Her team had followed to the letter. Section 6.2: container-closure integrity testing. Section 7.3: method selection based on product risk. They had chosen helium leak detection, the gold standard.
That was it. The vial stoppers were micro-deflecting during air freight, opening transient channels—channels that closed before any lab test could catch them. pda technical report 27 pdf
She reopened TR 27 to Chapter 9: Package Integrity Throughout Shelf-Life . Buried in a footnote was a warning she had skimmed past six times: “Leak rates measured under lab vacuum may not predict real-world flexing during transport.” Her team had followed to the letter
The next revision of TR 27 would cite her work. Would you like the real summary of PDA TR 27 instead? Just say the word. pda technical report 27 pdf