Hi All, I am charting out my processes that need to be validated for a new product. We will be sterilizing the product as an extra precaution, but we will NOT be claiming sterility of the product. Do I still need to validate the sterilization process? Is there a way I can just validate the EO Residual testing?
EO Residual testing
- Thread starter CCurran
- Start date
EmiliaBedelia
Quite Involved in Discussions
Why are you sterilizing it just as a precaution? What is the point?
If it's not actually sterile, why bother?
If it's not actually sterile, why bother?
FDA Would probably think your design process is sloppy if random requirements are in your input requirements and then lost along the way. If you tell the FDA you are doing X, they expect to see results for X, regardless of an argument against it.
EmiliaBedelia
Quite Involved in Discussions
You definitely need to test the EO residuals.
Are you going to declare an SAL at all? Even a lower one? How are you verifying the process (eg, are you doing parametric release?)
How did you define the requirement for the sterilization process in your design inputs? Eg, did you actually require that product should be sterilized or is it phrased as "expose product to ETO", etc? Did you use sterilization as a risk control measure in any way?
If your design controls require the product to be sterilized, and/or you use sterilization as a risk control measure, you need to validate it to show the effectiveness of the process.
Are you going to declare an SAL at all? Even a lower one? How are you verifying the process (eg, are you doing parametric release?)
How did you define the requirement for the sterilization process in your design inputs? Eg, did you actually require that product should be sterilized or is it phrased as "expose product to ETO", etc? Did you use sterilization as a risk control measure in any way?
If your design controls require the product to be sterilized, and/or you use sterilization as a risk control measure, you need to validate it to show the effectiveness of the process.
planB
Super Moderator
In line with what the others have already said: once you call your desired treatment being a "sterilisation process", you will have to meet - and validate - standardised aspects of process efficacy (in terms of SAL, sterility assurance level) and process safety (in terms of sterilisation residuals and continued product functionality) - no way out. You typically do not want to perform (and validate) a sterilisation process if you do not want to claim sterility.
Have you already put devices into your clinical trial?
- If not, validate your sterilisation process prior to continuing your trial.
- If yes, consider validating EO residuals immediately to have data /retrospective evidence at hand that you did not put humans at unacceptable risk, i.e. exposed your trial patient to unacceptable levels of sterilisation residuals. You might also consider reporting this issue to FDA: the agency is surely even less amused if they found out on their own.
HTH,
Have you already put devices into your clinical trial?
- If not, validate your sterilisation process prior to continuing your trial.
- If yes, consider validating EO residuals immediately to have data /retrospective evidence at hand that you did not put humans at unacceptable risk, i.e. exposed your trial patient to unacceptable levels of sterilisation residuals. You might also consider reporting this issue to FDA: the agency is surely even less amused if they found out on their own.
HTH,
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