27 Pdf - Pda Technical Report

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.

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.” pda technical report 27 pdf

Elena wrote a deviation request, citing TR 27’s own caution. And then she began drafting a new method: real-time pressure cycling during leak testing. Her team had followed to the letter