Accepted answer
The part that matters: thermal history during shipping is different for every vial, so a lot that experienced thermal abuse may have internal variation even if it was originally homogeneous.
If you have reason to suspect inhomogeneity — different appearance in different vials, or a long or warm shipment — testing more vials is the diagnostic move.
Mechanically, the statistical foundation here is well-established, which is why sampling plans from decades ago are still valid.
Published data on lot homogeneity from manufacturers who sample multiple vials consistently find variation below the published specifications, suggesting the sampling plans work.
Assume segregation is possible, and design your sampling to catch it if it exists.
edited 6 May 2026 by charge_state_3 — reworded for clarity after a comment
8Useful. I have added the accept threshold suggestion to my own notes. – rosa_mendieta 9 months ago add a comment