The Validation Kit (p/n CVK) is designed to perform the Operational Qualification of the Clarity Chromatography stations that acquire data using the A/D converters internal PCI cards INT7, INT9 or external USB boxes Colibrick, U-PAD, U-PAD2.
An optional SST Extension is necessary for data evaluation.
Using a precise peak generator, chromatographic data is acquired and analyzed with prepared procedures and the acquired results are compared to expected values.
OQ validation of Clarity software with digital data acquisition (if the A/D converter is not used) uses Virtual Detector, in such case the Validator hardware is not required.
The Validation Methodology can be ported to different software and hardware solutions. Implementation of the procedures described in the Validation kit manual into procedures specific to the software being used is required.
The Clarity Validation Kit is designed to perform the Operational Qualification of the Clarity Chromatography Station (version 2.8 or higher) with INT7, INT9, U-PAD, U-PAD2 or Net-PAD A/D converters. An optional Clarity SST Extension is necessary for data evaluation.
Clarity Validation Kit includes
- Validator (precise analog signal generator device)��
- Validation kit manual (M039)
- Clarity Software (version 2.8 or higher)
- SST Extension
- INT7, INT9, U-PAD, U-PAD2 or Net-PAD A/D converter
Field of use
The kit is primarily intended for trained service personnel, who regularly perform validations of chromatography systems using Clarity data stations. However it can also be used by experienced users for in-house validations. The operator must be familiar with Clarity datastation operations.
Validator is a precise peak generator device with predefined sets of signal. This device is connected to the A/D Converter instead of the detector.
Operational qualification tests
- Retention time precision and accuracy
- Voltage (peak height) measurement precision and accuracy
- Area determination precision and accuracy
- Calibration and calculations with ESTD and ISTD methods
- Consistency of acquisition ranges