3 USP Purified Water System – Feed Water Analysis Official MonographUnited States EPA NPDWREquivalent European RegulationsEquivalent Japanese RegulationsWorld Health Organization Reference
4 USP Purified Water System – Feed Water Analysis United States EPA – National Primary Drinking Water Regulations (NPDWR)Regulated ItemsTotal Viable Bacteria“Private” Water Supplies
5 USP Purified Water System – Feed Water Analysis Regulated Items - MicroorganismsCryptosporidiumGiardia lambliaLegionellaTotal ColiformTurbidityViruses
6 USP Purified Water System – Feed Water Analysis Regulated Items – Disinfection ByproductsBromateChloriteHaloacetic Acids (HAA5)Total Trihalomethanes (TTHMs)
7 USP Purified Water System – Feed Water Analysis Regulated Items – DisinfectantsChlorineChloraminesChlorine Dioxide
8 USP Purified Water System – Feed Water Analysis Regulated Items – Inorganic ChemicalsAntimonyArsenicAsbestosBariumBerylliumCadmiumTotal ChromiumCopper
9 USP Purified Water System – Feed Water Analysis Regulated Items – Inorganic ChemicalsCyanideFluorideLeadMercuryNitrateNitriteSeleniumThallium
10 USP Purified Water System – Feed Water Analysis Regulated Items – Organic Chemicals (53 Total)Sewage/Wastewater TreatmentHerbicidesLandfill LeachatesChemical/Industrial Facility WasteFumigantsPetroleum /Refinery WasteInsecticides
11 USP Purified Water System – Feed Water Analysis Regulated Item – RadionuclidesAlpha ParticlesBeta Particles and Photon EmittersRadium 226Uranium
12 USP Purified Water System – Feed Water Analysis Total Viable BacteriaNo limit in NPDWRTotal 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
13 USP Purified Water System – Feed Water Analysis Regulated Items - TestingMunicipality?Pharmaceutical Facility?Compliance?Obligation?Consequences?
15 USP Purified Water System – Periodic Monitoring General Monitoring – Storage and Distribution SystemPoint-of-Use TVBOnline ConductivityOnline TOC
16 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
17 USP Purified Water System – Periodic Monitoring Frequent Monitoring – Water Purification SystemSilt Density Index (Test Kit)Total Hardness (Test Kit)Chlorine (Test Kit)
18 USP Purified Water System – Periodic Monitoring Less Frequent Monitoring – Water Purification SystemInline ORP for Reducing Agent Injection MonitoringInline Total Hardness MonitorInline Chlorine Monitor
19 USP Purified Water System – Pretreatment Periodic Monitoring Raw WaterPost MultimediaPost Activated CarbonPost UVPost Lead Water SoftenerPost Polish Water SoftenerPost Cartridge FilterNPDWR TestsX-TVBBETChlorineTOCTSSTotal HardnessTotal IronTurbiditySDI
20 USP Purified Water System – RO/Polishing Periodic Monitoring Post RO Break TankPost ROPost CEDIPost UVPost Final FilterTVBXBET-pHTOCCarbon Dioxide
21 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
23 USP Purified Water System –Sanitization Provisions FrequencyDetermined by microbial monitoringMust include storage, distribution, ion removal, and pretreatmentEmploys chemical and thermal methodsIneffectiveness of SteamBiofilm requires chemical sanitizing agent
24 USP Purified Water System –Sanitization Provisions FundamentalsTVB destruction a function of concentration and time for chemical sanitizationTVB destruction a function of temperature and time for hot water with 65°C lowest temperatureDead Leg for thermal sanitizationDead leg for chemical sanitization
25 USP Purified Water System –Sanitization Provisions FundamentalsRemoval of BiofilmActivated Carbon IssuesRO Waste Recirculation IssuesPretreatment and Ion removal Recirculation IssuesHot water sanitizable ion removal systemsPretreatment must be included
26 USP Purified Water System –Sanitization Provisions Execution - 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
27 USP Purified Water System –Sanitization Provisions Execution – 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 annuallyDynamic-Stagnant-Dynamic Procedure
28 USP Purified Water System –Sanitization Provisions Execution – Storage & DistributionOzonationPeriodic Hot WaterMembrane Filtration discouragedChemical Sanitization with 1% solution of Hydrogen Peroxide and Peracidic Acid annuallyDynamic-Stagnant-Dynamic Procedure
30 Validation Criteria Commissioning Documentation Reference in IQ and OQ “Credit” for inspection and testingFactory Acceptance Test (FAT) DocumentationTurnover Packages (TOP)CoordinationInterface
31 Validation Criteria IQ Format Unit 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.
32 Validation Criteria IQ Information Limits 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.
33 Validation Criteria IQ Information All support information should reference the original manufacturer’s 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 manufacturer’s model number, useless for replacement on a “like-for-like” basis.
