ISPE Presentation Water Steam Systems 1681853503

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Everything You Wanted to R E
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Know about Pharma Water
G H &
Steam Systems…but R I Were
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Afraid to Ask! Webinar
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Speakers:
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Nissan Cohen
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Gary Zoccolante
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© 2
21 November 2019
Hosted by ISPE
Speakers ED
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Nissan is a worldwide expert, with 40 years' experience, in Total Organic
Carbon (TOC), high purity, ultrapure, reclaim and recycle water systems,
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with profound expertise in instrumentation, automation, and organic
contamination oxidation systems using ozone, UV, ion exchange and
catalysts.
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Nissan Cohen
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Owner
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Biopharmaceutical Water Doc
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Gary has over 40 years of experience in the design, operation and
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troubleshooting of pharmaceutical water systems. He has been involved in
the development of equipment for pretreatment, reverse osmosis,
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deionization, ultrafiltration, and distillation.
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Gary Zoccolante, BSME
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President
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Plymouth Rock Water Consultants
© 2 Connecting Pharmaceutical Knowledge ISPE.org 2

POLL ED
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Are you currently using the ISPE
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Water and Steam 2nd Edition?
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 Yes
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 No
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 We’re still using the 1st edition
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© Connecting Pharmaceutical Knowledge ISPE.org 3
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The Guide: A Quick Introduction G H
Nissan Cohen R I
Biopharmaceutical Water Doc L
Owner L
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Introduction to the Guide Update ED
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Brief background
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Why Revise the Guide?
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Revision Team
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Revision Guidelines
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Large and small changes
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Next Steps - A
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Water and Steam Guide 2011 ED
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Background from 2011
FDA reviewed R
Sponsored by ISPE Technical Doc
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Guidance provided by CU COP steering committee
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10 Different chapter leaders and 42 Team members
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13 Chapters, 260 pages appendix included
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2011 Guide Overview ED
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2011 Guide ED
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Difficulty with FDA review process
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Over 1 year delay as guide was in review
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G pharmaceutical water and
FDA reviewers were not SMEs on Ithe
steam systems
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Why Update Water and Steam Baseline Guide?
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Baseline Guide widely recognized as authoritative
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Written over a decade ago in 2008 - 2010, technology changesR
Some content needed updating and amending
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Recently released guidelines created gaps (e.g., ASTM, BPE, GPGs for C&Q of water and
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steam, Ozone, Sampling, Risk-Based Management
Expansion of Global Standards (e.g. USP,LEur. Ph., WHO, JP, China P, PIC/s, ICH)
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Why Update Water and Steam Baseline Guide?
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Additional content / information required
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Eur. Ph. non-distilled WFI water generation added
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Elimination of High Purity Water
Artificial Intelligence
Redefine the chapter contents
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Overall Improvements
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Smaller working groups and defined timelines
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Initiation to Publication just less than 18 months
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Industry acceptance and perception
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Risk-Based Approach
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Lean Manufacturing and Flexible Designs
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Most comprehensive document in existence
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Core Team ED
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This Baseline® Guide Third Edition was produced by a Task Team led by
Brian Pochini Sanofi

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Nissan Cohen Biopharmaceutical Water Doc
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Gary Zoccolante Plymouth Rock Water Consultants
Core team
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Nissan Cohen Biopharmaceutical Water Doc USA
Jamie Evans
Michelle Gonzalez
Green Cross Biotech
Amgen (Retired)
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USA
Brian Hagopian
Joseph Manfredi
Clear Water Consulting
GMP Systems Inc.
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USA
Brian McClellan
Christian Peterson
Aqua-Chem Inc.
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Abbvie A USA
USA
Brian Pochini Sanofi
P E USA
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Teri Cullen (T.C.) Soli Soli Pharma Solutions Inc. USA
Philip E. Sumner, Jr.
Steve Wisniewski
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Pfizer Inc.
Commissioning Agents Inc.
USA
USA
Gary Zoccolante
01 Plymouth Rock Water Consultants USA

