. 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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