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Millistak+HC AppGd_textC.qxd - Millipore

Millistak+HC AppGd_textC.qxd - Millipore

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Evaluation and<br />

Optimization<br />

Separation Mechanisms<br />

The particle removal achieved by<br />

Millistak+ HC filters is the consequence<br />

of two distinct separation mechanisms.<br />

The first of these mechanisms is<br />

mechanical sieving, in which particles<br />

are captured within the prefilter due to<br />

their physical size and/or orientation.<br />

In the case of a depth filter, the path<br />

through the media matrix is tortuous<br />

and varies greatly in effective pore<br />

dimensions, providing ample opportunity<br />

for particle retention by entrapment.<br />

The outward effect, typical of<br />

most filters, is a build-up in pressure<br />

differential in the direction of flow.<br />

The second particle capture<br />

mechanism for Millistak+ HC filters<br />

is adsorption: the physical/chemical<br />

binding of particles to the filter media.<br />

This process is aided by the net<br />

positive charge on the surface of the<br />

Millistak+ HC filter media. Colloidal<br />

particles in a biological suspension<br />

(cell wall fragments, agglomerated<br />

proteins, polynucleic acids, etc.)<br />

exhibit a net negative electrostatic<br />

charge on their surface at typical<br />

near-neutral pH conditions. The<br />

cationic charge on the Millistak+ HC<br />

filter media allows these particles to<br />

be captured, when otherwise they<br />

might escape retention due to their<br />

small size.<br />

This electrostatic retention mechanism<br />

allows the Millistak+ HC prefilter<br />

to be effective in removing particles<br />

well below the smallest pore size<br />

of the media and thereby provides<br />

additional protection to the sterile filter.<br />

This capture mechanism does not<br />

however reveal itself as a pressure<br />

build-up on the prefilter. Instead, the<br />

user must carefully monitor the quality<br />

of the filtrate, to detect the point at<br />

which all available adsorption sites<br />

within the media have been used.<br />

This can be done either by monitoring<br />

filtrate turbidity in relation to process<br />

throughput or by measuring the<br />

capacity of the downstream sterile<br />

filter in situ or off-line (with a post-run<br />

Vmax SM test).<br />

Depending on the properties of<br />

the feed stream (and the consequent<br />

relative contribution of the two separation<br />

mechanisms described above),<br />

two distinct types of behavior may<br />

be observed for the Millistak+ HC<br />

prefilter. These two distinct profiles<br />

Millistak+ HC Filters Application Guide 15

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