TABLE VI

Study 3. Vacuum Decay Liquid Leak Test at 1 mbar—Calibrated Air Flow Leak Challenge

Differential Pressure Readings (Pa)
Negative Controln0.05 ccmn0.10 ccmn
Site 1Average ± SD12 ± 3.54536 ± 4.61555 ± 3.615
Site 2Average ± SD12 ± 3.84537 ± 4.71557 ± 5.015
Site 3Average ± SD17 ± 2.74533 ± 5.01548 ± 6.815
Combined SitesAverage ± SD14 ± 4.013535 ± 4.94553 ± 6.345
Maximum Reading244869
Minimum Reading62737
% Passed10000
% Failed (Leaked)0100100
Average of Reported Lab Averages13.735.253.2
Standard Deviation of the Lab Averagessx¯3.02.44.6
Repeatability
Standard Deviationsr3.55.15.1
Reproducibility
Standard DeviationsR4.35.36.6
Repeatability Limitr9.814.114.2
Reproducibility LimitR12.214.918.6
  • SD = standard deviation.