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?
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Single-Use Technology for Microbial Fermentation
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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 The process piping from the stainless steel equivalent has been replaced by elastomeric tubing.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.
This post is sponsored by Cytiva (formerly GE).