Design and Construction of USP Purified Water Systems

William V. Collentro

Feed Water Analysis

USP Purified Water System Feed Water AnalysisOfficial MonographUnited States EPA NPDWREquivalent European RegulationsEquivalent Japanese RegulationsWorld Health Organization Reference

United States EPA National Primary Drinking Water Regulations (NPDWR)Regulated ItemsTotal Viable BacteriaPrivate Water Supplies

USP Purified Water System Feed Water Analysis

Regulated Items - Microorganisms CryptosporidiumGiardia lambliaLegionellaTotal ColiformTurbidityViruses

USP Purified Water System Feed Water Analysis

Regulated Items Disinfection ByproductsBromateChloriteHaloacetic Acids (HAA5) Total Trihalomethanes (TTHMs)

USP Purified Water System Feed Water Analysis

Regulated Items DisinfectantsChlorineChloraminesChlorine Dioxide

USP Purified Water System Feed Water Analysis

USP Purified Water System Feed Water AnalysisRegulated Items Inorganic ChemicalsAntimonyArsenicAsbestosBariumBerylliumCadmiumTotal ChromiumCopper

USP Purified Water System Feed Water Analysis

Regulated Items Inorganic ChemicalsCyanideFluorideLeadMercuryNitrateNitriteSeleniumThallium

USP Purified Water System Feed Water AnalysisRegulated Items Organic Chemicals (53 Total)Sewage/Wastewater Treatment HerbicidesLandfill LeachatesChemical/Industrial Facility WasteFumigantsPetroleum /Refinery WasteInsecticides

USP Purified Water System Feed Water AnalysisRegulated Item RadionuclidesAlpha ParticlesBeta Particles and Photon EmittersRadium 226Uranium

USP Purified Water System Feed Water AnalysisTotal Viable BacteriaNo limit in NPDWR Total Coliform (Confirmed as Fecal Coliform or E. coli, used as indicator) Action Limit of 500 cfu/ml in non enforceable General Information Section of USPTVB may only indicate a fraction of viable organisms present

USP Purified Water System Feed Water AnalysisRegulated Items - TestingMunicipality? Pharmaceutical Facility? Compliance?Obligation?Consequences?

Periodic Monitoring

USP Purified Water System Periodic Monitoring General Monitoring Storage and Distribution SystemPoint-of-Use TVBOnline ConductivityOnline TOC

USP Purified Water System Periodic Monitoring General Monitoring Water Purification SystemFinal TVBInline RO Feed Water and Product Water Conductivity plus % Rejection of IonsInline Post RO Polishing Conductivity

USP Purified Water System Periodic Monitoring Frequent Monitoring Water Purification SystemSilt Density Index (Test Kit)Total Hardness (Test Kit)Chlorine (Test Kit)

USP Purified Water System Periodic Monitoring Less Frequent Monitoring Water Purification SystemInline ORP for Reducing Agent Injection MonitoringInline Total Hardness MonitorInline Chlorine Monitor

USP Purified Water System Pretreatment Periodic Monitoring

Raw WaterPost MultimediaPost Activated CarbonPost UVPost Lead Water SoftenerPost Polish Water SoftenerPost Cartridge FilterNPDWR TestsX------TVB XXXXXXXBETX-X---XChlorineXXX----TOCXXX----TSSXXX-XX-Total HardnessX-X-XX-Total IronXXX-XX-TurbidityXX-----SDI------X

USP Purified Water System RO/Polishing Periodic Monitoring

Post RO Break Tank Post ROPost CEDIPost UVPost Final FilterTVB XXXXXBETXX---pHXX---TOCXXXXXCarbon DioxideXX---

USP Purified Water System Periodic Monitoring SummaryMonitoring of Pretreatment and Ion Removal steps identifies a problem before it effects point-of-use values.Frequency of the monitoring program established for each applicationRegulatory concerns

