Water validation testing is used for monitoring the performance qualifications of purified water. It establishes documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
Reasons for performing a water validation could be:
Qualification of a new piece of equipment
New process implementation
Equipment relocation or process change
Major maintenance of equipment
Updated procedures to improve quality program
Water validation will consist of two test phases. The first phase will have aggressive sampling over a short period of time to thoroughly challenge the equipment and demonstrate the reliability of water quality produced. The second phase will have a reduced sampling frequency, but be carried out over
a longer period of time to demonstrate the consistency of the equipment. A routine sampling plan post validation is then set up to monitor the system.
Nova offers the following tests for the validation of a purified water system:
Total Organic Carbon (TOC)
Pyrogen testing (LAL) (Gel clot, Turbidimetric, or Chromogenic method)
Heterotrophic plate count (HPC)(Membrane filtration or Pour plate)
Resistivity
pH
Color
Odor
Other testing requirements may be requested on an individual client basis. All tests are performed according to USP standards and Standard method analysis.
