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Allergen Testing: In-house vs. 3rd Party Lab

allergens testing BRC

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#1 shasha8705

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Posted 12 April 2016 - 04:49 PM

My company makes many products of which some contain allergens and some do not. We have always performed a full wash-down between production runs with allergen verification swabs after an allergen containing production run to validate the cleanliness of random food contact areas.  It has recently been decided to start performing these allergen swabs using a "Neogen Brand" test kit instead of sending swabs to an outside lab source due to financial reasons. Since this year will be the first year we are audited by the new BRC version that concentrates more on allergen control is am concerned of unforeseen issues of proper documentation or validation in the eyes of the auditor. The Neogen test kit will produce either a "negative" or "positive" test result based on if the ppm of the certain allergen was detectable or not however the 3rd party lab would give a quantitative ppm result.  A validation study has been performed in which an allergen compound such as milk was diluted to a certain ppm ratio and swabbed with both Neogen swab and separate swab for 3rd party lab analysis by our sister company's lab (consider it in-house but accredited lab). My concerns are as follows:

 

1. Are there unforeseen questions about the possible variability with the validation study? example: proving the ppm dilution was conducted properly or one swab absorbing more allergen residue based on different type of study type.

 

2. Is a Pass/Fail (negative/positive) test result sufficient in the auditor's eyes? I understand that this could be based on the results from the Validation study

 

3. Is there a certain requirement to result reporting? currently the 3rd party lab creates the result report and I know according to that lab's protocol, they have a separate person perform test, separate person, double check interpretation of result, and different person either enter or approve final report. Is this a requirement?

 

4. Would a frequency or number of test points per swabbing program increase for in-house testing? current program states 1 CIP swab and 1 other random food contact area swab per allergen type per month.

 

I apologize for the long post but the decision was made within my company and I want to make sure we aren't missing any potential issues.


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#2 Anika

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Posted 12 April 2016 - 05:35 PM

My company makes many products of which some contain allergens and some do not. We have always performed a full wash-down between production runs with allergen verification swabs after an allergen containing production run to validate the cleanliness of random food contact areas.  It has recently been decided to start performing these allergen swabs using a "Neogen Brand" test kit instead of sending swabs to an outside lab source due to financial reasons. Since this year will be the first year we are audited by the new BRC version that concentrates more on allergen control is am concerned of unforeseen issues of proper documentation or validation in the eyes of the auditor. The Neogen test kit will produce either a "negative" or "positive" test result based on if the ppm of the certain allergen was detectable or not however the 3rd party lab would give a quantitative ppm result.  A validation study has been performed in which an allergen compound such as milk was diluted to a certain ppm ratio and swabbed with both Neogen swab and separate swab for 3rd party lab analysis by our sister company's lab (consider it in-house but accredited lab). My concerns are as follows:

 

1. Are there unforeseen questions about the possible variability with the validation study? example: proving the ppm dilution was conducted properly or one swab absorbing more allergen residue based on different type of study type. I don't believe so. We are a confectionary and have soy lecithin and whey as allergens in the facility and production line only though. Also training the person involved in making the solutions/testing ppm. Recording the training of course. proper allergen testing training as well.

 

2. Is a Pass/Fail (negative/positive) test result sufficient in the auditor's eyes? I understand that this could be based on the results from the Validation study. Yes. We perform in-house testing during changeovers and use neogen test kit too. Calibrating with the external lab a  certain freq. say annually or bi-annually is also a good idea.

 

3. Is there a certain requirement to result reporting? currently the 3rd party lab creates the result report and I know according to that lab's protocol, they have a separate person perform test, separate person, double check interpretation of result, and different person either enter or approve final report. Is this a requirement? IMO, one person can do the test and manager or supervisor can verify/review.

 

4. Would a frequency or number of test points per swabbing program increase for in-house testing? current program states 1 CIP swab and 1 other random food contact area swab per allergen type per month. It depends on your RISK ASSESSMENT. Since this is the first year going in lab I would suggest increase frequency and start doing a trend map going forward and adjust your RA accordingly.

 

I apologize for the long post but the decision was made within my company and I want to make sure we aren't missing any potential issues.


