3M Steri-Vac GS Series - 13. Process Monitoring and Load Release; 13.1. Physical Parameters and Requirements

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3M
™
Steri-Vac
™
Sterilizer /Aerator GSSeries – Operator’sManual
13. Process Monitoring and LoadRelease
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilizationprocedures,
always use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this manual. Always use chemical indicators and biological
indicators per the device manufacturer’s instructions for use(IFU).
All sterilization processes require a comprehensive quality control program that includes sterility assurance monitoring. Comprehensive monitoring of the 3M™Steri-Vac™ Sterilizer/Aerator GS
Series consists of three essentialelements:
1. Monitoring of physical parameters (sterilizer cyclereports).
2. Use of biological indicators (BIs) within the appropriate process challenge device (PCD) or TestPack.
3. Use of chemical indicators(CIs).
13.1. Physical Parameters andRequirements
DANGER: To reduce the risks associated with exposure to ethyleneoxide,
always inspect cycle reports (printout or electronic file) to ensure the total aeration time matches the device manufacturer’s instructions for use(IFU).
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilizationprocedures:
Always inspect cycle reports (printout or electronic file) to ensure the Operator’s programmed parameters or the device manufacturer’s instructions for use (IFU)matches:
• %RH at the End ofConditioning,
• Temperature at the End ofConditioning,
• Actual Gas ExposureTime.
The 3M™Steri-Vac™ Sterilizer/Aerators GS Series is designed with embedded software that automatically controls and independently monitors the physical process parameters to ensure
sterilization conditions are maintained throughout the sterilization cycle. The sterilizer embedded software regulates, independently monitors, and records all critical sterilization process
parameters including pressure, temperature and percent relative humidity (%RH) inconditioning.
Documentation for physical parameters is provided on the 3M™Steri-Vac™ Sterilizer/Aerator GS Series cycle reports (printout and electronic file). Under normal operating conditions, the paper
cycle report produced at the end of the cycle will be similar to the one shown in Figures 48–52.
Each cycle report should be reviewed prior to load release per facility policies. Critical parameters for the 38°C and 55°C cycles are contained in Table 6. Verification of these parameters on the
printed cycle report is illustrated in Figures 61and 62. Verification of cycle performance should be conducted per facility policies. For all cycles confirm final status contains Cycle Complete on
the printout footer (Figure62). There is space on the cycle report for a signature anddate.
End time on the cycle report footer is the date and time (month/day/4-digit year + hh:mm:ss) when the Stop button was pressed after cycle iscomplete.
Total cycle time on the cycle report footer is the actual total elapsed time in hours and minutes (hh:mm) of the selected cycle. The Total cycle time is the duration between touching the cycle
Start button and when the Cycle Complete text appears on the display screen. If continuous aeration was selected, the Total cycle time is the duration between touching the cycle Start button and
touching the Stopbutton.
Cycle
Selected Final Status
End of
Conditioning
Temp (°C)
End of Conditioning
(%RH)
EO
ExposureTime
(hr + min) Aeration Temp (°C) Aeration Time (min)
38°C ‘Cycle Complete’ + ‘No Errors’ 38± 3 40- 80 4.5hr ± 5.4min
As P
rogrammed per
Manufacturers IFU
As Programmed per
Manufacturers IFU
55°C ‘Cycle Complete’ + ‘No Errors’ 55± 3 40- 80 1.0hr ± 1.2min
Table 6. Preprogrammed GS Series Cycle Report Physical ParameterRequirements