16 replies to this topic

[ati]

Hi all,

i'm confused, for cleaning and sanitation in process room. Do we need to have 2 swab test- allergen and sanitation?


Need help...

TQ

[Charles.C]

Hi all,

i'm confused, for cleaning and sanitation in process room. Do we need to have 2 swab test- allergen and sanitation?


Need help...

TQ

Dear ati,

The swab test mentioned is typically related to a regulatory and/or validation / verification procedure. In this case I daresay for different (although inter-related) objectives. Hence 2.

Further comment probably requires more info.

eg product / process / specific situation ??

Rgds / Charles.C

[gofoodtech]

Hi..I think this is my first time post in this forum.

Just wanna to share about the swab test and sanitation. Currently in our plant, we use same swab test to validate sanitation and allergen cleaning.

Our justification is based on protein detection. Consider the sanitation mainly to eliminate microbial or in dept as a protein. Allergen also types of protein thus the swab test use able to give positive result if the cleaning and sanitation not properly done.

Simple understanding..if protein absent (microbe or allergen)..the result positive..if the result negative it shows the cleaning & sanitation meets the purpose including the allergen.. It just that the result cannot clearly differentiate between microbial issue or allergen issue.

I do not know this kind of understanding right or wrong. Do correct me if I am wrong..

Sorry for bad English..just ignore it..Thanks.

Dear ati,

The swab test mentioned is typically related to a regulatory and/or validation / verification procedure. In this case I daresay for different (although inter-related) objectives. Hence 2.

Further comment probably requires more info.

eg product / process / specific situation ??

Rgds / Charles.C

[cazyncymru]

We use both

We use 3M Clean trace for checking hygiene and we also use 3M Clean Trace Surface Protein Plus to check for allergens.

WE also use Neogen 3D swabs to check for adequate cleaning for allergens.

The retailers prefer that we have the seperate tests.

Caz x

[Charles.C]

Hi..I think this is my first time post in this forum.

Just wanna to share about the swab test and sanitation. Currently in our plant, we use same swab test to validate sanitation and allergen cleaning.

Our justification is based on protein detection. Consider the sanitation mainly to eliminate microbial or in dept as a protein. Allergen also types of protein thus the swab test use able to give positive result if the cleaning and sanitation not properly done.

Simple understanding..if protein absent (microbe or allergen)..the result positive..if the result negative it shows the cleaning & sanitation meets the purpose including the allergen.. It just that the result cannot clearly differentiate between microbial issue or allergen issue.

I do not know this kind of understanding right or wrong. Do correct me if I am wrong..

Sorry for bad English..just ignore it..Thanks.

Dear mufar (@ati),

Welcome to the forum !

If you try a little searching on the forum for "allergen" you will find that this whole issue can be a very complex topic / requirement depending on a variety of factors, eg geographical / local regulation, relevant standard being addressed (if any), specific auditor (sometimes ), product ,process (>> possible variable criticality), etc.
For example, -

http://www.ifsqn.com...dpost__p__54469

http://www.ifsqn.com...dpost__p__55485

Regret i am not familiar with Malaysian local regulations, if any. A quick answer to yr query might be that yr procedure is not necessarily wrong but some authorities / customers evaluations may consider it insufficient (eg previous post).

For some more discussion of requirements, maybe see this thread and the link-URL in post #8 - http://www.ifsqn.com...dpost__p__52835
( >> Very nice website IMO).

Rgds / Charles.C

[gofoodtech]

Thanks Charles.C for the link included. Very helpful.

Dear mufar (@ati),

Welcome to the forum !

If you try a little searching on the forum for "allergen" you will find that this whole issue can be a very complex topic / requirement depending on a variety of factors, eg geographical / local regulation, relevant standard being addressed (if any), specific auditor (sometimes ), product ,process (>> possible variable criticality), etc.
For example, -

http://www.ifsqn.com...dpost__p__54469

http://www.ifsqn.com...dpost__p__55485

Regret i am not familiar with Malaysian local regulations, if any. A quick answer to yr query might be that yr procedure is not necessarily wrong but some authorities / customers evaluations may consider it insufficient (eg previous post).

For some more discussion of requirements, maybe see this thread and the link-URL in post #8 - http://www.ifsqn.com...dpost__p__52835
( >> Very nice website IMO).

Rgds / Charles.C

[Harminnie]

Just an FYI- this was a very lively and lengthy dsicussion with our BRC auditor at our April audit. We use a similar protein swab check for sanitation, but I received a major-turned-minor for using the same type swabs to validate allergens-peanut protein sepcifially. It was changed to a minor because BRC did not specifically state you had to use an allergen- specific test/swab, and we were checking for protien with the sanitation swabs. The new BRC interpretation is that you have to test with an allergen-specific test/swab---so if you're testing to validate the lack of a specifiec allergen then you need to use an allergen specific swab if there is one available. We now use a swab for environmental and a peanut specific allergen swab for checking peanut residue outside the peanut room. At the time I didn't know that there was a peanut swab. Hope this makes sense for you and is helpful!

