Allergen Validation Documentation
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?
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.
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
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?
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 –
VAL1 - Allergen Cleaning Validation, step-by-step.pdf 2.14MB 764 downloads
(typo in first line section D)
Val2 - allergen cleaning validation strategies.pdf 117.53KB 547 downloads
(especially pg 454 et seq.)
Val3 - allergen cleaning validation, extract.pdf 518.44KB 559 downloads
Val4 - SQF Allergen-Cleaning validation.pdf 91.73KB 609 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
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 –
VAL1 - Allergen Cleaning Validation, step-by-step.pdf (typo in first line section D)
Val2 - allergen cleaning validation strategies.pdf (especially pg 454 et seq.)
Val3 - allergen cleaning validation, extract.pdf
Val4 - 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.
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
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
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