Sanitization Provisions

USP Purified Water System Sanitization ProvisionsFrequencyDetermined by microbial monitoringMust include storage, distribution, ion removal, and pretreatmentEmploys chemical and thermal methodsIneffectiveness of SteamBiofilm requires chemical sanitizing agent

USP Purified Water System Sanitization ProvisionsFundamentalsTVB destruction a function of concentration and time for chemical sanitizationTVB destruction a function of temperature and time for hot water with 65C lowest temperatureDead Leg for thermal sanitizationDead leg for chemical sanitization

USP Purified Water System Sanitization ProvisionsFundamentalsRemoval of BiofilmActivated Carbon IssuesRO Waste Recirculation IssuesPretreatment and Ion removal Recirculation IssuesHot water sanitizable ion removal systemsPretreatment must be included

USP Purified Water System Sanitization ProvisionsExecution - PretreatmentHot Water Sanitizable Activated CarbonChemical Sanitization with 1% solution of Hydrogen Peroxide and Peracidic Acid (except activated carbon unit)Replace activated carbon media every 6-12 monthsDynamic-Stagnant-Dynamic Procedure

USP Purified Water System Sanitization ProvisionsExecution Ion RemovalContinuous operation (make-up and recirculation)Hot Water Sanitization Provisions (entire system)RO membrane rotation every 6 monthsChemical Sanitization with 1% solution of Hydrogen Peroxide and Peracidic Acid annually Dynamic-Stagnant-Dynamic Procedure

USP Purified Water System Sanitization ProvisionsExecution Storage & DistributionOzonation Periodic Hot WaterMembrane Filtration discouragedChemical Sanitization with 1% solution of Hydrogen Peroxide and Peracidic Acid annually Dynamic-Stagnant-Dynamic Procedure

Validation Criteria

Validation CriteriaCommissioning DocumentationReference in IQ and OQCredit for inspection and testingFactory Acceptance Test (FAT) DocumentationTurnover Packages (TOP)CoordinationInterface

Validation CriteriaIQ FormatUnit operation based with all support documentation for components and accessories verified. Support documents in document or as an appendix/attachment. Provides understanding of component by individuals preparing, reviewing, and executing IQComponent based program for items such as valves, gauges, pumps, etc. Poor tool for individuals to understand the system.

Validation CriteriaIQ InformationLimits on material? The more information available, the better. If a accessory breaks, it must be replaced. The model number, serial number, and/or manufacturer may change or no longer exists. Cut sheets of accessories provide an excellent vehicle for identifying a like-for-like replacement which significantly reduces the Change Control effort.

Validation CriteriaIQ InformationAll support information should reference the original manufacturers part number. Project specifications should clearly state that the name of the manufacturer as well as the part number be provided. The vast majority of this information is coded to the water purification equipment manufacturers model number, useless for replacement on a like-for-like basis.

Validation CriteriaOQ InformationPrepared and executed in an integrated basis. Individual Unit Operation will impact the operation of other components.Execution must provide exact operating condition. As an example, if media is not installed in a pretreatment component during execution of a FAT, execution (partial) may be required after installation and start-up.

Validation CriteriaOQ Information ConsiderationsFixed alarm and operating set points versus adjustable set pointsProcessor access levelsAlarm set points and time delaysControl set points and time delaysView screen navigationALERM banner displayOPERATOR OVERRIDE banner display

Validation CriteriaPQ CriteriaPost start-up and commissioning30 day sample periodSampling plan to duplicate water useWorking daysAttempt to duplicate water demandAttempt to duplicate actual conditions at individual points-of-use

Validation CriteriaPQ CriteriaEvery point-of-use every day if practicalTOC grab samples from each points-of-useConductivity grab samples from points-of-useSuggest transition for about 30-60 days after successful executionContinues for one year periodMonitoring never stops

