Water For Injection Measurements

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•Application Note: Water For Injection Measurements

Water is one of the most widely used raw materials in the pharmaceutical plant. Several grades of water are used throughout the plant. One grade, Water for Injection (WFI), is water purified by reverse osmosis or distillation as specified by the United States Pharmacopeia (USP). Specific tests for conductivity apply to WFI water produced on site for manufacturing purposes.

Process

The process starts with raw water conforming to US EPA National Primary Drinking Water Regulations or comparable standards of the European Union or Japan. The water contains no added substances. For Reverse Osmosis systems, the raw water is passed through semi-permeable membrane filtration where the pores in the membrane effectively reject dissolved ions, salts and organic compounds. Filtration units are located before and after the membrane modules, a booster pump to increase net pressure across the membranes, and storage tanks.

For Distillation systems, a phase change from liquid to vapor occurs, enabling the pre-treated feed water to be stripped of any residual ion materials, particulate, colloids and non-volatile organic compounds. Demisters and separation devices remove any material that may be entrenched in the purified vapors. Single effect distillation units consist of a series of columns where the phase change occurs, the evaporation and subsequent condensation being considered a single effect. Multiple effect units may be used depending on the water usage demand. The distillate is gravity fed to a storage tank.

Click Here To Download:
•Application Note: Water For Injection Measurements