EN 868-5 Annex D Sample Size


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Hello everyone,

I hope I am in the right place to receive some feedback.

I am running a Packaging Validation using EN 868-5 Annex D for Sterile Barrier Systems. I have wrongly created a protocol without a sample size or justification for. Now, today I was about to begin sample preparation when it dawned on me that I need a sample size. I have seen some calculators online suggesting confidence levels, margins of error, sample population, and so on. It's somewhat confusing and thought I would ask for help here before jumping into the calculator with random data.

Has anyone got any resources they could share to assist me with developing a sample size and rationale?
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