OM0283
Page 35 of 70
Rev 2 July/2021
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-543-400
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.
Summary of Contents for LabGard D NU-543-400
Page 7: ...OM0283 Page 7 of 70 Rev 2 July 2021 ...
Page 9: ...OM0283 Page 9 of 70 Rev 2 July 2021 ...
Page 10: ...OM0283 Page 10 of 70 Rev 2 July 2021 ...
Page 11: ...OM0283 Page 11 of 70 Rev 2 July 2021 ...
Page 12: ...OM0283 Page 12 of 70 Rev 2 July 2021 ...
Page 16: ...OM0283 Page 16 of 70 Rev 2 July 2021 ...
Page 21: ...OM0283 Page 21 of 70 Rev 2 July 2021 ...
Page 34: ...OM0283 Page 34 of 70 Rev 2 July 2021 ...
Page 65: ...OM0283 Page 65 of 70 Rev 2 July 2021 ...
Page 66: ...OM0283 Page 66 of 70 Rev 2 July 2021 ...
Page 67: ...OM0283 Page 67 of 70 Rev 2 July 2021 ...
Page 68: ...OM0283 Page 68 of 70 Rev 2 July 2021 ...
