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Standards Development
This document provides design principles for the installation, operation, and performance of reliable purified water (PW) and water for injection (WFI) storage and distribution systems based on membranes. This document covers the following topics: - distribution piping, - associated system components, - point of use (POU), - operating parameters, - piping and accessories for the POU and equipment inlet sanitization. - all distribution loops and sub-loops are included in the scope of this document. This document does not cover the following topics: - detailed specifications for the equipment design, construction, and inspection, - detailed specifications for pipeline installation, slope measurement, cleaning, and passivation, - detailed engineering design, commissioning, and operation of the PW/WFI system , - inspection and Verification / Qualification / Validation requirements, - pretreatment and purification systems that are used to generate PW/WFI (refer to ISO 22519), - hardware that will constitute the control system of a PW/WFI system.
The water quality specifications for purified water (PW) and water for injection (WFI) are given in national and international standards and are well defined and understood. The PW/WFI storage and distribution systems need to be in accordance with the company's policy and current good manufacturing practice (cGMP). Properly engineered, constructed, operated and maintained storage and distribution systems must reliability meet PW/WFI quality specifications with low operational costs.
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