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The Logic of Water System Validation: Start Well, Stay Well
by Dr. Teri C. ("T.C.") Soli
Soli Pharma Solutions, Inc.
Water system validation is often perceived as a meaningless exercise, a requirement only for pharmaceuticals and stemming from pharmaceutical product recalls in the 1970's and 80's that were caused by unvalidated water systems. Back then, demonstrating consistent microbiological control at the use points was the singular objective, and the purification process was a black box that typically worked because chemical purity requirements were poorly defined. Times have changed. The USP now has water conductivity and TOC specifications, the incoming water now could have chloramines instead of just chlorine in it, and non-pharmaceutical industries are seeing the financial value of water system validation in avoiding costly maintenance, downtime, and product quality problems. Nowadays, the validation of the chemical purification process is equally important to microbial control and each affects the other. Some of the intermediate purification steps may be the only control of certain contaminants (e.g. the ammonia from chloramines). That means that this black box may have to be opened up to the rigors of validation. This process often detects errors in design that emphasize the need for competent, experienced water system designers and fabricators. This presentation is intended to show that expert water system design and fabrication is the foundation for water system "success". It will also show that well-designed water system validation protocols are cost-effective "insurance" that can be created and implemented by the users with a reasonable understanding of the chemistry and microbiology of how the unit ops are intended to work. It's really only a matter of logic and financial common sense.
Participants will receive guidance to help them determine for their own water systems the following:
- What validation attributes and specifications are important for each unit op and use point
- What sampling should be done to assess those attributes
- How long and how frequently should the validation sampling be done
- What can affect those test results and what it means
- Why poorly designed or maintained systems can't be validated and cause unending headaches
- When validation is finally over, is it really over?
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Biofilm (Presented by: Dr. Ted Meltzer)
Biofilms are formed by planktonic organisms leaving the water by attaching to a solid surface of their container or pipe. The subject is complex and differences still need to be resolved. Biofilms in water storage and distribution systems offer an ongoing threat of microbial contamination. Biofilm randomly sheds into contacting waters creating the majority of the planktonic microbial population.
No surface is exempt from biofilm formation. Surface smoothness, flow velocities, and fluorinated surfaces have little effect, and only initially. Turbulent flows compact but do not remove biofilm.
Biofilms develop in stages over time intervals of weeks to months, but they inevitably develop. Contamination by biofilm shedding is avoided by periodic sanitizations, using oxidizing agents, or heating by hot water or steam. Efforts to totally remove biofilms are unavailing and are unnecessary. Their management and control are effected by periodic sanitizations. |
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Remote / Online Monitoring
Online monitoring has become an effective way to keep a constant eye on a high purity water treatment system to keep the system operating at the designed specifications
This presentation will identify key areas that should be monitored on a purified water system as well as discuss different types of instrumentation used in the monitoring process. Examples of current monitoring techniques will be shown.
Other areas that will be discussed will be ways to notify key personnel when the system moves out of specification and how you can log and trend the data from the monitoring points. This information can be used in forecasting problems that may arise in the system operation. |
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Water Chemistry (Presented by: Charles “Chubb” Michaud)
Water is a strategic industrial “chemical”. To be applied beyond its inherent ability to float a boat or put out a fire, water must be treated to rid it of impurities that inhibit its true chemical nature and utility.
To achieve this, the water purification professional must understand the characteristics of these “impurities” and possess the knowledge of how to remove them.
This course of study will introduce the participant the basics of chemistry, common types and sources of “impurities”, how to classify them and how to interpret the data so as to develop methods of removing them.
The ultimate focus of this study is for the application of ion exchange as that method of treatment. |
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Resin Oxidation (Presented by: Charles “Chubb” MIchaud)
As ion exchange resin age, they are subject to oxidation which causes them to swell and lose capacity. Additionally, higher moisture resins have lower selectivity leading to higher leakages. Oxidation also causes a loss of actual functional sites.
Each resin installation has a break even capacity where the cost of replacement will be lower than the costs of continued operation. This presents new opportunities.
This study course will teach the participant an understanding of the methods of resin degradation with age and how to determine when it is time to replace the resin.
The ultimate purpose is to save your customer money and improving customer satisfaction. |
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Understanding BioFilm in High Purity Water Systems (Presented by: T. C. Soli)
Biofilm represents the predominate form of microbial growth on this planet. From sewage treatment plants to high purity water systems, it’s simply the way bacteria have most successfully adapted to survival. Science is slowly unraveling the mysteries underlying how these microbes manage to survive and even thrive in austere environments, such as high purity water. All the while, those who manage, monitor, and are accountable for those water systems must try to foil these microbes’ tenacity for survival.
From this presentation, you will learn in layman’s language the basics of: Where these microorganisms come from and some of their traits, How biofilm develops in pure water systems, What strategies work and don’t work and why, Ways to monitor for their presence in a water system, Why conventional plate counts underestimate the total count, and What manufacturing and health significance these microorganisms might have. |
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Membrane Fundamentals for Ultrapure Water Applications (Presented by: Jeff Campbell)
This presentation will discuss the membrane modules utilized in ultrapure water systems. Topics that will be covered in the presentation include: Membrane module and system design, Membrane performance optimization, system performance tracking.
How membrane are used for TDS reduction in chemical and heat sanitizable systems as well as polishing filters in ultrapure water loops will be review in the presentation. |
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The Ion Exchange Resin System (Presented by: Charles “Chubb” Michaud)
Industrial deionization (DI) systems are usually designed to a higher level of reliability and performance than are residential or commercial water treatment systems. To meet those expectations, the equipment provider must “engineer” a balanced system that matches the feed water analysis to the equipment and the demands of the user.
Properly “rating” the resin and using proven hydraulic designs assures that end.
This course of study will teach the participant the differences in resin types and the proper procedure for determining system load demands, resin capacities and performance levels to allow the practice of sound engineering design for developing industrial DI systems.
Operating economics for different designs will be compared to help gain familiarity and confidence. |
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The Fundamentals of Passivation and Rouging (Presented by: Patrick Banes)
This presentation will address the fundamentals of establishing, performing, and evaluating passivation procedures. Rouging formation, types, distribution within systems, removal and prevention will be discussed. How to accomplish these activities in the pharmaceutical environment and “real world” issues will be incorporated into the discussion.
Areas of interest to included: Characteristics of the chromium oxide layer, Chemicals and chemical application, Oxide Film evaluation, Developing effective passivation procedures, System preparation, Documentation, Rouge formation, Types of rouge, Rouge removal, System preventative maintenance, and Disposal of waste solutions |
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Case Studies
As new technology enters the field of high purity water treatment, many companies are hesitant to try something that is different from what they are accustom. Often Pureflow will install pilot systems to help ease the concerns of the client. Pureflow works with the client and shares all data obtained from the operation of the system. After reviewing the data, we assist the client to help them decide if this the correct system for them.
This presentation will take systems that have been used as pilot studies, review the objective of the installed system and show the data that was obtained. This information can be used to make evaluation for similar situations for another client. |
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