Hi RMAV,
Thanks for link.
Looks like maybe 3 variables (critical limits?) involved - pH, temp., time
The "CCP" will logically depend on precisely how/where the >= 5log reduction is achieved/validated. If totally at steps 3,12 can probably either express as 2 CCPs or a combimed CCP.
If contributions to >=5log reduction from steps 4-11, will need to consider those also.
Hi RMAV,
I have a couple of questions. Are you recording temperatures at least daily in your storage using a NIST calibrated thermometer? I'd think that would be really important because the study you linked shows storage conditions at 22C (approx. 71F). I know this is typically room temperature (not always if the room isn't temperature controlled though), but you need to show that the storage is at least 22C. You should also think about having the room temperature controlled, if it isn't currently. We have a lot of warehouse space in my company and storage temperatures can vary from room to room.
Have you also been validating your 5-log reduction as well? I know that you have the document, but you should be able to show that you've done some testing as well, and you are indeed getting your needed reduction. CCP validation is extremely important, so you must be able to totally justify your processes.
QAGB
Edited by Tony-C, 02 February 2016 - 02:18 PM.
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