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#1 SPL

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Posted 28 July 2014 - 03:59 PM

I have a simple word document listing target allergen, equipment to be clean, reference cleaning SOP and validation method (aka test kit) , results  comments.

 

What should I be putting in my letter of Annual Allergen Validation? 



#2 fgjuadi

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Posted 28 July 2014 - 07:04 PM

As long as you have in the results your positive and negative controls, and include in the comments section that the clean has effectively removed all of the allergens, I think you have it covered.  I would also put in dates & what was run on the lines. 

 

7/28/14 - Line 5 - Product X (contains allergen) to Product Y (no allergen)

Product X -  >20 ppm

Surface post clean  - Not Detected

 

While I did run AOAC method to do my allergen testing initially in house, once I was sure the clean outs were effective, I sent samples to a 3rd party lab which was accredited for allergen testing.

AFAIK, Allergen validation only have to be completed once (with new equipment or a new allergen cleaning procedure) - not annually, but perhaps your system is set up differently.  Becuase we only had to complete once, the cost of sending to an accredited lab was justified.


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#3 Charles.C

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Posted 30 July 2014 - 05:29 AM

I have a simple word document listing target allergen, equipment to be clean, reference cleaning SOP and validation method (aka test kit) , results  comments.

 

What should I be putting in my letter of Annual Allergen Validation? 

 

Very cryptic.

 

Letter to whom ?

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#4 SPL

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Posted 30 July 2014 - 12:17 PM

Charles,

 

Haha, just my cautious side due to nondisclosure sensitivities. Usually I write a letter to my own company detailing Allergen Validation using commercial kits, what method the kits employ. I include date, times, production line and product/allergen involve. I state in the letter the results of positive ( pre-rinse test), the results of the test/cleaning.  Is there any other information I should add?  



#5 Charles.C

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Posted 30 July 2014 - 02:25 PM

Charles,

 

Haha, just my cautious side due to nondisclosure sensitivities. Usually I write a letter to my own company detailing Allergen Validation using commercial kits, what method the kits employ. I include date, times, production line and product/allergen involve. I state in the letter the results of positive ( pre-rinse test), the results of the test/cleaning.  Is there any other information I should add?  

 

Dear SPL,

 

Thks for clarification. Very cathartic I’m sure. :smile:

 

Slightly difficult to comment much in the absence of  method details. I deduce yr “validation”  is related to the cleaning sufficiency  rather than the analytical component. And is based on a “rinse” study.

 

I selected five  arbitrary documents which seem to me to give a rather comprehensive coverage of the cleaning  aspect  –

Attached File  VAL1 - Allergen Cleaning Validation, step-by-step.pdf   2.14MB   571 downloads

(typo in first line section D)

Attached File  Val2 - allergen cleaning validation strategies.pdf   117.53KB   407 downloads

(especially pg 454 et seq.)

Attached File  Val3 - allergen cleaning validation, extract.pdf   518.44KB   408 downloads

Attached File  Val4 - SQF Allergen-Cleaning validation.pdf   91.73KB   435 downloads

 

http://www.foodsafet...clean-standard/

 

Based on comparing the contents of above to your posted  “precis”, at least 4 items may be contenders to be added to yr “letter” –

 

(1) additional swab-type evaluations.

(2) du/tri-plications in sampling.

(3) verification which is a necessary part of the “combo”.

(4) Quantitative aspects.

 

Of course (1-4)  may have already been accounted for in yr full treatment or their applicability limited by yr actual process"X
.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


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#6 SPL

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Posted 31 July 2014 - 12:26 PM

Dear SPL,

 

Thks for clarification. Very cathartic I’m sure. :smile:

 

Slightly difficult to comment much in the absence of  method details. I deduce yr “validation”  is related to the cleaning sufficiency  rather than the analytical component. And is based on a “rinse” study.

 

I selected five  arbitrary documents which seem to me to give a rather comprehensive coverage of the cleaning  aspect  –

attachicon.gifVAL1 - Allergen Cleaning Validation, step-by-step.pdf

(typo in first line section D)

attachicon.gifVal2 - allergen cleaning validation strategies.pdf

(especially pg 454 et seq.)

attachicon.gifVal3 - allergen cleaning validation, extract.pdf

attachicon.gifVal4 - SQF Allergen-Cleaning validation.pdf

 

http://www.foodsafet...clean-standard/

 

Based on comparing the contents of above to your posted  “precis”, at least 4 items may be contenders to be added to yr “letter” –

 

(1) additional swab-type evaluations.

(2) du/tri-plications in sampling.

(3) verification which is a necessary part of the “combo”.

(4) Quantitative aspects.

 

Of course (1-4)  may have already been accounted for in yr full treatment or their applicability limited by yr actual process"X
.

 

Rgds / Charles.C

Charles,

 

Thanks you for the info.

Sorry again, too focus driven. I meant to title this allergen cleaning validation. When I get focus driven and I forget to mention certain details.  I haven't had my letters of allergen cleaning validation questioned by our past two SQF auditors. I wanted to make I had enough information but not too much. I am confident with our cleaning validation methods, with working directly with the manufacturer.



#7 Charles.C

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Posted 31 July 2014 - 02:06 PM

Dear SPL,

 

Well, in view of the "SQF" the attachment Val 4 would appear adequate to test sufficiency. The exact implementation depends on the processX of course.

 

My comments (1-4) et seq would appear to remain valid. Hopefully already addressed. :smile:

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#8 cazyncymru

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Posted 31 July 2014 - 03:06 PM

HI SPL

 

I have a Technical Audit Report, which is probably the same as your letter!

 

In it, I outline which allergens we handle on site, which products contains which allergen, which test methods I'm going to use (rapid, PCR etc) and what I'm going to test (before & after cleaning)

I also send away samples of product with the known allergen in, and the first product after an allergen clean. I have done this for each allergen.

 

 

Hope this helps

 

Caz x



#9 foodsafetyAUS

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Posted 16 June 2019 - 01:13 PM

Hi all,

If the allergen that need to be validated is a sachet e.g. a pine nut sachet. Can we contaminate the required surfaces with pine nuts and swab the area. Conduct the cleaning and swab the area. Please advise. Thanks 






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