Is there technology to support a fully single-use system for microbial fermentation? I mean are there any parts that still need to be cleaned validated?


With respect to the process contacting parts, which is the bioreactor/fermentor bag, there is nothing to clean as nothing gets reused from that assembly. This is one of the main benefits of single-use bioprocess technology as a whole. And, specifically, for fermentation, single-use technology eliminates cross-contamination previously associated with O-rings, gaskets, diaphragms and mechanical seals. The process piping from the stainless steel equivalent has been replaced by elastomeric tubing. No cleaning necessary, just discard similar to other process waste.

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