Efficient And EffectiveWFI Solutions

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Services RequiredFeed Water Temperature 15-25°CFeed Water Pressure 1 < P < 6 barPower Supply 380/480V; 3 Phase; 50/60 HzCompressed Air 6-8 barWater Drainage By gravity

Note: VCD model numbers 10000 to 25000 are from the POLARIS “modular” range. Pricing and delivery time should be confirmed on a case by case basis.

Treated Water QualityConductivity < 1,3 μS/cm @ 25°C

TOC < 500 ppb

Bacterial Endotoxins < 0,25 EU

Bacteria < 10 CFU/100ml

Nitrate < 0,2 ppm

Heavy Metals < 0,1 ppm

Feed Water Requirement (Minimum)Potable Water Chlorine FreeTotal Hardness < 0,1 °F (1 ppm as CaCO3)

Material SpecificationEvaporating Columns 316L (EN 1.4435) ASME BPEHeat Exchanger 316L (EN 1.4435) ASME BPE(Pre-heater)Heat Exchanger 316L (EN 1.4435) ASME BPE(Condenser)Feed Pump 316 (EN 1.4436)Compressor Body Aluminiumand Impeller FDA approved coatingCompressor Seals PTFECompressor Impeller’s 316LShaftSupport Frame 304 (EN 1.4301)Pipeline and Fittings 316L (EN 1.4435) ASME BPEControl Panel 304

Valve 316L/EPDM FDA approvedSealing and Gaskets PTFEPipe Welding Orbital

Veolia Water Solutions and TechnologiesGlobal HeadquartersL’Aquarène - 1, place Montgolfier94417 Saint-Maurice CedexFranceTél : +33 (0)1 45 11 55 55Fax : +33 (0)1 45 11 55 00

website at www.pharma.veoliawaterst.comEmail us on pharma-info@veoliawater.com

capability

6604

5283

3963

2642

1585

793

528

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0 100 500 1000 2000 3000 6000 10000 15000 20000 25000

VCD 200•

VCD 500•

VCD 1000•

VCD 2000•

VCD 3000•

VCD 6000•

VCD 10000•

VCD 15000•

VCD 20000•

VCD 25000•

••

US Gallon / h

Flow Rate litre/h

179682-Plaquette Polaris VCD - 4pages:Plaquette Polaris VCD 29/09/08 11:07 Page 4

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Modular Pure Water Solutions

®

ORION® Performance (Single Pass RO)Model 500 1000 2000 4000 6000 8000 10000Product (nominal) l/h 500 1000 2000 4000 6000 8000 10000Feed (nominal) l/h 625 1250 2500 5000 7500 10000 12500Concentrate (nominal) l/h 125 250 500 1000 1500 2000 2500Recovery (range) % 75 - 90(Twin Pass RO)Model 500 1000 2000 4000 6000 8000 10000Product (nominal) l/h 500 1000 2000 4000 6000 8000 10000Feed (nominal) l/h 715 1430 2860 5720 8580 11440 14300Concentrate (nominal) l/h 215 430 860 1720 2580 3440 4300Recovery (range) % 65 - 75*nominal flowrates based on 80% conversion (single pass), 70% conversion (twin pass), 15ºC, 500mg/l TDS, 20mg/l CO2, SDI<3 and maximum outlet pressure of 1 bar.

Feed Water RequirementsGeneral Potable water free from organ-

ics, colloids and suspended matter, SDI<3

Free Chlorine <0.25ppmTemperature 10 – 30ºCPressure 4 – 6 bar

Services Electrical 380/440V; 3 Phase; 50/60HzCompressed Air Oil free, instrument grade

6 – 9 bar

STANDARD ORION® ORION® WITH UF OPTION

Meets current USP & Ph Eur requirements

for Purified Water

Meets current Ph Eur requirements for Highly Purified Water

Conductivity <0.2 μS/cm <0.2 μS/cmTOC <250 ppb <250 ppbBacteria <10 cfu/ml <10 cfu/100mlEndotoxins N/A <0.125 EU/ml

