Cedex HiRes - The System Suitability Test (SST); Creating SST Checkpoints

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Maintenance and Care
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12 The System Suitability Test (SST)
To ensure proper operation of the Cedex HiRes Analyzer and valid analysis results, it is essential that the system
is in good condition. The majority of the critical parameters are regulated by design or preventive maintenance
activities carried out by a local Roche Service representative. The routine checkups performed by the user of
the Cedex HiRes Analyzer mainly focuses on the liquid management process (such as flow chamber, capillaries,
etc.).
The System Suitability Test (SST) is a feature of the Cedex HiRes Software that is designed to help monitor the
state of the system for quality supervision/assurance purposes. A routine checkup procedure that meets the
system owner’s specific needs can be created using the SST Software feature.
Verification that the Analyzer is in the required condition comprises both manual checks (internal as well as
external scrutiny of the equipment, for example, chamber inspection) and various checkup and calibration
measurements. These individual procedures are known as SST checkpoints. When an SST is set up on a Cedex
HiRes Analyzer, checks and measurements will have to be performed on a regular basis. Passing the checkpoints
will then be mandatory for normal continuation of measurement procedures.
The System Suitability Test consists of different types of SST checkpoints. Each checkpoint needs to be created
and its parameters, including the acceptance criteria, need to be configured by an authorized user (the Superuser
or Administrator). Once created and activated, the checkpoints apply to the whole system.
12.1 Creating SST Checkpoints
The System Suitability Test consists of different types of SST checkpoints. There are two main types of
checkpoints: an SST requiring inspection or maintenance activity performed by the user (e.g., syringe change,
chamber inspection) and SST procedures involving measurements with either Cedex HiRes Control Beads or
Density Reference Standard Beads, available from Roche Diagnostics. In order to pass a checkpoint involving
Beads measurements, the average result of a pre-defined number of one or more measurements needs to be valid
according to the checkpoint criteria. A checkpoint requiring an inspection or maintenance activity demands an
active confirmation in the System Suitability Test dialog box that the activity or inspection has been performed.
Each checkpoint needs to be created and its parameters, including the acceptance criteria, must be configured
by an authorized user. For this, authorized users need to be assigned the SST edit function. Users who perform
SST procedures only need access to the SST run function. Once created and activated, the checkpoints apply to
the whole system.
An inactive list of proposed SST checkpoints is automatically provided in the System Suitability Test List
dialog box. To activate these checkpoints, click in the box under the Active column for the checkpoint. A
checkmark will appear in the Active column, which indicates that the checkpoint has been activated.
The System Suitability Test (SST)
Creating SST Checkpoints