OM0284
Page 36 of 72
Rev 2 July/2021
5.
Determine decontamination system cycle parameters. Note that system parameters will change for
process type, as well as cabinet model and size.
For validation purposes, a LabGard® ES Model NU-543-600E was set using the following parameters on
the Bioquell Clarus II:
Pressure Setpoint:
-10 Pa
Airflow Setpoint:
22 m₃
/hr
Delivery Temperature:
65⁰C
Conditioning Time:
10 min
Gassing Time:
40 min
Gassing Injection Rate:
6.0 g/min
Dwell Time:
90 min
Injection in Dwell:
ON
Dwell Injection Rate:
3.5 g/min
Aeration Delay:
60 min
Aeration Time:
600 min
The following process was performed by the Steris X10 using the LabGard ES Model NU-543-400E
1.
Blower is turned off.
2.
Biological Indicators were placed at the exhaust filter, corner of working area and under the work tray of
BSC or anywhere inside the cabinet.
3.
Exhaust opening sealed with a metal plate and a tubing connection for the Hydrogen Peroxide (H
2
O
2
)
return.
4.
Front opening sealed with plastic film and a tubing connector mounting plate. Reference BCD-16509.
5.
Edges of the front window sealed with a low residue tape.
6.
Tubing connected to the inlet and outlet of X10.
7.
Insertion of Hydrogen Peroxide (H
2
O
2
) sterilant cup and desiccant cartridge to X10.
8.
Current BSC process selected.
Decontamination Process:
9.
The X10 will perform one (1) Preheat, Dehumidification, Decontamination and Aeration after start of the
program.
10.
Preheat
–
The cabinet is heated to 31⁰ C.
11.
Dehumidification
–
Cabinet is dehumidified to 15% RH.
12.
Condition
–
Sterilant vapor is added to sealed cabinet to target concentration.
13.
Checked for any Hydrogen Peroxide (H
2
O
2
) leakage from the cabinet. Applied extra tape as needed.
14.
Decontamination
–
The cabinet is filled with sterilant vapor for 45 minutes.
15.
During the decontamination, the blower was activated for 1 minute every 15 minutes.
Aeration:
16.
Aeration
–
The sterilant vapor is converted to water and oxygen by 3 options
a.
Connect the exhaust to Fumehood or outdoors
b.
Connect the AR60 Aerator which catalyzes the Hydrogen Peroxide (H
2
O
2
) vapor about 3 hours.
c.
Run Aeration cycle of the X10 for about 10 hours.
17.
Check the Hydrogen Peroxide (H
2
O
2
) level during the Aeration cycle and open the seal when level is less
than 1ppm.
Biological indicators were removed and incubated for 7 days.
Содержание LabGard NU-543-300E
Страница 7: ...OM0284 Page 7 of 72 Rev 2 July 2021...
Страница 9: ...OM0284 Page 9 of 72 Rev 2 July 2021...
Страница 10: ...OM0284 Page 10 of 72 Rev 2 July 2021...
Страница 11: ...OM0284 Page 11 of 72 Rev 2 July 2021...
Страница 12: ...OM0284 Page 12 of 72 Rev 2 July 2021...
Страница 16: ...OM0284 Page 16 of 72 Rev 2 July 2021...
Страница 21: ...OM0284 Page 21 of 72 Rev 2 July 2021 Figure 1...
Страница 22: ...OM0284 Page 22 of 72 Rev 2 July 2021...
Страница 35: ...OM0284 Page 35 of 72 Rev 2 July 2021...
Страница 67: ...OM0284 Page 67 of 72 Rev 2 July 2021...
Страница 68: ...OM0284 Page 68 of 72 Rev 2 July 2021...
Страница 69: ...OM0284 Page 69 of 72 Rev 2 July 2021...
Страница 70: ...OM0284 Page 70 of 72 Rev 2 July 2021...
Страница 71: ...OM0284 Page 71 of 72 Rev 2 July 2021...
Страница 72: ...OM0284 Page 72 of 72 Rev 2 July 2021...
