Tuesday, May 28, 2013

Best Floor Drain Design for Bioreactor Sterility

So back to our question of which floor drain design is better for bioreactor sterility...

On the left, we have piping that is contained.  When fluids from the process piping go to drain, there is 0% chance that this fluid (e.g SIP condensate, or CIP rinse, or unspent media, or whatever) ending up on the plant floor.

On the right, we have piping that stops above the drain and there's a possibility that process fluids end up on the plant floor.

Well, the answer to the question, which configuration (left vs. right) is better for mitigating bioreactor contamination risk is..... right.  And here's why:

Should the process piping draw a vacuum--say via the Venturi Effect or with collapsing steam, the sealed piping allows for the contents of the drain to return to the process (as depicted by the brown arrows pointing up).

On the right, should the process piping draw a vacuum, only air from the plant floor (as depicted by the light blue arrows) is drawn into the process.  While still not ideal, air on the plant floor of a biologics facility (that is changed at some specified interval) is much cleaner than whatever you've been dumping down your drain.

You drastically reduce your chances of bioreactor contamination abiding by the uni-directional-flow-of-materials-through-the-plant principle.

Not every manufacturing operations group has the luxury of good plant design.  Not many organizations have the resources to fund a greenfield plant starting with scratch paper.

As the executive vice president of that biologics manufacturer who was dinged with the 483 and a warning letter found out, these contamination and bioburden issues have a tendency to escalate.

The only way to get ahead of this escalation is to be proactive and apply prophylaxis.

With respect to microbial contamination of bioreactors, an ounce of sterility consulting is worth a pound of finished product.

Read how our consultant solved this string of 5 contaminations

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