TABLE I

Vacuum Decay Leak Test Studies Performed in Triplicate at Each Test Site

StudyLeak Test Method (target vacuum)Negative Controlsa (number tested)Positive Controlsb (number tested)NIST Flow Meter (number tests)
1Gas leak test (250 mbar)Empty syringes (15)NA0.05 ccm (5) 0.10 ccm (5)
2Gas leak test (250 mbar)Empty syringes (15)Empty syringes     5-μm hole (5)     10-μm hole (5)     15-μm hole (5)NA
3Liquid leak test (0–1 mbar)Water-filled syringes (15)NA0.05 ccm (5) 0.10 ccm (5)
4Liquid leak test (0–1 mbar)Water-filled syringes (15)Empty syringes     5-μm hole (5)     10-μm hole (5)     15-μm hole (5)NA
5Liquid leak test (0–1 mbar)Water-filled syringes (15)Water-filled syringes     5-μm hole (5)     10-μm hole (5)    15-μm hole (5)NA

  • ↵a The same negative control, no-defect syringes were used at all three test sites.

  • ↵b Each test site was provided a set of positive control, holed syringes (5 per hole size) to minimize risk of hole clogging due to multiple tests and handling.

  • NA = not applicable.