[RMAV]

Just an FYI- this was a very lively and lengthy dsicussion with our BRC auditor at our April audit. We use a similar protein swab check for sanitation, but I received a major-turned-minor for using the same type swabs to validate allergens-peanut protein sepcifially. It was changed to a minor because BRC did not specifically state you had to use an allergen- specific test/swab, and we were checking for protien with the sanitation swabs. The new BRC interpretation is that you have to test with an allergen-specific test/swab---so if you're testing to validate the lack of a specifiec allergen then you need to use an allergen specific swab if there is one available. We now use a swab for environmental and a peanut specific allergen swab for checking peanut residue outside the peanut room. At the time I didn't know that there was a peanut swab. Hope this makes sense for you and is helpful!

Why must the swab be allergen-specific? Protein is protein, right? If your protein swab is positive, you re-clean as if the allergen is present?

[Lexter Cruz]

Dear Ati,

Would like to share our current practice, like you we also did the swabstest for cleaning validation. We use sterilized cotton weighing approximately25g. 2 cotton inside one plastic sample in one application. This means bothcotton are inside the one plastic sample then we do swabbingon strategic area wherein e.g. cleaning is not carried properly andor in the area were hardening and or deposits of powder are visible.

The objective of this validation is to verify the effectiveness of cleaningby micro analysis (Salmonella) and allergen (specific allergen content of lastproduct produce).

But again the effectiveness whether it is 2 or 1 swab test is depend onyour establish and implemented procedure re lifting of swabs and what kind ofmaterial/s you are using during swabbing.

I do not know this kind ofunderstanding right or wrong. Do correct me if I am wrong...but this isour current practice...we are open for more precise procedure in conductingswabs.



Open for moreinformation...hoping to receive suggestions from our team.




Best regards,

Factory Hygienist

[Harminnie]

Why must the swab be allergen-specific? Protein is protein, right? If your protein swab is positive, you re-clean as if the allergen is present?

That was my argument exactly, but it all has to do with BRC Issue 6 Clause 5.2.8 ( page 58 in my Standard book ) I don't know what other GFSI governing bodies Standards state. If you are BRC-just do it and save yourself alot of headache and any possibility of a non-conformity. The allergen-specific swab is what we use to validate our cleaning and sanitation program. We still use the generic protein swabs for environmental. We've done side-be-side tests with both swabs and they always come up the same-negative, but the alergen specific are just that-sensitive and specific for that allergen, be it peanuts or dairy,etc. Good Luck!

[Charles.C]

Dear All,

Regarding previous recent posts, I think the trend to require more "depth" than ATP methods is due to increasingly strict interpretations of "validation", notably with respect to specificity and perhaps combined with sensitivity considerations also.

Assuming allergenic factors are a potential issue, "validation of a cleaning regime ideally entails generating data to show that the cleaning process is effective in removing allergens to a pre-defined acceptable level" (see extract from 2009 document foll.). Accordingly, "to use ATP as a marker for allergens, data showing a correlation between ATP and allergen residue level is then required. In practice it may well be easier to use a targetted allergen test directly."
 vv1 - validation cleaning and cross-contact 2009.png   2.87MB   46 downloads
(esp see pgs 139 and 145 et seq)

AIB (2011) offer a (very) detailed presentation of their own expectations (the underline is mine) -.

TESTING
There are two approaches to testing. One is to test the cleaned surface, and the other is to test the product that is produced after the surface has been cleaned. Both testing methods have limitations, primarily from the nature of sampling. By conducting both types of testing, most variables are addressed. Test kits may be purchased and used onsite, or samples may be taken and sent to an outside laboratory such as AIB or FARRP. For validating allergen change-over cleaning, allergen specific testing is necessary, where available. Other types of post-cleaning validation tests such as general protein residual or ATP tests will not provide the specific information that is needed to demonstrate that allergenic protein has been removed. If you are validating removal of an allergenic protein for which there has not yet been a test developed, you will need to rely on results from similar allergens that you run on the line in combination with visual examination and/or ATP results.
The chart provided here is an overview of the combinations you may have. Detailed written cleaning procedures must also be established beyond the information provided in this table ........

 vv2 - allergen cleaning validation AIB.pdf   140.76KB   208 downloads

Another operational (peanut) example (2012) I noticed contains this comment –

Choosing Methods
In most cases, companies should use a quantitative ELISA method to validate sanitation that is specific for the allergen to be measured. For example, if the facility is validating the absence of peanuts, it should use a quantitative peanut ELISA kit versus a total protein or an ATP swab due to the increased specificity and sensitivity of the quantitative peanut ELISA kit.

