Chapter 12: Qualification Reports
ValProbe RT User Manual 135
P-SAT P / Timestamp - Pressure - Saturation Pressure Band per Timestamp: Steam
quality is analyzed by comparing the measured pressure value against the calculated
Saturation Pressure derived from reference temperature measurements for every timestamp.
The temperature sensor used as the reference is displayed. The criterion describes a steam
quality band and is specified as the Min and Max allowable deviation from the measured
pressure to the calculated Saturation pressure. The criterion “Passes” if all values are equal to
or within the defined range.
Time of Sterilization (T – Sat T): The Time of Sterilization (T-Sat T) calculates the total time
of sterilization by combining the Steam quality criterion, as defined in the Edit Calculations
screen, along with the measured reference temperature. Time is counted if the measured
reference temperature is at or above the process temperature and the steam quality as
defined by Temperature minus calculated Saturation Temperature (T-Sat) is within the
specified range. A criterion for a minimum and a maximum time of sterilization can be defined
independently. The minimum time criterion “Passes” if the calculated time is equal to or above
the defined criteria. The maximum time criterion “Passes” if the calculated time is equal to or
below the defined criteria. If both Min and Max fields are defined the criterion “Passes” if the
calculated time is equal to or within the defined range.
Time of Sterilization (P – Sat P): The Time of Sterilization (P-Sat P) calculates the total time
of sterilization by combining the Steam quality criterion, as defined in the Edit Calculations
screen, along with the measured reference pressure. Time is counted if the measured
reference temperature is at or above the process temperature and the steam quality as
defined by Temperature minus calculated Saturation Temperature (T-Sat) is within the
specified range. A criterion for a minimum and a maximum time of sterilization can be defined
independently. The minimum time criterion “Passes” if the calculated time is equal to or above
the defined criteria. The maximum time criterion “Passes” if the calculated time is equal to or
below the defined criteria. If both Min and Max fields are defined the criterion “Passes” if the
calculated time is equal to or within the defined range.
Equilibrium Duration: The Equilibrium Duration calculates the time in seconds from when the
defined Reference Sensor in the Group reaches the Process Temperature until the last sensor
in the Group reaches the Process Temperature. The dropdown menu allows selection of the
reference sensor. The Equilibrium Duration field is only definable if the study has a one or
two second sampling rate. The criterion value is the Maximum time in seconds allowed. The
maximum definable criterion is 59 seconds. The criterion is “Passed” if the calculated
Equilibrium time is equal to or less than the defined criteria.
Exposure Duration/Holding Duration: The Exposure / Holding Duration calculates the total
time of Exposure / Hold. This criterion is only displayed if the selected cycle is an exposure
cycle. A criterion for a minimum and a maximum time of Exposure /Hold can be defined
independently. The minimum time criterion “Passes” if the calculated Exposure/Hold time is
equal to or above the defined criteria. The maximum Exposure / Hold time criterion “Passes” if
the calculated time is equal to or below the defined criteria. If both Min and Max fields are
defined the criterion “Passes” if the calculated Exposure / Hold time is equal to or within the
defined range.
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