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Nutritious_ff

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Posted 18 April 2022 - 10:43 PM

Hi there,

 

We recently had a gluten free audit where the auditor gave us a non conformance for our allergen cleaning validation procedure. We produce nutrition bars and have most of the allergens (soy, milk, peanut, tree nut, wheat/gluten, sulfites) in our facility. there is no dedicated line so cleaning is our procedure for controlling cross contamination.

 

Our current procedure for validation is to send out allergen specific swabs to a third party lab for testing. the swab samples are taken on each type of surface (plastic, stainless steel, etc) after cleaning is conducted post production. All our products have some allergen so naturally these allergens would transfer on the production equipment. The results from validation were within the detection limit of the test. this showed that there was no allergen residue on the production equipment/surfaces after cleaning. 

 

According to the auditor this is verification, not validation. we have been asked to show proof that allergens were present on the surface originally. therefore we have to do allergen specific swab before cleaning and another set after cleaning to show that those allergens were removed. Is this accurate? I have not come across any literature that prescribes allergen cleaning validation in this way. Has anyone else come across such a requirement?

 

Any help will be appreciated. Also, this increases the validation cost 2x and management is not onboard unless i can provide guidance/ specific industry standard that requires this. the gluten free standard does not prescribe how to do validation either.



Charles.C

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Posted 18 April 2022 - 11:17 PM

Hi there,

 

We recently had a gluten free audit where the auditor gave us a non conformance for our allergen cleaning validation procedure. We produce nutrition bars and have most of the allergens (soy, milk, peanut, tree nut, wheat/gluten, sulfites) in our facility. there is no dedicated line so cleaning is our procedure for controlling cross contamination.

 

Our current procedure for validation is to send out allergen specific swabs to a third party lab for testing. the swab samples are taken on each type of surface (plastic, stainless steel, etc) after cleaning is conducted post production. All our products have some allergen so naturally these allergens would transfer on the production equipment. The results from validation were within the detection limit of the test. this showed that there was no allergen residue on the production equipment/surfaces after cleaning. 

 

According to the auditor this is verification, not validation. we have been asked to show proof that allergens were present on the surface originally. therefore we have to do allergen specific swab before cleaning and another set after cleaning to show that those allergens were removed. Is this accurate? I have not come across any literature that prescribes allergen cleaning validation in this way. Has anyone else come across such a requirement?

 

Any help will be appreciated. Also, this increases the validation cost 2x and management is not onboard unless i can provide guidance/ specific industry standard that requires this. the gluten free standard does not prescribe how to do validation either.

Hi Nutritious,

 

Was there a GFSI-type Standard involved, eg SQF, BRC etc ?

 

The terminologies Validation and Verification may have a wide range of interpretations depending on the context.

 

SQF Code for Manufacturing Food IMO would probably agree with yr auditor as far as the interpretation of Allergen Cleaning Validation is involved.

 

Additionally, to demonstrate  Allergen Cleaning Validation, it is logical to have positive evidence that the Procedure is effective.

Note that in this context Validation is regarded as a separate "study" as compared to data from routine repetition of the validated allergen cleaning procedure. (In other contexts SQF auditors may exhibit differing interpretations of Validation).

 

There are many, many discussions on this Forum (and elsewhere) on the topics of  interpreting Validation and Verification.


Kind Regards,

 

Charles.C


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Posted 19 April 2022 - 12:01 PM

Recently had a similar issue to this but for me its how it was documented.

 

Validation = prove that the cleaning procedure if implemented works.... think of it as research that is conducted by you and documented. 

 

You clean surface using method X to see if this works you take some swabs and send away for testing to see if it comes up clear. also send some that are before cleaning to prove allergen is present prior to cleaning. Do this a number of times for various different products on different lines. Assuming that all returns clear. Then in my mind it is validated as proven to work. 

 

You can also include any know industry best practices as part of your validation i.e if GFSI standard  of Food authority guidance says that X and X following REGS is acceptable. id include that too.

 

Then your sending swabs away is for verification that that system works as intended / designed.

 

Lastly why send swabs away? there are systems that give instant results for egg soya etc. faster result and cheaper i think which would be a much better controlling factor as if the swab fails and you have had to wait a week to get the result then you'll have to recall product. with instant test the control would be to re-clean and re-test.

 

 

Lastly to my point about how it is documented, im sure there must be a example validation study document template out there, but i cant find any  :helpplease:



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Posted 19 April 2022 - 01:21 PM

Post #3 is correct---that is what is need to perform a validation

 

This process only needs completed ONCE or until you change your process (e.g. cleaning chemical, cleaning frequency, the addition of a new allergen etc)  after which you will perform verification swabs

FYI you can get in house swabs where you do not need to send them to a 3rd party lab-----way more cost effective 

 

You can also guarantee that at some point CFIA is also going to ask for your validation study


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Posted 19 April 2022 - 05:52 PM

Post #3 is correct---that is what is need to perform a validation

 

This process only needs completed ONCE or until you change your process (e.g. cleaning chemical, cleaning frequency, the addition of a new allergen etc)  after which you will perform verification swabs

FYI you can get in house swabs where you do not need to send them to a 3rd party lab-----way more cost effective 

 

You can also guarantee that at some point CFIA is also going to ask for your validation study

 

Yeh in house swabbing is much better, you can get lateral flow tests (like covid test kits) for some allergens. you could also but i dont think is required to send off swabs for independent verification though, as i know like covid test kits, they can not always work...