 vv3 - Allergen validation, Food Safety Magazine 2012.pdf   173.08KB   145 downloads

(Specificity yes undoubtedly, however some ATP systems do claim to match ELISA methods in sensitivity, eg  vv4 - Ensure Allergen Control.pdf   170.32KB   80 downloads
 vv5 - Sensitive ATP system.pdf   502.87KB   142 downloads

Various systems– Visual, ATP, Total Protein, ELISA, DNA are compared regarding cost, speed, food matrix, effectiveness etc in this USFDA document (2010). Predictably, the conclusion is not unique.
 vv6 - detection food allergens FDA, 2010.pdf   1.31MB   148 downloads

Rgds / Charles.C

[SpiceGenius]

Hello all,

We have had similar confusing issues at our plant.
After lengthy discussions and research it was understood that the protein swab is an indicator of cleanliness (key word here is "indicator"). So whatever method you use, there has to be a threshold where the equipment is considered clean (a.k.a. free of allergens). Then that threshold needs to be validated with a proper allergen method. We used 3M allergen swabs to do the screening of our swabbing method and then once we had settled on the threshold, we swabbed with Neogen swabs and sent it for allergen detection testing at an outside lab.
The validation needs to be done yearly to be accepted by the GFSI auditor (in our case SQF).

Hope this helps,

[RMAV]

Hello all,

We have had similar confusing issues at our plant.
After lengthy discussions and research it was understood that the protein swab is an indicator of cleanliness (key word here is "indicator"). So whatever method you use, there has to be a threshold where the equipment is considered clean (a.k.a. free of allergens). Then that threshold needs to be validated with a proper allergen method. We used 3M allergen swabs to do the screening of our swabbing method and then once we had settled on the threshold, we swabbed with Neogen swabs and sent it for allergen detection testing at an outside lab.
The validation needs to be done yearly to be accepted by the GFSI auditor (in our case SQF).

Hope this helps,

This is the best reasoning I could come up with as to why you would do specific allergen testing as opposed to only protein (a la 3M CleanTrace). It appears to me the assumption by BRC and some of the documents set forth earlier in this thread is that you may have an acceptable level in a generic protein swab that is not an acceptable level of allergen present. However, if you use a sensitive protein test and indicate acceptable limit is no proteins detected, I would think this would suffice. In fact, in a previous position I held, this is what we did. If we had a non-allergen product running on the same line and after an allergen product, we did a specified cleaning for the purpose of removing the allergens. Along with organoleptic inspection, we did protein swabs and if any were detected, it was assumed an allergen and recleaned.

Our facility ran 8 or 9 allergens and it was not practical to test for each specific allergen - if that is even possible for our facility. Unless I am missing something, this seemed to be a better system than trying to detect a specific allergen while a previous run and inspection may have missed one of the other 8 allergens we had. But please note, I am not an expert.

An interesting note in the Sciegiene document linked above, "Cleaning is a required preventative procedure for all food processors and is a CCP for allergen control." Who here has cleaning as a CCP and what does the auditor think about that?

[Marshenko]

Why must the swab be allergen-specific? Protein is protein, right? If your protein swab is positive, you re-clean as if the allergen is present?

I am curious about this as well. We have two allergens of concern (wheat and soy) ... but they are always together in their use within the facility, as they are present in the soy sauce and soy sauce-containing marinades that we use. I can't see any reason why I would need to further verify which specific allergen may be present when doing allergen swabs.

[Charles.C]

Dear RMAV,

Operationally speaking, if one wishes to extrapolate an ATP result towards allergenic aspects it seems that some standards / auditors now expect to see some actual validation data . Or the option is simply refused. (eg AIB quote, post #4).

Quoting from 1st attachment in post #4 – “The variation of ATP levels in different food residues suggests that using the presence of ATP as a marker for the presence of allergen residues following cleaning may be suitable in some situations and not others” (pg 146). In fact “absence” could also have been substituted for “presence” in this statement in view of the possibility of both false positives and false negatives as further discussed in same attachment (eg pg 147). Hence presumably the interest in Validation.

However I daresay some authorities / auditors may well accept yr intuitive (ATP) logic as suitable for allergenic conclusions – “However, if you use a sensitive protein test and indicate acceptable limit is no proteins detected, I would think this would suffice.” Certainly, ca 2006, the UK/FSA were apparently using “a visually and physically clean” standard for assessing the risk of allergen contamination ( see 1st attach., pg 140) although some of the ATP / ELISA etc products now in common use were possibly unavailable at that time?). Or financially unrealistic for routine use ? (I recall another thread suggested they still are in many cases [eg 8 or 9?? ] ). Not sure as to FSA's current viewpoint ?

