Amsco Evolution HC-600 - Sterilization Process Verification

4-2
P129390-106 Operator Manual Techniques of Sterilisation
4.2 Control Measure
for Verifying
Sterilization Process
As part of the operator’s verification of the sterilization process,
biological indicators may be used to demonstrate that sterilization
conditions have been met.
NOTE: Contact STERIS for information on specific biological
indicators recommended for use with this sterilizer.
4.2.1 Biological Monitors A live spore test utilizing B. stearothermophilus is the most reliable
form of biological monitoring. This type of product utilizes controlled
populations of a controlled resistance, so that survival time and kill
time can be demonstrated.
To verify the process, insert the biological indicator in a test pack
and place pack on the bottom shelf. Run test pack through a typical
cycle. On completion, forward test pack and monitor to appropriate
personnel for evaluation. Refer to EN ISO 17665-1:2006 guidelines to
conduct routine biological monitoring.
Table 4-1. Cycle Information
Cycle Type Load Sterilize Temp
Sterilize
Time
Dry
Time
Validation
Standard
Processing Cycles
Prevac
Sterilization Modules
(see Table 4-2 below)
134°C (273°F)
3 Min. 30 Sec. 20 Min. EN 285:2006
Prevac
Sterilization Modules
(see
Table 4-2 below)
134°C (273°F)
3 Min. 30 Sec. 30 Min. EN 285:2006
Prevac
Sterilization Modules
(see Table 4-2 below)
121°C (250°F)
30 Min. 20 Min. EN 285:2006
Prevac
Sterilization Modules
(see Table 4-2 below)
121°C (250°F)
30 Min. 30 Min. EN 285:2006
Test Cycles
Bowie-Dick Test Bowie-Dick Test Pack 134°C (273°F) 3 Min. 30 Sec. 1 Min. EN 285:2006
Warm-up Cycle None 134°C (273°F) 3 Min. 30 Sec. 1 Min. N/A
Leak Test
None N/A N/A N/A N/A
Table 4-2. Chamber Volume by Sterilizer Chamber Size
Model Chamber Size
Number of
Sterilization Modules
HC-600 660 x 660 x 991 mm (26 x 26 x 39") 6
HC-800 660 x 660 x 1245 mm (26 x 26 x 49") 8
HC-1000 660 x 660 x 1549 mm (26 x 26 x 61") 10
HC-900 660 x 950 x 1067 mm (26 x 37.5 x 42") 9
HC-1200 660 x 950 x 1372 mm (26 x 37.5 x 54") 12
HC-1500 660 x 950 x 1676 mm (26 x 37.5 x 66") 15