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#1 Loren

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Posted 29 January 2016 - 06:55 PM

Hi All,

 

I did Equipment Swab and have it tested for Standard Plate Count at an external Lab and the result came out 16-34 cfu as attached. The Reporting Limit as indicated on  by outside lab is 1 cfu only.

 

My problem is I can't find any reference material what should be our internal limit. My questions are the following:

 

- Do we have to use the reporting limit specified by the outside laboratory? Is this limit set out by regulating agencies (FDA) or we have to set our own?

- Does anyone have a reference material I can read to help me?

 

Appreciate all your usual help! Thanks!

 

 

Lorena

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#2 Simon

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Posted 29 January 2016 - 07:21 PM

What parts are you swabbing on the laminating and slitting machines?  And what are you swabbing for?


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#3 QAGB

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Posted 29 January 2016 - 07:57 PM

Hi All,

 

I did Equipment Swab and have it tested for Standard Plate Count at an external Lab and the result came out 16-34 cfu as attached. The Reporting Limit as indicated on  by outside lab is 1 cfu only.

 

My problem is I can't find any reference material what should be our internal limit. My questions are the following:

 

- Do we have to use the reporting limit specified by the outside laboratory? Is this limit set out by regulating agencies (FDA) or we have to set our own?

- Does anyone have a reference material I can read to help me?

 

Appreciate all your usual help! Thanks!

 

 

Lorena

 

Hi Lorena,

 

I believe the <1cfu/g number is the detection limit of the lab; this means they can't count anything below that (basically because the micro counts [yeast and mold in these case] are extremely small). You don't have to use <1cfu/g as your internal specification. You can establish specifications for food contact surfaces, as long as those counts are much lower than your finished product micro specifications.

 

For example, if you have a finished product spec of <500cfu/g Plate Count, and <50cfu/g Yeast and mold, you could set your food contact surfaces to <50cfu/g Plate Count, and <10cfu/g. It just depends on what your specs are.

 

QAGB



#4 QAGB

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Posted 29 January 2016 - 08:00 PM

Hi Lorena,

 

I believe the <1cfu/g number is the detection limit of the lab; this means they can't count anything below that (basically because the micro counts [yeast and mold in these case] are extremely small). You don't have to use <1cfu/g as your internal specification. You can establish specifications for food contact surfaces, as long as those counts are much lower than your finished product micro specifications.

 

For example, if you have a finished product spec of <500cfu/g Plate Count, and <50cfu/g Yeast and mold, you could set your food contact surfaces to <50cfu/g Plate Count, and <10cfu/g. It just depends on what your specs are.

 

QAGB

 

 

Also, be sure to check your finished products from time to time to make sure that the cleanliness level of the food contact surfaces is effective. If the specifications you set for your food contact surfaces are not good enough, you would have to re-evaluate the specs so that your finished product micro isn't thrown off by the micro on your food contact surfaces.

 

QAGB



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#5 Loren

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Posted 29 January 2016 - 08:15 PM

Also, be sure to check your finished products from time to time to make sure that the cleanliness level of the food contact surfaces is effective. If the specifications you set for your food contact surfaces are not good enough, you would have to re-evaluate the specs so that your finished product micro isn't thrown off by the micro on your food contact surfaces.

 

QAGB

 

 

Thanks QAGB! I didn't do any microbial testing of our finished product yet :(.. I can do that too but my problem is I don't really know what would be my internal limits. Do you have any idea of acceptable limits for packaging materials used to contain food products?



#6 Charles.C

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Posted 29 January 2016 - 08:35 PM

Hi Lorena,

 

Have a look at this post -

 

http://www.ifsqn.com...ces/#entry60958

 

 

You need to supply more info. to make quantitative sense of yr lab report.

 

Micro.data / specs for (some) packaging materials is reviewed in some other threads here.


Kind Regards,

 

Charles.C


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#7 QAGB

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Posted 29 January 2016 - 09:35 PM

Thanks QAGB! I didn't do any microbial testing of our finished product yet :(.. I can do that too but my problem is I don't really know what would be my internal limits. Do you have any idea of acceptable limits for packaging materials used to contain food products?

