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

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SYSTEM WP-35DI and WP-60DI use combination of reverse osmosis and ion-exchange deionization technologies to produce water of high ionic purity which meets USP 23-29 Purified Water¹ standards.  Include pre-treatment components, Purified water storage tank and high-flow delivery pumps. Compact, factory-assembled, factory-tested package occupies only 3'x6' space, makes on-site validation easy. Duplex high-flow delivery pumps produce up to 55 GPM instantaneous flow rates.  Bacteria levels typically 1-10/ ml. Electrical conductivity typically 0.1-1 microSiemen/cm. TOC levels typically 150-350 ppb.

SYSTEM WP-35DI can produce up to 600 GPD of Purified Water. SYSTEM WP-60DI can produce up to 1,440 GPD of Purified Water.

Ideal for medical device washing machines used for reprocessing of medical devices, and for other production uses requiring high flow rates, for short periods of time.

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SYSTEM WP-35 "Briefcase" 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.

Ideal for medical device rinsing and leak testing, also for laboratory media preparation and for pyrogen testing.

Industry-proven mechanical reliability and performance since 1980.

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WP-R-EDI Series water purifiers produce high-quality USP Purified Water¹ using a combination of reverse osmosis and electrodeionization technologies. The extra-ordinary purity of the water produced by these systems is maintained consistently, throughout the device manufacturing facility by Blue Spring's exclusive, continuous recirculation, closed-loop output technology. The system uses no storage tank or recirculation pumps that can re-contaminate the output water. And in fact, the Blue Spring closed-loop system enhances the biological purity of water with time, due to repeated purification, through the reverse osmosis membranes. These factory-assembled, factory qualified* systems produce water of high ionic and chemical purity, that surpasses the latest USP 29 Purified Water standards. Typical bacteria levels of 1-10 cfu/ ml. Typical electrical conductivity in the range of 0.2-0.8 microSiemen/cm. Typical TOC levels of 120-250 ppb. System capacities are available from 240 to1,600 GPH. 

Ideal as facility-wide, purified water supply system for variety of uses, including rinsing and testing of medical devices, reprocessing of devices, media preparation, also for laboratory uses. USP Purified Water is typically used for manufacturing and re-processing of non-critical devices that will not come in contact with blood or internal organs.

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WFI-R-EDI Series water purifiers produce high-quality USP Water-for-Injection¹, using a combination of double-pass reverse osmosis and electrodeionization technologies. The extra-ordinary purity of the water produced by these systems is maintained consistently, throughout the device manufacturing facility by Blue Spring's exclusive continuous recirculation, closed-loop output technology. The system uses no storage tank or recirculation pumps that can re-contaminate the output water. And, in fact, the Blue Spring closed-loop system enhances the biological purity of water with time, due to repeated purification through the reverse osmosis membranes. These factory-assembled, factory qualified systems produce non-pyrogenic water of high ionic and biological purity that surpasses the latest USP 29 Water-for-Injection¹ standards.  Typical endotoxin levels below of 0.05 EU/ml. Typical bacteria levels of 1-10 cfu/100 ml. Typical electrical conductivity in the range of 0.2 - 0.8 microSiemen/cm. Typical TOC levels of 70-250 ppb.  System capacities available from 200-1,400 GPH. 

Ideal as facility-wide purified water supply system, for a variety of uses, including rinsing and testing of medical devices, reprocessing of devices, media preparation, also for laboratory uses.  USP Water-for-Injection is typically used for rinsing and testing of critical devices that will come in contact with blood or internal organs, or may hold residual water in the packaged form. Note: Terminal sterilization is still necessary for the packaged devices.

With closed-loop output option, a single system can serve several medical device rinse lines, leak-testing line, disinfection line, as well as quality control laboratory, without storage tanks, pumps, sub-micron filters and without the maintenance associated with conventional water systems. 

It's that pure and simple . . .

Blue Spring Corporation is the pioneer (1980) in the application of reverse osmosis water purification technology, in the medical device industry. Now, with the addition of the latest electrodeionization (EDI) technology, and a storage-tank-less continuous re-circulating closed-loop output feature, the new breed of BLUE SPRING medical device rinse water systems offer non-pyrogenic, high-purity water, in a small footprint. 

With over 28 years of experience in water purification systems for medical device manufacturing, 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.

PURE AND SIMPLE !

 WP-35 "BRIEFCASE" REVERSE OSMOSIS WATER PURIFICATION SYSTEM

SYSTEM WP-60 slimline portable reverse osmosis water purifier. Produces 60 GPH of non-pyrogenic water of low ion content. Has 7"x22" footprint, 48" tall, fits into tight spaces in production and testing areas.  Uses reverse osmosis for water purification. Has built-in cleaning and sanitizing system. Optional built-in carbon filter to remove chlorine from city water.  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.

Ideal for medical device rinsing and leak testing, also for biological media preparation and for pyrogen testing.

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WP-60 "SLIMLINE" REVERSE OSMOSIS WATER PURIFICATION SYSTEM

 WP-35DI AND WP-60DI USP PURIFIED WATER  SYSTEMS

Shown with 100 gallon storage tank and 55 gpm high-flow attachment

WFI-R-EDI AND WP-R-EDI SERIES WATER PURIFICATION SYSTEMS WITH CLOSED-LOOP OUTPUT CONFIGURATION

CHOICE OF WATER QUALITY AND CAPACITY

Water used in manufacturing, reprocessing, rinsing, and testing operations, in the medical device industry, must be sufficiently pure to avoid contamination of the devices in their final, packaged form. Minerals and organics in the water may form residue on the surface of the device. Fabrication and mechanical tooling of the device may leave a residue of heavy metals; such as, iron, copper, nickel, and chromium. 

Particularly important are biological impurities; such as, bacteria and their endotoxins. In critical devices that come in contact with open wounds, blood and internal organs, it is particularly important to control endotoxins, because of their pyrogenic reaction during their end-use. In many packaged medical devices, water is retained inside the device, due to cavities and sometimes it is necessary to maintain the device wet. Such residual water presents increased risk of biological contamination. While terminal sterilization can kill bacteria, deactivation of endotoxins requires maintenance of high temperatures of the order of 240 °C for long period of time, which is not practical for devices made from plastics. Even for devices made out of metals, high temperatures can cause distortion.

In these cases, using endotoxin-free water, during critical manufacturing operations, during leak testing, and during final rinsing of the devices, provides the best assurance against endotoxin contamination from these environmental sources.

Blue Spring water purification systems provide a reliable source of purified water for fabrication, assembly, rinsing and testing operations used in medical device manufacturing.

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n WP-35 "Briefcase" portable reverse osmosis water purification system for general purpose medical device rinsing, leak testing, biological media preparation, and for Laboratory applications. Produces non-pyrogenic water of low ion content.

n WP-60 "Slimline" reverse osmosis water purification system for general purpose medical device rinsing, leak testing, and for biological media production. Produces non-pyrogenic water of low ion content.

n WP-35DI and WP-60DI compact deionized water systems for medical device washing machines, device testing, re-processing, and other applications that require high flow rates for short periods of time.  Produce USP 23-29 Purified Water¹.

n WP-EDI SERIES combination reverse osmosis electrodeionization USP Purified Water systems for medical device tooling, rinsing, leak testing, re-processing, and other manufacturing operations. Produce USP 23-29 Purified Water¹.

n WFI-EDI SERIES combination double-pass reverse osmosis electrodeionization USP Water-for-Injection systems for critical medical device tooling, rinsing, leak testing, and other manufacturing operations.  Produce USP 23-29 Water-for-Injection¹.

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