Water and Steam Baseline Guide version 3 - Everything you ...

1 Everything You Wanted to Know about Pharma Water & Steam Were Afraid to Ask! WebinarSpeakers:Nissan CohenGary Zoccolante21 November 2019 Hosted by ISPE 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical CohenOwnerBiopharmaceutical Water DocNissan is a worldwide expert, with 40 years' experience, in Total Organic Carbon (TOC), high purity, ultrapure, reclaim and recycle Water systems, with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and Zoccolante, BSMEP residentPlymouth Rock Water ConsultantsGary has over 40 years of experience in the design, operation and troubleshooting of pharmaceutical Water systems.

2 He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration, and distillation. 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical you currently using the ISPE Water and Steam 2ndEdition? Yes No We re still using the 1stedition3 2019 ISPE - ALL RIGHTS RESERVEDThe Guide : A Quick IntroductionNissan CohenOwnerBiopharmaceutical Water Doc 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical to the Guide Update5 Brief backgroundWhy Revise the Guide ?Revision TeamRevision GuidelinesLarge and small changesNext Steps 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical and Steam Guide 20117 Background from 2011 FDA reviewedSponsored by ISPE Technical DocGuidance provided by CU COP steering committee10 Different chapter leaders and 42 Team members13 Chapters.

3 260 pages appendix included 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Guide Overview8 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Guide9 Difficulty with FDA review process Over 1 year delay as Guide was in reviewFDA reviewers were not SMEs on the pharmaceutical Water and Steam systems 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Update Water and Steam Baseline Guide ?10 Baseline Guide widely recognized as authoritativeSome content needed updating and amendingWritten over a decade ago in 2008 - 2010, technology changesRecently released guidelines created gaps ( , ASTM, BPE, GPGs for C&Q of Water and Steam , Ozone, Sampling, Risk-Based Management Expansion of Global Standards ( USP, Eur.))

4 Ph., WHO, JP, China P, PIC/s, ICH) 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Update Water and Steam Baseline Guide ?11 Additional content / information requiredEur. Ph. non-distilled WFI Water generation addedElimination of High Purity WaterArtificial Intelligence Redefine the chapter contents Overall ImprovementsSmaller working groups and defined timelinesInitiation to Publication just less than 18 monthsIndustry acceptance and perceptionRisk-Based ApproachLean Manufacturing and Flexible DesignsMost comprehensive document in existence 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Team12 This Baseline Guide Third Edition was produced by a Task Team led by Brian Pochini Sanofi Nissan Cohen Biopharmaceutical Water

5 Doc Gary Zoccolante Plymouth Rock Water ConsultantsCore teamNissan Cohen Biopharmaceutical Water DocUSAJ amie EvansGreen Cross BiotechCanadaMichelle Gonzalez Amgen (Retired)USAB rian Hagopian Clear Water ConsultingUSAJ oseph Manfredi GMP Systems McClellanAqua-Chem PetersonAbbvieUSAB rian PochiniSanofiUSATeri Cullen ( ) SoliSoli Pharma Solutions E. Sumner, WisniewskiCommissioning Agents ZoccolantePlymouth Rock Water ConsultantsUSA 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Contributors13 Robert AugustineEli Lilly & BairdJacobs EngineeringUSAA nthony BevilacquaMettler-Toledo ThorntonUSAR obert ColemanIHL Consulting Group Inc.

6 (FDA-Retired) USA Martin EmeryIndependent USA Diana Fischer Bausch & Lomb USA W. Roderick T. FreemanBeckman Coulter USAA riel KehatiOmrix, Johnson & JohnsonIsrael Shlomo Sackstein Biopuremax Ian Shanahan MECO IrelandRoland ThoendelTakeda Austria Anders WidovWiphe ABSweden John WalkerVWS LimitedUnited Kingdom Paul WhiteheadVWS LimitedUnited Kingdom 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Guidelines14 Chapter Leaders had the same set of basic directionsEmphasize

7 Revision not rewrite .Purpose of revision is to update the document, remove duplication, and fine imperative words like all, shall, must but utilize many, could, and typical .The revision process is a team effort driven by Chapter LeaderAll chapters managed differently based on strengthsSome divided the chapter based upon individual group reviewed the chapter Group members provided input to leader who then made personality impacted chapters were reviewed by Co-chair task leaders 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Completion Status15 Received approx.

8 800 commentsComments addressed and revisions madeResponses provided to reviewers3rdEdition is 260 pagesReviewed by ISPE (Guidance Documents Committee)Published September 2019 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical Changes16 Redefinition of all chaptersContent reduced, refined, and enhanced to meet global needsGreater Flexibility is designs and configurations especially for non-distilled WFI generationIncorporation of all major pharmacopeias and mention of India, Brazil, and Mexico pharmacopeias 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical of revisions (Ch.)

9 1- 4)17 Introduction: revised for consistency with other Baseline guides, regulatory, and new Philosophies: clarified the correlation between design and operating ranges as well as alert and action Options and Planning: expanded to include ICH, China P, : enhanced to include pretreatment options utilized globally and definitive options for Water purification with flexible alternatives 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical of revisions (Ch. 5 - 6)18 Chap 5: Final Treatment options for Compendial PW, WFI: enhanced and rewritten to include final treatment options and improved final treatment 6: Systems for the Production of Compendial PW, WFI, and non-compendial: Completely new written chapter focusing on non-distilled WFI and module technology employed to produce PW, WFI and non-compendial waters 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical 7.

10 Pure Steam19 Incorporation of USP StandardsPrepared from Water meeting drinking Water Standards of EPA, WHO, major and minor pharmacopeias where added substancePure Steam quality is determined by the attributes of its Dryness and amount of Non-condensable Gasses are determined by the application. - References 2019 ISPE - ALL RIGHTS RESERVEDC onnecting Pharmaceutical 7: Pure Steam 20 Incorporation of International StandardsPure or Clean Steam Eur. Eur. Ph. sterilizer guidelines of EN 285 and HTM 2010:2015 for dryness and non-condensable gasesIncorporation of ASME BPE guidance documents.