Typical Treated Water Quality

ORION® Material Specifications

Cold Sanitised Pre-treatment Hot Water Sanitised Pre-treatment

Pre-treatment System

Pipework PVC or Stainless Steel 316L Stainless Steel

Softeners High Density Polyethylene & GRP Composite

316Ti Stainless Steel

Filter Vessels Polypropylene or 316L Stainless Steel

316L Stainless Steel

Purified Water System

Tank

Reverse Osmosis

CEDI

Pipework

General

Frame

Control Panel

visit our websites:www.veoliawaterst.com.au

www.veoliawaterst.co.nzwww.pharma.veoliawaterst.com

316L Stainless Steel

316L Stainless Steel

FDA approved materials

316L Stainless Steel

304 Stainless Steel

Mild Steel Painted or 304 Stainless Steel

ORION® Dimensions (Single Pass RO)Model 500 1000 2000 4000 6000 8000* 10000*Height (max) (varies with options selected)

mm 2100 2380 2380 2200* 2200*

Width mm 3000 3500 3750 4000* 4000*Depth mm 1500 1750 1750 2000* 2000*Weight (varies with options selected) kg 2050 2250 2950 4780 6200 5600* 6400*(Twin Pass RO)Model 500 1000 2000 4000 6000 8000* 10000*Height (max) (varies with options selected)

mm 2100 2100 2100 2380 2380 2200* 2200*

Width mm 3000 3750 3750 3750 3750 4000* 4750*Depth mm 1500 1500 1500 1750 1750 2000* 2000*Weight (varies with options selected) kg 2150 2450 3350 5780 7400 7200* 8400** Excludes softeners (these are not mounted on the ORION® 8000/10000 skid).Weights and dimensions are subject to change

SydneyUnit 2, 5 Stanton RoadSeven Hills NSW 2147Ph: + 61 2 8824 0200Fax: + 61 2 8824 0201

Melbourne341 Fitzgerald RoadDerrimut VIC 3030Ph: +61 3 9369 1555Fax: +61 3 9369 5054

Perth124 Kewdale RoadKewdale WA 6105Ph: + 61 8 9449 1700Fax: + 61 8 9353 4689

Brisbane5/26 Navigator PlaceHendra QLD 4011Ph: +61 7 3268 5990Fax: +61 7 3268 5993

Adelaide 500 Churchill RoadKilburn SA 5084Ph: +61 8 8168 0500Fax: +61 8 8168 0599

Darwin5 Dennis CourtBerrimah NT 0828Ph: +61 8 8947 8931Fax: +61 8 8947 3310

New ZealandLevel 3, 149 - 155 Parnell RdParnell, Auckland 1052Ph: + 64 9 354 4174Fax: + 64 9 354 4175 nzsales@veoliawater.com

Veolia Water Solutions & Technologies Australia Level 4, Bay Centre, 65 Pirrama RoadPyrmont NSW 2009 – AustraliaPh. + 61 2 8572 0400 / Fax + 61 2 8572 0410systems@veoliawater.com

LITR

600

04/R

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:01/

08 In

keep

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with

the

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natu

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pany

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rese

rve

the

right

to a

men

d de

tails

with

out n

otic

e.

Modular Pure Water Solutions

®

ORION® Performance (Single Pass RO)Model 500 1000 2000 4000 6000 8000 10000Product (nominal) l/h 500 1000 2000 4000 6000 8000 10000Feed (nominal) l/h 625 1250 2500 5000 7500 10000 12500Concentrate (nominal) l/h 125 250 500 1000 1500 2000 2500Recovery (range) % 75 - 90(Twin Pass RO)Model 500 1000 2000 4000 6000 8000 10000Product (nominal) l/h 500 1000 2000 4000 6000 8000 10000Feed (nominal) l/h 715 1430 2860 5720 8580 11440 14300Concentrate (nominal) l/h 215 430 860 1720 2580 3440 4300Recovery (range) % 65 - 75*nominal flowrates based on 80% conversion (single pass), 70% conversion (twin pass), 15ºC, 500mg/l TDS, 20mg/l CO2, SDI<3 and maximum outlet pressure of 1 bar.

Feed Water RequirementsGeneral Potable water free from organ-

ics, colloids and suspended matter, SDI<3

Free Chlorine <0.25ppmTemperature 10 – 30ºCPressure 4 – 6 bar

Services Electrical 380/440V; 3 Phase; 50/60HzCompressed Air Oil free, instrument grade

6 – 9 bar

STANDARD ORION® ORION® WITH UF OPTION

Meets current USP & Ph Eur requirements

for Purified Water

Meets current Ph Eur requirements for Highly Purified Water

Conductivity <0.2 μS/cm <0.2 μS/cmTOC <250 ppb <250 ppbBacteria <10 cfu/ml <10 cfu/100mlEndotoxins N/A <0.125 EU/ml

