modular pure water cgmp clean steam solutions on · pdf filepipe welding orbital ... cold...
TRANSCRIPT
cGMP Clean SteamOn Demand
CSG
LITR
6000
6 Re
v A
05/0
8. In
kee
ping
with
the
prog
ress
ive
natu
re o
f the
com
pany
, we
rese
rve
the
right
to a
men
d de
tails
with
out n
otic
e.
3000
2000
1500
1000
750
500
300
200
100
0
0 50 60 80 100 120 150 200 250 300 400 500 750 1000 1250 1500 1750 2000 2500 3000 4000 5000 6000 8000
3 6 9
3 6 9
3 6 9
3 6 9
3 6 9
3 6 9
3 6 9
3 6 9
3 6 9
POLARIS CSG Treated Steam QualityComplying to EN 285Clean steam condensate should comply to WFI characteristics Conductivity < 1,3 μS/cm @ 25°CTOC < 500 ppbBacterial Endotoxins < 0,25 EUBacteria < 10 CFU/100mlNitrate < 0,2 ppmHeavy Metals < 0,1 ppm
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 [email protected]
capability (according to industrial steam pressure)
CSG Model
Capacity Kg/h
CSG
Services RequiredFeed Water Temperature 15-25° C
Feed Water Pressure 1 < P < 6 bar
Power Supply 380 / 480 V; 3 Phase; 50 / 60 Hz
Compressed Air 6-8 bar
Water Drainage By gravity
Cooling Water 15° C (if necessary)
Feed Water Requirement (Minimum)Potable WaterTotal Hardness < 0,1° F (1 ppm as CaCO3)Conductivity < 5 µS/cm
Silica < 1 ppm
Material SpecificationEvaporating Columns 316L (EN 1.4435) ASME BPE
Heat Exchanger 316L (EN 1.4435) ASME BPE(Pre-heater)
Heat Exchanger 316L (EN 1.4435) ASME BPE(Condenser)
Feed Pump 316 (EN 1.4436)
Support Frame 304 (EN 1.4301)
Pipeline and Fittings 316L (EN 1.4435) ASME BPE
Control Panel 304
Valve 316L/EPDM FDA approved
Sealing and Gaskets PTFE
Pipe Welding Orbital
179906-VEOLIA POLARIS CSG BROCHURE:Plaquette Polaris CSG 29/09/08 11:27 Page 4
LITR
600
04/R
ev A
:01/
08 In
keep
ing
with
the
prog
ress
ive
natu
re o
f the
com
pany
, we
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 [email protected]
Veolia Water Solutions & Technologies Australia Level 4, Bay Centre, 65 Pirrama RoadPyrmont NSW 2009 – AustraliaPh. + 61 2 8572 0400 / Fax + 61 2 8572 [email protected]
LITR
600
04/R
ev A
:01/
08 In
keep
ing
with
the
prog
ress
ive
natu
re o
f the
com
pany
, we
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 [email protected]
Veolia Water Solutions & Technologies Australia Level 4, Bay Centre, 65 Pirrama RoadPyrmont NSW 2009 – AustraliaPh. + 61 2 8572 0400 / Fax + 61 2 8572 [email protected]
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
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