TABLE I

Mass Flow Results for Defect Samples (# of Positive Results/# of Samples)

Defect Types (c/c System)Contents
Mannitol PowderDI WaterPlacebo SolutionProduct A Low Conc. SolutionProduct B High Conc. SolutionSurrogate Solution
2 μm glass micropipette (vials)10/1010/1010/105/5
5 μm glass micropipette (vials)5/50/55/5
10 μm glass micropipette (vials)2/55/5
5 μm laser drilled cracks (syringes)10/1010/1010/1020/200/6
75 μm wire in interference fit (syringes/uncoated plunger)4/50/5
  • Note: All defects were exposed directly to the contents.