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Water and Steam Baseline Guide +
Water/Energy/Cost Savings Measures
Nissan Cohen
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Introduction to the Guide Update
• Brief background
• Why Revise the Guide?
• Revision Team
• Revision Guidelines
• Large and small changes
• Next Steps
• Saving Water/Energy/Cost
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First Edition
January ‘01
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Original Water & Steam Guide
Background from 2000
• FDA Foreword included
• Sponsored by ISPE Advisory Council• Guidance provided by Steering
Committee
• 23 Team members
• 10 Chapters, 214 pages with appendix
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Original Guide Overview
Section Title Number of Pages
Forward Forward 9
Chapter 1 Introduction 3
Chapter 2 Key Design Philosophies 9
Chapter 3 Water Options & System Planning 10Chapter 4 Treatment Options 11
Chapter 5 Final Treatment Options:Compendial & Non-Compendial PW
15
Chapter 6 Final Treatment Options: WFI 11
Chapter 7 Pharmaceutical Steam 19
Chapter 8 Storage & Distribution Systems 33
Chapter 9 Instrumentation & Control 8
Chapter 10 Commissioning & Qualification 5
Appendix Appendix 81
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• Difficulty with FDA approval ofcontent• Much of the original work was modified,
deleted or moved to appendix to gainFDA concurrence
• ≈ 38% of guide is appendix
• FDA reviewers and Guide Authors with strong opinions
• Extensive delays
Original Guide
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Forwardfrom
First Edition
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Why Update Water and Steam Baseline Guide?
• Baseline Guide widely recognized asauthoritative
• Some content needs updating
• USP revised significantly (Pure SteamMonograph)
• Written over a decade ago, technology changes
• Recently released guidelines created gaps
(e.g., ASTM, BPE, C&Q GPG)• Incorporation of Global Standards (e.g. EP,
WHO, JP)
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Why Update Water and Steam Baseline Guide?
• Additional content / information required• Laboratory water
• Rouge
• Microbiology• Overall Improvements
• Reorganized for flow of information
• Elimination of duplication and errors
• Industry acceptance and perception
• Risk Based Approach
• Lean Manufacturing
• Water/Energy Conservation
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Revision Team (52 members)
Cameron Sipe, Subject Matter Expert - Critical Utilities, WyethCarl Roe, Technical Leader Water Systems, Abbott
Nissan Cohen, Owner, Start-up Business Development
Gary Zoccolante, Pharmaceutical Technical Mgr, Siemens
Water Technology
Andrew W. Collentro, Technical Director, Water Consulting
Specialists, Inc.
Joseph J. Manfredi, President & CEO, GMP Systems, Inc.
Michael Holland, Product Manager, GE Water & Process
Technologies
Robert Vecchione – VP Sales & Marketing, Christ Water
Technology Americas
Bruno Rossi Product Manager, Millipore Bioscience Division
Anders Widov Managing Director, FR Pharma
Peter T. Vishton, SME Pharma Water Systems, Wyeth
Bill Alkier Product manager, Paul Mueller Company
Sharif Disi VP Product Development, MECO
Timo Heino, Product Mgr Pure water & Steam. STERIS Finn- Aqua
Brian McClellan Commercial Sales Mgr, Aqua-Chem, Inc.
Robert M Augustine Engineering Consultant, Eli Lilly and
Company
T. C. Soli Ph.D. President, Soli Pharma Solutions, Inc.
Philip E. Sumner SME, Pfizer Global EngineeringMichelle M. Gonzalez Corp. Engineer (retired), Amgen Inc.
Bruno Rossi WW Group Product Manager, Millipore
Paul Whitehead Ph.D. ELGA LabWater
Drew Coleman Biodynamics, Inc.
Patrick H. Banes Astro Pak Corporation
Sunniva Collins Swagelok Technology Services Co.
Bill Huitt W. M. Huitt Company
Ken Kimbrel UltraClean Electropolish, Inc.
Peter Petrillo Millennium Facilities Resources, Inc.
Daryl Roll Astro Pak Corporation
James “Jim” Vogel, Process Facilities Services, Inc.
Dr. Anthony Bevilacqua, Mettler Toledo Thornton
Alex J. Konopka Eng. Consultant, Eli Lilly and Company
Graham C. Wrigley Ph.D. Senior Manager/Team Leader,
Global Quality Operations Center, Pfizer Inc.
