ISPE_CCChUSPH2OSuccess

OBK Technology Ltd. 2008

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Successful Project Delivery ofUSP PW & WFI Systems


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“Define it, Design it, Deliver it”©

This is a review of all the key steps required for a successful USP water system deliveryThis review covers; Science & Technology, Pretreatment & Generation, Distribution System, Project Management & ValidationConcept design to a validated conclusion


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Water Water ––

“Science & Technology”“Science & Technology”


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Water is the worlds most ubiquitous solventWater is able to absorb and carry some of most of the known elementsWith today’s ability to measure down to parts per trillion – if you look for it - you can find it!


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Basic criteria: “Purified water must meet the requirements for ionic and organic chemical purity and must be protected from microbial contamination. PW systems must be validated to reliably and consistently produce and distribute water of acceptable chemical and microbiological quality”.


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USP XXIX allows WFI from distillation OR USP XXIX allows WFI from distillation OR an equivalent process (equivalent an equivalent process (equivalent processes not yet accepted by European processes not yet accepted by European Pharmacopoeia)Pharmacopoeia)WFI for global use products must come WFI for global use products must come from distillationfrom distillationSo to produce WFI So to produce WFI -- either vapor either vapor compression or Multicompression or Multi--Effect distillation Effect distillation


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Water source is critical:Water source is critical:Potable sources include: surface, ground Potable sources include: surface, ground and groundwater under surface influenceand groundwater under surface influenceIt is critical to understand seasonal It is critical to understand seasonal variability since this can mean big variability since this can mean big difference in water sourcesdifference in water sources


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With characteristics defined With characteristics defined -- pretreatment pretreatment equipment can be selectedequipment can be selectedPretreatment systems manage:Pretreatment systems manage:

Scaling (precipitation) of mineral salts & Scaling (precipitation) of mineral salts & silicasilicaFouling due to organic and inorganic Fouling due to organic and inorganic materialsmaterialsOxidation due to chlorine, chloraminesOxidation due to chlorine, chloramines


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Most scaling is controlled by one of; Most scaling is controlled by one of; softening, lowering pH, anti scalants, or nano softening, lowering pH, anti scalants, or nano filtrationfiltration

Fouling is controlled with a multiFouling is controlled with a multi--media filter media filter and / or cartridge filtrationand / or cartridge filtration

pH to remove dissolved gas, particularly pH to remove dissolved gas, particularly carbon dioxidecarbon dioxide


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For organic & inorganic reduction For organic & inorganic reduction -- ultraultra--filtration, ultraviolet light, organic filtration, ultraviolet light, organic scavenging and regular cleaning and scavenging and regular cleaning and sanitizationsanitizationFor oxidation control For oxidation control -- sodium bisodium bi--sulphite sulphite addition, activated carbon and ultraviolet addition, activated carbon and ultraviolet lightlight


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With preWith pre--treatment defined treatment defined –– select the main select the main purification methodpurification method

Most usual is RO (Revere Osmosis) to Most usual is RO (Revere Osmosis) to remove salt and organic materialremove salt and organic materialDeionization (polishing) Deionization (polishing) -- either anion and either anion and cation resins or Electrocation resins or Electro--Deionization.Deionization.


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Project ManagementProject Management


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Start with a high level definition of the requirements – a draft URS The supply of USP - PW appears very complicated.The reality – follow the many steps of simple chemistry and logical process engineering from start to finish


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Finalize the technical content of URS Develop a water consumption matrixDevelop clearly defined end water quality specifications from;What product(s) and/or cleaning processes will be served at the points of useDevelop the process requirementsDevelop the process requirements


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Draft an outline scheduleDraft an outline scheduleThis provides a preliminary indication of This provides a preliminary indication of the expected end datethe expected end dateThis also provides a flag for those long This also provides a flag for those long lead time items that need to be ordered lead time items that need to be ordered earlyearly

This is also the time you can reconfirm the This is also the time you can reconfirm the budgetbudget


