2 replies to this topic

[RazM4tt]

Hello all!

 

I have been working with my facilities EM program and trying to learn as much as possible about setting limits for zone 1,2,3. Historically we have had the same limits for years and years. I am trying to create a baseline and cross reference it with similar facilities. Unfortunately, it seems this information is quite coveted and I was hoping to shine some light on this topic. Would anyone be able to direct me to a thread or source where many different types of production facilities have their zone limits set at?

 

I am working at a nutraceutical facility so most of the resources referencing food production are not applicable and we handle materials with a very high microbial load. That being said, APC limits are set at 100 for zone 1,2 and 3. I have about 2 years worth of "before sanitation" (after production but before cleaning) data and 8 months of "after sanitation" data. What is the best method for adjusting my baseline? 

 

Thank you for all the help!

[Tony-C]

Hi RazM4tt,

 

I presume that you have corresponding product results that also show product micro compliance and that you are also monitoring other indicator organisms such as Enteros/Y&M??

 

As your APC swab limits are relatively low, I don’t see a need to adjust your baseline, surely you must have bigger fish to fry rather than worrying about this?

 

Kind regards,

 

Tony

[RazM4tt]

Hi RazM4tt,

 

I presume that you have corresponding product results that also show product micro compliance and that you are also monitoring other indicator organisms such as Enteros/Y&M??

 

As your APC swab limits are relatively low, I don’t see a need to adjust your baseline, surely you must have bigger fish to fry rather than worrying about this?

 

Kind regards,

 

Tony

Thanks for the reply Tony,

 

The program was handed over to me from a previous employee. All of the guidelines were set based on recommendations and never adjusted for a baseline. Due to this, I am generating about 3 CAPA every month. I feel this is taking time and attention from issues that may be more important. That being said, yes we do strenuous final product testing. My zone 1 and 2 swabs include APC, coliform and salmonella. My zone 3 swabs include APC, coliform, salmonella and Listeria. This is why I feel the APC limit is set too low because of all of the pathogen testing we do. Im hoping to find some resources, books or articles to read that can help me. I feel there is not a lot of guidance for EM out there and it has been a struggle to find what is acceptable, especially in an industry that handles high microbial load products. Our components on average test about 2 x 10^3 so I am trying to take that into consideration as well. Thanks for the feedback.

 

-RazM4tt