 

"Ditto" to Charles' link from another thread. You should read that to get an idea of typical contact surface specs. I would presume you would want fairly low micro counts on contact surfaces for packaging. Your end product (packaging) is a starting product for many customers (food). They need your packaging to have low micro counts.

 

What I would suggest you do:

  1. Swab some finished product packaging (perhaps 3 items at the beginning, 3 items at the middle, and 3 items at the end of a run).
  2. Take a look at your finished product packaging micro results. Average your counts for each type (APC, Yeast, Mold, etc.). Be aware that items like e.coli and listeria are zero-tolerance.
  3. You can repeat the finished product packaging testing a few times to get a true average, and determine what you believe will be your specifications.
  4. Now, for product contact surfaces, make sure that you are swabbing after a cleaning is done (you probably did that, but just checking).
  5. Pick at least 10-15 test points to swab (try to keep them where the packaging comes in contact with the equipment).
  6. Swab each point for APC, Yeast, Mold, and other items you wish to test. The results should come back that each test point is lower than your finished product spec. As a matter of fact, you probably shouldn't have any particular test point generate more than 10% (that number might even be too high) of the micro of your finished product. If any particular test point generates more than 10% of the micro of your finished product, you may want to re-evaluate the cleaning of that area.
  7. Repeat your product contact surface swabbing a few more times, and compare data at each test point after cleaning.
  8. Removing any outliers from the data, take a look at trends and averages. You can establish what you want as your specifications for cleaning, but generally try to keep them less than 10% of finished product specs at each test point (unless it is just not feasible for you at that step).
  9. There may come a point where you have to re-evaluate your specifications (if they aren't low enough to meet certain requirements). You can follow the basic steps (with necessary modifications) above to re-evaluate.

 

QAGB



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#8 Charles.C

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Posted 29 January 2016 - 09:46 PM

Hi Lorena,

 

For packaging, can try this thread -

 

http://www.ifsqn.com...ing/#entry51255

 

In practice, a lot (but by no means all) of food-contact packaging is via high temp. processes so that counts derive from post-process contamination, eg storage, re-fabrication, printing.

 

As QAGB notes, results for specified reference areas/weights will typically be low-very low >>>> "Food Grade"


Kind Regards,

 

Charles.C


#9 Loren

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Posted 29 January 2016 - 11:16 PM

Hi Lorena,

 

Have a look at this post -

 

http://www.ifsqn.com...ces/#entry60958

 

 

You need to supply more info. to make quantitative sense of yr lab report.

 

Micro.data / specs for (some) packaging materials is reviewed in some other threads here.

 

 

Thanks Charles! I will read this thread.



#10 Loren

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Posted 29 January 2016 - 11:19 PM

"Ditto" to Charles' link from another thread. You should read that to get an idea of typical contact surface specs. I would presume you would want fairly low micro counts on contact surfaces for packaging. Your end product (packaging) is a starting product for many customers (food). They need your packaging to have low micro counts.

 

What I would suggest you do:

  1. Swab some finished product packaging (perhaps 3 items at the beginning, 3 items at the middle, and 3 items at the end of a run).
  2. Take a look at your finished product packaging micro results. Average your counts for each type (APC, Yeast, Mold, etc.). Be aware that items like e.coli and listeria are zero-tolerance.
  3. You can repeat the finished product packaging testing a few times to get a true average, and determine what you believe will be your specifications.
  4. Now, for product contact surfaces, make sure that you are swabbing after a cleaning is done (you probably did that, but just checking).
  5. Pick at least 10-15 test points to swab (try to keep them where the packaging comes in contact with the equipment).
  6. Swab each point for APC, Yeast, Mold, and other items you wish to test. The results should come back that each test point is lower than your finished product spec. As a matter of fact, you probably shouldn't have any particular test point generate more than 10% (that number might even be too high) of the micro of your finished product. If any particular test point generates more than 10% of the micro of your finished product, you may want to re-evaluate the cleaning of that area.
  7. Repeat your product contact surface swabbing a few more times, and compare data at each test point after cleaning.
  8. Removing any outliers from the data, take a look at trends and averages. You can establish what you want as your specifications for cleaning, but generally try to keep them less than 10% of finished product specs at each test point (unless it is just not feasible for you at that step).
  9. There may come a point where you have to re-evaluate your specifications (if they aren't low enough to meet certain requirements). You can follow the basic steps (with necessary modifications) above to re-evaluate.

