Q&A
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Does the FDA accept an EtO “batch release” using AAMI TIR 16? Specifically, Section 4.7(b): Release of small batches or lots. We can’t find evidence that this is an FDA-recognized standard. Our contractor says that it uses this standard all the time, but I have never seen it. So I’m skeptical.Answered August 24th, 2011 by Expert:We have not had any issues with the FDA for any of the batch-release testing we have performed for any of our sponsors. Although we base our testing on TIR16, our testing is also based on ISO 11135. As the contractor, we do it all the time.