TABLE V

Study 2. Vacuum Decay Gas Leak Test at 250 mbar—Empty, Holed Syringe Challenge

Differential Pressure Readings (Pa)
Negative Controln5 μmn10 μmn15 μmn
Site 1Average ± SD13 ± 3.84562 ± 2215208 ± 4215389 ± 6815
Site 2Average ± SD8 ± 4.24549 ± 2215207 ± 4615389 ± 5615
Site 3Average ± SD13 ± 3.94557 ± 1415186 ± 5015342 ± 3915
Combined SitesAverage ± SD11 ± 4.813556 ± 2045201 ± 4645373 ± 5945
Maximum Reading24110295502
Minimum Reading−222137284
% Passed1002a00
% Failed (Leaked)098100100
Average of Reported Lab Averages11.355.9200.3372.9
Standard Deviation of the Lab Averagesbsx¯3.6NANANA
Repeatability
Standard Deviationsr3.84.815.217.2
Reproducibility
Standard DeviationbsR4.9NANANA
Repeatability Limitr10.713.542.748.1
Reproducibility LimitbR13.8NANANA
  • a Differential Pressure reading ≤ dP Ref = 22 Pa.

  • b Syringes with hole defects were not tested across sites, therefore reproducibility between labs is not applicable (NA).

  • SD = standard deviation.