Other Contributors ED
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Robert Augustine Eli Lilly & Co. USA
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Andrew Baird Jacobs Engineering USA
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Anthony Bevilacqua Mettler-Toledo Thornton USA
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Robert Coleman IHL Consulting Group Inc. (FDA-Retired) USA
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Martin Emery Independent USA
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Diana Fischer Bausch & Lomb USA
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W. Roderick T. Freeman Beckman Coulter USA
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Ariel Kehati Omrix, Johnson & Johnson Israel
Shlomo Sackstein Biopuremax Ltd.
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Ian Shanahan MECO Ireland
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Roland Thoendel Takeda Austria
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Anders Widov Wiphe AB Sweden
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John Walker VWS Limited United Kingdom
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Paul Whitehead VWS Limited United Kingdom
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Revision Guidelines ED
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Chapter Leaders had the same set of basic directions
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Emphasize “revision” not “rewrite”.
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Purpose of revision is to update the document, remove duplication, and fine tune.
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Avoid imperative words like “all, shall, must” but utilize “many, could, and typical”.
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The revision process is a team effort driven by Chapter Leader
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All chapters managed differently based on strengths
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Some divided the chapter based upon individual strengths.
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Entire group reviewed the chapter Group members provided input to leader who then made
revisions.
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Leaders personality impacted performance.
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All chapters were reviewed
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3rd Edition Completion Status ED
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Received approx. 800 comments
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Comments addressed and revisions made
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Responses provided to reviewers
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3rd Edition is 260 pages
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Reviewed by ISPE (Guidance Documents Committee)
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Published September 2019
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Significant Changes E D
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Redefinition of all chapters
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Content reduced, refined, and enhanced to meet global needs
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Greater Flexibility is designs and configurations especially for non-distilled WFI
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generation
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Incorporation of all major pharmacopeias and mention of India, Brazil, and Mexico
pharmacopeias
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Summary of Revisions (Ch. 1- 4) E D
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Introduction: revised for consistency with other baseline guides,E
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new content.
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Key Philosophies: clarified the correlation betweenTdesign and operating ranges as
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well as alert and action levels.
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System Options and Planning: expanded
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Pretreatment: enhanced to E
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include pretreatment options utilized globally and
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definitive options for water purification with flexible alternatives
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Summary of Revisions (Ch. 5 - 6) E D
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Chap 5: Final Treatment options for Compendial PW, WFI: enhanced
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include final treatment options and improved final treatment E
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technologies.
Chap 6: Systems for the Production of Compendial T

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PW, WFI, and non-compendial:
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Completely new written chapter focusing on non-distilled WFI and module technology
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employed to produce PW, WFI and non-compendial
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Chapter 7: Pure Steam E D
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Incorporation of USP Standards
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Prepared from water meeting Drinking Water Standards of EPA, WHO, E major and minor
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pharmacopeias where applicable.
No added substance
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Pure steam quality is determined by the attributes
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Steam “Dryness” and amount of “Non-condensable Gasses” are determined by the application.
- References
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Chapter 7: Pure Steam ED
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Incorporation of International Standards
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Pure or Clean steam – Eur. Ph.
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Meets Eur. Ph. sterilizer guidelines of EN 285 and HTM 2010:2015 for dryness and
Incorporation of ASME BPE guidance documents. T

