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Pharmaceutical Water System Microbiology Everything You Need to Know
Presented by T. C. Soli, Ph.D.
USP Pharmaceutical Water Expert Committee Member* and Vice Chair** *2000-2005 and **2005-2010
Dates Available: Nov 23, 2010 - Nov 24, 2010, Jun 14, 2011 - Jun 15, 2011
Cost: $895.00 + GST
Location: 200 Consumers
Road, Suite 200, Toronto, Ontario
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Abstract:
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. 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. The instructor can provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance 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.
Course Outline
In order to understand the microbiology of a water system, one has to understand biofilms since that is the mode of microbial growth in a water system. There is much hype and fear about water systems biofilms by users and regulators alike who do not understand how they grow, how to effectively control that growth, or even how to monitor their presence. This course will help you understand how microorganisms respond to our efforts (or lack of effort) to control their numbers and even to how we try to count them.
A key resource for this course is the latest revision of the USP informational chapter on water <1231> “Water for Pharmaceutical Purposes”, first published in Supplement 2 to USP28 and current through USP 32. The course instructor is the primary author of that revised chapter.
- The “real” story behind some common water system design and control myths
- Biofilm properties and examples
- Biofilm resistances and susceptibilities
- Where biofilm grows in water systems and how it affects each unit operation
- How routine water system maintenance impacts biofilm growth/removal
- Water system microbial enumeration issues
- USP’s view on sampling and microbial enumeration
- Microbial enumeration options/advantages/disadvantages
- How to chose the best microbial enumeration method and “validate” it
- Significance of biofilm microbes
- Patient impact
- Product impact
- Water system impact
Distinguished Faculty
Teri C. (“T.C.”) Soli, Ph.D.
President
Soli Pharma Solutions, Inc.
Dr. Soli has been consulting for 12 years, serving the pharmaceutical, biological, and medical device industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. He has 29 years of diverse pharmaceutical experience beginning with Pfizer and ending with DSM Pharmaceuticals (formerly Catalytica, Glaxo Wellcome, and Burroughs Wellcome) before moving into full time consulting. That experience spanned the disciplines of Chemical and Microbiological Development, Quality Operations, Aseptic Process and Sterilization Validation, Regulatory Affairs, and Project Management. His career-long involvement with pharmaceutical microbiology and participation with pivotal industry water committees, coupled with his extensive consulting experience afford him valuable practical knowledge of all aspects of contamination control, quality operations, microbiological testing, and high purity water systems with an ability to troubleshoot complex microbiological issues and communicate the results and recommendations. He has lectured extensively and authored numerous papers and several book chapters for PDA and ISPE publications, and is Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he has authored or co-authored several USP Monographs, and Chapter revisions, including his complete rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>. Prior to this, he served on the PhRMA Water Quality Committee that derived the now globally used USP Water Conductivity and TOC tests and specifications. He holds B.S. and M.S. degrees in Microbiology from Texas A&M University and a Ph.D. in Microbiology and Immunology from the University of Arizona.
Learning Objectives:
At the completion of the course, attendees will be able to:
- Understand the role of system design and maintenance in controlling microbial levels
- Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems
- Devise water system validation protocols that truly validate microbial control
- Validate your microbial test method
- Develop sound Alert and Action Levels and Water Specifications
- Defend your test method, in-process control levels and specifications to FDA
Who Should Attend
- Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
- Quality Assurance personnel responsible for water system deviation management
- Regulatory and Compliance professionals responsible for FDA interactions
- Process and Utility Engineers responsible for water system maintenance
- Facility Engineers responsible for water system design or renovation
COURSE LOCATION
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J
4R4
tel: 416-502-2277
www.aaps.ca
*Registration Fee Includes:
Presentation Materials, Luncheon, Refreshment and
Free Parking
*Please indicate any special Dietary requirements
when registering for the course
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