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 29 Water for Injection¹ standards.

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With over 27 years of experience in pharmaceutical water systems, when you go with Blue Spring, you are in safe hands!

 

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To learn more about EDI and about USP standards, please click here

 

¹ According to U.S. FDA, USP purified water and USP WFI 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 Except WFI-700R-EDI and WFI-1400R-EDI models in which RO modules are outside cabinet

Specify "R" option for closed-loop output.

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TYPICAL CLOSED LOOP OUTPUT CONFUGURATION  OF BLUE SPRING SYSTEM WFI-R-EDI IN MANUFACTURE OF PHARMACEUTICAL PRODUCTS

HIGH-QUALITY USP WATER FOR INJECTION¹ USING COMBINATION OF DOUBLE-PASS REVERSE OSMOSIS AND ELECTRODEIONIZATION

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

PRODUCE HIGH QUALITY PHARMACEUTICAL USP WATER FOR INJECTION¹ PER USP 23-29

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UNIQUE FEATURES

 

n 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 23-29 Water for Injection standards¹

 

n Exceptionally Consistent Water Quality: Replacement of conventional de-ionizing resin beds with electrodeioning modules (EDI) results in highly consistent biopurity and lower ion content

 

n Exceptional Economy:  Costs fraction of conventional, distillation-based USP water for injection systems to purchase, to operate and to maintain

 

n Exceptionally Space-Saving Design:  Small 76 cm x 148 cm footprint for 1,300 L/ hr
capacity unit

 

n Sanitary Construction: Fully enclosed² 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

 

n Ultimate Contamination Control: Totally sealed system including distribution network prevents infusion of environmental contaminants

 

n Integrated Re-circulation Loop (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 delivery systems. 

 

n 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 UV lights, no sub-micron filters, no heat exchangers, no clean steam generators required for delivery of Water-for-Injection to points of use

 

n Water-Saving Design: 60-70%  overall water recovery

 

n 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

 

n Environmentally Friendly Design: No chemicals used to regenerate de-ionizing resins. No chemical discharge to sewer other than impurities present in source water

 

n 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

 

n 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

 

n Easy Operation: Single-switch daily operation with manual over-ride. Quick stabilization avoids 24/7 operation. Ergonomic instrumentation and control panel

 

LATEST COMBINATION DOUBLE-PASS REVERSE OSMOSIS / ELECTRODEIONIZATION SYSTEMS WITH BUILT-IN, PUMP-LESS CLOSED LOOP RECIRCULATION OUTPUT CONFIGURATION MAKES DISTILLATION SYSTEMS OBSOLETE

WFI-R-EDI SERIES

n Easy Sanitizing: Single-shot cold sanitizing of water purification unit and distribution piping with built-in cleaning and sanitizing system.  No steam generator required

 

n 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