Allergen validation - Can Neogen swabs be used in-house vs sending to 3rd party lab

Our allergen verification includes visual inspection, ATP, and observations.

 

Our validation includes a monthly Neogen allergen swabs of product contact surfaces after cleaning along with program review.

 

Thoughts on this, although room for growth - is this acceptable to meet the standard?   

Yes. Also, GMP policies, cross contamination prevention etc.

 

How do you do visual inspection for allergen?

You may find this link useful.
Although it is UK based (I am not sure where you are), there it is a really useful read.

https://www.food.gov...-and-discussion

It is important to consider the differences between validation and verification, of which the BRCGS Standard requires both.

What you have described this far are examples of verification. It is perfectly acceptable to undertake tests internally, such as visual inspection, protien swabs, ATP and specific allergen swabs. You could also undertake swabbing on a routine basis and send to lab for testing. You will also do things like internal audits. That is all verifying the systems you have introduced are effective.

Validation is something that generally you only do once (repeated for any significant changes) which proves it will be effective. Examples of this would be information from your cleaning chemical provider that the product has been validated to remove X allergen following Y method.
Another example would be conducting your own allergen tests which you may do after your first run - you map the process, identify highest risk points and swab those following clean to show the cleaning method you have used will be effective at removing the allergen you are considering.

The lateral flow tests for most allergens are around $25 a pop and pretty easy to do.

 

Neogen has been pretty unreliable for the supply of ELISA tests though if you need quantification.

Hi Craig, 

 

A few things you may wish to consider adding to your plan:

• Testing surfaces you know are unclean, to confirm that yes your rapid tests WILL pick up allergens if present. Some allergens are particularly hard to test for and if your tests are not able to pick them up, you’ll need to find alternative methods to demonstrate cleanliness. This would be a good part of a yearly validation step. 
• If parts of your production equipment are enclosed / unreachable with swabs, you could test rinsewater and/or the supposedly allergen-free product that is first off the line.
• If any of your suppliers’ policies and protocols are not to your needed standards, you maybe want to add ingredient testing to your list.