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Is cleaning after allergen a CCP or not?


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damienh

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Posted 22 July 2021 - 08:55 AM

Hello, I have just started in an oil packaging company and have a concern with HACCP and allergens. Was considered a CCP, cleaning after allergen, except for me, cleaning was not a manufacturing step, it cannot be a CCP. Do you agree with this approach? Thank you in advance, Regards


Evans X.

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Posted 22 July 2021 - 11:20 AM

Greetings damienh,

 

Cleaning is a PRP, but it becomes a grey area when it is used to control a specific existent hazard (allergen) due to your previous production and not a random possibility, meaning do you have another step which reduces the risk of the allergen in your end product ?

A somewhat similar example is metal detector. It is not a manufacturing step but it is the final way to ensure no metals in your end product, so many list it as a CCP.

There is not an easy answer, but whatever your hazard analysis lists it as, someone can argue how do you verify the effectiveness of the cleaning, which can be done maybe with an allergen test after the cleaning (with a fast kit). So if you have a control measure which you monitor and have a set limit maybe it is a CCP ?

 

More opinions can shed further light in the matter.

 

Regards!



damienh

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Posted 22 July 2021 - 11:41 AM

Dear Evan, 

 

Thank you for your response. 

 

For the metal detector, this is not quite the same, because even if it is not a manufacturing step, it is a visually physical process step and where 100% of the products pass. So this is visible in the HACCP diagram

 

Here it is a step before manufacture. For the moment there is just a validation of the flushing oil volume and an annual validation (Cleaning is a rinse with a defined volume with rapeseed oil)

. The idea is to set up rapid tests (Neogen or Romer Lab)

 

Regards


Edited by damienh, 22 July 2021 - 11:41 AM.


Scampi

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Posted 22 July 2021 - 12:11 PM

So what you're saying is that the swabbing IS NOT done every time you empty/change the oil?  Then no, it cannot be a CCP or you'd be in deviation all other oil flushings 

 

this is a PC


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FSQA

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Posted 22 July 2021 - 01:09 PM

As mentioned above it is a PC and post cleaning allergen verification should be done for Sanitation effectiveness.

In case, there is not big Allergen cross-contact concern of the product you process (oil), verification and validation (at scheduled intervals) should be conducted.



Evans X.

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Posted 22 July 2021 - 01:12 PM

Agree with Scampi, if you are not swabbing every time then no it's not a CCP, it's just the ensurance of your cleaning that it works. However, during your hazard analysis you score the hazards according to some criteria (I guess). So my question is this. You do know for example that you have microorganisms in the raw material and so you apply heat reatment for their mitigation, hence a CCP. When you have a constant known allergen (hazard) what are the measures you take to eliminate it and how do you monitor/control it. I mean it isn't just a possible cross-contamination which can be controlled through GMP and cleaning. It is there constantly with a max score in occuring and a max score in health danger after every "allergen" production and waiting for a single failure in cleaning to happen.

I could be seriously overthinking it, but it is kind of a hot issue!


Edited by Evans X., 22 July 2021 - 01:15 PM.


damienh

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Posted 22 July 2021 - 02:17 PM

Hi All, 

 

Thank you for your reply. The current CCP is to ensure that the defined volume has been passed for rinsing (qualification made in the past). I'm not comfortable with this, that's why I asked the question because for me it was not a CCP and I will set up rapid tests to increase the safety of our products.

 

Still in the same HACCP, the glass bottle breakage and its corrective actions have been put in PRPO, I also have trouble with this principle, since it is on an incident. For me this is an incident management. What do you think ?

 

Thank you in advance



FSQA MKE

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Posted 22 July 2021 - 03:01 PM

Evans. X above is right, it's a pre-requisite program & not a CCP. Nonetheless is must be done.


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damienh

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Posted 22 July 2021 - 06:38 PM

Thank you for your reply.



Charles.C

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Posted 24 July 2021 - 03:44 AM

 

Hello, I have just started in an oil packaging company and have a concern with HACCP and allergens. Was considered a CCP, cleaning after allergen, except for me, cleaning was not a manufacturing step, it cannot be a CCP. Do you agree with this approach? Thank you in advance, Regards

 

 

Specific answers might have been rationalized if you had mentioned the relevant FS Standard (if any).

 

Frequently allergen management programs are an auto- PRP by a Standard's definition.


Kind Regards,

 

Charles.C





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