Charles.C

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Posted 19 April 2022 - 11:01 PM

Perhaps SQF's detailed exposition on their interpretation of allergen cleaning validation and verification might assist, eg -

 

https://www.ifsqn.co...an/#entry145657

 

@ Nutritious - Any Comments ?


Kind Regards,

 

Charles.C


Nutritious_ff

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Posted 19 April 2022 - 11:39 PM

@charles we are an SQF certified facility however the validation procedure was not an issue in any of our SQF audits previously. this was a gluten free certification audit.

 

I will conduct the validation with allergen specific lateral flow test kits. the test kit supplier offers training and proficiency testing for the user. 

 

 

Thank you all for your help. the IFSQN community is so helpful.



Charles.C

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Posted 20 April 2022 - 01:00 AM

@charles we are an SQF certified facility however the validation procedure was not an issue in any of our SQF audits previously. this was a gluten free certification audit.

 

I will conduct the validation with allergen specific lateral flow test kits. the test kit supplier offers training and proficiency testing for the user. 

 

 

Thank you all for your help. the IFSQN community is so helpful.

 

Hi Nutritious,

 

SQF themselves have previously experienced internal/external difficulties in "standardizing/normalizing" their general, auditorial approach  to  Validation/Verification.(A similar comment may also apply to  "proficiency" [note the latter's recent discussions here].)

 

IIRC their lengthy (and impressive) exposition on "allergen cleaning validation" is a relatively recent inclusion in the Standard's Code.

 

The above may relate to the seemingly increased attention to "detail" which you have noted.

 

PS - JFI, note that it is not obligatory to use an allergen-specific Procedure for Verification.
 


Kind Regards,

 

Charles.C


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Posted 28 April 2022 - 03:30 PM

Validation that your swabs detect the allergen being tested in the presence of the other ingredients in your product at the lowest level of detection first (Method validation) and then documentation of the equipment containing the allergen followed by cleaning/sanitizing and validation of cleaning would be the way I would document this.  Documenting the allergen is in the blender is verified by batch records.  In our case we used massive amount of the allergen for a worst case scenario of an experimental blend with the most difficult to clean ingredients, validated that the swabs would recover at the LOD.  We then followed cleaning procedures and validated the removal of the allergen with swabs.  We then repeated this study 3 times in every blending room, blender, equipment that may be used.  You may even have to do multiple validations for multiple ingredients, for example oils, acidic diluents, lards, etc.  



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fuse_23

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Posted 23 June 2022 - 12:33 PM

Hi good day to all.  I just want to have a follow up on this.  We also did an allergen specific validation study for our machines but 1 of our auditor (FSSC 22000) required to have all the allergens (that our factory handled) to have validation records.  Peanut, milk, and egg are the other allergens that cannot pass our validation, since the result of the test was >LOD but <LOQ ng/mL.  Does this mean our cleaning was not effective?  Some of the sampling points results are <LOQ ng/mL.  Hope someone can enlighten us on this, as we are not able to have the documentation finalised.

 

Thanks everyone.☺️



Charles.C

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Posted 24 June 2022 - 01:51 PM

Hi good day to all.  I just want to have a follow up on this.  We also did an allergen specific validation study for our machines but 1 of our auditor (FSSC 22000) required to have all the allergens (that our factory handled) to have validation records.  Peanut, milk, and egg are the other allergens that cannot pass our validation, since the result of the test was >LOD but <LOQ ng/mL.  Does this mean our cleaning was not effective?  Some of the sampling points results are <LOQ ng/mL.  Hope someone can enlighten us on this, as we are not able to have the documentation finalised.

 

Thanks everyone.☺️

Hi fuse,

 

No details given regarding Product/Procedure/data. I offer one published Procedure / example although other interpretations may exist.

 

I deduce yr primary query is as to the choice of LOD or LOQ as the criterion for cleaning effectiveness.

 

A second query might also be regarding the auditor's request for validation on all allergens for which consider -

 

Target Allergen: When there are multiple allergens present on a line, cleaning validation does not need to
be done for all allergens. A target or marker allergen can be selected and used to collect evidence that the
cleaning has been effective. The decision will be based on which is present at the highest level and whether
there is a suitable quantitative ELISA test available.

(see attachment below)

 

or (SQF) -

When there is a mixture of different allergens in use, the acceptable method for confirming the thoroughness
of cleaning is to test for the highest risk allergens, the highest concentration allergens, or the ones that are
most difficult to remove.  Examples of difficult to remove allergens include milk proteins, such as in
chocolates or caramels, and cooked eggs.  In some cases, a supplier may choose to test for an allergen
protein which is lower in concentration.  Such is the case with low-fat peanut butters where the soy flour is
used at a much lower concentration in the mixture with peanuts.

