4 replies to this topic

[ddaniels316]

I work in a facility that is predominately dry and RTE products.  We have all the FDA big 8 (soon 9) allergens so although we try to minimize it, we do have to do wet cleans when the allergen matrix dictates it. 

 

In the past, we had a third party sanitation company perform cleaning services over the weekend as we seldom ever run during the weekends.   During this clean, the facility was returned to "zero".  because all equipment and floors were cleaned.  After a rough patch with this company, the service is no longer going to continue.  This has me rethinking the need to reset the entire facility to clean at the same time as we are limited by crew and production hours to either clean on weekends, or cut Friday schedules to preform cleaning.  

 

Some questions I am trying to find any regulatory or industry answers to include the following:

 

1) If a line contained a powdered product like a Jello type mix, but the machinery can be sealed or covered with plastic, can the line stay dormant over the weekend and cleaned only when switching to a new product type or allergenically forced to do so.  Is there a need to clean Friday and then start up on the same product Monday.  What is that day of clean is a Wednesday or Thursday?   I want to say based on risk assessment, if there is nothing really sitting exposed to the environment, it shouldn't matter.  

 

2) We perform our environmental swabs on Monday mornings after approving and verifying the weekend clean.  IF we go away from this reset, we will be swabbing during production.  We currently do zone 1 for APC, 2 for Enterobacter and 3 and 4 for salmonella and listeria as applicable.  Knowing that our APC and EB results could end up just giving us results for the ingredients on the line when swabbing, how could we factor that into the plan?  I feel like a solution might be to switch Zone 1 to EB, 2 to salmonella and keep 3 and 4 the same.  However, spices can have high coliform loads and still be safe, so a EB result of 100 might not be a critical finding.  

 

There is a lot to unpack here and sorry for the long read.  I would appreciate any insight from the community.  

 

[mgourley]

What specifically do you produce?

Why are you swabbing zone 1?

The FDA says "no visible residue" when verifying allergen cleans, so again, that comes back to what you actually produce and why you need wet cleans?

Obviously, risk assessment does come into play. 

You say you do environmental swabs on Monday after weekend cleaning, but have you verified your cleaning procedures with a variety of allergen swabs?

 

I know it's all questions and no answers, but clarification might help us to be more on point.

 

Marshall

[Charles.C]

I work in a facility that is predominately dry and RTE products.  We have all the FDA big 8 (soon 9) allergens so although we try to minimize it, we do have to do wet cleans when the allergen matrix dictates it. 

 

In the past, we had a third party sanitation company perform cleaning services over the weekend as we seldom ever run during the weekends.   During this clean, the facility was returned to "zero".  because all equipment and floors were cleaned.  After a rough patch with this company, the service is no longer going to continue.  This has me rethinking the need to reset the entire facility to clean at the same time as we are limited by crew and production hours to either clean on weekends, or cut Friday schedules to preform cleaning.  

 

Some questions I am trying to find any regulatory or industry answers to include the following:

 

1) If a line contained a powdered product like a Jello type mix, but the machinery can be sealed or covered with plastic, can the line stay dormant over the weekend and cleaned only when switching to a new product type or allergenically forced to do so.  Is there a need to clean Friday and then start up on the same product Monday.  What is that day of clean is a Wednesday or Thursday?   I want to say based on risk assessment, if there is nothing really sitting exposed to the environment, it shouldn't matter.  

 

2) We perform our environmental swabs on Monday mornings after approving and verifying the weekend clean.  IF we go away from this reset, we will be swabbing during production.  We currently do zone 1 for APC, 2 for Enterobacter and 3 and 4 for salmonella and listeria as applicable.  Knowing that our APC and EB results could end up just giving us results for the ingredients on the line when swabbing, how could we factor that into the plan?  I feel like a solution might be to switch Zone 1 to EB, 2 to salmonella and keep 3 and 4 the same.  However, spices can have high coliform loads and still be safe, so a EB result of 100 might not be a critical finding.  

 

There is a lot to unpack here and sorry for the long read.  I would appreciate any insight from the community.  

Hi ddaniels,

 

I deduce your Sanitation Program is implemented at weekends. This seems opposed to the oft-referenced philosophy seen in textbooks (and FDA?), ie Clean as you Go although consequences (if any) may relate to the specific Product/Process involved.

 

Regarding (2), swab data is usefully, initially, referenced to a standard situation, eg shortly after cleaning/sanitising but prior to Production.There are a few EMPG studies which utilise limits for in-process surfaces and IIRC one (crude) rule of thumb for such situations suggested the (empty) surface should exhibit counts (eg APC) below 10% of that for the Product being handled on it. . For some general examples of EMPG data can see this compilation/discussion -

 

https://www.ifsqn.co...ces/#entry60958

 

(the above is perhaps most meaningful within a "continuous" Sanitation Program).

 

I agree with Post 2 that, particularly for allergens, appropriate Validation/Verification are fundamental requirements where changeovers are involved.

[ddaniels316]

We product a variety of dry powder blends (dips, drinks..), spice blends and snacks.  The products can contain allergens and powder can get everywhere on equipment.  Just wiping off or a standard dry clean will leave us testing positive for allergens.  That is why we need detergent/soap to do a wet clean. 

 

 We had validated the cleaning practices of the third party sanitation company with specific allergen swabs.  We would verify the cleans on a monday morning with ATP swabs.  When we do our own cleanings as needed (if we cannot make it to the weekend due to allergen schedule) we verified with specific allergen testing.  We always had the weekly weekend clean "reset though".  If we move to a sanitation as needed without all equipment being on the same clean interval, that is where my questions are.  

 

Is there any regulation that would not allow me to cover or close in use equipment, and then start back up on it over the weekend?  If I do not have production to always clean on a Friday so monday is reset, I do not want to.  

 

Regarding swabbing zone 1, we environmental swab zone 1 because quite honestly I thought you have to swab zones 1-4.  I am against zone 1 pathogen swabs.  WE did APC because we thought it a good measure of showing cleanliness level.  Is that the best way, I was thinking of changing to EB is the equipment is not going to be reset for every monday.  WE send all samples out to a lab.  No testing in house, so I was to keep sampling activities standardized on days and times for pick ups.  

 

FDA might say visually is ok, but we are also SQF certified which has additional verbiage around validation/verification.  Can you point me to the FDA ruling on just visual.  It seems that would not hold under scrutiny I have had with FDA inspections.  

 

Please keep asking questions to help clarify my asks.   This is really a paradigm shift for my plant.  

[mgourley]

Here are a couple of documents from the FDA that contain some of the info you are seeking.

While they are for fisheries, the general information is applicable to any allergens.

 

There are numerous articles and papers that refer to: The U.S. Food and Drug Administration (FDA) mandates that food contact surfaces of shared equipment be “visually clean” after running an allergen-containing product and before a non-allergen-containing product (or product with a different allergen profile) is run on that same equipment.

 

I'll have to wait until I get back in the office tomorrow to dig up the actual wording from a FDA document.

Obviously, not all products can get away with that, and you are probably in that category.

 

Marshall

Attached Files

•  Fish_Fishery_Products_Hazards_Controls_Allergen_Cross_Contact_Prevention_Appendix9_August2019.pdf   337.58KB   15 downloads
•  Fish-Fishery-Products-Hazards-Controls-Allergen-Cleaning-Sanitation-Appendix10-August2019.pdf   232.58KB   14 downloads