WATER PURIFIERS AND WATER PURIFICATION SYSTEMS FOR MEDICAL DEVICE MANUFACTURING, MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE RINSING AND MEDICAL DEVICE TESTING

Blue Spring Corporation manufactures USP Water for Injection systems


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1. Water purification equipment intended for manufacturing, testing and rinsing of medical devices.  Not
intended for direct use as a medical device in medical treatment. On-site Installation Qualification,
Operational Qualification, Performance Qualification and long-term System Validation is usually required,
according to Current Good Manufacturing Practices (CGMP).

2. All models except large capacity models WFI-700-EDI, WFI-1400-EDI, WP-800-EDI, WP-1600-EDI are
fully cabinet enclosed.  In models WFI-700-EDI, WFI-1400-EDI, WP-800-EDI, WP-1600-EDI, reverse
osmosis modules are attached externally to the cabinet.

CHOICE OF WATER QUALITY AND CAPACITY FOR MEDICAL DEVICE MANUFACTURING

LATEST COMBINATION OF DOUBLE-PASS REVERSE OSMOSIS AND ELECTRODEIONIZATION TECHNOLOGIES PRODUCES HIGH QUALITY, ENDOTOXIN-FREE, WATER FOR INJECTION PER USP 23-32. CAPACITIES FROM 50 GPH -1400 GPH AVAILABLE

Exceptional Quality USP Water for Injection:  Typical output water measures 0.2-0.8  mS/cm electrical conductivity, 70-150 ppb TOC, 0-10 cfu/100 ml bacteria content, <0.125 EU/ml endotoxin content. Consistently meets USP 23-32 Water for Injection standards.
Exceptionally Consistent Water Quality:  Replacement of conventional de-ionizing resin beds with electrodeioning modules (EDI), results in highly consistent biopurity and lower ion content.
Exceptional Economy:  Costs fraction of conventional, distillation-based USP water for injection systems to purchase, to operate and to maintain.
Exceptionally Space-Saving Design:  Small 56 cm W x 76 cm D  footprint for 190 L/hr capacity unit.
Sanitary Construction:  Fully enclosed
2
inside stainless-steel cabinet. High-purity, low-extractable PVC output piping,
superior to
PVDF or stainless-steel.
Ultimate Contamination Control:  Totally sealed system.  No open tanks exposed to atmosphere. No infusion of environmental contaminants.
Water-Saving Design:  60-70% overall water recovery.
Energy-Saving Design:  Only 5.1 watt.hours of total energy consumption per liter of water for injection. Compare this with 80 - 230 watt.hours/liter energy consumption of conventional distillation stills.
Easy Installation:  Factory-assembled, factory qualified unit.  Integrated RO/EDI design for Plug-n-Go installation.
Easy Operation:  Single-switch daily operation with manual over-ride. Quick stabilization avoids 24/7 operation. Ergonomic instrumentation and control panel.
Easy Sanitizing:  Single-shot cold sanitizing of water purification unit and distribution piping, with built-in cleaning and sanitizing system. No steam generator required.
Easy Maintenance:  Only 2 moving parts (RO pumps), in the entire water system,  Single circuit board electronics. Integrated EDI power supply. Very few things to break down.
Easy Validation:  Factory-assembled, factory pre-qualified water purification unit simplifies on-site qualification and validation. Factory OQ and PQ certification provided with each system

