Water for Hemodialysis— is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
It is produced and used on-site and is made from EPA Drinking Water that has been further purified to reduce chemical and microbiological components.
It may be packaged and stored in unreactive containers that preclude bacterial entry.
The term “unreactive containers” implies that the container, especially its water contact surfaces, is not changed in any way by the water, such as by leaching of container-related compounds into the water or by any chemical reaction or corrosion caused by the water.
The water contains no added antimicrobials and is not intended for injection.
Its attributes include specifications for water conductivity, total organic carbon (or oxidizable substances), microbial limits, and bacterial endotoxins.
The water conductivity and total organic carbon attributes are identical to those established for Purified Water and Water for Injection; however, instead of total organic carbon (TOC), the organic content may alternatively be measured by the test for Oxidizable Substances.
The microbial limits attribute for this water is unique among the “bulk” water monographs, but is justified on the basis of this water's specific application that has microbial content requirements related to its safe use.
The bacterial endotoxins attribute is likewise established at a level related to its safe use.
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