Sterile filtration downstream process

Downstream Processing Microfiltration plays a significant role in downstream processing of fermentation products in the pharmaceutical and bioprocessing industry. Examples are clarification of fermentation broths, sterile filtration, cell recycle in continuous fermentation, harvesting mammahan cells, cell washing, mycelia recovery, lysate recovery, enzyme purification, vaccines, and so forth. 

Downstream processing is normally undertaken under clean room conditions, with the final steps (e.g. sterile filtration and aseptic filling into final product containers) being undertaken under Grade A laminar flow conditions (Figure 3.18). 

Enzymes produced by fermentation processes are recovered and refined through downstream processing into the slurry or paste form which can directly be used for industrial applications. For example, the concentrate from a polyethylene glycol (PEG) extraction step may directly be used if the enzyme is sufficiently pure and free of microbial contamination. In this case, the formulator must work closely with the recovery engineer to produce a clean and sterile formulation. The addition of a sterile filtration step prior to a concentration step, in a clean, sterile tank, might be all that is necessary to obtain the final product. Another option is to force the precipitation or crystallization of the enzyme and then disperse it into a formulation that is compatible... 

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