VIIIc.

Positive and Negative Control Tests Summary

Package DescriptionTest Count TotalTest Count Passed2 (No Leak Detected)Test Count Failed2 (Leak Detected)
Negative controls1401400
Negative controls + 0.050 ccm NIST airflow leak15015
Packages with holes 2.39–2.93 μm990
Packages with holes ≥3.38 μm33033
Package with vial land channels (V-2, V-4)606
Packages with vial valve channels (V-6, V-7, V-8)990
Packages with vial land+valve channels (V-10, V-11)606
Packages with stopper defects (S-1, S-6, S-7)990
  • 2 Acceptance criteria (pass/fail) based on 3.7 mbar and 67 Pa, absolute and differential pressure reference limits, respectively.