Users Manual Part 2

Chapter 11: Qualification Reports
Kaye ValProbe RT User Manual 116
Note: This is the only criterion that is not using the cycle defined in the criteria template, but
the definition of the lethality calculation set in the Edit Calculations screen.
Only lethality per cycle or per Edit Calculations can be calculated within the same
report. The selection of one automatically deselects the other one.
T-SAT T / Timestamp - Temperature - Saturation Temp Band per Timestamp: Steam
quality can be analyzed by comparing the measured process temperature value against the
calculated Saturation Temperature derived from pressure measurements for every timestamp.
The pressure 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
temperature to the calculated Saturation temperature. The criterion “Passes” if all values are
equal to or within the defined range.
P-SAT P / Timestamp - Pressure - Saturation Pressure Band per Timestamp: Steam
quality can be 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.