 Reverse Osmosis Systems: Pharmaceutical Uses December 7, 2009 The pharmaceutical industry must adhere to strict guidelines to ensure that their products are chemically and biologically safe for human use and consumption. The United States Pharmacopeia (USP) is an official public standards – setting authority for all prescription and over the counter medicines and other health care products manufactured or sold in the United States. Any pharmaceutical product that contains water or undergoes processing with water must be assured that its safety will not be compromised by a contaminated water source. This is exactly why the USP has created a detailed set of requirements that the water must meet in order to be used in any pharmaceutical products. USP 23 requires incoming feed water to meet US EPA National Drinking Water Regulations. There are two main categories of water used in pharmaceutical applications, the first being USP purified water and the second being water for injection (WFI). Table 1 provides the specific water quality that both purified and WFI must meet in order to be approved for pharmaceutical use.  While distillation can be used to produce both purified water and WFI the astronomically high energy costs associated with operating a distillation system pose a significant problem. The lower energy requirements of an RO system make it an ideal source for the production of ultrapure water. Another benefit of operating an RO system over a distillation unit comes with the modular design of RO systems. In a distillation unit if there is a problem the entire process must be shut down until the problem is identified and fixed. In a RO system the element causing the problem can be interchanged quickly with minimal down time. With low operating and capitol costs along with proven performance Reverse Osmosis systems are quickly becoming the future for ultrapure water production in the pharmaceutical industry. |
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