Hello!! I've written a simple validation plan for micro and allergen cleaning of a new CIP system we've got. The issue is that I'm having a roadblock here with setting the micro limits.
The limits for allergen, after CIP, would need to be <2.5 ppm (detectable range of quantification tests). That is not a problem, as we've been seeing a clear distinction between >25 ppm during production and <2.5 ppm after cleaning.
However, this issue is APC results. Ideally, if we can achieve a <10 CFU/swab result for all swabs after CIP, that'd be great. The problem is that we're not- we're not seeing that. I know if a decline from, for example, 50,000 CFU to 50 CFU is seen, then its "successful" since it declined by a about 3 logs. However, I'm having issues with writing the justification or explanation. I can reference the SSOP if it has information on expected decline in microbial load, but what should the maximum limit of microbial load be after CIP, and why, if it's not (in our last example) 50 CFU. Just looking for some directions as to what the resulting microbial load can be and why, if not <10 CFU.