Blue Spring Corporation manufactures USP Water for Injection systems







Schematic explaining how closed loop reverse osmosis works
BLUE SPRING Closed-loop output technology was developed in 1982 to meet the demands of the pharmaceutical and medical device manufacturing industries, to provide a central source of  purified water to feed numerous points of use, without the risk of biological contamination of water in the distribution network.  In these applications of water purification, bacteria growth and their resultant endotoxins are of major concern. The closed-loop output system addresses this concern most reliably and most economically.
There is no storage tank. A storage tank is known as a bacteria breeder and an endotoxin generator. This major source of water contamination is eliminated in the Blue Spring’s storage-tank-less closed-loop output systems.
There is no separate distribution pump. A pump is a source of particulate and chemical contamination.  This major source of water contamination is eliminated in the Blue Spring closed-loop systems. The Blue Spring closed-loop output system uses the RO pump itself, for the recirculation of water. The RO pump is before the RO membranes, which means any contamination introduced by the RO pump is continuously removed by the RO membranes, before the water enters the distribution loop.
There is no piping, valves, or gauges associated with the storage tank and pumps. These mechanical components involve dead-legs, which are sources of bacteria. This major source of water contamination is eliminated in the Blue Spring closed-loop systems. The Blue Spring closed-loop output system is a passive water distribution system without dead legs and other sources of microbiological contamination of water.
There are no in-line bacteria filters, or air-breather filters. These filter components are used in storage-tank based systems to remove bacteria from water, because water storage tanks provide excellent breeding ground for bacteria. Unfortunately, the filters retain the bacteria and the retained bacteria become a source of endotoxins, which are the byproducts of live and dead bacteria. The endotoxins being non-particulate chemicals, pass through the bacteria filters and continuously contaminate the water. Blue Spring closed-loop output systems eliminate endotoxin contamination by continuously purging out the bacteria and their endotoxins from the water distribution network
In a storage-tank based distribution system, chemical and endotoxin contamination level increases rapidly with time, with no upper limit in sight. In the Blue Spring’s closed-loop system, the contamination level actually decreases with time, as the water makes repeated passes through the RO unit, due to repeated reverse osmosis purification. The impurity level, both chemical and biological, stabilizes to a very low value, after a few hours of system operation.

RO system performance is improved. Mixing raw, makeup water with water returning from the loop, which is of much higher quality than raw water, results in quality enhancement of the output water that is used at the user outlets. Typically, the conductivities of output water are lower by a factor of 1.3 to 2.0 compared with conventional, open loop and storage tank based RO systems.
Maintenance is much lower because there are no tanks to clean and sanitize, no pumps to repair, no filters to replace, no heaters and coolers to replace. Loop piping is cleaned and sanitized simultaneously with the RO equipment, using chemical sanitizing agents.
Operating costs are lower, because of reduced maintenance and reduced power consumption. Conventional water systems based on storage tanks and recirculation pumps often require heating and cooling, in order to reduce microbiological contamination of water in storage. Heating and cooling systems consume a lot of energy and require mechanical maintenance. Blue Spring closed-loop system does not require heating and cooling. Being passive system, it does not require mechanical maintenance.
Mechanical system reliability is much higher, because there is only one mechanical component (RO pump), in the entire water system including the distribution loop. The number of passive components in the piping is also reduced to a minimum. Almost nothing to break down.
Reliability of water-quality is much higher, because of elimination of the major sources of contamination and constant re-purification of water.

Closed-loop output system is a pump-less, storage-tank-less purified water distribution system, in which (a) purified output water generated by the RO unit is continuously circulated in a closed-loop piping encompassing the facility; (b) unused portion of the purified water is continuously returned back to the RO unit where it is mixed with raw, makeup water; and (c) mixture of recycled output water and the makeup water gets continuously re-purified by the RO unit. It differs from conventional, storage-tank based recirculation loop systems in the following important ways:

BLUE SPRING closed-loop output reverse osmosis water purification systems are available in

WFI-R-EDI series USP Water for Injection systems,

WP-R-EDI series USP Purified Water systems, and in WP-R series multipurpose water purifiers. Each series is designed to produce output water of certain level of chemical and biological purity.

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Pharmaceutical USP Water System

Schematic explaining how closed loop USP water system works
According to United States Pharmacopoeia, Water-for-Injection is “intended for use in the preparation of parenteral solutions.” In the production of parenteral solutions, process water is used for preparation of the parenteral solutions, for washing bottles prior to filling, and for generating clean steam for terminal sterilization of the finished product.

Process water used in the production of parenteral solutions must meet the strict requirements of the U.S. Pharmacopoeia. The most critical part of the U.S.P. standard for Water-for-Injection is freedom from bacterial endotoxins, which are considered pyrogenic. Even water free of bacteria can contain endotoxins, because the endotoxins are byproducts of live and dead bacteria. Unlike bacteria, endotoxins can not be filtered out, since they are chemical species rather than particulates. Neither can endotoxins be de-activated by terminal sterilization since endotoxins are not live species. A product batch contaminated with endotoxins must be discarded.

Conventional WFI systems use a hot storage tank and a re-circulation pump to supply water to various user points and then return it to the storage tank. In spite of all precautions, maintaining low endotoxin level, which relates to pyrogenicity of water is difficult to achieve with conventional re-circulation systems.

USP Water-for-injection must also be low in electrical conductivity - a requirement difficult to achieve by conventional reverse osmosis based water purification systems.

BLUE SPRING SYSTEM WFI-R-EDI is a specialized water purification system, which uses an ingenious combination of double-pass reverse osmosis and electro-deionization technologies in a closed-loop output configuration, to attain extremely low bacteria levels, almost unmeasurable endotoxin levels, and the required low electrical conductivity levels. All system components are housed inside a single enclosure making installation and qualification easy. The system is essentially maintenance-free, because of low equipment count, lack of: WFI hot storage tanks; external pumps;  external UV lights; sub-micron filters, etc. And it occupies a small fraction of the space occupied by competitive Water-for-injection systems. The system is also highly energy-efficient compared with distillation-based pharmaceutical USP Water-for-Injection systems.

For use as an ingredient in the preparation of non-parenteral compendial dosage forms, which call for USP Purified Water, use BLUE SPRING WP-R-EDI system. This system also incorporates the closed-loop output feature and uses combination single-pass RO electrodeionization technology instead of double-pass RO.

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Manufacturing, Rinsing and Testing of Medical Devices

Schematic explaining how closed loop water system works in medical device amanufacturing
Water used in manufacturing, re-processing, rinsing and testing operations, in the medical device industry, must be sufficiently pure to prevent contamination of the devices in their final, packaged form. Minerals and organics in the water may form residue on the surface of the device. The residue may include heavy metals, which may arise from tooling operations. 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. 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 physical distortion.

Blue Spring WP-R series closed-loop output reverse osmosis water purification systems provide a reliable source of endotoxin-free purified water for tooling, assembly, rinsing and testing operations performed in medical device manufacturing. For critical medical device manufacturing, rinsing and testing operations, use Blue Spring WFI-R-EDI series USP Water-for-Injection systems for even better ionic purity.

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