Validation of cleaning process
Hello.
I wonder if you can help?
A non conformance to work on from our 1st ever BRC audit this month was to "Validate" our allergen cleaning methods in our packing rooms. We have 28days to close out.
How is the best way to deal with this?
We have done environmental swabbing through a market leading company but the lead times are horrendous and time is against us.
How is the best to do this? Can anyone purchase a APT machine and swabs and do in-house? Is training needed to do this and validate with certificate?
Open to suggestions and how do I best present the information in future? Risk assessment / swabbing schedule.
Is there a template anyone can share?
Thanks for your time. Lots of questions, sorry!
Hi, welcome to the forum. We're using ATP to swab surfaces after cleaning to ensure there's no dairy proteins leftovers. We do it prior to non-dairy production. Also, once a month I send our non-dairy samples to the accredited lab for allergen milk testing - as a validation of our practices.
I don't think you need a training to use ATP machine and do swabbing.
If i were in your position, I would call 3M (sorry for the company post) They can offer support to find the right solution, and in the case of the ATP swabbing/machine/trending, all the training you need is included in the price AND they will do the initial swab location set up for/with you
BUT that only detects "protein" , and IS NOT sufficient for allergen cleaning validation ATP is only a relative measure of how clean an area is and means nothing on it's own
You need to purchase allergen specific swabs ll(egg/milk/mustard) which ever applies, and then perform a swab a thon of your own post cleaning (PRIOR TO SANITIZING) repeatedly to VALIDATE that your cleaning procedure works for your allergens in your facility
ATP is a good way to validate clenaing in general. It is less valuable for allergen cleaning. A high result would most likely mean that you cleaning was not effective. However, a low result might not mean all protein has been removed.
Alergen specifdc swabs and tesing is a better way to validate cleaning after a allergen
Another way to validate cleaning after a allergen run is to test product after a allergen clean for protein(s) in question.
Hello.
I wonder if you can help?
A non conformance to work on from our 1st ever BRC audit this month was to "Validate" our allergen cleaning methods in our packing rooms. We have 28days to close out.
How is the best way to deal with this?
We have done environmental swabbing through a market leading company but the lead times are horrendous and time is against us.
How is the best to do this? Can anyone purchase a APT machine and swabs and do in-house? Is training needed to do this and validate with certificate?
Open to suggestions and how do I best present the information in future? Risk assessment / swabbing schedule.
Is there a template anyone can share?
Thanks for your time. Lots of questions, sorry!
Hi 3 caz,
More details of the Product/Process might have helped.
Have a look at the, IMO, impressive SQF analysis of the situation (should be equally applicable to BRC) -
https://www.ifsqn.co...nt/#entry175561
(Also see comments in the following Post to the one linked above [Post 7])
Thank you all for your reply.
A mixed bag of responses to take on board.
To give a better back ground, which I realise I should of done prior, We're dealing with dry foods of pre-manufactured vitamins and minerals on counting machines. Theres no mixing involved or fresh / meat etc. All dry food.
In your experiences, can you recommed a device to purchase? I release the Allergen swabs is what we need to validate our cleaning process.
I'm unsure of the protein? Does this is apply to dry foods in my case?
Thank you all for your reply.
A mixed bag of responses to take on board.
To give a better back ground, which I realise I should of done prior, We're dealing with dry foods of pre-manufactured vitamins and minerals on counting machines. Theres no mixing involved or fresh / meat etc. All dry food.
In your experiences, can you recommed a device to purchase? I release the Allergen swabs is what we need to validate our cleaning process.
I'm unsure of the protein? Does this is apply to dry foods in my case?
Hi 3caz,
afaik, this illustrates some potential technical limitations associated with total protein tests and certain other methods -
6.7 Rapid tests used on site (Optional test)
There are several testing methods for allergens that could be used on site that do not involve the use of an
external laboratory. These include:
1. Rapid Lateral Flow Devices (RLFD) (e.g. Neogen Reveal, Romer Agrastrip or R-Biopharm)
2. Qualitative ELISA Tests (e.g. Neogen Alert).
3. Non-specific total protein tests (Should be only considered if neither of the above tests are available)
These three tests can only be used as an optional, additional test, after a clean, to demonstrate that the
cleaning has been effective. They do not replace the quantitative ELISA swabs and finished product
tests. The preferred method is RLFD as they do not require an internal QC testing lab. They must be validated
prior to use.
8.Rapid Testing Validation
Before being used, all rapid tests must be validated. These tests are simple and cannot replicate the
performance of the quantitative ELISA tests. Different rapid testing kits will have different sensitivities and
may not detect the allergen of concern at the same sensitivity on surfaces that have been in contact with
different matrices (e.g. A milk rapid test may detect milk well in liquid milk, but not very well in cheese or
yogurt). Therefore, it is critical that ALL rapid tests are validated prior to use.
This validation of a rapid test (RLFD, qualitative ELISA or non-specific protein test) involves two steps:
1. Selectivity – The rapid test must be validated to demonstrate that it can detect the allergen in the
form it is present in the sample type that is produced prior to the clean.
2. Sensitivity – The rapid test must be validated to demonstrate at what level the qualitative test
changes from a positive result to a negative result. This will provide an estimate of how sensitive the
rapid test is. Ideally, this should be close to the sensitivity of the quantitative ELISA used for the food
contact surface swab testing.
This validation should ideally be conducted by the manufacturer that produces the rapid test. This is the most
appropriate option as the manufacturer is the expert on their test kit. Most manufacturers of rapid tests
recommend this validation and will offer this service.
The next option is to ask the approved laboratory that is conducting the quantitative ELISA testing to validate
a rapid test. This validation can be conducted alongside the ELISA testing. This is a service that approved
labs may offer. The site will have to provide the sample and an estimate of the amount of allergen protein in
it (this could be through the specification).
Guidance for Allergen Management and Testing.pdf 564.75KB 113 downloads
However, for Cleaning Validation, SQF apparently do (directly) accept methods 1,2 in para 6.7 but not 3. BRC have not checked.
One basic objection to total protein is that it's "non-specific" although one can still find detailed proposals for its usage in certain situations, eg -
Allergen-Screening_2022.pdf 261.39KB 99 downloads
PS - this link is quite readable although it seemingly makes no mention of qualitative vs quantitative aspects -
Hi 3caz,
afaik, this illustrates some potential technical limitations associated with total protein tests and certain other methods -
Guidance for Allergen Management and Testing.pdf
However, for Cleaning Validation, SQF apparently do (directly) accept methods 1,2 in para 6.7 but not 3. BRC have not checked.
One basic objection to total protein is that it's "non-specific" although one can still find detailed proposals for its usage in certain situations, eg -
PS - this link is quite readable although it seemingly makes no mention of qualitative vs quantitative aspects -
Hi 3caz,
Re ^^^^(blue)
BRC's Interp. Guidelines has a comment -
Rapid tests, ATP and lateral flow devices are good for verification activities but are not suitable for validation.
Appears to rule out use of the on-site rapid tests in 6.7/Post 7 although the Guidelines are technically regarded as non- auditable material.
Would be interesting to get some feedback from BRC users as to their chosen methodology (assuming the latter was found auditorially acceptable).
PS - this post has a maybe useful summary of the allergen situation -