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PDA Technical Information Bulletin No.4

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Description

Design Concepts for the Validation of a Water for Injection System

This publication outlines methods for evaluating a Water-For-Injection System for use in pharmaceutical manufacturing. The considerations presented are intended solely as review of factors specific to the design, operation and evaluation of a system generally considered to be capable of consistently delivering WFI. The method described is only one of many possible alternatives of evaluating a system and is limited to the most common method of producing WFI.

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