DESIGN EDI EQUIPMENT ION EXCHANGE PHARMACEUTICALS USP

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Abstract

Traditionally, the high-purity water system design approach has been to divide and conquer. Highly specified, yet traditional designs have engineered risk out and reliability into projects without sufficient input from commissioners (validation) and endusers (utilities, quality, and metrology). But history has proven that no project is an island. The sooner multi-functional teams are brought into the project, the easier the handoff at each stage, the lower the lifecycle operating expense, and the less the project cost creep. This article offers a high-level case study of such an achievement. It examines a major pharmaceutical facility in the Midwest that recently completed a near nine-figure expansion, including a state-of-the-art Water for Injection (WFI) generation, storage, distribution, and compliance system. The project leader, who is not an engineer by training, balanced design, technology, and compliance to deliver an owner-centric expansion. Although membrane and electrodeionization (EDI) purification methods generally dominate water treatment, in this case distillation proved to be a more effective process due to natural gas pricing trends in the United States. Thermal sanitization might also have been expected to be efficient, but ozone proved the best choice for controlling bioburden and reducing total organic carbon (TOC) to almost undetectable levels. By taking full advantage of the U.S. Food and Drug Administrationﾒs (FDA) strong encouragement to use robust Process Analytical Technology (PAT), the project demonstrated it is possible to simultaneously minimize human error, lab and metrology man-hours, and instantly release WFI for production with high confidence. Semiconductor manufacturers may also benefit from this design approach, while healthcare professionals may reduce their critical utilityﾒs risk and operating expense while improving compliance.

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