Typical Treated Water Quality

ORION® Material Specifications

Cold Sanitised Pre-treatment Hot Water Sanitised Pre-treatment

Pre-treatment System

Pipework PVC or Stainless Steel 316L Stainless Steel

Softeners High Density Polyethylene & GRP Composite

316Ti Stainless Steel

Filter Vessels Polypropylene or 316L Stainless Steel

316L Stainless Steel

Purified Water System

Tank

Reverse Osmosis

CEDI

Pipework

General

Frame

Control Panel

visit our websites:www.veoliawaterst.com.au

www.veoliawaterst.co.nzwww.pharma.veoliawaterst.com

316L Stainless Steel

316L Stainless Steel

FDA approved materials

316L Stainless Steel

304 Stainless Steel

Mild Steel Painted or 304 Stainless Steel

ORION® Dimensions (Single Pass RO)Model 500 1000 2000 4000 6000 8000* 10000*Height (max) (varies with options selected)

mm 2100 2380 2380 2200* 2200*

Width mm 3000 3500 3750 4000* 4000*Depth mm 1500 1750 1750 2000* 2000*Weight (varies with options selected) kg 2050 2250 2950 4780 6200 5600* 6400*(Twin Pass RO)Model 500 1000 2000 4000 6000 8000* 10000*Height (max) (varies with options selected)

mm 2100 2100 2100 2380 2380 2200* 2200*

Width mm 3000 3750 3750 3750 3750 4000* 4750*Depth mm 1500 1500 1500 1750 1750 2000* 2000*Weight (varies with options selected) kg 2150 2450 3350 5780 7400 7200* 8400** Excludes softeners (these are not mounted on the ORION® 8000/10000 skid).Weights and dimensions are subject to change

SydneyUnit 2, 5 Stanton RoadSeven Hills NSW 2147Ph: + 61 2 8824 0200Fax: + 61 2 8824 0201

Melbourne341 Fitzgerald RoadDerrimut VIC 3030Ph: +61 3 9369 1555Fax: +61 3 9369 5054

Perth124 Kewdale RoadKewdale WA 6105Ph: + 61 8 9449 1700Fax: + 61 8 9353 4689

Brisbane5/26 Navigator PlaceHendra QLD 4011Ph: +61 7 3268 5990Fax: +61 7 3268 5993

Adelaide 500 Churchill RoadKilburn SA 5084Ph: +61 8 8168 0500Fax: +61 8 8168 0599

Darwin5 Dennis CourtBerrimah NT 0828Ph: +61 8 8947 8931Fax: +61 8 8947 3310

New ZealandLevel 3, 149 - 155 Parnell RdParnell, Auckland 1052Ph: + 64 9 354 4174Fax: + 64 9 354 4175 nzsales@veoliawater.com

Veolia Water Solutions & Technologies Australia Level 4, Bay Centre, 65 Pirrama RoadPyrmont NSW 2009 – AustraliaPh. + 61 2 8572 0400 / Fax + 61 2 8572 0410systems@veoliawater.com

Your WFI need… the solution

coupled with time-based replacement of specific parts and consumables,significantly reduces the risk of downtime. This approach enables us toguarantee the quality and value of your system for a lifetime.

ALL IN PACK®

We understand your need for a new WFI installation and the investmentthis involves. This is why we bring you ALL IN PACK®, which provides youwith a complete commercial and technical solution, including: equip-ment supply, installation, system maintenance and a leasing package tomeet all costs. This innovative package gives you peace of mind for yourcurrent and future needs without a large initial capital investment.

POLARIS – a whole life solutionModularity+ Repeatability = Flexibility + Cost Effectiveness + ReliabilityModular POLARIS solutions optimise product production and system integration costs, eliminatedesign flaws and provide a reliable solution to meet your WFI needs for many years to come. All POLARIS solutions are designed in accordance with GAMP, cGMP, ISPE and FDA guidelinesand will meet the product quality specifications of all of the world’s major pharmacopeia,including the USP and Ph Eur, giving you peace of mind and compliance assurance, whereveryour facility is.POLARIS systems are backed by a comprehensive range of service maintenance products.Standardised Performance Qualification Maintenance Contracts (PQMC) are tailored toyour system and ensure continuing compliance. Scheduling service on a pre-planned basis

Your WFI need… The POLARIS VCD Solution1. Pre-heater/Cooler POLARIS VCD is equipped with Double Tube Sheet heatexchangers for eliminating contamination risk betweenthe feed water inlet and the water for injection, whilstoptimising heat recovery from the outgoing WFI andalso from the waste gases produced by the gas removaldevice. Polaris VCD integrates the WFI cooling systemproducing distilled water between 25°C and 90°Cdepending on customer needs.

