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Hello, looking for help with EMP, Compressed air testing.

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Shanked5i

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Posted 12 September 2022 - 07:48 PM

Hi Everyone,

 

I’ve browsed this site for a long time but have never made a post or introduced myself – figured this was as good a time as any .

 

I've been a PCQI for a little over 6 years and have 10 years+ in the baking/snack food industry in production management. Recently, I've been promoted to a QA Director position and am currently in the process of getting us certified with SQF. We manufacture a low risk snack food with low water activity.

 

I've hit a snag with our environmental monitoring and compressed air sampling. I’ve conducted sampling over the past 4 months which has largely come back <10 CFU/swab for APC and Enterobacteriaceae, with the occasional 20-50 CFU swab mixed in.

 

We did sample a footpath in our warehouse before cleaning which was <10 for ENT, 750 for APC. Post clean – 3 samples came back <70 CFU for APC.

 

With our compressed air we tested for Mold and Yeast Count, as well as APC (all via CAMTU system) on all areas of food contact or where CA is used for cleaning. Yeast and Mold did not climb above 2 CFU on any area and for the large portion was <1 CFU. APC was mostly similar – but we did have one sample at 50 CFU.

 

Edit: Spelling, sentence structure

 

Hoping someone can point me in the direction of some plain instructions on developing a baseline or standard deviation range for these readings. I’ve seen standard numbers thrown out here and there like 10 CFU for ENT, 250 CFU for APC as a baseline requiring corrective action.

 

Thanks, and much appreciation for all the great advice I have gotten from here over the years!


Edited by Dhstutzman, 12 September 2022 - 07:49 PM.


juanolea1

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Posted 12 September 2022 - 09:40 PM

Use your historical counts generated over the years and determine the highest and the lowest. Normal baseline should be somewhere between your lowest value and the median.



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Charles.C

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Posted 12 September 2022 - 11:49 PM

Hi Everyone,

 

I’ve browsed this site for a long time but have never made a post or introduced myself – figured this was as good a time as any .

 

I've been a PCQI for a little over 6 years and have 10 years+ in the baking/snack food industry in production management. Recently, I've been promoted to a QA Director position and am currently in the process of getting us certified with SQF. We manufacture a low risk snack food with low water activity.

 

I've hit a snag with our environmental monitoring and compressed air sampling. I’ve conducted sampling over the past 4 months which has largely come back <10 CFU/swab for APC and Enterobacteriaceae, with the occasional 20-50 CFU swab mixed in.

 

We did sample a footpath in our warehouse before cleaning which was <10 for ENT, 750 for APC. Post clean – 3 samples came back <70 CFU for APC.

 

With our compressed air we tested for Mold and Yeast Count, as well as APC (all via CAMTU system) on all areas of food contact or where CA is used for cleaning. Yeast and Mold did not climb above 2 CFU on any area and for the large portion was <1 CFU. APC was mostly similar – but we did have one sample at 50 CFU.

 

Edit: Spelling, sentence structure

 

Hoping someone can point me in the direction of some plain instructions on developing a baseline or standard deviation range for these readings. I’ve seen standard numbers thrown out here and there like 10 CFU for ENT, 250 CFU for APC as a baseline requiring corrective action.

 

Thanks, and much appreciation for all the great advice I have gotten from here over the years!

 

Hi Dhstutzman,

 

From a statistical POV, a Process (Environment ?) which is "in control" (as can be numerically tested) is theoretically describable by limits ("borderlines")  as in traditional SPC. Variations can be investigated via ANOVA. This has been done for some food systems but IMEX the intrinsic / sampling variabilities associated with microbial counts present a substantial challenge.

 

"Baselines", I suspect, act as a limited practical replacement for the preceding paragraph although the former can be derived from quite heavy mathematical methods as was, IIRC, implemented in FDA's well-known screening procedure for pathogenic E.coli in meat.

