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Hi All,
We recently validated an ETO cycle using the overkill approach.
A question has come back "1/2 cycles were performed date 1, date 2, date 3. Can it be demonstrated that these were consecutive experiments?"
Which leads me to two questions: since the dates listed pretty much were consecutive dates, are they asking whether there was overlap in the studies or is there something extra that I don't comprehend maybe based on an ISO 14161?
thanks for your help!
We recently validated an ETO cycle using the overkill approach.
A question has come back "1/2 cycles were performed date 1, date 2, date 3. Can it be demonstrated that these were consecutive experiments?"
Which leads me to two questions: since the dates listed pretty much were consecutive dates, are they asking whether there was overlap in the studies or is there something extra that I don't comprehend maybe based on an ISO 14161?
thanks for your help!