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#1 srich12

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Posted 25 July 2017 - 08:45 PM

Just curious if others are willing to share their versions of EMPs?  

 

We are in the process of trying to completely revise our program to be more in line with FDA's Draft Guidance for Industry - "Control of Listeria monocytogenes in Ready-To-Eat Foods".  

 

We have been sampling 30 sites (zones 2-4) weekly for several years and we are looking at more than doubling our total number of sites/week and mimic the new zones definition in this guidance as well (i.e. drains in RTE areas are zone 2 now instead of zone 3). 

 

To get to the point - one of my main questions is whether or not manufacturers are complying with the guidance for zone 1 swabs "we recommend that even the smallest processors collect samples from at least 5 sites of food-contact surfaces...on each production line for RTE foods".  

 

Of note, we manufacture and package a high-risk product and test each batch of product produced for Listeria mono.  

 

Thanks in advance for any input!   



#2 Maillard

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Posted 28 July 2017 - 11:11 PM

Just curious if others are willing to share their versions of EMPs?  

 

We are in the process of trying to completely revise our program to be more in line with FDA's Draft Guidance for Industry - "Control of Listeria monocytogenes in Ready-To-Eat Foods".  

 

We have been sampling 30 sites (zones 2-4) weekly for several years and we are looking at more than doubling our total number of sites/week and mimic the new zones definition in this guidance as well (i.e. drains in RTE areas are zone 2 now instead of zone 3). 

 

To get to the point - one of my main questions is whether or not manufacturers are complying with the guidance for zone 1 swabs "we recommend that even the smallest processors collect samples from at least 5 sites of food-contact surfaces...on each production line for RTE foods".  

 

Of note, we manufacture and package a high-risk product and test each batch of product produced for Listeria mono.  

 

Thanks in advance for any input!   

 

I'm not sure if there are very many processors rushing to start swabbing Z1 surfaces for pathogens. I think a lot of processors are still holding on to swabbing for indicators on Z1 and intensifying frequency and locations of Z2 and Z3 for pathogens.

 

If it is a high-risk product and you know you have a persistent listeria issue present in the environment or with your RMs then you probably should be swabbing Z1 for listeria. Solely relying on finished product testing is always a gamble on very high-risk products since your relying on having the appropriate sample size and also luck in that you're picking a sample with it present (if it's in a lot/batch).



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#3 Maillard

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Posted 28 July 2017 - 11:28 PM

I'm not sure if there are very many processors rushing to start swabbing Z1 surfaces for pathogens. I think a lot of processors are still holding on to swabbing for indicators on Z1 and intensifying frequency and locations of Z2 and Z3 for pathogens.

 

If it is a high-risk product and you know you have a persistent listeria issue present in the environment or with your RMs then you probably should be swabbing Z1 for listeria. Solely relying on finished product testing is always a gamble on very high-risk products since your relying on having the appropriate sample size and also luck in that you're picking a sample with it present (if it's in a lot/batch).

 

Just to add to my previous post, if your curious as to the position organizations are taking i would recommend reading through the official comments posted on the guidance which can be found here: https://www.regulati...FDA-2008-D-0096

 

A lot of bigger organizations are pushing back a bit on Z1 pathogen swabbing.



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