I agree with the previous comments – also note that, per Richard's statement that he usually sees sample sizes of 3–10, this is called out in ISO 11737-1:2018, A.8.1 as "common practice" for routine monitoring.
In addition to the considerations Richard has listed, as you build a bioburden data set, your own historical data can help justify the sample size you use (i.e., if your bioburden has been consistently low, you may be able to more easily justify using N=3 as opposed to N=10).
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Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
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Original Message:
Sent: 29-Jul-2020 06:28
From: Anonymous Member
Subject: Bioburden Sample Size
This message was posted by a user wishing to remain anonymous
Hi,
Is there a recommended number of samples to test for bio burden under ISO 11737-1?
We are doing a bio burden test under ISO 11737-1. The lab suggests to ask Regulatory about the number of samples to be tested per batch. I would have thought the sample would have to be scientifically justified by Engineering with QA. The item is a balloon for an endorectal procedure.
Thank you