Study 5. Vacuum Decay Liquid Leak Test at 1 mbar—Water-Filled, Holed Syringe Challenge
| Differential Pressure Readings (Pa) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Negative Controla | n | 5 μm | n | 10 μm | n | 15 μm | n | ||
| Site 1 | Average ± SD | 15 ± 2.9 | 45 | 122 ± 134 | 15 | 599 ± 0 | 15 | 599 ± 0 | 15 |
| Site 2 | Average ± SD | 12 ± 3.4 | 45 | 162 ± 56 | 15 | 599 ± 0 | 15 | 599 ± 0 | 15 |
| Site 3 | Average ± SD | 17 ± 2.7 | 44a | 143 ± 16 | 15 | 487 ± 117 | 15 | 570 ± 51 | 15 |
| Combined Sites | Average ± SD | 15 ± 3.8 | 134 | 143 ± 84 | 45 | 562 ± 85 | 45 | 589 ± 32 | 45 |
| Maximum Reading | 25 | 599 | 599 | 599 | |||||
| Minimum Reading | 6 | 63 | 322 | 467 | |||||
| % Passed | 100 | 0 | 0 | 0 | |||||
| % Failed (Leaked) | 0 | 100 | 100 | 100 | |||||
| Average of Reported Lab Averages | x¯ | 15.5 | 132.3 | 561.8 | 592.0 | ||||
| Standard Deviation of the Lab Averagesb | sx¯ | 4.3 | NA | NA | NA | ||||
| Repeatability | |||||||||
| Standard Deviation | sr | 4.8 | 13.2 | 13.5 | 9.1 | ||||
| Reproducibility | |||||||||
| Standard Deviationb | sR | 6.0 | NA | NA | NA | ||||
| Repeatability Limit | r | 13.4 | 36.9 | 37.7 | 25.4 | ||||
| Reproducibility Limitb | R | 16.7 | NA | NA | NA | ||||
↵a One data point was eliminated due to procedural error.
↵b Syringes with hole defects were not tested across sites, therefore reproducibility between labs is not applicable (NA).
Note: ABORT test results were assigned differential pressure readings of 599 Pa for analysis purposes
SD = standard deviation.