PHARMACEUTICAL WATER SYSTEMS, USP WATER FOR INJECTION SYSYEMS,  WFI SYSTEMS, PHARMACEUTICAL USP WATER FOR INJECTION SYSTEMS

Blue Spring Corporation manufactures reverse osmosis equipment in U.S.A. since 1980

Bottles being filled with pharmaceutical product

With over 29 years of experience in USP water systems,
when you go with Blue Spring, you are in safe hands !
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* Closed-loop output option not available for these models.

1. Intended for formulation of pharmaceuticals and pharmaceutical ingredients, and for manufacturing of
medical devices.  Water purification equipment not intended for direct use as a medical device in medical
treatment.  Product water not intended for direct use as a drug in medical treatment.  On-site Installation
Qualification, Operational Qualification, Performance Qualification and long-term System Validation is
usually required, for establishing long-term consistency of product water quality, under seasonal variations
of feed water quality and operating conditions.

According to U.S. FDA, USP Purified Water and USP Water for Injection are components or “ingredient
materials” as they are termed by the USP, intended to be used in the production of drug products.  Neither
FDA nor USP considers them as drug products.  These two water categories are popularly used within
pharmaceutical and medical device manufacturing establishments.

2. All models except WFI-700-EDI and WFI-1400-EDI are fully cabinet enclosed.  In models WFI-700-EDI
and WFI-1400-EDI, reverse osmosis modules are attached externally to the cabinet.
NEW
Blue Spring model WFI-1400R-EDI USP Water for Injection system
Blue Spring Model WFI-360 USP Water for Injection system

WFI-R-EDI SERIES PHARMACEUTICAL USP WATER SYSTEM

PRODUCE HIGH QUALITY PHARMACEUTICAL USP WATER FOR INJECTION1 PER USP 23-32
For WP-EDI Series USP Purified Water systems, click here

LATEST COMBINATION OF DOUBLE-PASS REVERSE OSMOSIS AND ELECTRODEIONIZATION TECHNOLOGIES WITH BUILT-IN, CLOSED-LOOP RECIRCULATION OUTPUT SYSTEM PRODUCES HIGH QUALITY PHARMACEUTICAL WATER FOR INJECTION

1

PER USP 23-32

Blue Spring Corporation is the pioneer (1982) in commercialization of double-pass reverse osmosis technology for the production of Water for Injection1 per United States Pharmacopoeia. Now, with the addition of electrodeionization (EDI) technology and a storage-tank-less re-circulating
closed loop output feature, the new breed of BLUE SPRING WFI-R-EDI series pharmaceutical water purification systems, produce even higher quality USP Water for Injection which surpasses the latest USP 32 Water for Injection1 standards.



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Typical installation of Model WFI-700R-EDI USP Water-for-Injection system
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 76 cm x 145 cm footprint for 1,300 L/hr capacity unit.
Sanitary Construction:  Fully enclosed
2
inside stainless-steel cabinet. High-purity, low-extractable PVC output piping, better than PVDF or stainless-steel. Cold-sterilizable with easy-to-use, built-in cleaning and sanitizing system.
Ultimate Contamination Control:  Totally sealed system, including distribution network, prevents infusion of environmental contaminants.
Integrated Closed-Loop Re-Circulation
(optional):  Closed-Loop output water distribution system (see below). Unused water from production area is continuously recycled to water purification section where it gets repeatedly purified with every pass. Continuously purges out bacteria and their endotoxins generated in pipelines, instead of accumulating them, as in conventional, storage-tank based delivery systems.
Exceptionally Simplified Distribution System Design:  Only a few passive piping components required for completing delivery system. No storage tanks, no breathing filters, no re-circulation pumps, no sub-micron filters, no heat exchangers, no clean steam generators required for delivery of Water-for-Injection to points of use.
Water-Saving Design:  60-70% overall water recovery.
Energy-Saving Design:  High-efficiency EDI power supply. Cold re-circulation loop. No steam used for distillation or for hot-water recirculation loop. Only 5.1 watt.hours of total energy consumption per liter of water for injection, including delivery system. Compare this with 80 - 230 watt.hours/liter energy consumption of conventional distillation stills with hot water storage tank.
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. Only pre-treatment components and simple, WFI delivery loop passive piping required to complete installation.
Easy Validation:  Factory-assembled, factory pre-qualified, water purification unit simplifies on-site qualification and validation of the pharmaceutical WFI process water system. Factory OQ and PQ certification provided with each system

UNIQUE FEATURES

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, including delivery loop piping.  Single circuit board electronics for all instrumentation. Integrated EDI power supply. Very few things to break down.
Diagram showing how closed-loop WFI output  system works
       SPECIFICATIONS FOR WFI-EDI SERIES USP WATER FOR INJECTION SYSTEMS
MODEL
WFI-50-EDI*
WFI-120-
EDI*
WFI-200-EDI
WFI-360-EDI
WFI-700-EDI
WFI-1400-
EDI
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
230 VAC/
1 ph/10 A
230 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 LPM
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.      

TYPICAL INSTALLATION OF BLUE SPRING WFI-R-EDI PHARMACEUTICAL USP WATER FOR INJECTION SYSTEM