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#3 JPO

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Posted 12 April 2016 - 06:07 PM

 

My company makes many products of which some contain allergens and some do not. We have always performed a full wash-down between production runs with allergen verification swabs after an allergen containing production run to validate the cleanliness of random food contact areas.  It has recently been decided to start performing these allergen swabs using a "Neogen Brand" test kit instead of sending swabs to an outside lab source due to financial reasons. Since this year will be the first year we are audited by the new BRC version that concentrates more on allergen control is am concerned of unforeseen issues of proper documentation or validation in the eyes of the auditor. The Neogen test kit will produce either a "negative" or "positive" test result based on if the ppm of the certain allergen was detectable or not however the 3rd party lab would give a quantitative ppm result.  A validation study has been performed in which an allergen compound such as milk was diluted to a certain ppm ratio and swabbed with both Neogen swab and separate swab for 3rd party lab analysis by our sister company's lab (consider it in-house but accredited lab). My concerns are as follows:

 

1. Are there unforeseen questions about the possible variability with the validation study? example: proving the ppm dilution was conducted properly or one swab absorbing more allergen residue based on different type of study type. I don't believe so. We are a confectionary and have soy lecithin and whey as allergens in the facility and production line only though. Also training the person involved in making the solutions/testing ppm. Recording the training of course. proper allergen testing training as well.

 

2. Is a Pass/Fail (negative/positive) test result sufficient in the auditor's eyes? I understand that this could be based on the results from the Validation study. Yes. We perform in-house testing during changeovers and use neogen test kit too. Calibrating with the external lab a  certain freq. say annually or bi-annually is also a good idea.

 

3. Is there a certain requirement to result reporting? currently the 3rd party lab creates the result report and I know according to that lab's protocol, they have a separate person perform test, separate person, double check interpretation of result, and different person either enter or approve final report. Is this a requirement? IMO, one person can do the test and manager or supervisor can verify/review.

 

4. Would a frequency or number of test points per swabbing program increase for in-house testing? current program states 1 CIP swab and 1 other random food contact area swab per allergen type per month. It depends on your RISK ASSESSMENT. Since this is the first year going in lab I would suggest increase frequency and start doing a trend map going forward and adjust your RA accordingly.

 

I apologize for the long post but the decision was made within my company and I want to make sure we aren't missing any potential issues.

 

What Anika said, plus the following.

 

 

My BRC allergen cleaning verification plan involved pre-op swabbing EVERY TIME of food contact surfaces using Hygenia AllerSnap (another positive/negative color change test) along with ATP testing.  The owners of the company and a few major customers noted that they wanted evidence that the system was ready for use after every allergen run.  Previously, we had been doing something similar to your plan (periodic sampling of food contact sites, but not after every clean) and we were asked, "great, you have evidence that the equipment was adequately cleaned and allergen free prior to starting THAT run, but what about all the OTHER runs that month?? 

 

That got us on an "after every clean" schedule.

 

We wanted to have evidence of effective cleaning.  We swabbed some major food contact areas per line and because of our RISK ASSESSMENT, thought it was appropriate for the process.  In a system where there was a blender, an auger for transfer, a hopper, and a filler, we would swab all of those components once.  If they came back negative after incubation (think it was 10 minutes) we were good.  If they turned funny colors, reclean.

 

Document training of the employees who are doing the swabbing.  Have a site map.  Have a pre-planned corrective action plan for a "bad" test.

 

Every quarter, we did swabs and sent them to an outside lab to prove that our rapid test was valid.

 

Nobody has ever stated that our plan was not an adequate for the risk. 


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#4 GMO

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Posted 18 April 2016 - 01:22 PM

My company makes many products of which some contain allergens and some do not. We have always performed a full wash-down between production runs with allergen verification swabs after an allergen containing production run to validate the cleanliness of random food contact areas.  It has recently been decided to start performing these allergen swabs using a "Neogen Brand" test kit instead of sending swabs to an outside lab source due to financial reasons. Since this year will be the first year we are audited by the new BRC version that concentrates more on allergen control is am concerned of unforeseen issues of proper documentation or validation in the eyes of the auditor. The Neogen test kit will produce either a "negative" or "positive" test result based on if the ppm of the certain allergen was detectable or not however the 3rd party lab would give a quantitative ppm result.  A validation study has been performed in which an allergen compound such as milk was diluted to a certain ppm ratio and swabbed with both Neogen swab and separate swab for 3rd party lab analysis by our sister company's lab (consider it in-house but accredited lab). My concerns are as follows:

 

1. Are there unforeseen questions about the possible variability with the validation study? example: proving the ppm dilution was conducted properly or one swab absorbing more allergen residue based on different type of study type.