Jay C. Buffi Sr. Mgr/Team Leader, Pfizer Inc.
Rostyslaw Slabicky Senior Associate Director, BoehringerIngelheim Pharmaceuticals Inc.
Annelie Hultqvist, QA / Validation Manager, Christ Nishotech
Water Systems Pvt. Ltd.
Thomas Beck Associate Director Pharmaceutical & Process
Quality Assurance, AstraZeneca R&D
Carla Garvin Thomann, Engineering Technician, Wyeth
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Revision Team ContinuedEuropean Team Chapter 10 Andreas Marjoram Bayer Healthcare AG
Wolfgang Fischer Bayer Healthcare AG
Christian Stark Christ Water Technology Group
Manfred Seifert Christ Water Technology Group
Bruno Walcher Merck Serono
Holger Lettnin NNE Pharmaplan
Martin Naegelin ChemgineeringMike Saltz Ateco Services AG
Roland Thoendel, Baxter
Stefan Raabe, Mettler-Toledo Thornton
Tanja Loehe, Veolia Water
Thomas Bischof, Foster Wheeler AG
Birgit Lorsbach, Bayer Technology Services
Michael Renner , Bayer Technology Services
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Chapter Leaders
1. Introduction Cameron Sipe/Carl Roe2. Key Design Philosophies Cameron Sipe/Carl Roe
3. Water Options and System Planning Andrew Collentro
4. Pretreatment Options Andrew Collentro
5. Final Treatment Options: Gary Zoccolante
Non-compendial and Compendial PW
6. Final Treatment Options: Peter VishtonWater for Injection
7. Pharmaceutical Steam Sharif Disi
8. Storage and Distribution Systems Cameron Sipe
9. Laboratory Water Phil Sumner
10. Rouge Michelle Gonzalez
11. Instrumentation and Control Nissan Cohen
12. Commissioning and Qualification Al Konopka
13.Microbiological Considerations TC Soli
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Revision Guidelines
• Chapter Leaders had the same set of basic directions• Emphasize “revision” not “rewrite”.
• Purpose of revision is to update the document, removeduplication, and fine tune.
• Avoid imperative words like “all, shall, must” but utilize “many,could, and typical”.
• The revision process is a team effort, do not dominate the group.
• All chapters managed differently based on strengths• Some divided the chapter based upon individual strengths.
• Entire group reviewed the chapter and revisions made during
conference calls.• Group members provided input to leader who then made
revisions.
• Leaders personality impacted performance.
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2nd Edition Completion Status
Received approx. 900 comments
Comments addressed and revisions made
Responses provided to reviewers
2nd Edition is approx. 270 pages
Reviewed by ISPE Technical Documents Committee
Sent for FDA review July 2009
Published December 2011
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Significant Changes
• New chapters
• Laboratory Water (Phil Sumner)
• Rouge (Michelle Gonzalez)• Microbiology (T. C. Soli)
• Incorporation of Appendix material
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Summary of Revisions (Chp. 1-4)
• Introduction: revised for consistency with otherbaseline guides and new content.
• Key Philosophies: clarified the correlation
between design and operating ranges as wellas alert and action levels.
• System Options and Planning: expanded toinclude EP and JP requirements.
• Pretreatment: enhanced to includepretreatment options utilized globally andoptions for water conservation.
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Summary of Revisions (Chp. 5-6)
• Final Treatment PW: enhanced to include final
treatment options for highly purified water and
new / improved final treatment technologies.• Final Treatment WFI: revised due to
Pharmacopoeial revisions on WFI production
including the EMEA reflection paper.
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Chapter 7: Pure Steam
• Incorporation of USP Standards
• Prepared from water meeting EPA
Drinking Water Standards or
equivalent EU or Japanese guidelines.• No added substance
• Pure steam quality is determined by
the attributes of its condensate.• Steam “Dryness” and amount of “Non-
condensable Gasses” are determined
by the application. - Different from EP
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Chapter 7: Pure Steam
• Incorporation of International Standards
• Pure or Clean steam – EP
• Meets EP sterilizer guidelines of EN 285 andHTM 2010 for dryness and non-condensable
gases
• Incorporation of ASME BPE guidance
documents.• Defined industry baseline practices on
types of steam and applications.