Rgds / Charles.C

[RMAV]

Dear RMAV,

Operationally speaking, if one wishes to extrapolate an ATP result towards allergenic aspects it seems that some standards / auditors now expect to see some actual validation data . Or the option is simply refused. (eg AIB quote, post #4).

Quoting from 1st attachment in post #4 – “The variation of ATP levels in different food residues suggests that using the presence of ATP as a marker for the presence of allergen residues following cleaning may be suitable in some situations and not others” (pg 146). In fact “absence” could also have been substituted for “presence” in this statement in view of the possibility of both false positives and false negatives as further discussed in same attachment (eg pg 147). Hence presumably the interest in Validation.

However I daresay some authorities / auditors may well accept yr intuitive (ATP) logic as suitable for allergenic conclusions – “However, if you use a sensitive protein test and indicate acceptable limit is no proteins detected, I would think this would suffice.” Certainly, ca 2006, the UK/FSA were apparently using “a visually and physically clean” standard for assessing the risk of allergen contamination ( see 1st attach., pg 140) although some of the ATP / ELISA etc products now in common use were possibly unavailable at that time?). Or financially unrealistic for routine use ? (I recall another thread suggested they still are in many cases [eg 8 or 9?? ] ). Not sure as to FSA's current viewpoint ?

Rgds / Charles.C

I apologize, I was not clear. We used 3M's CleanTrace Surface Protein (formerly Biotrace's Aller-tect), not the ATP. I personally would not trust ATP testing as some extension of controlling allergens, but I am no expert. My limited experience with rapid ATP tests has led me not to trust it. For history sake, I found a brochure for the Aller-tect surface protein swab dated 2006 so they have been around at least since that time.

By the way, Charles C., thanks for your responses. I continue to learn much from you.

[Charles.C]

Dear RMAV,

Thks for the kind words and sorry for my misinterpretation. I should hasten to add that I also am no expert on allergen evaluation, far from it.

For an idea of the general situation, I hv constructed the table below from combining parts of pages within the vv6 file of my earlier post, plus adding a heading (A). A lot more detail, especially relating to pros and cons, is in the original attachment. Attachment vv7 below also amplifies many of the comments in vv6.

I think the Clean Trace method you refer is included within category B1. I agree it is surely more meaningful in the present context than ATP (eg the text bottom pg 147 in 1st attachment post #4) but also see the comments in attachment vv7, pg 30) .....
Added later - However i did notice that although the potential detection limit of ELISA is invariably assessed significantly below Total Protein,in some circumstances the latter can exhibit a better performance than ELISA. For example see the data in this reference -
 FDA 2007 Comparison ELISA, visual, sensitive ATP, total protein to detect presence allergenic food residues- EX-0170.pdf   95.11KB   106 downloads

Allergen Detection “Toolbox”

(A) (“Relatively” Specific)
Immunochemical methods
(1) ELISA - Antibody-based detection of allergenic protein or other protein in food
Kits available for most of the 8 major allergens
(2) Lateral flow devices (dipsticks)
(3) Multiplex

DNA-based methods -
(1) PCR - Detects DNA sequences indicative of allergenic species
Kits available for milk, peanut, soy, walnut, hazelnut, fish, crustaceans
(2) Multiplex

Mass spectrometry - Detects proteins and peptides
Absolute identification and quantification of allergens
Not useful for routine analyses

(B) - Non-specific Methods

(1 )Total Protein - Measures protein (all proteins, not only from allergenic food)
(2) ATP - Detects ATP from biological sources.
(2a) Conventional ATP swabs – hygiene
(2b) Sensitive ATP swabs – detect presence of food soils.
(3) Visual inspection - Most common method for validating/verifying cleaning procedures (?!)
(4) Other methods.

All the methods have some limitations IMO, be it, cost, speed, sensitivity, specificity, etc. It is necessary to clearly define your target objective / scope, eg attachment vv9 below.

These additional, fairly up-to-date documents / link seemed of some interest –

 vv7 - global perspective food allergens 2011.pdf   1.07MB   87 downloads
 vv8 - control, validation review to prevent allergen xcontam. in food process 2008.pdf   117.53KB   113 downloads
 vv9 - rapid methods for allergen control 2012.pdf   138.08KB   112 downloads
 vv10 - Allergen Handbook Feb08.pdf   573.86KB   110 downloads
(just noticed there is a later ed.of vv10 in middle thread linked below, courtesy shea quay )

http://www.holchem.c...en-testing.aspx

These earlier threads/posts are also relevant to original query -

http://www.ifsqn.com...dpost__p__47262

http://www.ifsqn.com...dpost__p__52783

http://www.ifsqn.com...dpost__p__54163

Rgds / Charles.C