2. Boiling ChamberPOLARIS VCD can use two different heating sources –steam and electrical heating – these can be used inde-pendently or combined depending on customer pref-erence. This system is used to continuously maintainthe operating temperature at boiling point.

3. Core Heat Exchanger The heat exchanger is the heart of the system wherethe balance between condensation and the evapora-tion feeds the system with as much energy as isrequired to keep the evaporation process ‘alive’.POLARIS VCD has minimised the energy consumptionthanks to the advanced design of its heat exchanger.In this process step, gas removal also takes place,maintaining the optimum WFI conductivity.

4. Water Droplet SeparatorThis part of the distillation process is responsible forpyrogen and bacteria removal, the most critical areaof WFI microbiological quality. In POLARIS VCD, thecontaminants are released from the vapour in thewater droplet separator by close control of the shearand speed ratio between the vapour and any waterdroplets present.

5. Vapour CompressorThe vapour compressor increases the pressure andconsequently the temperature of the clean steam. The purpose of this stage, is to optimise the energybalance of the distiller. The POLARIS VCD compressor uses all sanitary components and an optimised seal design to ensure the highest possiblesteam quality. The POLARIS VCD always operates at apositive pressure differential relative to the surround-ings, making ingress of contaminants impossible.

6. Condensable Gas SeparationThe last fraction of contaminant elements is separatedfrom the steam condensate through WFI re-circulation.In POLARIS VCD, the re-circulating pump also maintainsthe WFI outlet pressure.

7. Automation And ControlPOLARIS shares a common control system architectureand software design with the other VWS CriticalWater Utilities system components, allowing easyintegration for complete Purified Water and WFI sys-tems. Access to the PLC based control system is via acolour touch screen HMI. The graphic display screensare intuitive and easy to navigate. Options include 21 CFR Part 11 compliance and panel mounted PC SCADA.

� Pre-heater/cooler Double Tube Sheet heat exchanger

� Vapour compressor

� Condensable gas separation

� Boiling chamberTube heat exchanger/electrical coil

� Water droplet separator/Decontamination step Standard Features

Mechanical> ASME BPE piping > Sanitary WFI sample point > Thermal insulation > Stainless steel frame and control panel

IP 54> Surface finishing Ra<0,6 μm> Feed water pump> WFI tank + pressurising transfer pump> Condensable and uncondensable gas

removal system> Sight glass inspection point> Drain cooling system

Functional> Softened feed water > Operation in stop/start or continuous

mode (band width control on tank level)> Automatic blow down> WFI quality switchover system

Controls and Instrumentation> PLC control + HMI interface > Non compensated conductivity meter > Automatic pressure, temperature and

level controller.

Validation and Documentation> Operating manual in English,

qualification documentation in English

Shipping> Wooden pallet and plastic cover

suitable for road transport

Optional FeaturesMechanical> Electropolishing Ra<0,4 μm > Industrial steam pressure reducing valve> Electrical heating> Combined electrical/steam heating

Functional> Modulated production – 0% to 100%> WFI temperature production to 20-25 °C> WFI temperature production to all

temperature from 95 to 20°C > Automatic steam sanitisation

Controls and Instrumentation> SCADA supervision system (2 month

operating data recording) /HMI in 4 languages + printer (interface onlyrequired)

Validation and Documentation> DQ, IQ, OQ, protocols > Operating manual in 4 languages

Shipping> Wooden crate> Waterproof packing> Fumigated crate

� Core heat exchanger

179682-Plaquette Polaris VCD - 4pages:Plaquette Polaris VCD 29/09/08 11:08 Page 2

GAS REMOVAL DEVICE

CLEAN STEAMOUTLET

CE

Your WFI need… the solution

coupled with time-based replacement of specific parts and consumables,significantly reduces the risk of downtime. This approach enables us toguarantee the quality and value of your system for a lifetime.

ALL IN PACK®

We understand your need for a new WFI installation and the investmentthis involves. This is why we bring you ALL IN PACK®, which provides youwith a complete commercial and technical solution, including: equipmentsupply, installation, system maintenance and a leasing package to meetall costs. This innovative package gives you peace of mind for your currentand future needs without a large initial capital investment.