34 Validation Criteria OQ Information Prepared 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.
35 Validation Criteria OQ Information – Considerations Fixed alarm and operating set points versus adjustable set pointsProcessor access levelsAlarm set points and time delaysControl set points and time delaysView screen navigation“ALERM” banner display“OPERATOR OVERRIDE” banner display
36 Validation Criteria PQ Criteria Post start-up and commissioning 30 day sample periodSampling plan to duplicate water use“Working days”Attempt to duplicate water demandAttempt to duplicate actual conditions at individual points-of-use
37 Validation Criteria PQ Criteria Every point-of-use every day if practicalTOC “grab” samples from each points-of-useConductivity “grab” samples from points-of-useSuggest transition for about days after successful executionContinues for one year periodMonitoring never stops
38 Validation Criteria PQ Microbial Monitoring Duplicate sampling schedule over length of intense monitoring program and less frequently thereafterDifferent agar (PCA versus R2A)Different incubation temperatures (22°C and 30-35°C)Extended incubation time period (3, 5, 8, and 10 days)
41 Standard Operating Procedures General ConsiderationsPrepared, reviewed, and accepted before OQ executionVerbatim complianceKeep as concise as possibleDo not include maintenance procedures“Control” of copies importantFormal training
42 Standard Operating Procedures General ConsiderationsVideo tape training sessionsTraining ManualsSystem P&IDs mounted in water system areaDocumentation of individual attending training sessionsPeriodic retrainingPersonnel incident/excursion retraining
44 Preventative Maintenance Program Objective- Proactive not reactive- Shutdown Considerations – frequency- Cost of lost production time- Cost of quarantine of product- Cost of lost product- “Micro delay”
45 Preventative Maintenance Program Pretreatment Component Example – Activated Carbon UnitItemSuggested FrequencyConsequencesMedia ReplacementSix MonthsTOC and/or Chloramine BreakthroughSanitize Column InternalsMicrobial ExcursionReplace GasketsTwo YearsLeak/ShutdownAccess GasketsClean/Replace DistributorsOne YearFailure – Media in Product WaterInstrument CalibrationImproper System OperationReplace Valve DiaphragmsBypass/Cross Contamination
46 Preventative Maintenance Program Ion Removal Component Example – Reverse Osmosis UnitItemSuggested FrequencyConsequences“Rotate RO Membranes”Six MonthsLoss in Product Water Flow Rate and Quality (Chemical and TVB)Contract Clean Rotated MembranesChemical SanitizationTVB ExcursionsInterconnector O-RingsWaste-to-Product LeakEnd Fitting O-RingsInstrument CalibrationOne YearLoss of System ControlReplace Interconnectors
47 Preventative Maintenance Program Ion Removal Component Example – Reverse Osmosis UnitItemSuggested FrequencyConsequencesReplace Feed Water Pump SealsTwo YearsPump Leak – Introduction of Air/Water – TVB IncreaseVale Seals/DiaphragmsBypassSanitize Pressure VesselsSix MonthsTVB ExcursionsChange PrefiltersOne WeekFoulant Increase Resulting in TVB IncreaseHot Water Sanitize (if equipped)Two WeeksReplace “Rotated Membranes”Three YearsLoss in Product Water Flow Rate and Quality (Chemical and TVB)
48 Preventative Maintenance Program Storage & Distribution Loop Example – USP Purified Water Storage Tank (No Ozone)ItemSuggested FrequencyConsequencesInstrument CalibrationOne YearLoss of Level ControlInspect Rupture DiscSix MonthsTVB ExcursionReplace Rupture DiscTVB ExcursionsReplace Hydrophobic Vent Filter CartridgeInspect Tank InteriorRouging/BiofilmReplace Manway GasketTVB Excursion/Leak
49 Preventative Maintenance Program Ion Removal Component Example – Reverse Osmosis UnitItemSuggested FrequencyConsequencesRepassivateOne -Two YearsRouging – Biofilm – TVB IncreaseDerouge & RepassivateTwo -Three YearsHot Water SanitizationOne Week – One MonthTVB ExcursionsChemical SanitizationSix MonthsBiofilm – TVB Excursion