TABLE VIII

Outliers Using Mean and Standard Deviation for All Filtersa

IndexProduct TypeMembranebFactorBP RatioTest Characteristics
43 – F1BiologicPVDF10.402.11Factor far from 1.00; Factor Suspect; Surfactant; Potential Filter Plugging
43 – F2BiologicPVDF10.402.13Factor far from 1.00; Factor Suspect; Surfactant; Potential Filter Plugging
43 – F3BiologicPVDF10.402.17Factor far from 1.00; Factor Suspect; Surfactant; Potential Filter Plugging
43 – 0.45BiologicPVDF10.401.85Factor far from 1.00; Factor Suspect; Surfactant; Potential Filter Plugging
44 – F1BiologicPVDF10.402.35Factor far from 1.00; Potential Filter Plugging; Factor Suspect
44 – F2BiologicPVDF10.402.12Factor far from 1.00; Potential Filter Plugging; Factor Suspect
44 – F3BiologicPVDF10.402.16Factor far from 1.00; Potential Filter Plugging; Factor Suspect
44 – 0.45BiologicPVDF10.402.06Factor far from 1.00; Potential Filter Plugging; Factor Suspect
103 – F1DrugcPVDF-phobic1.001.69None Identified
103 – F2DrugcPVDF-phobic1.002.18None Identified
103 – F3DrugcPVDF-phobic1.002.17None Identified
103 – 0.45DrugcPVDF-phobic1.001.58None Identified
111 – F1BiologicPVDF31.001.59None Identified
111 – F2BiologicPVDF31.001.41None Identified
111 – F3BiologicPVDF31.001.50None Identified
111 – 0.45BiologicPVDF31.001.64None Identified
472 – F1BiologicPVDF10.831.83Filter Plugging
472 – F2BiologicPVDF10.831.92Filter Plugging
472 – F3BiologicPVDF10.831.83Filter Plugging
472 – 0.45BiologicPVDF10.834.16Filter Plugging
508 – F1BufferPVDF10.352.72Factor far from 1.00
508 – F2BufferPVDF10.352.82Factor far from 1.00
508 – F3BufferPVDF10.352.73Factor far from 1.00
508 – 0.45BufferPVDF10.352.52Factor far from 1.00
  • a The first column lists the individual filter bubble point (BP) ratios that exceed the mean +3 standard deviations for the complete data set (first row of Table VII), by test index number and filter number used to identify the data point in Appendix Table S-I. The second and third columns give the type of fluid and membrane type, respectively, for the bacterial challenge test (BCT) that produced the data point. The fourth column gives the correction factor used in calculating the BP ratio (i.e., the ratio of a filter BP conducted with the filter wet with product to the BP of the same filter wet with the standard fluid used for the pre-use BP). The fifth column gives the observed BP ratio. The last column lists any characteristics identified for the subject BCT that might account for an elevated BP Ratio.

  • b PVDF, polyvinylidene fluoride. Numerical suffixes refer to different manufacturers. PVDF-phobic is a hydrophobic PVDF membrane.

  • c Excluded from ANOVA.