PHARMACEUTICAL USP 22 WATER SYSTEM, USP 22 WATER FOR INJECTION SYSTEM, USP 22 PURIFIED WATER SYSTEM

Blue Spring Corporation manufactures USP Water for Injection systems
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.

WFI-R SERIES DOUBLE-PASS REVERSE OSMOSIS SYSTEMS 

PRODUCE HIGH QUALITY PHARMACEUTICAL WATER FOR INJECTION
1
ACCORDING TO USP 22 AND EARLIER. ALSO MEETS PHARMACEUTICAL PURIFIED WATER SPECIFICATIONS
1
ACCORDING TO USP 22 AND EARLIER


For latest WFI-EDI series pharmaceutical USP 23-32 Water for Injection systems, click here

For latest WP-EDI seriespharmaceutical USP 23-32 Purified Water systems, click here
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.  The WFI-R Series combine double-pass reverse osmosis and closed loop output recirculation technologies to produce exceptional quality pharmaceutical process water for the entire facility.  These systems are simple, compact and economical compared with conventional distillation and deionization based pharmaceutical water systems.  The water purified by WFI-R units consistently meets USP 22 and earlier standards.  When higher ionic purity is required to meet USP 23 and later standards, Blue Spring WFI-R-EDI series combination double-pass reverse osmosis systems with  EDI  (electrodeionization) are recommended.



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High Quality Pharmaceutical Water for Injection: Typical output water measures 1.5-2.5 mg/L Total Dissolved Solids, 70-150 ppb TOC,  1-20 cfu/100 ml bacteria content, 0.06-0.125 EU/ml endotoxin content. Meets USP 22 standards for Water for  Injection
1
.  For latest USP 32 Water for Injection requirements, please select Blue Spring WFI-R-EDI system.
Exceptionally Consistent Water Quality: Replacement of conventional de-ionizing resin beds with second pass of reverse osmosis  not only results in extremely consistent
output water quality but also more efficient removal of bacteria and their endotoxins.
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 x 145 cm footprint for 1,300 L/ hr
capacity unit.
Sanitary Construction:  Fully enclosed inside cabinet. High-purity, low-extractable PVC output piping, superior to PVDF or stainless-steel.
Ultimate Contamination Control:  Totally sealed system, including distribution network. Prevents infusion of environmental contaminants.
Integrated Closed-Loop R
e-circulation
(optional):  Closed-Loop purified 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: No steam required.  Cold re-circulation loop. Only 3.4 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 double-pass RO 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 1 moving part (RO pump), in the entire water system, including delivery loop piping.  Single circuit board electronics for all instrumentation. Very few things to break down.
       SPECIFICATIONS FOR WFI SERIES USP WATER FOR INJECTION SYSTEMS
MODEL
WFI-35*
WFI-90*
WFI-180
WFI-360
SIZE
(W x D x H)
11"x21"x30"
22"x57"x30"
22"x57"x30"
22"x57"x66"
WEIGHT
56 kg
94 kg
154 kg
315 kg
ELECTRICAL
117 VAC/1 ph/11A
230 VAC/1 ph/8A
230 VAC/1 ph/6A
230 VAC/3 ph/12A
SUPPLY
WATER
4 - 5 LPM
9 - 11 LPM
16.5-20.5 LPM
32-37 LP
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
OUTPUT FLOW
120-150 LPH 
at 25 oC Water Temp.
300-365 LPH
at 25 oC Water Temp.
615-740 LPH
at 25 oC Water Temp.
1,225-1,500 LPH
at 25 oC Water Temp.
OUTPUT WATER
QUALITY
Output water meets Water-for-Injection specifications per U.S.P Vol. 22 and earlier, also Purified Water
per U.S.P. Vol. 22 and earlier.  Typical TDS 1.5 - 2.5 mg/L,  > 3.5 log reduction in heavy metals. 
Meets heavy metals, oxidizables and other chemical purity tests.  Typical bacteria count in
output water 5-20 cfu/100 ml.  Typical endotoxin level in output water 0.05 - 0.125 EU/ml. 
Note: day-to-day biological quality of output water will also depend on sanitizing schedule and
general equipment maintenance.     

TYPICAL INSTALLATION OF BLUE SPRING WFI-R PHARMACEUTICAL USP WATER FOR INJECTION SYSTEM
Blue Spring Model WFI-360R pharmaceutical USP 22 Water for Injection system
Blue Spring Model WFI-180R USP 22 Water for Injection system installation
Schematic explaining how Blue Spring closed loop output system works in WFI series USP water systems