TABLE V

HVLD as a Function of Package Plastic Laminate Lot

Test MethodClip (None/Up/Down)Test Direction (Septum or Bag First)Coefficient of Variation (%)Bag Count Over 3 Replicate Test Days
Day 1Day 2Day 3PassFailWarningTotal
Lot A
    1NoneSeptum543990099
    2NoneBag444990099
    3UpSeptum455971098
    4UpBag464971098
    5DownSeptum344970097
    6DownBag434961097
Lot B
    1NoneSeptum7748315199
    2NoneBag443981099
    3UpSeptum875915096
    4UpBag665906096
    5DownSeptum565942096
    6DownBag675897096
Lot C
    1NoneSeptum775971199
    2NoneBag545990099
    3UpSeptum655922094
    4UpBag533922094
    5DownSeptum554940094
    6DownBag445940094
  • Note: Fail HVLD reading ≥ Ref Max, Warning HVLD reading ≤ Ref Min.