non-condensable gases
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Gsteam and applications.
Defined industry baseline practices on types Iof
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Chapter 8: Storage & Distribution ED
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Content upgraded
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General Overview
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System Components
Microbial Concerns
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Design Examples
Content Simplified or Moved
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Installation Materials and Methods Referenced to other Industry Standards (e.g. BPE)
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Microbiological moved to separate chapter
Enhanced Design Examples
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Definitive Advantages / Disadvantages
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Chapter 8: Section Example ED
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8.3.1 Tanks
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When properly designed, storage tanks can offer a number of advantages
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over tankless systems, including reserve capacity during a purification
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outage, atmospheric air break for loop return, or to facilitate service of the
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upstream water purification equipment, as well as minimizing purification
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system instantaneous demand capacity. Careful consideration should be
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given to sizing, based on various factors including associated costs. The
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storage tank also may be used as a contact chamber for sanitization
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using ozone.
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Chapter 8: Section Example ED
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Advantages:
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Well suited if water is generated at
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ambient temperature and used at
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ambient temperature
Well suited for small systems.
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Moderate capital and operating costs
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Non-metallics may be suitable based
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on application
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Microbial control is a concern.
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Periodic sanitization is required
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Sanitization can limit water availability
Additional equipment may increase
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capital cost
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Ιf the tank is supplied with hot water,
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then this design is not energy efficient.
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Chapter 9 – Lab Water E D
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ISPE recognized the need for guidance on lab water systems
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Provides overview of different lab water purification and distribution designs
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Includes step-by-step guidance on the type of system to best meet user
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needs
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Compares water quality requirements for laboratory grade waters and
compendial waters
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Discussions included on monitoring and compliance
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Chapter 10 – Rouge E D
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Condensed and compacted from 2011 version
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Intended to provide an understanding of this phenomenon inE
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Detailed explanations on types of rouge
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Provides guidelines on how to address the presence of rouge and what may be the
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consequences for the water/steam systems and/or production equipment.
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Provides suggested methodology for rouge remediation (de-rouging)
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Conclusions emphasize a well-balanced approach for dealing with rouge
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Summary of Revisions (Ch. 11-12) E D
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Instrumentation revised to incorporate updates in instrument technologies
Advancements in Rapid Microbial Monitoring
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Statistical Process Control
Artificial Intelligence
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Continuous data acquisition and alert/action limits
C&Q: updated to reflect the ISPE GPG Approaches
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Qualification of Water and Steam Systems,
Evolving approaches to C&Q (e.g.
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commissioning) CPP & CQA
- assignations
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Chapter 13 – Microbiology ED
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The most comprehensive document on microbials in water systems
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Detail included from pretreatment through use point management
mechanisms driving biofilm proliferation
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microbial control strategies
microbial sampling and monitoring,
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compendial compliance issues
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Key Points for Discussion ED
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Design Philosophies and System Planning
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Establishing appropriate quality attributes
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Operational Ranges
Establishing Life Cycle Costs
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Pretreatment Options
Alternative Filtration Options
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Quality Pretreatment = Reliable Final Treatment
Optimizing Regeneration/BackwashA
Alternative Materials of Construction
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Frequency
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Final Treatment Options
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Configurations to achieve compendial classifications
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Use of different modules to attain non-distilled WFI
ME vs VC Distillation Comparison
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Storage and Distribution
Alternative Distribution Examples Pros/Cons R

