CHLORAMINES DISTILLATION OZONE PHARMACEUTICALS REVERSE OSMOSIS USP UV WATER FOR INJECTION

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Abstract

The standard practice for producing Water-for-Injection (WFI) in the worldwide pharmaceutical industry is distillation. In the United States, and production facilities that supply the American market, all water used for injectable productsﾗ or others designated as having a WFI requirementﾗ must meet the United States Pharmacopoeia (USP) (current edition USP 34), achieving specifications of 1.3 microsiemens per centimeter (ﾵS/cm) at 25oC conductance; 500 micrograms per liter (ﾵg/L) total organic carbon (TOC), 0.25 endotoxin units, and 10 colony forming units per 100 milliliters (cfu/100 mL) microorganisms with zero coliform bacteria. The European Pharmacopoeia (EP) adds specifications for nitrate and nitrite, heavy metals and aluminum. In some geographical areas, such as Japan and even the United States, alternates to distillation are allowed; and, there are other means of achieving these objectives. However, conventional wisdom typically suggests that the safe production of WFI is through the distillation process. There are two keys to the distillation process: are phase change and heat. As a still converts water from a liquid to a vapor, most contaminants physically cannot make the transition to the product water because they require a greater temperature to reach their vaporization heat. The exceptions include all dissolved gases (e.g., carbon dioxide, ammonia) that are entrained within the water and are liberated from the solution once heat is applied. These need to be removed by degasification or other means, either prior to or following the distillation process. The heat maintains microorganism-free product water as long as the temperature is held above 80oC.

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