Study 4. Vacuum Decay Liquid Leak Test at 1 mbar—Empty, Holed Syringe Challenge
| Differential Pressure Readings (Pa) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Negative Controla | n | 5 μm | n | 10 μm | n | 15 μm | n | ||
| Site 1 | Average ± SD | 16 ± 4.3 | 45 | 63 ± 20 | 15 | 599 ± 0 | 15 | 599 ± 0 | 15 |
| Site 2 | Average ± SD | 9 ± 2.9 | 45 | 68 ± 32 | 15 | 229 ± 53 | 15 | 422 ± 95 | 15 |
| Site 3 | Average ± SD | 14 ± 2.7 | 45 | 73 ± 15 | 15 | 220 ± 49 | 15 | 371 ± 28 | 15 |
| Combined Sites | Average ± SD | 13 ± 4.3 | 135 | 68 ± 23 | 45 | 350 ± 183 | 45 | 465 ± 113 | 45 |
| Maximum Reading | 24 | 148 | 599 | 599 | |||||
| Minimum Reading | 4 | 35 | 159 | 337 | |||||
| % Passed | 100 | 0 | 0 | 0 | |||||
| % Failed (Leaked) | 0 | 100 | 100 | 100 | |||||
| Average of Reported Lab Averages | x¯ | 12.9 | 67.9 | 349.6 | 465.1 | ||||
| Standard Deviation of the Lab Averagesb | sx¯ | 3.9 | NA | NA | NA | ||||
| Repeatability | |||||||||
| Standard Deviation | sr | 3.1 | 5.7 | 8.3 | 8.2 | ||||
| Reproducibility | |||||||||
| Standard Deviationb | sR | 4.8 | NA | NA | NA | ||||
| Repeatability Limit | r | 8.7 | 16.0 | 23.2 | 22.8 | ||||
| Reproducibility Limitb | R | 13.3 | NA | NA | NA | ||||
↵a All no-defect syringes were water-filled. Air-filled defects simulate leaks found in the gas headspace region of packages filled with liquid.
↵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