 

QAGB

 

Thanks QAGB, this is very helpful although I am looking for limits that is ready to use, applicable to our process :rofl2: ..but definitely this is very informative in building our own specification based on our own data.

 

I will read that threads that Charles posted, hoping to gain more inputs. You guys are amazing!

 

Regards,

 

Lorena



#11 Charles.C

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Posted 30 January 2016 - 12:41 AM

Hi Lorena,

 

The usual first requirement to interpret yr lab report is to work out what (swabbed) equipment surface area corresponds to the reported count. This then enables a calculation of count/cm2 to compare with  reference values.

 

Afaik, there are no general regulatory values for US process, food contact surfaces. However you will see some Guideline limits in several of the examples in the excel document. Specifications, if any, may also relate to the specific equipment / process you are sampling.

 

I daresay the count values shown, eg 16, 34cfu are based on plating 1ml of the total sample you supplied then calculated by the lab for the total volume. This needs to be confirmed.

If so, and the total volume of sample supplied  contained the swabbed material from, say, Xcm2 of equipment surface, then count/cm2 = 16/X or 34/X respectively.

 

Or perhaps some other procedure custom-designed for the sampling kit was used.


Kind Regards,

 

Charles.C


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#12 Loren

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Posted 10 February 2016 - 12:47 AM

Hi Lorena,

 

The usual first requirement to interpret yr lab report is to work out what (swabbed) equipment surface area corresponds to the reported count. This then enables a calculation of count/cm2 to compare with  reference values.

 

Afaik, there are no general regulatory values for US process, food contact surfaces. However you will see some Guideline limits in several of the examples in the excel document. Specifications, if any, may also relate to the specific equipment / process you are sampling.

 

I daresay the count values shown, eg 16, 34cfu are based on plating 1ml of the total sample you supplied then calculated by the lab for the total volume. This needs to be confirmed.

If so, and the total volume of sample supplied  contained the swabbed material from, say, Xcm2 of equipment surface, then count/cm2 = 16/X or 34/X respectively.

 

Or perhaps some other procedure custom-designed for the sampling kit was used.

 

Hi Charles,

 

Thank you again. Which excel document do you mean on this statement? (*However you will see some Guideline limits in several of the examples in the excel document.*)

 

Regards,

Lorena

 

 

* Interestingly, you're right the report doesn't say about the volume or area of the counts reported. I will have to call them for that. Thanks!



#13 Charles.C

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Posted 10 February 2016 - 05:46 AM

Hi Charles,

 

Thank you again. Which excel document do you mean on this statement? (*However you will see some Guideline limits in several of the examples in the excel document.*)

 

Regards,

Lorena

 

 

* Interestingly, you're right the report doesn't say about the volume or area of the counts reported. I will have to call them for that. Thanks!

 

Hi Lorena,

 

The excel (mostly equipment, some hand, surfaces) is included in the link shown in post 6.

 

* Interestingly, you're right the report doesn't say about the volume or area of the counts reported. I will have to call them for that. Thanks!

 

Maybe you didn't tell the lab what the swabbed area was ? If so, they can only (somehow) report as per the volume (or weight) of sample received.

 

(If a commercial sampling kit, this often includes a swabbing procedure / area to swab / calculation formula)


Kind Regards,

 

Charles.C


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#14 Loren

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Posted 10 February 2016 - 05:08 PM

Hi Lorena,

 

The excel (mostly equipment, some hand, surfaces) is included in the link shown in post 6.

 

 

Maybe you didn't tell the lab what the swabbed area was ? If so, they can only (somehow) report as per the volume (or weight) of sample received.