UNIQUE FEATURES

       SPECIFICATIONS FOR WFI-EDI SERIES USP WATER FOR INJECTION SYSTEMS
MODEL
WFI-50
WFI-120
WFI-200
WFI-360
WFI-700
WFI-1400
SIZE
(W x D x H)
56 X 76 X 126
CM
68 x 118 x 145
CM
68 x 118 x 148
CM
76 x 145 x 148
CM
91 x 236 x 152
CM
162 x 244 x 152
CM
SHIP. WT.
145 KG
210 KG
320 KG
419 KG
715 KG
1,180 KG
ELECTRICAL
220 VAC/
1 ph/10 A
220 VAC/
1 ph/16 A
460 VAC/
3 ph/8A
460 VAC/
3 ph/9.5A
460 VAC/
3ph/18A
460 VAC/
3ph/32A
SUPPLY
WATER
9-11 LPM
15-19 LPM
19-24 LPM
29-35 LPM
56-65 LPM
112-130 LPM
SUPPLY
WATER
QUALITY
EPA quality municipal water. 20-60 psig pressure. 22-32oC temperature. Pre-softening of feed water required, to
reduce hardness below 5 mg/L. May require carbon filtration, if chlorine or other disinfectant is present in feed
water. Contact us for details.      
OUTPUT
PORT
1/2" O.D. Tubing
1/2" High Purity
PVC Union
Standard
3/4" High Purity
PVC Union
Standard
1" High Purity
PVC Union
Standard
1-1/4" High
Purity PVC
Union Standard
1-1/2" High Purity
PVC Union
Standard
OUTPUT
FLOW
2.8-3.3 LPM
at 25 oC Water
Temp.
6.8-8.4 LPM
at 25 oC Water
Temp.
11.0-13.6 LPH
at 25 oC Water
Temp.
20-25 LPM
at 25 oC Water
Temp.
36-47 LPM
at 25 oC Water
Temp.
73-92 LPM
at 25 oC Water
Temp.
OUTPUT
WATER
QUALITY
Output water meets Water-for-Injection specifications per U.S.P, also Purified Water per U.S.P.
Typical electrical conductivity  0.2 - 0.8 mS/cm,  Typical TOC 70-150 ppb, Typical bacteria count 0-10 cfu/100
ml, Typical endotoxin level < 0.125 EU/ml.  Note: day-to-day biological quality of  water will depend on sanitizing
schedule and general equipment maintenance.      

WFI-EDI SERIES USP WATER FOR INJECTION SYSTEMS

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Blue Spring Model WFI-50-EDI USP Water for Injection System for Medical Device Manufacturing

WP-EDI SERIES USP PURIFIED WATER SYSTEMS

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Blue Spring Model WP-420-EDI USP Purified Water System for Medical Device Manufacturing

LATEST COMBINATION OF REVERSE OSMOSIS AND ELECTRODEIONIZATION TECHNOLOGIES PRODUCES HIGH QUALITY PURIFIED WATER PER USP 23-32. CAPACITIES FROM 100 GPH-1600 GPH AVAILABLE

Ideal for mediam and large-sized manufacturers of non-implantable medical devices. Suitable for production operation such as extrusion, machining, also for reprocessing, leak testing and final rinsing before packaging of non-implantable medical devices which are not intended to come in contact with internal organs and blood
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UNIQUE FEATURES

