A
Dear forum Members,
Ethylene Oxide Sterilization Process is complex process and not very simple as mentioned in guidelines and standards. We have validated our process on following parameters;
1) Temperature of Chamber: 65.
2) Humidity of Chamber: 60 -70 %.
3) Exposure Time: 8 hrs.
4) EO gas Admission Temp: 30-40.
5) EO gas Conc: 400 mg / L.
6) Pre-Vacuum: -40 KPa.
7) De-gassing: -40 KPa.
8) Aeration Cycle: 1 hr.
We are using EO-Cross Check chemical indicators to monitor sterilization parameters and SGM Bacillus atropheus 106 for microbiological monitoring.
We are facing now-a-days problem in achieving color change in chemical indicators. Is there any seasonal effect on EtO sterilization Process as our problem started in rainy days.
Expertise in EtO sterilization validation are required for help.
Ahmed Zafar.
Ethylene Oxide Sterilization Process is complex process and not very simple as mentioned in guidelines and standards. We have validated our process on following parameters;
1) Temperature of Chamber: 65.
2) Humidity of Chamber: 60 -70 %.
3) Exposure Time: 8 hrs.
4) EO gas Admission Temp: 30-40.
5) EO gas Conc: 400 mg / L.
6) Pre-Vacuum: -40 KPa.
7) De-gassing: -40 KPa.
8) Aeration Cycle: 1 hr.
We are using EO-Cross Check chemical indicators to monitor sterilization parameters and SGM Bacillus atropheus 106 for microbiological monitoring.
We are facing now-a-days problem in achieving color change in chemical indicators. Is there any seasonal effect on EtO sterilization Process as our problem started in rainy days.
Expertise in EtO sterilization validation are required for help.
Ahmed Zafar.