 

(If a commercial sampling kit, this often includes a swabbing procedure / area to swab / calculation formula)

 

 

 

I'm sorry I would take that back-for Plate count their report doesn't say if it is in volume or weight but the yeast & mold say cfu/g. As for the procedure, I swab approximately 100cm2.



#15 Charles.C

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Posted 10 February 2016 - 05:42 PM

Hi Lorena,

 

As per Post 4, the <1cfu/g probably means no colonies found after incubating 1ml (~=1g) of yr delivered sample.

 

I find it strange that the lab gives no mention of reference weight (or volume) for the plate count data.

 

Do you know the volume of liquid delivered to the lab ? i daresay it was specified in the swabbing procedure.


Kind Regards,

 

Charles.C


#16 Loren

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Posted 17 February 2016 - 04:47 PM

Hi Lorena,

 

As per Post 4, the <1cfu/g probably means no colonies found after incubating 1ml (~=1g) of yr delivered sample.

 

I find it strange that the lab gives no mention of reference weight (or volume) for the plate count data.

 

Do you know the volume of liquid delivered to the lab ? i daresay it was specified in the swabbing procedure.

 

Hi Charles,

 

I did call the Lab and you're right. It is cfu/100cm2 because of the surface area being swab. Thanks lots!

 

Lorena



#17 Charles.C

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Posted 17 February 2016 - 05:43 PM

Hi Charles,

 

I did call the Lab and you're right. It is cfu/100cm2 because of the surface area being swab. Thanks lots!

 

Lorena

 

Hi Lorena,

 

Sounds like a very clean machine. :thumbup:


Kind Regards,

 

Charles.C


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#18 Loren

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Posted 16 March 2016 - 09:44 PM

Hi Lorena,

 

Sounds like a very clean machine. :thumbup:

 

Thanks Charles but I would say not that clean, really :).



#19 sivac191

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Posted 31 March 2016 - 10:15 AM

Hi All,

 

I did Equipment Swab and have it tested for Standard Plate Count at an external Lab and the result came out 16-34 cfu as attached. The Reporting Limit as indicated on  by outside lab is 1 cfu only.

 

My problem is I can't find any reference material what should be our internal limit. My questions are the following:

 

- Do we have to use the reporting limit specified by the outside laboratory? Is this limit set out by regulating agencies (FDA) or we have to set our own?

- Does anyone have a reference material I can read to help me?

 

Appreciate all your usual help! Thanks!

 

 

Lorena

Hi Lorena

 

There is no standard reference for Equipment Swab .

 

you can validated the your results with frequent testing  . 

 

You have to set the limit  and Testing Frequent according to your HACCP PLAN.

 

In India  , Export Inspection Agency which is Government of India have published the Specification for Equipment Swab. If you need , you  can download from EIC INDIA.NIC.IN Website



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#20 Charles.C

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Posted 31 March 2016 - 04:40 PM

Hi Lorena

 

There is no standard reference for Equipment Swab .

 

you can validated the your results with frequent testing  . 

 

You have to set the limit  and Testing Frequent according to your HACCP PLAN.

 

In India  , Export Inspection Agency which is Government of India have published the Specification for Equipment Swab. If you need , you  can download from EIC INDIA.NIC.IN Website

 

Hi Sivac,

 

A few product sectors/locations do have swab standards for equipment.  But i agree there are no widely agreed limits, just like micro.

 

I think most limits are based on achievable cleaning experience / GMP / intuition. Bit like ATP.

 

Some EIC swab specs (2007) are attached within link in Post 6 (see Post 9) (no idea if still current)


Kind Regards,

 

Charles.C


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#21 Loren

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Posted 12 April 2016 - 07:28 PM

Hi Lorena

 

There is no standard reference for Equipment Swab .

 

you can validated the your results with frequent testing  . 

 

You have to set the limit  and Testing Frequent according to your HACCP PLAN.

 

In India  , Export Inspection Agency which is Government of India have published the Specification for Equipment Swab. If you need , you  can download from EIC INDIA.NIC.IN Website

 

 

Thank you Sivac!






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