Exceptional Quality USP Purified Water:  Typical output water measures 0.3-1.0  microS/cm electrical conductivity, 150-200 ppb TOC, 1-10 cfu/ml bacteria content.  Consistently meets USP 23-32 Purified Water standards.
Exceptionally Consistent Water Quality:  Replacement of conventional de-ionizing resin beds with electrodeioning modules (EDI), results in highly consistent biopurity and lower ion content.
Exceptional Economy:  Costs fraction of conventional, distillation-based USP water systems to purchase, to operate and to maintain.
Exceptionally Space-Saving Design:  Small 56 cm W x 76 cm D footprint for 400 L/hr capacity unit.
Sanitary Construction:  Fully enclosed
2
inside stainless-steel cabinet. High-purity, low-extractable PVC output piping, superior to PVDF or stainless-steel.
Ultimate Contamination Control:  Totally sealed system.  No open tanks exposed to atmosphere.  No infusion of environmental contaminants.
Water-Saving Design:  60-70% overall water recovery.
Energy-Saving Design: Only 4 watt.hours of total energy consumption per liter of purified water. Compare this with 80 - 230 watt.hours/liter energy consumption of conventional distillation stills.
Environmentally Friendly Design:  No chemicals used to regenerate de-ionizing resins. No chemical discharge to sewer other than impurities present in source water.
Easy Installation:  Integrated RO/EDI design for Plug-n-Go installation.
Easy Operation:  Single-switch daily operation with manual over-ride. Quick stabilization avoids 24/7 operation. Ergonomic instrumentation and control panel.
Easy Sanitizing:  Single-shot cold sanitizing of water purification unit and distribution piping, with built-in cleaning and sanitizing system. No steam generator required.
Easy Maintenance:  Only 1 moving part (RO pump), in the entire water system,  Single circuit board electronics. Integrated EDI power supply. Very few things to break down.
Easy Validation:  Factory-assembled, factory pre-qualified, water purification unit simplifies on-site qualification and validation. Factory OQ and PQ certification provided with each system.
       SPECIFICATIONS FOR WP-EDI SERIES USP PURIFIED WATER SYSTEMS
MODEL
WP-100-EDI
WP-240-EDI
WP- 420-EDI
WP-800-EDI
WP-1600-EDI
SIZE
(W x D x H)
56 X 76 X 126
CM
68 x 118 x 148
CM
76 x 145 x 148
CM
91 x 236 x 152
CM
162 x 244 x 152
CM
SHIP. WT.
135 KG
290 KG
365 KG
650 KG
1,000 KG
ELECTRICAL
220 VAC/
1 ph/8 A
460 VAC/
3 ph/6.5A
460 VAC/
3 ph/8A
460 VAC/
3ph/14A
460 VAC/
3ph/24A
SUPPLY
WATER
8.5-11 LPM
19-24 LPM
29-35 LPM
56-65 LPM
112-130 LPM
SUPPLY WATER
QUALITY
EPA quality municipal water. 20-60 psig pressure. 22-32oC temperature. Pre-softening of feed water required,
to reduce hardness below 5 mg/L. May require carbon filtration, if chlorine or other disinfectant is present in
feed water. Contact us for details.      
OUTPUT PORT
1/2" O.D. Tubing
3/4" High Purity
PVC Union Standard
1" High Purity PVC
Union Standard
1-1/4" High Purity
PVC Union Standard
1-1/2" High Purity
PVC Union Standard
OUTPUT FLOW
5.9-7 LPM
at 25 oC Water
Temp.
11.0-13.6 LPH
at 25 oC Water
Temp.
23.5-28.0 LPM
at 25 oC Water
Temp.
43-50 LPM
at 25 oC Water
Temp.
86-100 LPM
at 25 oC Water
Temp.
OUTPUT WATER
QUALITY
Output water meets Purified Water specifications per U.S.P.  Typical electrical conductivity  0.3 - 1 mS/cm, 
Typical TOC 150-200 ppb, Typical bacteria count 0-10 cfu/ml.  Note: day-to-day biological quality of  water
will depend on sanitizing schedule and general equipment maintenance.      

MODEL WP-35USP DUAL PURPOSE

PORTABLE

USP WATER SYSTEM

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Blue Spring Model WP-35USP Portable USP Water System for Medical Device Manufacturing
NEW
Ideal for small and medium-sized manufacturers of implantable and non-implantable medical devices. Suitable for manufacturing operation such as extrusion, machining, also for reprocessing, leak testing and final rinsing of implantable and non-implantable medical devices, before packaging.
Uses Mixed-bed, Ion-exchange Resin-based Deionizer to Reduce Electrical Conductivity of reverse osmosis purified water to USP level
Uses Blue Spring Model WP-35 Portable Reverse Osmosis Water Purifier
Large, 90 LPH Output Flow Capacity
Small 2 ft x 2 ft Foot-print for Portability
Skid-mounted, Factory Assembled, Factory Tested, Plug-N-Go unit
Includes Pre-treatment Components for Removing Hardness and Chlorine from City Water
Includes 60 Gallon (220 L), Closed-Top, Conical Bottom Storage Tank for Storage of USP Purified Water.  Conical Bottom Assures Complete Drainage
Includes Automatic Level Controller to Keep Storage Tank Full of Purified Water
Includes Programmable Auto Dump Valve to Empty Storage Tank on Schedule, to Maintain Water Purity
IIncludes Conductivity Monitors to Monitor Water Quality at Various Stages of Purification
Includes Built-in Valves to Switch from First-pass Mode to Second-pass Mode
Includes UV-light Sterilizer for Reduction in Bacteria-count in Water-for-Injection
Exceptional Economy:  In-house Production Costs fraction of Bottled USP Water
Highly Energy Efficient.  Runs on Regular, 120 VAC Household Electrical Outlet
Easy Sanitizing: Single-shot Cold Sanitizing of Water Purification Unit, Internal Piping Components and Storage Tank with Built-in Cleaning and Sanitizing System.  No Steam Generator Required
Easy Maintenance: Only 1 Moving Part (RO pump) in the entire Unit.  Makes system Mechanically Reliable.  Very few things to break down
Easy Validation: Factory-assembled, Factory Pre-qualified Unit Simplifies On-site System Validation

