This issue is specifically addressed by Section 12.7 which states that “equipment
cleaning/sanitation studies should address microbiological and endotoxin contamination for those
processes where there is a need to reduce total microbiological count or endotoxins in the API, or
other processes where such contamination could be of concern.”
The primary issues with a non-sterile API intended for use sterile drug products are the possibility
of microbial and endotoxin contamination of the API and subsequent incorporation into the drug
product. Endotoxins, once in the API, are generally not removed by drug manufacturing
processes.
If you’re producing an API that is susceptible to microbial contamination or supports microbial
growth, it may be prudent to sanitize or sterilize equipment to minimize microbial and endotoxin
levels.
