ISO 11135 Monitoring Routine ETO Sterilisation Parameters

[Nash27]

Hi All,

Just wondering if someone could suggest the ETO parameters to monitor as part of the routine ETO sterilsaition. One of our lower class device is outsourced to the contract manufacturer, the contract manufacturer shall also perform ETO sterilisation process (in-house). The ETO process is validated.

What parameters should we need to monitor for routine ETO sterilisation process to demonstrate control over contract manufacturer. What I am trying to do is, set an excel based register and for each lot record the important ETO paramaters supplied by the contract manufacturer. This register then can be evaluated for trend. However not sure what parameters I should include in this excel based register.

Any comments, suggestions would be much appreciated. Thanks

 

[shimonv]

Re: ISO 11135 Monitoring routine ETO Sterilisation

Hi Nash27,
During routine sterilization what is usually being tested is LAL and BI.
From my experience what you get from the sterilization sub-contractor includes checklists, QC Form, QC report, chamber parameters with test results, and images of package and box labels.

Hope it helps.

Shimon

 

[Doug Tropf]

ISO 11135 provides requirements for routine monitoring and control of the ETO sterilization process.

 

[Nash27]

Re: ISO 11135 Monitoring routine ETO Sterilisation

Hi Nash27,
During routine sterilization what is usually being tested is LAL and BI.
From my experience what you get from the sterilization sub-contractor includes checklists, QC Form, QC report, chamber parameters with test results, and images of package and box labels.

Hope it helps.

Shimon

Hi Shimonv, Doug

Thanks for your reply. I agree with your suggestions, unlike gamma irradiation (which we are more familier with) ETO process relies on yearly validations. Would the bio-burden count have any weight for routine monitoring.

ISO 11135 section 10 Routine Monitoring and Control list the points that can be monitored by the contract manufacturer, however being product manufacturer, regulator may want to see the controls that are applied by us. I hope that bio-burden, BI results, LAL test and ETO residuals may be sufficient to monitor the routine sterilisation trend.