SST - System Suitability Test Extension

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.

Brochure
Manual
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.
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).
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 to the Mean of a set of samples - used for Validation of the chromatography system.
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.

Main features

Measuring

Simultaneous data acquisition from up to four signals (detectors) attached to one chromatograph.
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.

Specification

  SST Extension
Part Number (p/n) A22
Required Product Clarity (p/n C50)
Related products Clarity Offline (p/n C59)
Validation Kit (p/n CVK)