Optimization of Equipment Sizing I
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Materials of Construction
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Design configurations for optimization
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Instrumentation and Control
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Selecting a Control Strategy
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Online Instruments and 24/7 operations
Statistical Process Control and EWPS
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Microbiological Considerations
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Alternative Sanitization Methods
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Microbial Enumeration
Speciation when needed
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Frequency of Sanitization
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Guide Use for System Design G H
Gary Zoccolante, BSME R I
President
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System Planning
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Planning & Programming 32 ISPE.org
Pharmaceutical Water Categories ED
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Ingredient
Ingredient Equipment
in
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or BPC or Rinsing
Form
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Fig. 3.1 Pharmaceutical Water Quality Decision Tree
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Water for Injection Questions
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What countries require distillation?
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What are advantages and disadvantages of multiple effect and vapor compression stills?
Where is membrane based WFI allowed?
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Do membrane based systems have special requirements?
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Are redundant membrane barriers required?
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Are redundant membrane barriers a good idea?
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Is Purified Water required for WFI final treatment feed?
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Pharmacopoeial Water Grade Summary
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United States
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Europe
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Japan
China
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India
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Mexico
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Table 9.3 Specifications ED
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European Pharmacopoeia 9.8 Japanese Pharmacopoeia XVII US Pharmacopeia 42 Indian Pharmacopoeia Chinese Pharmacopoeia Brazilian Pharmacopoeia 5 Pharmacopoeia of the United Mexican States 12
Organization / Reference International Pharmacopoeia
(2019) (2016) (2018) (2018) (2015) (2010) (2018)
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Water for Highly Purified Water for Water for Water for Water for Water for Purified Water Purified Water Water for Water for
Water Grade or Type Purified Water Water Purified Water Purified Water Purified Water Purified Water Purified Water Ultrapure Water Purified Water
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Injections Water(5) Injection Injection Injections Injection Injection Level 1 Level 2(7) Injection Injections
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Drinking Water
Drinking Water Drinking Water Japanese Drinking "Water" Source; Drinking Water Purified Water Drinking Water Drinking Water Purified Water
Source Suitable water
Source; Source; Water (Water RO, UF, Water or Purified Drinking Water Source; Source; Source; Source; Properly treated Source; Drinking Water Drinking Water Potable Water Potable or Purified
(US,EU,Japan, Purified Water source; Dist, DI,
Specified Source and Purification Approaches Dist or IX or RO or Distillation or Supply Law, Deionization, Water Source; Source; Dist or DI or RO or Distillation or Dist or DI or RO or Dist or DI or RO or water Source; supplemental Source; Dist or RO Source: e.g. 1P/2P Source: Dist or Water Source;
WHO); Distillation or Source; Distillation RO, or other suitable
other suitable purification process Ordinance No.101, Distillation, or a Distillation or RO-UF Suitable process other suitable equiv/superior other suitable other suitable Distillation purification with Dist, or DI or Other RO; UF, DI, EDI equivalent Distillation
equiv/superior methods
methods equivalent Article 4, 2003) combination thereof methods process methods methods DI, RO, other
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process
European Pharmacopoeia (Ph. Eur.) Commission Suppressed Highly Purified Water (HPW) from the Ph. Eur. effective 01APR2019
