Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
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Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
Though some excursions are real and a sign of system control problems, most are probably self-inflicted, being caused by poorly designated "trigger values", poorly designed use points, or poorly executed sampling or testing. This presentation will explore these possible causes, including the symptoms of real (as well as false) water system problems, and provide effective alternatives to avoiding most of your current superfluous excursions, as well as how to build supporting data useful in pinpointing causes when investigations are indeed necessary.
Why Should You Attend:
When was the last time you performed a water system excursion investigation and could not definitively conclude the root cause? If you are like most firms, this scenario was probably your most recent experience, happens quite often, and frankly, is probably completely unnecessary. Most excursions are usually caused by self-inflicted phenomena. This presentation will discuss the most common causes of microbial excursions in water systems and how they can easily be avoided with minimal effort. Just think of the resources, production downtime, product losses, and cost you could save by making a few rational changes to your action "trigger values", sampling and testing, while still being able to (more clearly now) see real system problems when they do occur. You simply cannot afford to not tune in to this valuable webinar!
Areas Covered in the Session:
Who Will Benefit:
- What are excursions?
- Water system dilemma: process control or quality control (utility or raw material), or both
- Intended functions 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
The employees who will benefit include:
- QA managers and personnel involved in investigations of excursions and preparing CAPAs
- QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
- Utility operators and their managers involved in maintaining and sanitizing water systems
- Validation managers and personnel
- QA managers and other personnel involved in Change Control programs
- QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
- Consultants and Troubleshooters
T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
His career-long water systems and contamination troubleshooting experience, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is in his 17th year on USP Expert Committees responsible for Pharmaceutical Water and has co-authored everything related to water in USP. He previously served for 18 years on the PhRMA Water Quality Committee who achievements included creating the Water Conductivity and TOC specifications used in USP Purified Water and Water for Injection and adopted world-wide.
Dr. Soli is a recognized global expert in contamination and biofilm control in the Biopharmaceutical, Medical Device, and Personal Care Product Industries and has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.