DataApex and Jaytee Clarity - SST Extension

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SST Extension - System Suitability Test

The SST extension serves to monitor the correct function of the chromatography system.

The program compares up to 12 selected parameters (e.g. retention time, efficiency, asymmetry of peaks) calculated according to one of three pre-selected methods (USP, EP, JP).

These calculated values are either compared to the user’s set limit values for each chromatogram separately or together for the selected series. Deviation of any parameter from the permissible limits is immediately reported and may lead to the termination of the sequence in progress.

The SST Extension allows the user to monitor the parameters of individual substances and thus evaluate the reproducibility of the results of the entire chromatography system.

The SST extension is required when using the Validation Kit.

Main Features

The SST Extension serves to monitor the correct function of the chromatography system.

Parameters

The program compares up to 12 selected parameters (e.g. retention time, efficiency, asymmetry of peaks) calculated according to one of three pre-selected methods (USP, EP, JP).

Limit values

These calculated values are compared to user set limit values, either for each chromatogram separately or together for the selected series. Deviation of a certain parameter from the permissible limits is immediately reported and may lead to the termination of the sequence in progress.

Versatility

Even though validation primarily focuses on testing system reliability, it can also be used in many other ways. Validation can be run during measurements, or additionally, using batch processing. Validated data can be automatically saved to a database file for further processing.

Enhanced sequencing

In connection with a sequence, the SST module can even pause a sequence when a specified value has been exceeded or to perform predefined functions

GPC Screenshots

SST Results in Chromatogram window

CE Instrument type in the System Configuration

The SST Extension enables to monitor the parameters of individual substances and thus to evaluate the reproducibility of the results of the entire chromatography system.

SST Method - Parameters

Modified terminology in the Method Setup - Measurement Options dialog

The program compares up to 12 selected parameters (e.g. retention time, efficiency, asymmetry of peaks) calculated according to one of three pre-selected methods (USP, EP, JP).

SST Method - Subparameters

The selected parameters can be controlled against Lower and Upper Limits or checked whether all the results fit into defined standard deviation range.

The limits can be checked against values from individual chromatograms - suitable for online monitoring of the individual samples or the Mean of a set of samples - used for Validation of the chromatography system.

SST Method - Events

The SST can fire specified events such Stopping the running Sequence or running an external program (e.g. sending a predefined Email to Administrator) depending on the SST Results.

EXTENSIONS

Capillary Electrophoresis

PDA

GPC

System Suitability Test

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