Clear, colorless, Clear, colorless, Clear, colorless,
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Clear and colourless Clear and colourless Clear and colourless Clear and colourless Clear, colourless, Clear, colourless, Clear, colourless Clear, colourless Transparent and Transparent and Transparent and Clear, colourless Clear, colourless
Description
liquid liquid * liquid having no odor liquid having no odor * * odourless liquid odourless liquid liquid, odourless liquid, odourless
tasteless, odorless tasteless, odorless tasteless, odorless
colorless liquid colorless liquid colorless liquid liquid; odourless liquid; odourless
liquid liquid liquid
pH value at 25°C (inclusive range) * * * * * * * * * * 5.0 - 7.0 * * * 5.0 - 7.0 * * * *
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MRed - not red, MRed - not red, MRed - not red, MRed - not red, MRed - not red, MRed - not red, MRed - not red,
Acidity or Alkalinity * * * * * * * BTBlue - not blue BTBlue - not blue BTBlue - not blue * BTBlue - not blue BTBlue - not blue * * * * BTBlue - not blue BTBlue - not blue
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2.1(2) 2.1(2) 1.3 (Alt to NH3, 1.3 (Alt to NH3,
Conductivity µS/cm @25°C, max 5.1(1) 1.3(1) * [1.3(1) [1.3(1) 1.3(1) 1.3(1) 5.1(1) 1.3(1) 5.1(1) 1.3(1) Ca/Mg, Cl, NO3, Ca/Mg, Cl, NO3, 0.1 5.1(1) 1.3(1) 1.3(1) * *
in JP Info Ch 21] in JP Info Ch 21] SO4) SO4)
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Instrument response Instrument response 0.05
0.5 mg/L 0.5 mg/L 0.50 mg/L 0.50 mg/L 0.50 mg/L 0.5 mg/L
0.5 mg/L 0.50 mg/L 0.50 mg/L to 0.50 to 0.50 0.5 mg/L 0.50 mg/L (50 ppb) 0.5 mg/L 0.5 mg/L
TOC (as C), max (500 ppb)(3)
(500 ppb)(3) * (500 ppb)(3) (500 ppb)(3)
(500 ppb)(3)
(500 ppb)(3)
(500 ppb)(3)
(500 ppb)(3)
(500 ppb)(3) (500 ppb)(3) (500 ppb)(3)
(500 ppb)(3) (500 ppb)(3) * *
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mg/L standard mg/L standard [Optional,
[Alt to Ox Sub] [Alt to Ox Sub] [Alt to Ox Sub] [Alt to Ox Sub] [Alt to Ox Sub] [Alt to Ox Sub]
(500 ppb)(3) (500 ppb)(3) application-specific]
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Negative to test of Negative to test of Negative to test of Negative to test of Negative to test of Negative to test of
Negative to test of Negative to test of
Oxidisable Substances (Permanganate Red. 0.1 mL of 0.02M 0.1 mL of 0.02M 0.10 mL of 0.02M 0.2 mL of 0.02M 0.2 mL of 0.02M 0.1 mL of 0.02M
Subst.) KMnO4 * * * * * * KMnO4 * KMnO4 * KMnO4 KMnO4 KMnO4 * * 0.5 mL of 1% 0.2 mL of 0.02M
KMnO4 KMnO4
[Alt to TOC] [Alt to TOC] [Alt to TOC] [Alt to TOC] [Alt to TOC] [Alt to TOC]
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Residue after evaporation on heating at 1 1
105°C, mg/100mL, max * * * * * * * * * 1 1 * * * * * * (5mg from 500mL) (5mg from 500mL)
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1 (100cfu/100mL)
0.1 (optimal 0.1
Action Level Action Level 100 (R2A) 0.1 0.1 (R2A) using any valid 0.01
Action Level Action Level 100 (optimal medium) (10cfu/100mL)
0.1 (10cfu/100mL, 0.1 (10cfu/100mL) Absence specified (10cfu/100mL, 100 (R2A) (10cfu/100mL, method; also (1cfu/100mL, 200mL
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100 100 (R2A) medium) (10cfu/100mL, 200mL, using any
Heterotrophic Bacteria Count cfu/mL, max
[in monograph,
200mL test) [in * [in Info Ch 21,
(R2A)
[in Info Ch 1231, 200mL test)
pathogens 200mL test) [in monograph, 200mL test) absence of E. coli
valid method)
test) * * * * *
monograph, [in Info Ch 21, [in monograph, [in monograph, mandatory] [in monograph, and P. aeruginosa [in monograph,
mandatory] non-mandatory] non-mandatory] [in Info Ch 1231, [in monograph,
mandatory] non-mandatory] mandatory] mandatory] mandatory] [in monograph, mandatory]
non-mandatory] mandatory]
mandatory]
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Bacterial Endotoxins <0.25 (dialysis ≤ 0.25 (dialysis
<0.25 <0.25 <0.25 ≤ 0.25 <0.25 ≤ 0.25 < 0.25 ≤ 0.25
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EU/mL or IU/mL (note ≤ or <) solutions only) * * * solutions only) * * * * * *
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Chloride µg/L, max * * * * * * * * * * * pass pass * * * * pass pass
Sulfate, ppm, max * * * * * * * * * * * pass pass * * * * pass pass
9
Calcium and Magnesium ppm, max * * * * * * * * * * * 1 1 * * * * pass pass
1
Carbon Dioxide ppm, max * * * * * * * * * * * * * * * * * pass pass
Ammonia ppm, max * * 0.05(6) * * * * * * 0.3 0.2 0.2 0.2 * * * * pass pass
0
Nitrates ppm, max 0.2 0.2 * * * * * 0.2 0.2 0.06 0.06 0.2 0.2 * 0.2 0.2 0.2 pass pass
2
Nitrites ppm, max * * * * * * * * * 0.02 0.02 * * * * * * * *
10 (dialysis solutions 10 (dialysis solutions 10 (dialysis solutions 10 (dialysis solutions
Aluminium ppb, max
only) only) * * * * * only) only) * * * * * * * * * *
©
Heavy Metals ppm, max 0.1(4) * * * * * * 0.1(4) * 0.1 0.1 * * * 0.1 * * pass pass
Connecting Pharmaceutical Knowledge ISPE.org 37