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Define the detail of the water source(s)Define the detail of the water source(s)Temperatures, composition variabilityTemperatures, composition variabilityArrange for source sampling analysis if Arrange for source sampling analysis if required (recommended)required (recommended)Check to ensure that all seasons and all Check to ensure that all seasons and all likely sources are covered and documentedlikely sources are covered and documented


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Reconfirm the consumption usage matrix Reconfirm the consumption usage matrix spread sheetspread sheetVerify all the process requirements Verify all the process requirements ––volumes, flows, temperature & pressurevolumes, flows, temperature & pressureCheck all the points of use and their capacity Check all the points of use and their capacity requirements & diversificationrequirements & diversificationReconfirm the required quality parameters Reconfirm the required quality parameters


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Make system capacity decisions from the Make system capacity decisions from the usage matrixusage matrixWhat is the hourly, daily and weekly What is the hourly, daily and weekly consumption need?consumption need?Is usage batch or continuous?Is usage batch or continuous?This will drive the system capacity choice & This will drive the system capacity choice & prospective storage tank sizeprospective storage tank size


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What does a typical system look like?What does a typical system look like?


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Full USP system diagram hereFull USP system diagram here


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WFIWFIRORO® ® is a patented RO system that meets is a patented RO system that meets or exceeds USP guidelines for WFI, but not or exceeds USP guidelines for WFI, but not currently accepted in Europecurrently accepted in Europe

WFIWFIRORO®® technology does not require a tank technology does not require a tank & is self sanitizing& is self sanitizing


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45 GPM 2 x Pass WFI45 GPM 2 x Pass WFIRORO®®

Self Contained & Compact (20 x 6 x 6)Self Contained & Compact (20 x 6 x 6)Softeners not shownSofteners not shown5 years of Municipal water data5 years of Municipal water dataDrought conditions upon start upDrought conditions upon start up8 Months of operation 8 Months of operation –– zero micro zero micro count & zero cleaningcount & zero cleaning


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Supplied by a 10 GPM systemSupplied by a 10 GPM system

30,000 gallon tank 30,000 gallon tank –– flat bottom flat bottom -- poor poor turn over turn over –– outdoor outdoor –– micro issuesmicro issues

Ozone system solutionOzone system solution


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2 floors each @ 25 K Sq Ft2 floors each @ 25 K Sq Ft

International vaccines supplierInternational vaccines supplier

Equipment 18 months in outdoor Equipment 18 months in outdoor unsheltered storage prior to installation unsheltered storage prior to installation -- problemsproblems


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2 Pass RO system with multi media 2 Pass RO system with multi media filtration and EDIfiltration and EDI

25 GPM capability25 GPM capability

Silica issues with rainy seasonSilica issues with rainy season


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185 GPM RO system185 GPM RO systemOver 30 Points of UseOver 30 Points of UseSerious supply water issues Serious supply water issues ––Municipality not in control Municipality not in control –– Municipal Municipal softeners not functional at time of softeners not functional at time of commissioningcommissioningCity supply not to EPA standards at City supply not to EPA standards at timestimes


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Account for inbound and outbound Account for inbound and outbound water use for cost credits from supply water use for cost credits from supply sourcesource


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Project management continues;Project management continues;

Document all the usage criteriaDocument all the usage criteria

Review all criteria with the end usersReview all criteria with the end users


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Update and expand the preliminary URS into Update and expand the preliminary URS into the completed URSthe completed URS

Sign off the user acceptanceSign off the user acceptance

Reconfirm the budget and the scheduleReconfirm the budget and the schedule

“Black box” P & ID“Black box” P & ID


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10 Minute Networking Break10 Minute Networking Break


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System DesignSystem Design


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Evolve the initial detail design for;Evolve the initial detail design for;Generation equipmentGeneration equipmentStorage requirements (buffer & quality Storage requirements (buffer & quality balance)balance)Distribution needsDistribution needsPoints of use Points of use


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Continue to evolve the initial detail design;Continue to evolve the initial detail design;

Confirm piping run(s)Confirm piping run(s)(no dead legs and no air traps & 1 Mps (no dead legs and no air traps & 1 Mps return flow)return flow)

Plan for expansion needsPlan for expansion needsHot or chemical sanitization?Hot or chemical sanitization?

