Change over cleaning FDA vs FSIS (USDA) and lot size for enviromental sampling

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!

Hi awalkers,

Maybe I’m missing something here, but if you are changing the product are you not changing the ‘lot’ number?

Kind regards,

Tony

I think I understand this.

At end of day clean you do:

Gross debris removal.

Clean using detergent.

Rinse.

Disinfect.

But at change over of product during the shift you just do:

Gross debris removal.

Rinse, no detergent (sometimes).

Disinfect.

I would have doubts that the latter would be effective against Listeria and Salmonella when detergent isn't used.  How have you validated that changeover clean for microbiological purposes?  What does "sometimes" mean?  ATP is not a validation of microbiologically clean I'm afraid.

The purpose of disinfectants is to kill pathogens or reduce to a safe level but they are ineffective if the pathogens are protected by soil.  Sodium hypochlorite (which is what I suspect you mean by chlorine) is particularly prone to being "deactivated" by soil so there's a double whammy that it might not be able to access the pathogens but also it's being depleted by the dirt it's encountering.

What is the purpose of those interim cleans?  What is your product?  While you're controlling allergens from your validation (depending on how effective a test that was), you might actually be increasing the risk of pathogens.

So if you get a detection, no I would not be relying on that interim clean.

A left of field thought.  To COMPLETELY turn all of this on its head, when you have changeovers, have you ever adopted a SMED approach to see if you can externalise some of the cleaning and make it more effective?