Hello,
I would like to get some opinions about the lot size based on change over cleaning.
Here is the scenario:
The SOP for cleaning and sanitation at the end of production is in summary: dry cleaning, wet cleaning, foam, rinse, sanitize (chlorine 100-200ppm).
However, the cleaning change over between products during production is dry cleaning, wet cleaning or rinse and sanitize (chlorine 100-200ppm). After this ATP swab is require and inspection. It has been validated that this process prevent allergen cross contamination (validation done annually).
In a environmental sampling for Listeria and Salmonella, it has been considered that the change over cleaning breaks down the lot size.
I could not find anything under FDA guidelines that states something about change over, but USDA states that a lot size can be reduce by a cleaning between products following the SOP for cleaning and sanitation in place.
Therefore, base on that statement the current practice of change over does not comply because it is missing the foaming step.
so, if one FCS comes back positive; would you consider all products produced in the line adulterated even after change over cleaning?
Thank you
Have a nice day!