Validation CriteriaPQ Microbial MonitoringDuplicate sampling schedule over length of intense monitoring program and less frequently thereafterDifferent agar (PCA versus R2A)Different incubation temperatures (22C and 30-35C)Extended incubation time period (3, 5, 8, and 10 days)

Validation CriteriaPQ Microbial MonitoringEP Monograph ReferenceVerify enumeration parametersBacteria identificationMISRiboprinterGram StainObjectionable organismsSummary Report

Operating Procedures

Standard Operating ProceduresGeneral ConsiderationsPrepared, reviewed, and accepted before OQ executionVerbatim complianceKeep as concise as possibleDo not include maintenance proceduresControl of copies importantFormal training

Standard Operating ProceduresGeneral ConsiderationsVideo tape training sessionsTraining ManualsSystem P&IDs mounted in water system areaDocumentation of individual attending training sessionsPeriodic retrainingPersonnel incident/excursion retraining

Preventative Maintenance Program

Preventative Maintenance ProgramObjective- Proactive not reactive- Shutdown Considerations frequency- Cost of lost production time- Cost of quarantine of product- Cost of lost product- Micro delay

Preventative Maintenance ProgramPretreatment Component Example Activated Carbon Unit

ItemSuggested FrequencyConsequencesMedia ReplacementSix MonthsTOC and/or Chloramine BreakthroughSanitize Column InternalsSix MonthsMicrobial ExcursionReplace GasketsTwo YearsLeak/ShutdownAccess GasketsSix MonthsLeak/ShutdownClean/Replace DistributorsOne YearFailure Media in Product WaterInstrument CalibrationOne YearImproper System OperationReplace Valve DiaphragmsTwo YearsBypass/Cross Contamination

Preventative Maintenance ProgramIon Removal Component Example Reverse Osmosis Unit

ItemSuggested FrequencyConsequencesRotate RO MembranesSix Months Loss in Product Water Flow Rate and Quality (Chemical and TVB)Contract Clean Rotated Membranes Six MonthsLoss in Product Water Flow Rate and Quality (Chemical and TVB) Chemical Sanitization Six MonthsTVB Excursions Interconnector O-Rings Six MonthsWaste-to-Product Leak End Fitting O-Rings Six MonthsWaste-to-Product Leak Instrument Calibration One YearLoss of System Control Replace InterconnectorsOne YearWaste-to-Product Leak

Preventative Maintenance ProgramIon Removal Component Example Reverse Osmosis Unit

ItemSuggested FrequencyConsequencesReplace Feed Water Pump SealsTwo Years Pump Leak Introduction of Air/Water TVB Increase Vale Seals/Diaphragms Two YearsBypass Sanitize Pressure Vessels Six Months TVB ExcursionsChange Prefilters One Week Foulant Increase Resulting in TVB IncreaseHot Water Sanitize (if equipped) Two WeeksTVB Excursions Replace Rotated Membranes Three YearsLoss in Product Water Flow Rate and Quality (Chemical and TVB)

Preventative Maintenance ProgramStorage & Distribution Loop Example USP Purified Water Storage Tank (No Ozone)

ItemSuggested FrequencyConsequencesInstrument CalibrationOne YearLoss of Level ControlInspect Rupture DiscSix MonthsTVB ExcursionReplace Rupture DiscOne Year TVB ExcursionsReplace Hydrophobic Vent Filter CartridgeSix Months TVB ExcursionInspect Tank InteriorSix MonthsRouging/BiofilmReplace Manway GasketOne YearTVB Excursion/Leak

Preventative Maintenance ProgramIon Removal Component Example Reverse Osmosis Unit

ItemSuggested FrequencyConsequencesRepassivateOne -Two Years Rouging Biofilm TVB Increase Derouge & RepassivateTwo -Three YearsRouging Biofilm TVB Increase

Hot Water Sanitization One Week One Month TVB ExcursionsChemical SanitizationSix Months Biofilm TVB Excursion

Thank you!Questions?

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