Water Purification System Validation

Water purification systems must be validated to demonstrate that they can produce the required water quality. The FDA have produced guidelines for commissioning a water purification system, that requires various levels of monitoring as the 

Purpose of analytical procedure Characteristics Identification Testing for impurities Quantitat. Limit Assay - dissolution (measurement only) - content/potency 

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The quality of PW and WFI is constantly monitored. The FDA has provided guidance for the validation of water systems. The validation program consists of three phases. Phases 1 and 2 are for 2-4 weeks each of continuous sampling and testing of water to establish the effectiveness of the pretreatment and purification and distillation processes. Phase 3 is routine monitoring of the water quality over the remainder of a 1 year period to gauge the influences of seasonal conditions on the water quality. 

Water systems are expected to be demonstrated to be suitable for their intended uses. At a minimum, water is required to meet the World Health Organization requirements for drinking (potable) water. Processing steps such as isolation and purification will require purified water as outlined in USP 23 (2), pharmaceutical grade water. Validation of water systems is required for all product contact water systems. We... 

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