12 points) Considering data (see Charts 1 and 2) from a Vmax experiment conducted using a 15 cm2 test filter to support an aseptic drug product filling process: a. Considering Chart 1, which experiment results do NOT allow for the determination of a Vmax? Why? (2 points, no partial credit) b. Considering Chart 1, which experiment results will allow for the determination of a Vmax? Why? (2 points, no partial credit) c. Considering Chart 1, which experiment result demonstrates the best flux? Why? (1 point, no partial credit) d. According to the gradual pore clogging model, what is the approximate size range (diameter) of material clogging the filter? Why? (2 points) e. On Chart 1, line “a” has been generated by a Vmax study. Calculate the filter size required to filter 100 L of drug product in 2 hours. (1 point) f. On Chart 2, line “g” has been generated from a Vmax experiment using the model you have described above. The line shown has a slope of 0.33. Considering the experimental data, obtained using the 15 cm2 test filter, what size filter is required to filter 100 L? (2 points) g. Considering the data presented, which line represents the smallest Vmax? Why? (2 points, no partial credit)Chart 1 Chart 2
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[Solved]: 12 points) Considering data (see Charts 1…