135
Maintenance and Care
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3
To create a checkpoint for a manual check or maintenance activity, click on the SST Without Measurement
button. This will open the System Suitability Test New window that allows for the creation of a checkpoint
for a manual check. Enter an SST Name (e.g. Flow Chamber) and an SST Description that provides
suffi cient information for any user performing this SST.
4
To create checkpoints for calibration measurements, click on the SST including Measurement button. The
appropriate System Suitability Test New area will appear. A set of parameters needs to be defi ned. See
Table 2, for a detailed description of the parameters.
5
Click on the Save button to create a new SST checkpoint. The checkpoint will be immediately added to the
System Suitability Test List.
6
Clicking on Close will close the window without creating an SST checkpoint.
■
Parameters for SST including Measurement:
SST Name/
SST Description
Enter an SST Name and Description for identifi cation purposes during routine
check-up procedures.
Overall Type
Select the characteristic that is to be inspected during the measurements for this
checkpoint (e.g. Total Cell Count, Total Concentration) from the drop-down list.
Cell Type/
Measurement precision/
Sample Volume/
Sample Initial Dilution
Defi ne different measurement parameters for different checkpoints to verify
operational reliability in various situations.
Target Value The Target Value serves as benchmark for the acceptance criteria. It can be based,
for example, on the average result of a set of measurements carried out with
Control Beads.
Offset
The offset in % determines the acceptance range applicable to the results of SST
measurements carried out for this checkpoint based on the target value entered.
Target Value Check/
Upper Limit/
Lower Limit
If the Target Value Check is activated, the user carrying out SST measurements
can enter another target value before running the fi rst SST measurement for this
checkpoint (e.g. when a new container of Control Beads is used). Acceptable
limits
for what can be entered by a user for the variable target
value are set using Upper
Limit and Lower Limit fi elds.
Note: the Upper Limit and Lower Limit fi elds are not related to the acceptable
range for results from an SST measurement! The acceptable range for results is
determined by the % entered in the Offset fi eld.
Fixed Target Value If the target value is not to be entered by users, the Fixed Target Value must be
activated.
Count For Passing
Count for Passing refers to the number of SST measurements
that has to be carried
out for this checkpoint.
Table 2: SST parameters for SST with Measurement
In general, the Target Value is determined before the SST checkpoint is activated. For further information
on the procedure for the determination of a target value, Roche technical services provides appropriate
recommendations. It is necessary to re-determine the target value if a new container of Control Beads is used.
An SST checkpoint includes a validity period. This can be set in the System Suitability Test List in the Days
Valid column. After this period of time, the SST procedures must be performed. If the SST procedure is not
performed within the validity period, all measurements apart from SST measurements will be prohibited (e.g.,
the system status is changed to MeasurementLock).
The System Suitability Test (SST)
Creating SST Checkpoints
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