8 replies to this topic

[Alexxx]

Hi everyone,

Hope you are all doing great! I am currently in the process of validating our cleaning by swabbing for allergens, specifically eggs, since we produce vegan and non-vegan products. I am not quite sure how to proceed with the swab tests. From my understanding, this cleaning validation is done to ensure that the cleaning is properly done by our employees and that no egg residue is present on the working surfaces. This leads me to do my swabbing tests after the employees are done with the cleaning at the end of the day.

 

On the other hand, I've also been told that I should supervise the employees cleaning the surface before doing the swabbing to ensure that the cleaning is properly done. My only concern is that if I am there to supervise them, I will be incline to guide them if they are not following the cleaning procedures. If that happens, a result showing no allergen detected would not necessarily be accurate and representative of day-to-day cleaning (when I'm not there to watch them).

 

My question to you is: should I supervise the employee(s) doing the cleaning before I do cleaning validation swabbing tests (allergen or microbiological)?

[kconf]

Supervise when they are in training phase. 

I would not be watching them every time this activity occurs unless it's a procedural requirement. Trust your employees.

[MDaleDDF]

What swabs are you using?   In my mind allergen swabs isn't validation of cleaning, am I off?   Like protein swabs, ATP, something like that would be better, no?   

 

Perhaps that's what you're doing, but you said you're swabbing for eggs..... clarify?

[Alexxx]

What swabs are you using?   In my mind allergen swabs isn't validation of cleaning, am I off?   Like protein swabs, ATP, something like that would be better, no?   

 

Perhaps that's what you're doing, but you said you're swabbing for eggs..... clarify?

Sorry if I was not clear, but we do protein swabs that we send to an external lab.

[MDaleDDF]

Sorry if I was not clear, but we do protein swabs that we send to an external lab.

Man, you send protein swabs out to external?    How does that work?   Do you not run until you have results?   Or do you have to have product on a positive hold release plan?

 

I couldn't do this at my place, would take too long.   We use the hygenia protein swabs, they get you feedback in under 10 minutes....

[Alexxx]

Man, you send protein swabs out to external?    How does that work?   Do you not run until you have results?   Or do you have to have product on a positive hold release plan?

 

I couldn't do this at my place, would take too long.   We use the hygenia protein swabs, they get you feedback in under 10 minutes....

Oh, I never heard about Hygenia swabs before. I will most certainly give it a look! Thanks.

[MDaleDDF]

Oh, I never heard about Hygenia swabs before. I will most certainly give it a look! Thanks.

https://www.hygiena....sidue/pro-clean

Oh for sure, check these out.   Will make life easier and cheaper.....

[GMO]

The external lab testing using ELISA is more sensitive than rapid swabbing so as part of validation, that's the method you should use.

 

The method we established as best practice was as follows:

 

Test the product containing the allergen (this is to confirm the allergen can be recovered from the product matrix, that's not necessarily a "given").  Swab the dirty surface (again to check the allergen can be recovered with a swab).  Normally we chose 3-6 difficult to clean places on equipment, depending on how complex it is.

 

Then check the team follow the method as written.  Swab the surfaces again in triplicate and sample the first product made with the machine.

 

Repeat all three times over.  That is your validation unless your machinery changes or equipment changes.  Normally though we repeated it yearly because equipment surfaces can deteriorate.  The "dirty" and spiked samples are important for recovery but also to make sure you're testing for the right protein.  For eggs you will have different proteins in yolk and white for example.  Milk there are choices about what to test for as well which differ on if it's say milk or cheese.

 

This should be validation ie before the product is launched (even if the FDA allow it to be later, they're wrong).  If you're going back and doing it later, I can understand the concern of the delay in test results; then you have one of several options:

 

• Take the risk of the product being in market with pending allergen tests.
• Put the product on hold until test results are confirmed (you can get them in 24 hour turn around time but they cost a lot of money)
• Use rapid swabbing as suggested above to give you some level of comfort about putting the product on the market.

I would lean towards the second option.  Remember it's only the vegan product which would need to go on hold and potentially depending on your process, you could use a small batch for this.  An ideal time would be during the trial process as you're doing factory scale up.

 

There is a big but.

 

Here it is:

 

BUT

 

Rapid swabbing needs to be validated for the recovery from the matrix it's being found in.  Even then it's not as accurate as ELISA which is quantitative.

 

Elisa is absolutely a method for validation.  I would be tempted to use rapid swabbing if I was making a free from claim or an implied free from claim (like vegan, even though it doesn't mean free from, people think it does).  But only as a gross indicator and also as some due diligence.  It is absolutely not good enough for validation.  Some of these companies will quote ppm sensitivity but genuinely question them on "how much is it in my product" and I can tell you now, if they say they know they aren't telling you the truth.  

[Alexxx]

The external lab testing using ELISA is more sensitive than rapid swabbing so as part of validation, that's the method you should use.

 

The method we established as best practice was as follows:

 

Test the product containing the allergen (this is to confirm the allergen can be recovered from the product matrix, that's not necessarily a "given").  Swab the dirty surface (again to check the allergen can be recovered with a swab).  Normally we chose 3-6 difficult to clean places on equipment, depending on how complex it is.

 

Then check the team follow the method as written.  Swab the surfaces again in triplicate and sample the first product made with the machine.

 

Repeat all three times over.  That is your validation unless your machinery changes or equipment changes.  Normally though we repeated it yearly because equipment surfaces can deteriorate.  The "dirty" and spiked samples are important for recovery but also to make sure you're testing for the right protein.  For eggs you will have different proteins in yolk and white for example.  Milk there are choices about what to test for as well which differ on if it's say milk or cheese.

 

This should be validation ie before the product is launched (even if the FDA allow it to be later, they're wrong).  If you're going back and doing it later, I can understand the concern of the delay in test results; then you have one of several options:

 

• Take the risk of the product being in market with pending allergen tests.
• Put the product on hold until test results are confirmed (you can get them in 24 hour turn around time but they cost a lot of money)
• Use rapid swabbing as suggested above to give you some level of comfort about putting the product on the market.

I would lean towards the second option.  Remember it's only the vegan product which would need to go on hold and potentially depending on your process, you could use a small batch for this.  An ideal time would be during the trial process as you're doing factory scale up.

 

There is a big but.

 

Here it is:

 

BUT

 

Rapid swabbing needs to be validated for the recovery from the matrix it's being found in.  Even then it's not as accurate as ELISA which is quantitative.

 

Elisa is absolutely a method for validation.  I would be tempted to use rapid swabbing if I was making a free from claim or an implied free from claim (like vegan, even though it doesn't mean free from, people think it does).  But only as a gross indicator and also as some due diligence.  It is absolutely not good enough for validation.  Some of these companies will quote ppm sensitivity but genuinely question them on "how much is it in my product" and I can tell you now, if they say they know they aren't telling you the truth.  

Thank you for your comprehensive response! Gave me much more clarity on this matter.