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Drugs and the pharmaceutical sciences

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Filter Sizing: The Requirements <strong>and</strong> Their Attainment 181<br />

Differential pressure (pH)<br />

50<br />

45<br />

40<br />

35<br />

30<br />

25<br />

20<br />

15<br />

10<br />

5<br />

X<br />

X<br />

X<br />

Acroflow 121 0.45 with 1 micron prefilter (prefilter too right prefilter plugged)<br />

X<br />

X<br />

X<br />

X<br />

Acroflow 121 0.45 (no prefilter)<br />

Acroflow 121 0.45 with to micron prefilter (prefilter too loose)<br />

Acroflow 121 0.45 with 2.5 micron prefilter (correct prefilter)<br />

X<br />

X<br />

1 2 3 4 5 6<br />

Time (minutes)<br />

X<br />

FIGURE 12 Throughput of trypticase soy broth (1.25%) effects of prefiltration. Source: From<br />

Lukaszewicz, Johnston, <strong>and</strong> Meltzer, 1981.<br />

stock to pleated membranes due to influences inherent in <strong>the</strong> pleating process. The<br />

measurement of <strong>the</strong> EFAs of flat disc filters is uncomplicated. That of pleated filters is<br />

appreciably more complex. The flow rate scale-up using 47-mm flat discs reflects only<br />

<strong>the</strong> influences of <strong>the</strong> membrane thickness <strong>and</strong> its porosity. The modifications in EFA<br />

resulting from pleat-pack constructions must not be neglected. These derive from <strong>the</strong><br />

flow-attenuating influences of <strong>the</strong> cartridge’s support <strong>and</strong> drainage layers. To this must be<br />

added <strong>the</strong> reduction in flow caused by <strong>the</strong> occurrence of pleat compaction. The utmost<br />

caution has to be exercised when filter choices are made by evaluating flow rates using<br />

47-mm flat disc filters. The flow data will not extrapolate well from flat stock to pleated<br />

filter cartridges.<br />

A more responsible action is to follow <strong>the</strong> “indicator trials” using 47-mm discs with<br />

“verification trials” wherein <strong>the</strong> total throughput <strong>and</strong> flow rate measurements are<br />

X<br />

X<br />

X

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