36
37
11.5. Defining Set Points for Cycle Stages and Parameters
1151 Preheat Stage
•
Cycle temperature
is the target chamber temperature for the entire sterilization process
•
Timeout
is the maximum time allowed for the chamber and the vaporizer to reach target temperatures Reference the Air Removal Stage for a description of the vaporizer
•
Hold time
is the duration of time to maintain chamber temperature before exiting the Preheat stage
1. Preheat
55
60
0
34
30
0
60
Maximum
Set Point
Minimum
Parameter
Cycle temperature
Timeout
Hold time
Units
200
999
˚C
min
min
Figure 40
Preheat Stage
1152 Air Removal Stage
•
The vaporizer is a heating element connected directly to the GSX Series sterilizer chamber used to vaporize distilled water for the conditioning stage The vaporizer is also used in vaporizing
liquid ethylene oxide (EO) during the EO Injection stage
•
Vaporizer temperature
is the target vaporizer temperature for the Conditioning stage and EO Injection stage
•
Vacuum level
is the target chamber pressure for the Air Removal stage
•
Vacuum rate
is the rate air is removed from the chamber while proceeding to the programmed vacuum level Four (4) vacuum rates are available; 100%, 75%, 50% and 25% The
vacuum rate programmed in the Air Removal stage will be applied to
all
vacuums of the sterilization process
Note:
The
Vacuum rate
is controlled by the percentage of time the vacuum is applied to the chamber
• A
Vacuum rate
set point of 100% is the fastest air removal rate The vacuum is applied to the chamber 100% of the time until the programmed vacuum level is reached The
preprogrammed cycle vacuum rate is 100%
• A
Vacuum rate
set point of 25% is the slowest rate during which the vacuum is applied to the chamber 25% of the time while proceeding to the programmed vacuum level
2. Air removal
95
160
100
95
100
25
99
Maximum
Set Point
Minimum
Parameter
Vaporizer temperature
Vacuum level
Vacuum rate
Units
160
100
˚C
mbar
%
Figure 41
Air Removal Stage
1153 Chamber Test Stage
•
The Chamber Test stage is a check on the chamber integrity to assure the chamber and system are adequately sealed before proceeding with the cycle If the Chamber Test fails, the cycle
will automatically cancel
•
Duration
of the Chamber Test is the programmed time between the initial chamber pressure measurement at start of the stage and the final pressure measurement at the end of the stage
•
To pass the Chamber Test the final pressure measurement minus the initial chamber pressure measurement must be less than 18 mBar (18 kPa)
3. Chamber test
6
5
99
Maximum
Set Point
Minimum
Parameter
Duration
Units
min
Figure 42
Chamber Test Stage