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Validation of Purified Water Systems requires a thorough understanding of the facility design and the utility itself. For example, in a USP Water System: Does the source water meet EPA drinking water standards? Are procedures in place to test this? If PVC pipe is used, have proper procedures been followed when preparing and installing the pipe? Could any leachables or extractables be introduced into the system from the PVC pipe, the cement or the solvent? What is the design of the processing loops? Does the design avoid standing water in any loop? Have all deadlegs been minimized? What is the appropriate measurement for a "deadleg": 2-, 3-, 4D? What methods are being used to remove contaminants? Particulate? What control system is in place to monitor and regulate water temperature, pH, and conductivity? How is the water being stored? Does it interact with the air in the storage vessel? How is pressure being regulated throughout the purification system and the distribution loop? Does the purified water meet USP standards? These and others are all questions that need to be answered to understand the design intent of a facility's USP Water System.

From design qualification (DQ) through installation qualification (IQ), operational qualification (OQ) and process qualification (PQ) we are able to develop a Purified Water System validation package to suit you.

PreVUE Systems
Millipore
Purite
Karcher
Pall
US Filter
Siemens
Siemens Water Technologies
GEA Filtration
US Stills

GAMP5... [more info]
Auditing Services... [more info]
Quality Plans.... [more info]
Validation Master Plans... [more info]
IQ Protocol Generation & Implementation.... [more info]
OQ Protocol Generation & Implementation.... [more info]
PQ Protocol Generation & Implementation.... [more info]
Summary Reports... [more info]
Computer System Validation... [more info]
Project Management.... [more info]
SAT Generation & Implementation.... [more info]
FAT Generation & Implementation.... [more info]
SOP Development & Review.... [more info]
Equipment/Process Specification
URS Generation.... [more info]
FRS Generation.... [more info]
DDS Generation.... [more info]
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