 

 

Regarding the choice of  LOD or LOQ the Procedure (Kraft) attached uses LOQ as per the definitions given in the document.

 

Attached File  Guidance Allergen Management and Testing, 2021.pdf   529.76KB   125 downloads


Kind Regards,

 

Charles.C


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Brothbro

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Posted 24 June 2022 - 03:32 PM

An interesting aside, another user has brought an allergen validation question to the forum that does a great job of showing why validation is important:

 

https://www.ifsqn.co...ectable-limits/

 

Proving that your allergen is detectable via your method before cleaning is fundamental to the validation experiment. If this user had instead assumed a positive result pre-cleaning, they would have incorrectly felt secure in their negative post-sanitation allergen results! Instead, they will likely build a good program because they've done their due-diligence from the start. This is a large part of why validation provides the foundation for ongoing verification testing.

 

This kind of scenario is why auditors pay close attention to allergen verification programs. If it is not based in a good validation study, it becomes harder to trust.



Charles.C

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Posted 28 June 2022 - 02:05 AM

An interesting aside, another user has brought an allergen validation question to the forum that does a great job of showing why validation is important:

 

https://www.ifsqn.co...ectable-limits/

 

Proving that your allergen is detectable via your method before cleaning is fundamental to the validation experiment. If this user had instead assumed a positive result pre-cleaning, they would have incorrectly felt secure in their negative post-sanitation allergen results! Instead, they will likely build a good program because they've done their due-diligence from the start. This is a large part of why validation provides the foundation for ongoing verification testing.

 

This kind of scenario is why auditors pay close attention to allergen verification programs. If it is not based in a good validation study, it becomes harder to trust.

Hi Brothbro,

 

You're right but sadly the potentially relevant Post 6 of the referenced thread got no response.

 

From the Neogen Handbook (2012), two more "interesting" asides -
 

 How  many  ppm  can  be  detected  from  a swab?
 It  is  not  possible  to  discuss  sensitivity  from  a
surface swab as this type of analysis does not
have a defined sample size. By definition, ppm
is mg of contaminant per kg of sample. Because
sample  size  widely  fluctuates  depending  on
the amount of material captured on the swabs
surface, a ppm definition cannot apply. Instead
it is appropriate to define sensitivity in terms of
µg of contaminant found in a 100 cm 2  surface.  
(10 cm x 10 cm surface was used during validation). Given this definition, 5–10 µg of allergen per
100 cm 2  is achievable; however, this can vary depending on the surface and type and concentration
of cleaning chemicals or sanitizers present on the surface

 

 


 

Limitations of ELISA-based Food Allergen Tests
ELISA-based food allergen tests, like Neogen’s, are not appropriate for use in certain applications. Be-
cause the tests are based on an antibody reaction with an extracted allergenic protein, the protein in the
sample must be close to its natural state and readily extractable. Although this normally is the case, in
certain instances the test may not yield results totally indicative of the sample’s potential to produce an
allergic reaction in susceptible consumers. The user cannot assume that if a protein is undetectable it
is not allergenic.
Some of these instances include (but are not limited to):
     •     Hydrolyzed    and    proteolyzed    proteins    (e.g.,    HVP,    hydrolyzed    egg    protein)
     •     Fermented    products    and    cultures    (e.g.,    guar    gums,    xanthan    gums,    soy    sauce)
     •     Probiotic    cultures    
     •     Enzyme    proteases
     •     Some    concentrated    food    additives,    colors    and    flavors
     •     Some    oil-based    ingredients    (e.g.,    oil,    lecithin,    oil-soluble    flavors,    etc.)

 

Also see this link which queries what is regarded as an acceptable level of (negative) detection (may also be effectively asking as to a qualitative/quantitative evaluation ?) -

 

https://www.ifsqn.co...ts/#entry177060


Kind Regards,

 

Charles.C


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Posted 29 June 2022 - 03:40 PM

Hi Brothbro,

 

You're right but sadly the potentially relevant Post 6 of the referenced thread got no response.

 

From the Neogen Handbook (2012), two more "interesting" asides -
 


 

 

Also see this link which queries what is regarded as an acceptable level of (negative) detection (may also be effectively asking as to a qualitative/quantitative evaluation ?) -

 

https://www.ifsqn.co...ts/#entry177060

 

Thanks for making all these connections, Charles. From the information you've brought up it should become clear to anyone looking validate their allergen cleaning process that the experiment must be carefully constructed. Many variables to consider, from the appropriateness of the testing method, to the actual concentration of the allergen in your food. If a firm lacks staff with experience in good experimental design, they may want to seek out professional consultation for their validation.



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Posted 29 June 2022 - 04:12 PM

I think the take away here is that people are straying too far from basic HACCP principals (which regardless of "interpretations") is the basis of ANY food safety system

 

While the waters have been muddy over the years, validation and verification are NOT the same and CANNOT be used interchangeably

 

I wonder how many facilities have never validated the MD or X-ray they think they are depending on?  Or say, freezer storage, or blast chilling times/temps etc.


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