Clarity Validation Kit for Operational Qualification

The quality of analytical data is an issue gaining increased attention in many laboratories today. One condition for ensuring the reliability of generated results lies in the validation of all instrumentation and procedures used for the acquisition of said data. Commonly, three levels of validation (qualification) are relevant for chromatography data stations:

• · Installation Qualification: a procedure confirming that the datastation was successfully installed and that the installation contains all the required files of the correct version. Installation qualification is an integral part of the Clarity Chromatography datastation installation procedure.
• · Operational Qualification: a procedure confirming that the datastation is performing according to the manufacturer’s specification. The Clarity Validation kit serves this purpose. Using a precise peak generator, chromatographic data is acquired and analyzed with prepared procedures and the acquired results are compared with expected values.
• · Performance Qualification: a procedure confirming that the analytical system is fit for a given type of analysis. Usually, the overall system performance is tested by this procedure with respect to the requirements of the desired application. The Clarity data station offers many tools in the System Suitability Test (SST) module to efficiently evaluate the system performance.

The Clarity Validation Kit is designed to perform the Operational Qualification of the Clarity Chromatography Station (version 2.2 or higher) with INT7 or U-PAD A/D converters. An optional Clarity SST module is necessary for data evaluation.

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.

Operational qualification tests:

• · Retention time precision and accuracy
• · Voltage (peak height) measurement precision and accuracy
• · Area determination precision and accuracy
• · Calibration and calculations – ESTD and ISTD methods
• · Consistency of acquisition ranges

Clarity Validation Kit includes:

- Clarity Validator (precise analog signal generator device)
- Clarity Validation Kit Manual
- CD with all files necessary for performing the Operational Qualification
- Cables