 

2. Is a Pass/Fail (negative/positive) test result sufficient in the auditor's eyes? I understand that this could be based on the results from the Validation study

 

3. Is there a certain requirement to result reporting? currently the 3rd party lab creates the result report and I know according to that lab's protocol, they have a separate person perform test, separate person, double check interpretation of result, and different person either enter or approve final report. Is this a requirement?

 

4. Would a frequency or number of test points per swabbing program increase for in-house testing? current program states 1 CIP swab and 1 other random food contact area swab per allergen type per month.

 

I apologize for the long post but the decision was made within my company and I want to make sure we aren't missing any potential issues.

 

I would say for BRC, this would probably be acceptable but perhaps some thought about the compliance vs. real food safety should be given.  These fast test kits are not tested using accredited test methods, it's also as you say, not quantitative.  I will put down what we do and what some other sites do and see what you think.

 

Once a year we test our allergen validation.   We take a sample of the worst case scenario product before the clean (containing maximum allergen) and swab (apart from sulphites where you can't swab) on the dirty surface in two key difficult to clean locations.

 

We then clean in the same way we always clean.  We swab three times in each of the same locations as the dirty swabs were taken.  We then take the first three products off the production run after the clean.

 

So in total for each validation you have four product samples and eight swabs to process.  The idea is the "dirty" swabs and pre samples validate the off site testing we do is effective at picking up the allergen in the first place and that the allergen is actually present in the product (not always the case).

 

Now we have a low risk site for allergen cross contamination but some sites where the risk is higher also then do these quick tests as a positive release. What do I think of this?  It has it's place, I wouldn't use it for every run personally but then I'm suspicious of ATP testing if I'm honest.  You have to remember that you are only swabbing where you can get access to and you might chose the wrong place, that's why in allergen validation actually sampling product is also important.  What the validation is there to do is that by following your normal cleaning procedures, you are effective at removing allergen residues.  If you think about it, that's what cleaning validation is meant to do for micro as well but then you have an additional step of testing micro of finished products and swabs as verification.  What I would say is that strictly speaking under HACCP validation only has to be done once so retesting yearly is kind of my verification but probably best practice is to use these rapid kits as an occasional verification exercise.

 

Do I think the quick tests are a substitute for the lab test?  If I'm honest, no.  I would rather see one test done well but you could always do a combination; e.g. use the quick test for your swabs and also test product before and after in a lab?

But for BRC?  There are 1000s of small manufacturers in the UK who have BRC and I would have to say I've seen allergen validation done badly in most sites far more times than I've seen it done well.  What you're proposing is a compromise but I think it would get you through BRC.  Customers?  Well they may ask for more...

 


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#5 GMO

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Posted 18 April 2016 - 01:26 PM

I forgot to say - the other way of verifying it is indirectly.  I.e. your target is visually clean.  You verify this with swabbing (conventional) and this is also an indicator that cleaning is ineffective whether that's for bacteria or allergens.


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#6 Charles.C

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Posted 18 April 2016 - 04:10 PM

Hi All,

 

I deduce this thread is mainly talking about BRC7 clause 5.3.8 which appears to have very few explicit  requirements as far as Va/Ve “Procedure” is concerned.

The OP’s Product/Process is unknown.

 

IMO “allergen control” is a complicated subject in every FS Standard.

Discussions of  the topic invariably/inadvertently  generate a lot of intra-mixing of the Va/Ve terminologies although these are (arguably) intended to have different meanings/chronologies. For example the second line of the OP.

 

I have attached below some documents previously posted here. May help to answer some of the general queries in the OP although some BRC-centric, auditorial  expectations for specific items will surely occur as is the case in every FS Standard .

 

Attached File  ag1 - SQFI Allergen-Guidance-Document.pdf   91.73KB   31 downloads

Attached File  ag2 - Step-by-Step procedure - Allergen Cleaning Validation-Verification.pdf   2.14MB   43 downloads

Attached File  ag3 - AIB - allergen cleaning validation.pdf   140.76KB   30 downloads

Attached File  ag4 - review of validation-verification of allergen-cleaning procedures.pdf   117.53KB   28 downloads

 


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Charles.C


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