Q7A is silent on that point. In many cases, companies doing classical fermentations do not claim
that the fermenters are sterile. They may be sanitized, and have reduced bio-burden. But there
should be procedures to make sure batches do not get contaminated.
You have to understand that in fermentation processes, the reactors are not typically sterilized
empty. What is really sterilized is the culture media. The culture media is prepared and
transferred to the fermenter and sterilized in situ inside the fermenter before you transfer the
inoculum into the fermenter.