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Table 3.2: Point of Use Criteria
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Fig 3.3 Water Consumption Graph
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Fig 3.4 Storage Tank Capacity Determination
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System Unit Process Selection
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Pharmaceutical Water Generation System Detail
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Pretreatment (Chapter 4)
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• Protect primary purification units
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• Normal feed water conditions
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• Feed water upset conditions
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• Specific contaminant reduction
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Table 4.1 System Pretreatment Selection
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Pharmaceutical Water System Detail Design
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Final Treatment
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• Primary ionic reduction
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• Conductivity spec
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• Specific ion
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• Primary microbial/endotoxin control
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Final Treatment Options ED
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• Primary Treatment (Chapter 5)
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• Ion Exchange
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• Reverse Osmosis
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• Distillation
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• Polishing Process Options
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• UV
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• MF - A
• UF
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• Membrane Degas
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Table 5.1 Multiple Effect Still Utility Requirements
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Table 5.2: VC Utility Consumption per 1,000 Gallons
(3,785 liters) of WFI Produced V R
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Typical CEDI Process Drawing
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System Process Technology
G H Maps
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Fig. 6.2 Deionization Technology Map
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Fig. 6.1 RO Technology Map
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FIG 6.3 VAPOR COMPRESSION STILL TECHNOLOGYV MAP
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Fig. 6.4 ME Still Technology Map
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Fig. 6.5 Membrane Based WFI Technology Map
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Storage and Distribution TS
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Design and SanitizationIGStrategy
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© 55
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RV
Fig. 8.1 Storage & Distribution Decision Flow Chart
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Continuous
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No Special Design Consideration
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and Distribution
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56
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Fig. 8.3: Ambient/Reduced Temperature Storage &
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© Storage Configurations 57
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Fig. 8.5: Ozonated Storage and Distribution
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Fig. 8.9: Hot Storage, Cooled Bypass Circulating Distribution
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Table 8.1:
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Comparison
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Table 8.2 Distribution Piping Materials Comparison
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AL6XN Impeller after 2 Years 80OC Service
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Rouge Risk Assessment
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© Rouge, Passivation & Stainless Steel 63
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Example of Localized Systems
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1Reference: Figure 9.2 (p. 172)
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© Laboratory Water 64
D
Critical Design Element (CDE) – DefinitionVE
E R
E S
R
• Design function or feature of an engineered system that is necessary to consistently manufacture products with the
desired quality attributes.
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• Examples of automation design functions include alarms and data management.
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• Examples of engineering design features include components, instruments, and materials of construction.
CDEs are identiﬁed and documented based on technical understanding of the product CQAs, process CPPs, and
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•
•
equipment design/automation.
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Biofilm Formation
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Mark Wiencek, Rohm & Haas Company, Spring House, PA 19477
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© 2 Microbial Considerations 66
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WRAP UP G H
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Do you have plans to implement
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changes recommended in the new
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 Immediately
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 Within the next 6 months to 1 Year
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 I have no plans to implement changes at this time
1 9
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Q&A E D
R V
Contact Information Upcoming Webinars
S E
• 11 December E
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© 2 Connecting Pharmaceutical Knowledge ISPE.org 2

Brian Pochini Sanofi

01 Plymouth Rock Water Consultants USA

© 2 Connecting Pharmaceutical Knowledge ISPE.org 12

I S by Co-chair task leaders

Chap 6: Systems for the Production of Compendial T

Incorporation of ASME BPE guidance documents. T

Alternative Distribution Examples Pros/Cons R

Where is membrane based WFI allowed?

pH value at 25°C (inclusive range) * * * * * * * * * * 5.0 - 7.0 * * * 5.0 - 7.0 * * * *

Sulfate, ppm, max * * * * * * * * * * * pass pass * * * * pass pass

Connecting Pharmaceutical Knowledge ISPE.org 37

© Planning & Programming 38

IGStrategies for Bringing Advanced

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