Study 2. Vacuum Decay Gas Leak Test at 250 mbar—Empty, Holed Syringe Challenge
Differential Pressure Readings (Pa) | |||||||||
---|---|---|---|---|---|---|---|---|---|
Negative Control | n | 5 μm | n | 10 μm | n | 15 μm | n | ||
Site 1 | Average ± SD | 13 ± 3.8 | 45 | 62 ± 22 | 15 | 208 ± 42 | 15 | 389 ± 68 | 15 |
Site 2 | Average ± SD | 8 ± 4.2 | 45 | 49 ± 22 | 15 | 207 ± 46 | 15 | 389 ± 56 | 15 |
Site 3 | Average ± SD | 13 ± 3.9 | 45 | 57 ± 14 | 15 | 186 ± 50 | 15 | 342 ± 39 | 15 |
Combined Sites | Average ± SD | 11 ± 4.8 | 135 | 56 ± 20 | 45 | 201 ± 46 | 45 | 373 ± 59 | 45 |
Maximum Reading | 24 | 110 | 295 | 502 | |||||
Minimum Reading | −2 | 22 | 137 | 284 | |||||
% Passed | 100 | 2a | 0 | 0 | |||||
% Failed (Leaked) | 0 | 98 | 100 | 100 | |||||
Average of Reported Lab Averages | x¯ | 11.3 | 55.9 | 200.3 | 372.9 | ||||
Standard Deviation of the Lab Averagesb | sx¯ | 3.6 | NA | NA | NA | ||||
Repeatability | |||||||||
Standard Deviation | sr | 3.8 | 4.8 | 15.2 | 17.2 | ||||
Reproducibility | |||||||||
Standard Deviationb | sR | 4.9 | NA | NA | NA | ||||
Repeatability Limit | r | 10.7 | 13.5 | 42.7 | 48.1 | ||||
Reproducibility Limitb | R | 13.8 | NA | NA | NA |