6 replies to this topic

[Bryan C]

Hello!  This is my first post on this site after creating an account for the first time.  I'm excited to be here and want to start off asking for some help.

 

My facility has manufactured a product, which is a powdered coffee creamer, that has shown characteristic growth for staphylococcus aureus in a 10g test and 25g retest.  I have additional samples being tested as well as genetic testing taking place.  I understand that staph is not wanted at any levels, but is there an acceptable limit at which it is not harmful? 

 

What areas of my facility should I perform swab testing to try and locate potential contamination points?  I am already starting to swab product contact surfaces, hands, and gloves of employees.  I am also reviewing all gowning and GMP standards to see where improvements can be made.

 

Any help and advice is greatly appreciated. 

[Charles.C]

Hello!  This is my first post on this site after creating an account for the first time.  I'm excited to be here and want to start off asking for some help.

 

My facility has manufactured a product, which is a powdered coffee creamer, that has shown characteristic growth for staphylococcus aureus in a 10g test and 25g retest.  I have additional samples being tested as well as genetic testing taking place.  I understand that staph is not wanted at any levels, but is there an acceptable limit at which it is not harmful? 

 

What areas of my facility should I perform swab testing to try and locate potential contamination points?  I am already starting to swab product contact surfaces, hands, and gloves of employees.  I am also reviewing all gowning and GMP standards to see where improvements can be made.

 

Any help and advice is greatly appreciated. 

Hi Bryan,

 

The possibilities may relate to the details of the Process as well as the environment. Non-dairy creamer ? Is there a step where pathogens like Salmonella, S.aureus COOP, would expect to be eliminated ? (I anticipate yes)

 

What level of S.aureus COOP detected ?

 

Does your Product have a microbial Specification ?, eg something like this -

 micro coffee creamer.PNG   18.11KB   1 downloads 

 

The cause of S.aureus COOP pathogenicity in food is the production of toxin at elevated levels of the bacterium. However, this is typically not a zero-tolerant species like Salmonella spp. although some RTE requirements might be product-specific.

Edited by Charles.C, 17 June 2023 - 03:28 PM.
added

[sqflady]

Please also check your sampling procedure.  In a past position, when our personnel pulled cheese plugs to send for sampling, Staph would show up when there was incidental contact with skin (hands, forearm, etc.) while taking the sample.

[Scampi]

My money is on human contamination 

 

Staph is present on about 1/3 the general population

 

Found a reference 

The unsatisfactory level for Staphylococcus aureus in food is ≥ 10⁴ CFU/gram (potentially hazardous).

 OR this

https://www.albertah...o-eat-foods.pdf

 

Staphylococcus (S.) aureus  critical limits of 10 cfu/g (USDA cooked chicken)

https://www.ams.usda...logical-testing

 

plus many many more references 

[Tony-C]

Hi Bryan,

 

 

Welcome to the IFSQN forums.

 

Limits in powders are typically maximum of 100/g.

 

S.aureus needs to be present in relatively large levels to produce a dangerous level of toxin. From FDA:

S.aureus toxin does not normally reach levels that will cause food poisoning until the numbers of the pathogen reach 500,000 to 1,000,000 per gram.

 

Kind regards,

 

Tony

[Bryan C]

Hi Bryan,

 

The possibilities may relate to the details of the Process as well as the environment. Non-dairy creamer ? Is there a step where pathogens like Salmonella, S.aureus COOP, would expect to be eliminated ? (I anticipate yes)

 

What level of S.aureus COOP detected ?

 

Does your Product have a microbial Specification ?, eg something like this -

micro coffee creamer.PNG

 

The cause of S.aureus COOP pathogenicity in food is the production of toxin at elevated levels of the bacterium. However, this is typically not a zero-tolerant species like Salmonella spp. although some RTE requirements might be product-specific.

 

Hi Charles - thank you for your response, sorry for my delay! Yes, this is a non-dairy creamer.  It is entirely coconut milk powder.  There is no kill step.  It is a low aw product.

 

I'm not sure what you mean by S.aureus COOP?

 

Here are the micro spec limits provided by the customer.   Creamer Micro Spec.png   102.46KB   1 downloads

 

Thank you for the information and guidance!

 

 

 

Hi Bryan,

 

 

Welcome to the IFSQN forums.

 

Limits in powders are typically maximum of 100/g.

 

S.aureus needs to be present in relatively large levels to produce a dangerous level of toxin. From FDA:

S.aureus toxin does not normally reach levels that will cause food poisoning until the numbers of the path

 

 

Hi Tony!  Thank you for the welcome message and for the link.  This is helpful to further my research.

 

 

 

To this point, all testing performed on a multiplicity of products, even ones filled directly before and after the positive test, have all come back negative.  I am still awaiting the OOS report from the Lab, but there have been no additional findings thus far. 

[Charles.C]

Hi Charles - thank you for your response, sorry for my delay! Yes, this is a non-dairy creamer.  It is entirely coconut milk powder.  There is no kill step.  It is a low aw product.

 

I'm not sure what you mean by S.aureus COOP?

 

Here are the micro spec limits provided by the customer.  Creamer Micro Spec.png

 

Thank you for the information and guidance!

 

 

 

 

 

Hi Tony!  Thank you for the welcome message and for the link.  This is helpful to further my research.

 

 

 

To this point, all testing performed on a multiplicity of products, even ones filled directly before and after the positive test, have all come back negative.  I am still awaiting the OOS report from the Lab, but there have been no additional findings thus far. 

Hi Bryan,

 

I presume yr product is marketed as RTE. This typically has micro. consequences from a Safety/Non-Safety POV. (Especially afaik regarding L.monocytogenes in the US).

 

COP (apologies extra redundant "O" ) means coagulase positive . If coagulase negative, the result is not relevant from a safety POV..

 

Note the several quantitative astronomic differences between your spec, and mine. Some cause for thought IMO.

 

PS - I'm surprised neither spec. mentions L.monocytogenes.