|
Performed
validation to verify that the Nanopure Infinity Base Water System
was
installed per manufacturer's specifications and client's requirements.
The purification water system was designed to provide high resistivity
(18 mega ohm-cm) grade water that exceeds ASTM type 1 standards. It consisted
of a four-stage deionization process combined with a 1.0-micron filter
to polish the feed water.
The high purity water will be used to prepare buffers (for sample preparation
and HPLC) to perform product testing. Passing the validation tests provided
assurance that the system was properly installed and will establish a
baseline of operational data used to maintain change control and troubleshooting.
Installation Qualification (IQ) entailed verification of the installation
of the water system to ensure compliance with manufacturer's and client's
specification. Operational Qualification (OQ) consisted of functional
testing for evaluation of system operation.
All major findings and issues, including deviations encountered during
the testing were addressed. The test results were summarized with reference
to acceptance criteria and system requirements.
|
