8 replies to this topic

[awalkers]

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!

 

 

[Tony-C]

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

 

[GMO]

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?

[MDaleDDF]

Lots of questions here.   What's your product?   What allergens are in your building?   

To answer the last question, if something from my production room tested positive for listeria, yeah, I would consider anything else that touched that machine dirty as well.....  But again, it all depends on your cleaning procedures, swabs between batches, etc.   

[awalkers]

Hello Tony-C

 

Yes, we are changing the lot number for the product because it may have different SKUs of similar products but different names. For example, there is a ready-to-eat potato salad that only has egg as an allergen, but the next might be a cheese dip that only has milk as an allergen. 

We do change over, clean up (rinsing and sanitizing, which has been done for years), and verify cleaning with ATP and Protein residue swab tests for allergen verification. When all this is acceptable, they can continue with the following product. 

 

The question is about microbiological potential contamination:

Twice a week, we collect environmental samples, FC, and NFC. However, we have not validated the current changeover using a microbiological swab to confirm that it is sufficient to conclude that an FC is positive, and that the rest of the products from the line will be acceptable after the changeover cleaning. My analysis suggests that it might not, but I am trying to gather enough arguments for Operations to support the idea that we should not hold items from that line if something comes back positive. 

 

Thank you.

 

 

 

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

[awalkers]

Hello, 

 

We do change over, because we might be moving from one item that has egg as allergen to another one that only has milk, for example. so, change over clean up is needed (rinsing all debris then sanitizing (Sodium hypochlorite ), which has been done for years), then QA verify cleaning with ATP and Protein residue swab tests for allergen verification (which we have annually validated with a third party lab). When all this is acceptable, they can continue with the following product. Agree, ATP is not for microbiological testing. 

 

The question is about microbiological potential contamination:

Twice a week, we collect environmental samples, FC, and NFC. However, we have not validated the current changeover using a microbiological swab to confirm that it is sufficient to conclude that an FC is positive, and that the rest of the products from the line will be acceptable after the changeover cleaning. My analysis suggests that it might not, but I am trying to gather enough arguments for Operations to support the idea that we should not hold items from that line if something comes back positive. I have suggested that if a contact surface is positive all products need to be on hold because we did not performed a cleaning and sanitation according to the SOP when the shift ends which that we verify with our environmental samples.

 

Thank you.

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?

 

For example, there is a ready-to-eat potato salad that only has egg as an allergen, but the next might be a cheese dip that only has milk as an allergen. 

[GMO]

Protein swabs are not sufficiently accurate methods to exclude allergen presence.  ATP swabs are not sufficiently accurate to prove cleanliness nor pathogen absence.

 

Have you validated your mid shift cleans using traditional microbiological methods?  

 

Also, not the question but have you validated them using ELISA for allergen cleaning efficacy?

 

If not, you should do both before you go any further.

[awalkers]

Have you validated your mid shift cleans using traditional microbiological methods?  

 

No, until this point we always consider the whole production shift in a day is in potential risk of contamination.

but it will be worth doing it if operations wants to change things.

 

Also, not the question but have you validated them using ELISA for allergen cleaning efficacy?

yes, the third party lab validated our allergen cleaning with ELISA test, using swabs that they provided us specifically for that purpose.

 

Thank you for your feedback, I think it support again that what we have in place of holding all the product from a production day is the right thing to do. I like to learn from other people experiences.

 

Protein swabs are not sufficiently accurate methods to exclude allergen presence.  ATP swabs are not sufficiently accurate to prove cleanliness nor pathogen absence.

 

Have you validated your mid shift cleans using traditional microbiological methods?  

 

Also, not the question but have you validated them using ELISA for allergen cleaning efficacy?

 

If not, you should do both before you go any further.

[GMO]

Thanks, I'd really want to dig into your allergen validation because of the type of cleaning, honestly?  I don't fully believe it.  Just going to be totally blunt there as rinsing and disinfecting to remove allergens is not what those chemicals are designed for.  I'd put money on being able to find allergens after that mid shift clean.  But also part of validating that is using the appropriate materials and chemicals for the job.  Not using detergent is not using the right process to remove allergens even if your swabs said they were gone (you should also do positive spike swabs and product samples for best practice.)

 

But...  Please on the microbiological side, you are introducing water and disinfection processes which are readily deactivated by soil.  That process might actually be increasing risk not lowering it.  So for me it's not just about validating that process so you'd know what to do in the event of a positive swab or product but validating it's actually helpful and doing anything good for you.

 

As I am sat here, not knowing your plant as you do, this is my "gut feel" right now.  Your swabs for allergens were more luck than judgement.  You actually routinely have allergen cross contact but it's not at a high enough level (yet) that you've had consumer harm.  You are introducing water into systems with ineffective disinfection and potentially increasing loading as a result throughout your shift.

 

Why has it been designed this way?  How has it been designed this way with zero knowledge on efficacy at least when it comes to micro?  It has a whiff of "this is a lot cheaper than doing it properly" about it which is probably a decision which long preceded you.