LIFE SCIENCES MICROBIALS MONITORING ORGANICS PHARMACEUTICALS OPERATIONS PURIFIED WATER SANITIZATION SYSTEM DESIGN USP WFI

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Abstract

High-purity water systems can be found across multiple industries, including pharmaceutical, healthcare, food and beverage, biotech, nuclear, aerospace, and microelectronics.

High-purity water systems typically include pretreatment, primary treatment, and sometimes final or polishing treatment equipment along with a storage and distribution system. The pretreatment is typically used to prolong the life or service period of the primary treatment equipment by removing certain impurities using lower cost technology. The primary treatment system (or in some cases the final treatment) refines the quality of the water even further and is often the last step taken to create or maintain the desired water quality needed for production. The storage and distribution system supplies the product water at desired temperatures, pressures, and velocities to use points throughout a facility.

Feedwater evaluation is pertinent to water system design as it will impact the selection of treatment equipment utilized in the system. Ideally, feedwater is tested at the inlet to the building, and also tested throughout the year to gain a complete understanding of the quality of the feedwater across seasonal changes. It must be understood that there are many factors that can affect the quality and consistency of feedwater to a facility. Some factors are seasonal temperature, supply source changes, treatment additives, and feedwater variability, including items such as fertilizers, salt, and rainfall. 

Based on the intended use of the pharmaceutical product water, the United States Pharmacopeia (USP) dictates analytical quality requirements that must be met. The USP defines specific requirements such as chemical purity and, if applicable endotoxin levels.

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