Baseline Guide Overview - NC

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Water and Steam Baseline Guide +

Water/Energy/Cost Savings Measures

Nissan Cohen



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



First Edition

January ‘01



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



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



• 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



Forwardfrom

First Edition



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)



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



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



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



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



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.



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



Significant Changes

• New chapters

• Laboratory Water (Phil Sumner)

• Rouge (Michelle Gonzalez)• Microbiology (T. C. Soli)

• Incorporation of Appendix material



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.




• 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.



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



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.



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



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.



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.



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



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.



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




• 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)



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



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




• 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)




• 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



Questions or Comments?

Baseline Guide Overview - NC

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