 

ATP environmental sampling offer a short, semi-statistical calculation for setting baselines which is relatively straightforward to implement. Maybe try it out for your system. Can see the methodology linked here -

 

https://www.ifsqn.co...ia/#entry186131

 

An even simpler approach could be via Trend Analysis and simply calculating Standard deviations which will give you an immediate idea as to the variability/consistency of your data. I assume "swab" in yr post represents 100cm2 on which basis yr count data looks exceptionally good IMEX (eg compare with the Excel data in following link) but this may inevitably depend on the specific sampling points and Process type.

http://www.ifsqn.com...ent/#entry81054

 

PS - I speculate yr <10 cfu/swab implies "undetected", ie no colonies. If so, you will maybe need a more detailed analytical procedure to get some actual numbers.

What do you currently regard as an "acceptable" limit ? If 10cfu/100cm2 then not much further analysis may be required ? :smile:


Kind Regards,

 

Charles.C


Shanked5i

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Posted 13 September 2022 - 06:43 PM

Charles,

 

Thanks so much for the information. Follow-up questions are such:

  • I am unsure with the 100cm2 - my swabs come back from a third-party lab with /swab identified on the COA. They are your standard 3M Sponge Stick with NB. 
  • You are most likely correct regarding the <10 cfu readings indicating no colonies - but again unsure with the 100cm2. Are those standard basis's or is there a calculation to determine what I should be measuring based off of? Hopefully that makes sense - forgive my ignorance on the subject.
  • Finally, we do use Hygenia Suretrend for our ATP swab tracking and are consistently 0-10 rlu's on our finishing area (FCS) readings. Unsure how to correlate my micro readings to my RLU values.

Again sorry for the confusion and follow-up questions.



Charles.C

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Posted 13 September 2022 - 09:44 PM

Charles,

 

Thanks so much for the information. Follow-up questions are such:

  • I am unsure with the 100cm2 - my swabs come back from a third-party lab with /swab identified on the COA. They are your standard 3M Sponge Stick with NB. 
  • You are most likely correct regarding the <10 cfu readings indicating no colonies - but again unsure with the 100cm2. Are those standard basis's or is there a calculation to determine what I should be measuring based off of? Hopefully that makes sense - forgive my ignorance on the subject.
  • Finally, we do use Hygenia Suretrend for our ATP swab tracking and are consistently 0-10 rlu's on our finishing area (FCS) readings. Unsure how to correlate my micro readings to my RLU values.

Again sorry for the confusion and follow-up questions.

Hi Dhstutzman,

 

Thks for feedback. No apologies necessary, it's a highly complicated topic for all concerned. Queries are welcome.

 

I'm not quite clear as to whether your 3rd party lab are doing the complete (sampling + analysis) or only the analysis ? The uncertainty over 100cm2 suggests the former ?.

Regardless, to compare yr own data with any other results will necessitate some knowledge of the area sampled. Also necessary to ensure the reported lab result refers to the total sample delivered since, based on earlier threads here, some lab reporting methods  can vary.

 

A 3M environment sampling Procedure is illustrated here -

 

https://multimedia.3...-with-stick.mp4

 

As you can see, areas can vary, possibly depending on the specific product-environment / targetted cleanliness level (IIRC 3M do recommend a specific area for their individual products). 10 cm x 10cm is quite common IMEX but a variety of choices can be found in the Literature. Some official reports do only refer to a "Swab" which is sort of "limited" for comparison purposes.

 

ATP data, per se, is generally not well correlated with micro APC results although occasionally it can happen. I referenced the ATP baseline method more for convenience since one could analogise repeating the same practical exercise for micro data (have never tried it personally due my own previous caveat about intrinsic variations in micro. results however my [wet] product experience is likely more variable than yours).

 

You might find it easier to initially select a set of "appropriate" (to yr Product) "Standard" micro. limits and do a (your) data comparison. For example the values given in previously linked Excel for UK and USA. (Note that counts are all nominally per cm2 although this can get tricky for non-uniform objects. (Yr 3rd Party lab may have useful input also).

 

PS - Compressed air tends to have it's own Standards additional to environmental surface testing, eg this Excel -

 

http://www.ifsqn.com...ent/#entry81054

 

Hope the above assists.


Kind Regards,

 

Charles.C


Shanked5i

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Posted 14 September 2022 - 01:27 PM

Wonderful. This has helped a lot Charles! I really appreciate the thoroughness of your explanation!  





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