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Cedex HiRes Analyzer Operator’s Guide
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8 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 local Roche technical services. The routine check-ups performed by the user of the
Cedex HiRes Analyzer mainly focuses on the liquid management process (such as fl ow chamber, capillaries etc.).
A feature of the Cedex HiRes Software 2.2, the System Suitability Test (SST), is designed to help monitor the
state of the system for quality supervision/assurance purposes. A routine check-up procedure that meets the
system owner’s specifi c needs can be created using the SST software feature.
Ve r i fi cation that the Analyzer is in the required condition comprises both manual checks (internal as well
as external scrutiny of the equipment, e.g. chamber inspection) and various check-up 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 confi gured by an authorized user (the Superuser
or Administrator). Once created and activated, the checkpoints apply to the whole system.
8.1 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 Control Beads or Density
Reference Standard Beads. In order to pass a checkpoint involving Control Beads measurements, the average
result of a pre-defi ned 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 confi rmation in the
System Suitability Test window that the activity or inspection has been performed.
Each checkpoint needs to be created and its parameters, including the acceptance criteria, confi gured 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.
On some systems, an inactive list of proposed SST checkpoints may be automatically provided in the System
Suitability Test List window. To activate these checkpoints, click in the box under the Active column for the
checkpoint. A check mark will appear in the Active column, which indicates that the checkpoint has been
activated.
8.1.1. Creating SST Checkpoints With and Without Measurements
To create a new SST checkpoint, proceed as follows:
1
Click on SST in the Functions menu to access the System Suitability Test List window, or else click
directly on the SST button in the Control Center.
2
Click on the New button and the System Suitability Test New window will appear. Using this window, a
measurement checkpoint or a manual checkpoint can be created.
The System Suitability Test (SST)
Creating SST Checkpoints
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