PRODUCES BOTH USP PURIFIED WATER AND USP WATER FOR INJECTION GRADES OF WATER

The WP-35USP system produces 90 LPH of USP Purified Water on
continuous basis. The USP Purified Water may be stored in the
storage tank (supplied with the unit).  The USP Purified Water may
be upgraded to USP Water for Injection standards by making
second pass through the reverse osmosis unit using a couple of
valves (supplied).

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UNIQUE FEATURES

  SPECIFICATIONS
Model
WP-35USP
Size
24" W x 24" D x 61" H (61 x 61 x 155 cm)
Weight
240 lbs (109 kg)
Electrical
120 VAC/ 1 ph/ 60 Hz/ 5.5 A
Plumbing
Feed: 3/4" FPT                                         Purified Tank Outlet: 1/2" FPT
WFI Outlet: 1/4" O.D. Tubing                    R.O. Reject (Drain): 3/8" Tubing
Auto Dump Valve (Drain): 1" FPT             Water Softener Drain: 3/8" O.D. Tubing
Capacity
USP Purified Water: 21-29 GPH (80-110 LPH) continuous flow measured at 25 oC. 60
Gallons (220 L) of storage capacity built-in.

USP Water for Injection: 21-29 GPH (80-110 LPH) continuous flow measured at 25 oC.  25-
32 Gallons (95-120 L) available per batch of second pass
Output Water Quality
First- pass output water meets USP Purified Water standards.  Typical electrical
conductivity 0.2-1 microS/cm, typical TOC 120-200 ppb, Typical bacteria count 1-10 cfu/ml

Second-pass output water meets USP Water for Injection standards.  Typical electrical
conductivity 0.2 - 0.8 microS/cm, typical TOC 100-150 ppb, Typical bacteria count 1-10
cfu/100 ml.  Typical endotoxin level <0.125 EU/ml.

Note: Day-to-day biological quality of water will vary, depending on sanitizing and cleaning
schedule, and general equipment maintenance.
Supply Water and
Quality
1 GPM (3.7 LPM) of EPA drinking water quality municipal water, 15 -60 psig pressure, 15 -
32 oC water temperature.
Ideal for mediam and large-sized manufacturers of implantable and non-implantable medical devices. Suitable for production operation such as extrusion, machining, also for reprocessing, leak testing and final rinsing before packaging of critical, implantable medical devices which are intended to come in contact with internal organs and blood

MODEL WP-35

"BRIEFCASE-SIZED"

REVERSE OSMOSIS WATER PURIFIER

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PRODUCES  ENDOTOXIN-FREE, REVERSE OSMOSIS  PURIFIED WATER OF

LOW ION-CONTENT
Blue Spring Model WP-35 "Briefcase" Reverse Osmosis Water Purifier for Meeical Device Laboratory and Manufacturing
Ideal source of endotoxin-free water of low ion-content for laboratory work, also for non-critical production operations such as extrusion, machining, initial rinsing and leak testing of implantable and non-implantable medical devices
SYSTEM WP-35 "Briefcase-sized" portable reverse osmosis water purifier produces 25 GPH of non-pyrogenic water of low ion content, for general purpose device manufacturing, rinsing and testing applications.  Measures 6"x21"x14".  Fits on counter-top, or can mount piggyback on some other equipment. Uses reverse osmosis for water purification.  Output endotoxin levels typically 0.05-0.125 EU/ml. Bacteria levels typically 10-100 per 100 ml.  Total Dissolved Solids levels typically 3-8 mg/L.

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