POLARIS – a whole life solutionModularity+ Repeatability = Flexibility + Cost Effectiveness + ReliabilityModular POLARIS solutions optimise product production and system integration costs, eliminatedesign flaws and provide a reliable solution to meet your WFI needs for many years to come. All POLARIS solutions are designed in accordance with GAMP, cGMP, ISPE and FDA guidelinesand will meet the product quality specifications of all of the world’s major pharmacopeia,including the USP and Ph Eur, giving you peace of mind and compliance assurance, whereveryour facility is.POLARIS systems are backed by a comprehensive range of service maintenance products.Standardised Performance Qualification Maintenance Contracts (PQMC) are tailored toyour system and ensure continuing compliance. Scheduling service on a pre-planned basis

Clean steam for critical utilities…The POLARIS CSG Solution1. Feed Water PreheatingOptimised heat recovery for maximum efficiency.Conventional CSG systems introduce cold feed water, via external pipework, directly into the evaporation chamber. The POLARIS CSG column is equipped with an internal feedwater manifold which enters the column from the top, pre-heating the feed water prior to entering the boiling area.2. Evaporation ChamberThe POLARIS evaporation column design maximises the effi-ciency of the evaporation process. Saturated steam generat-ed into the heat exchanger expands into the evaporationcolumn, and then separates under gravity, into gas andwater droplets. The proportions of the POLARIS evaporationcolumn are perfect for optimising this separation process.3. Natural Circulation EffectPerfect operating conditions are maintained due to continu-ous water circulation between the evaporation column andthe heat exchanger (tube side). This process eliminates lowflow zones and maximises the thermal efficiency of thecontinuous evaporation process.4. Steam HeatingPOLARIS uses Double Tube Sheet Heat exchangers for maxi-mum heat transfer and ultimate process security. The ener-gy required for the phase change from purified feedwater to clean steam is provided by industrial steam orelectricity. The double tube sheet design of the POLARISheat exchanger ensures that the industrial steam cannotcome into contact with the clean steam.5. Water Droplet SeparationThe POLARIS water droplet separation system ensures com-plete water droplet removal across the full range of operat-ing conditions. Efficient droplet separation is a critical stepin pyrogen removal, which is the critical process in cleansteam production. Since pyrogens are non-volatile theycan only be carried by water droplets, once the feed waterhas been turned to steam. By forcing the steam to rapidlychange direction in a ‘tortuous path’ chamber, shear is maximised, and the droplets are stripped from the cleansteam, providing the ultimate pyrogen removal security.6. Uncondensable Gas SeparationThe first step for ultimate Clean Steam purity. POLARIS usesa clean steam operated device to strip out uncondensablegas from the feed water avoiding carry over of impuritiesthat could compromise the final clean steam quality.7. Steam Quality Control - EN 285ComplianceCompliance to CS requirements thanks final quality control.Having produced high quality clean steam, POLARIS isequipped with and EN285 sampling device that uses a tube intube heat exchanger to condense the clean steam, and a vali-dated conductivity meter to measure the condensate quality.8. Automation And ControlPOLARIS shares a common control system architecture andsoftware design with the other VWS Critical Water Utilitiessystem components, allowing easy integration for completePurified Water and WFI systems. Access to the PLC basedcontrol system is via a colour touch screen HMI. Thegraphic display screens are intuitive and easy to navigate.Options include 21 CFR part 11 compliance and panelmounted PC SCADA.

CSG

Standard FeaturesMechanical> ASME BPE piping> Steam sample point EN285

compliance> Thermal insulation> Stainless steel frame and control panel

IP 54> Surface finishing Ra<0,6 μm> Feed water pump> Stand-by heating phase> Drain cooling system

Functional> Operation in stop/start mode> Automatic blow down> Clean steam available from 3 to 6 bar

Controls and Instrumentation> PLC control + HMI interface> Automatic pressure, temperature

and level controller

Validation and Documentation> Operating manual in English,

qualification documentation in English

Shipping> Wooden pallet and plastic cover

suitable for road transport

Optional FeaturesMechanical> Electropolishing Ra<0,4 μm> Feed water tank> Clean Steam outlet check valve> Non compensated conductivity meter

with automatic sample condensingand cooling system

> Feed water gas removal device (steamstripping)

> Feed water CO2 removal membrane

Controls and Instrumentation> SCADA supervision system (2 month

operating data recording) /HMI in4 language + printer (only interfacerequired)

Validation and Documentation> DQ, IQ, OQ, protocols> Operating manual in 4 languages

Shipping> Wooden crate> Waterproof packing> Fumigated crate

� Uncondensable Gas Separation

� Steam QualityControl - EN 285Compliance

� Feed WaterPreheating

� Evaporation Chamber

� Natural CirculationEffect

� Water DropletSeparation

� Steam Heating

CLEANSTEAM

CE

179906-VEOLIA POLARIS CSG BROCHURE:Plaquette Polaris CSG 29/09/08 11:28 Page 2