Ozone generation system requirementsOzone generation system requirements


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Create the final P & IDCreate the final P & ID

Create the schematic flow diagram & Create the schematic flow diagram & preliminary layoutpreliminary layout


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Prepare a FRS (Functional Requirement Prepare a FRS (Functional Requirement Specification)Specification)

This is a detailed description of the This is a detailed description of the functionality of the total systemfunctionality of the total system

Along with the URS Along with the URS –– it provides important it provides important overview documentation for the later overview documentation for the later validation stagevalidation stage


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PrePre--qualify vendors and suppliersqualify vendors and suppliers

Prepare all detail arrangement drawingsPrepare all detail arrangement drawings

Draft and finalize tender packages for all key Draft and finalize tender packages for all key supply itemssupply itemsPrePre--order long lead time itemsorder long lead time items


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Specification package includes;Specification package includes;

URS, FRS, Water Analysis, URS, FRS, Water Analysis, Design Detail (surface finishes, Design Detail (surface finishes, materials specs for product contact)materials specs for product contact)Instrumentation & ControlsInstrumentation & ControlsLayout, orientation, sizes & access needsLayout, orientation, sizes & access needs


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Evaluate all submitted tender packages for Evaluate all submitted tender packages for content and scope coveragecontent and scope coverage


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Review systems design in the context of Review systems design in the context of tender packages and vendor / supplier input tender packages and vendor / supplier input detaildetail


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Reconfirm the budget and time line

Confirm vendor and suppliersConfirm vendor and suppliers

Issue purchase orders (long leads Issue purchase orders (long leads –– pre pre ordered)ordered)


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Prepare detail work packages for;Prepare detail work packages for;MechanicalMechanicalPipingPipingElectricalElectricalCivil / structural if requiredCivil / structural if required


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Verification & ValidationVerification & Validation


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Develop FAT and SAT protocolsDevelop FAT and SAT protocols

Develop the commissioning protocol and Develop the commissioning protocol and check sheetscheck sheets

Execute the FAT on all key equipmentExecute the FAT on all key equipment


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Develop validation documentation;Develop validation documentation;IQ IQ (installation)(installation)OQ OQ (operation)(operation)PQ PQ (performance)(performance)SOP’s (required for training)SOP’s (required for training)

The above are all based on the URS, The above are all based on the URS, FRS and operations manuals from the FRS and operations manuals from the suppliers and vendorssuppliers and vendors


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Install all equipmentInstall all equipment

Connect all pipingConnect all piping

Connect all control requirementsConnect all control requirements


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Execute the SAT from the developed SAT Execute the SAT from the developed SAT protocolprotocol


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Commission the system based on the Commission the system based on the commissioning protocol developedcommissioning protocol developed


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Update all “as built” drawings for the system Update all “as built” drawings for the system turnturn--over packageover package


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Execute the validation protocols based on Execute the validation protocols based on the approved documentationthe approved documentation

Note: IQ can overlap with final installation Note: IQ can overlap with final installation and the start of commissioningand the start of commissioningOQ can overlap with the execution & OQ can overlap with the execution & completion of commissioningcompletion of commissioning


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PQ requires the SOP’s approved and PQ requires the SOP’s approved and operator training to be completeoperator training to be completePQ execution is user driven, requires PQ execution is user driven, requires constant monitoring (usually first month) and constant monitoring (usually first month) and full documentationfull documentationSystem requires ongoing monitoring, System requires ongoing monitoring, recording & maintenancerecording & maintenance


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System ready for turnover to usersSystem ready for turnover to users

Questions PleaseQuestions Please

Documents

ISPE_CCChUSPH2OSuccess