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.
