Pharmaceutical Water System Use & Monitoring

Why Should You Attend:

Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly inconclusive problem investigations. At the heart of the problem is a fundamental misunderstanding of the purposes and practice of sampling and testing, and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination.

This presentation will correct these misunderstandings and explain practical best practices for outlet use and sampling to reflect the true water quality, including grab samples and on-line testing, that could pave the way to adoption of dramatic resource saving Real-Time Release approaches for BOTH chemistry and microbiological attributes of these waters.

Learning Objectives:

• Dispel mistaken paradigms regarding the purpose of sampling.
• Understand how to eliminate sampling variability – the cause of most deviations.
• Understand how to best deliver water from a high purity water distribution system.
• Capitalize on the advantages of on-line analytical instrumentation.
• Understand the value and limitations of rapid microbiological methods as replacements for slow cultural approaches.
• Understand what it would take to transition to Real-Time Release of water.

Areas Covered in the Seminar:

• Importance of proper sampling.
• Process or Raw Material?
• Uses of water sampling data – PC or QC?
• Data use impact on sampling locations for.
  • Chemical testing
  • Endotoxin testing
  • Microbial testing
• Data use impact on microbial sampling techniques.
• Sampling plan options.
• Test method options.
• Practicality of real time release.

Who Will Benefit:

This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to water:

• Quality Assurance/ Quality Control (Chem and Micro)
• Process and Design Engineering
• Process Automation
• Manufacturing Operations
• Validation
• Utility Operations
• Regulatory Affairs

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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