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Dear All,
I had been asked by one of my clients to conduct validation of large ETO sterilizer. As I do not have enough sensors to cover the sterilizer volume, we discussed that we can repeat each physical performance qualification twice to cover the volume of the chamber. I remember that this practice was acceptable in old version of may be of ISO 11135:1994 or EN:550, but I did not find it in the current version. Can anyone help by confirming whether this approach is correct or wrong, is there any guideline for this issue.

I had been asked by one of my clients to conduct validation of large ETO sterilizer. As I do not have enough sensors to cover the sterilizer volume, we discussed that we can repeat each physical performance qualification twice to cover the volume of the chamber. I remember that this practice was acceptable in old version of may be of ISO 11135:1994 or EN:550, but I did not find it in the current version. Can anyone help by confirming whether this approach is correct or wrong, is there any guideline for this issue.
