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. Blue Spring also  pioneered storage-tank-less re-circulating closed loop output technology (1983). 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 easily 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 with  EDI (electrodeionization) systems are recommended.

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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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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.

 

Specify "R" option for closed-loop output.

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TYPICAL CLOSED LOOP OUTPUT CONFIGURATION  OF BLUE SPRING SYSTEM WFI-R IN MANUFACTURING OF PHARMACEUTICAL PRODUCTS

USP 22 WATER FOR INJECTION AND PURIFIED

WATER USING DOUBLE-PASS REVERSE OSMOSIS

WFI-R SERIES

DOUBLE-PASS REVERSE OSMOSIS SYSTEMS  WITH CLOSED-LOOP OUTPUT FEATURE PRODUCE HIGH QUALITY PHARMACEUTICAL WATER FOR INJECTION¹ ACCORDING TO USP 22 AND EARLIER. ALSO MEETS PHARMACEUTICAL PURIFIED WATER SPECIFICATIONS¹ ACCORDING TO USP 22 AND EARLIER

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n 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 better removal of bacteria and their endotoxins

n Exceptional Economy:  Costs fraction of conventional, distillation-based USP water for injection systems to purchase, to operate and to maintain. Operating costs lower than purified water systems utilizing deionizing beds.

n Exceptionally Space-Saving Design:  Small 56 cm x 145 cm footprint for 1,300 L/ hr
capacity unit

n Sanitary Construction: Fully cabinet enclosed design. 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 prevents infusion of environmental contaminants.

n Integrated Re-circulation Loop:  Closed-Loop purified water distribution system (see below). Unused Purified 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.

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

n 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

n Environmentally Friendly Design: No chemicals used to regenerate de-ionizing resins. No steam used for distillation or for hot-water recirculation loop.  Low energy consumption.  No chemical discharge to sewer other than impurities present in the source water

n Easy Installation:  Integrated RO design for Plug-n-Go installation. Only pre-treatment components and passive delivery loop piping required to complete installation

n Easy Validation: Factory-assembled, factory pre-qualified water purification unit simplifies on-site qualification and validation of process water system. Factory OQ and PQ certification provided with each system

SPECIFICATIONS

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

 

UNIQUE FEATURES

 

n Exceptional Quality Pharmaceutical Water for Injection: Typical output water measures 1-2 mg/L Total Dissolved Solids, 70-150 ppb TOC, 0-10 cfu/ml bacteria content, <0.06 EU/ml endotoxin content. Meets USP 22 and similar international standards for Water for Injection¹.  To meet the latest USP 29 Water for Injection standards, please select Blue Spring WFI-R-EDI systems.

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

n Easy maintenance: Only one moving part in the entire water system.  Not much to break down.  Built-in cleaning and sanitizing system with easy-to-use front panel controls.  Allows entire water system including delivery loop to be cleaned and sanitized.