Roadblock to validation plan of CIP
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.
Hi bpoon,
I don't use CIP systems but I assume you are swabbing some part of the equipment. An alternative evaluation technique is based on rinse water analysis.
i would anticipate that the supplier of a CIP system would provide specification capabililities and the measurement thereof ?
afaik generally implementable micro. criteria for so-called "clean" surfaces do not exist. .
Appropriate micro. criteria may relate to your specific product/process. A wide micro.survey/summary of general criteria in current food use for "clean" surfaces is here -
http://www.ifsqn.com...ntact-surfaces/
For cip can also see this earlier thread -
http://www.ifsqn.com...for-validation/
These files have sections on cip systems which may assist -
Vave 1 - ecolab - Validation and Verification White Paper pdf.pdf 350.25KB 449 downloads
vave 2 - Plant Sanitation -Cleanliness Validation Program.pdf 533.3KB 478 downloads
vave3 - SPX CIP Systems for Plant Sanitation.pdf 3.5MB 414 downloads
vave4 - safefood360 Cleaning,disinfection in food processing operations.pdf 2.04MB 369 downloads
vave 5 - Efficient_Brewery_Sanitation.pdf 1.94MB 312 downloads
There are many, many other previous threads here which discuss in detail the validation of cleaning processes with respect to allergens.
Users of CIP systems may be able to give more quantitatively detailed responses.
I see. Thanks for the direction and advice! We're using food and water samples from during production as a baseline to see what load the system has, then we're doing swabs in multiple areas after CIP to evaluate the results against the baseline. The general criteria is definitely helpful to my question!