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Chapter 8: Storage & Distribution
• Content rearranged into logical sequence
• General Overview
• System Components
• Microbial Concerns
• Design Examples
• Content Simplified or Moved
• Installation Materials and Methods Referenced to other
Industry Standards (e.g. BPE)
• Microbiological moved to separate chapter• Enhanced Design Examples
• Better Graphics
• Definitive Advantages / Disadvantages
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Chapter 8: Section Example
8.3.1 TanksWhen properly designed, storage vessels can offer a number ofadvantages over tank-less systems, including reserve capacityduring a purification outage or service of the water purificationequipment as well as minimizing purification system
instantaneous demand capacity.8.3.1.1 Sizing / CapacityCriteria affecting storage capacity include the user’s existingand future demand profile or the amount of use, duration,timing, diversity (in the case of more than one user), and
whether the system is circulating or non-circulating. 8.3.1.2 Design ConsiderationsVessels should be designed using appropriate standardsand installed such that they do not compromise the waterquality or system operation.
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Chapter 8: Section Example
8.6.4.1 Ambient or Reduced Temperature Storage and
Distribution with heat or chemical sanitization Advantages:Well suited if water is generated atambient temperature and used atambient temperature
Well suited for small systems.Moderate capital and operating costs Non-metallics may be suitable basedon application
Disadvantages:Microbial control is a concern. Periodic sanitization is required Sanitization can limit water availability Additional equipment may increasecapital cost if the tank is supplied with hot water,then this design is not energy efficient.
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New Chapter 9 – Lab Water
• ISPE recognized the need for guidanceon lab water systems
• Provides overview of different lab waterpurification and distribution designs
• Includes step-by-step guidance on thetype of system to best meet user needs
• Compares water quality requirements for
laboratory grade waters and compendialwaters
• Discussions included on monitoring andcompliance
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New Chapter 10 – Rouge
• Recognized as a highly debated topic
• Intended to provide an understanding of
this phenomenon in stainless steel
• Detailed explanations on the formationand types of rouge based on research
• Provides guidelines on how to address
the presence of rouge and what may be
the consequences for the water/steam
systems and/or production equipment.
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New Chapter 10 – Rouge (cont.)
• Explains oxidation, corrosion, and surface
passivity of stainless steel.
• Suggests the establishment of a baseline
level of acceptance for particulates andmetal oxides, based on Risk Assessment
analyses
• Provides suggested methodology for
rouge remediation (de-rouging)
• Conclusions emphasize a well-balanced
approach for dealing with rouge
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Summary of Revisions (Chp. 11-12)
• Instrumentation (old Chp 9): revised toincorporate updates in instrument technologies• advancements in quality analysis (TOC)
• Statistical Process Control
• emerging technology (e.g. On-line RougeMonitoring, Rapid Microbiological Measurements – RMM)
• C&Q: updated to reflect the subsequent
publication of the ISPE Good Practices Guidefor Commissioning and Qualification of Waterand Steam Systems• Evolving approaches to C&Q (e.g. risk based,
enhanced commissioning)
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New Chapter 13 – Microbiology
• Content originally included in multiple
chapters of Edition #1
• Detail included from pretreatment through
use point management• mechanisms driving biofilm proliferation
• microbial control strategies
• microbial sampling and monitoring,
• compendial compliance issues
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Water/Energy/Cost Savings
• Design Philosophies and System Planning
• Establishing appropriate quality attributes
• Operational Ranges
• Establishing Life Cycle Costs• Pretreatment Options
• Alternative Filtration Options
• Quality Pretreatment = Reliable Final Treatment
• Alternative Materials of Construction
• Optimizing Regeneration/Backwash Frequency
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Water/Energy/Cost Savings
• Final Treatment Options
• Reuse options for waste water
• CEDI vs Regenerated Resin Pros/Cons
• MEF vs VC Distillation Comparison• Storage and Distribution
• Optimization of Equipment Sizing
• Alternative Distribution Examples Pros/Cons
• Materials of Construction
• Energy Consumption (Temperature, Flow)
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Water/Energy/Cost Savings
• Instrumentation and Control
• Selecting a Control Strategy
• Added Instruments Save Operating Costs
• Proper Control Saves Energy• Microbiological Considerations
• Alternative Sanitization Methods
• Microbial Enumeration
• Frequency of Sanitization
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Questions or Comments?