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Kaye ValProbe RT - Page 135

Kaye ValProbe RT
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Chapter 12: Qualification Reports
ValProbe RT User Manual 125
Equilibrium
The Equilibration Time graph displays whether all temperature sensors in the Edit
Sensors list reached the lethality base temperature within a 15 or 30 second time period,
satisfying the equilibration conditions.
Regulations require that sterilization chambers less than 800 liters have an equilibration
time no greater than 15 seconds; sterilization chambers greater than 800 liters should
have an equilibration time of no more than 30 seconds.
This graph is only available if the sensors had a one second sampling rate, and at least
one sensor reached the lethality base temperature. If a lethality base temperature is not
defined during the study setup, a default temperature of 121.1°C is used.
The first vertical red line indicates the time the first Temperature sensor reached the
lethality base temperature (Tb). The lethality base temperature is marked by the
horizontal red line.
The second vertical line is either 15 or 30 seconds after the first Temperature sensor
reaches base temperature, depending on the time period selected. The text at the top
right of the graph indicates if the sensors passed (including the actual equilibration time)
or failed according to the equilibration criteria.
From Graph Report screen, check the Equilibrium box to open the Edit Sensors screen.
On this screen:
Select / unselect sensors.
Select the Reference Sensor from the dropdown list.
Enter a reference temperature.
Choose a time of 15 or 30 seconds from the dropdown list.
Select OK to display the Equilibration Time graph.
Important:
Excluded sensors from any graph reports are not included in the calculation graphs.
Groups with only one sensor have no statistical calculations available and the
checkboxes are grayed out.
The Lethality calculation is only available if lethality has been defined for the study.
The saturation pressure calculation is only available if the study includes at least one
temperature sensor along with a pressure sensor.
The saturation temperature calculation is only available if the study includes at least one
pressure sensor along with temperature sensors.
The Equilibrium calculation is only accessible if the Qualification data storage rate is one
sec.

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