TABLE IV

Study 1. Vacuum Decay Gas Leak Test at 250 mbar—Calibrated Air Flow Leak Challenge

Differential Pressure Readings (Pa)
Negative Controln0.05 ccmn0.10 ccmn
Site 1Average ± SD11 ± 3.74532 ± 2.11551 ± 3.015
Site 2Average ± SD8 ± 3.44530 ± 3.01546 ± 3.815
Site 3Average ± SD12 ± 4.24532 ± 4.81547 ± 6.915
Combined SitesAverage ± SD11 ± 4.113531 ± 3.64548 ± 5.145
Maximum Reading254262
Minimum Reading22430
% Passed1004a0
% Failed (Leaked)096100
Average of Reported Lab Averages10.731.048.1
Standard Deviation of the Lab Averagessx¯2.51.83.0
Repeatability
Standard Deviationsr3.93.04.7
Reproducibility
Standard DeviationsR4.33.45.0
Repeatability Limitr11.08.313.0
Reproducibility LimitR12.19.413.9
  • a Differential pressure readings ≤ dP Ref = 24, 25 Pa.

  • SD = standard deviation.