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#1 akool18

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Posted 07 March 2017 - 06:55 AM

Dear everybody,

I am writing to ask about micro challenge testing.

Could you help me with guidline for this

I appreciate your helps a lot



#2 Charles.C

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Posted 08 March 2017 - 09:12 AM

Dear everybody,

I am writing to ask about micro challenge testing.

Could you help me with guidline for this

I appreciate your helps a lot

 

Hi akool,

 

This is a very wide subject.

 

Do you have any particular area of interest/application ?


Kind Regards,

 

Charles.C


#3 akool18

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Posted 09 March 2017 - 01:40 AM

Hi akool,

 

This is a very wide subject.

 

Do you have any particular area of interest/application ?

Dear Charles C,

Thank you for your precious response

My Japan customer ask for Microbio challenge testing activities in Lab. The framework include:

          -Selection of pathogen or surrogate

          -Level of challenge inoculum

          -Duration of the study

          -Formulation factors and processing condition

          -Sample analyses and calculation of log reduction 

          -Interpretation of the data 

          -Pass / fail criteria & Recommendations    

I wondering if there is any standard (ISO , AOAC, .....etc) for these activities and there is any guideline for these mentioned above

I wish you and everyone here who work with microbio challenge testing can help me

Sincerely yours.



#4 Charles.C

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Posted 09 March 2017 - 05:14 PM

Dear Charles C,

Thank you for your precious response

My Japan customer ask for Microbio challenge testing activities in Lab. The framework include:

          -Selection of pathogen or surrogate

          -Level of challenge inoculum

          -Duration of the study

          -Formulation factors and processing condition

          -Sample analyses and calculation of log reduction 

          -Interpretation of the data 

          -Pass / fail criteria & Recommendations    

I wondering if there is any standard (ISO , AOAC, .....etc) for these activities and there is any guideline for these mentioned above

I wish you and everyone here who work with microbio challenge testing can help me

Sincerely yours.

 

Hi akool,

 

Thks for details.

 

I am wondering why yr customer is asking for this info.

IMEX routine, in-plant labs infrequently perform such testing unless there is a specific necessity. Commercial analytical services do offer such facilities, eg

https://www.leatherh...llenge-testing/

http://www.merieuxnu...nge-studies/548

 

A detailed example of the theoretical/practical factors involved is attached -

 

Attached File  challenge testing of micro,safety of raw milk cheeses,2011.pdf   1.92MB   20 downloads

 

and one more -

 

Attached File  micro.challenge testing for L.monocytogenes,2014.pdf   579.49KB   21 downloads


Kind Regards,

 

Charles.C


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#5 Ryan M.

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Posted 09 March 2017 - 05:43 PM

It depends.  Is your process and product unique?  If not, you will likely find the regulatory or peer-reviewed documentation to support the validation of your process and product.

 

For example, we produce milk in the US.  Our validation for the milk processing/pasteurization is the FDA pasteurization time and temperature limits.  All we do is reference that standard to validate.

 

Your process could be that simple.



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#6 akool18

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Posted 13 March 2017 - 08:48 AM

Hi akool,

 

Thks for details.

 

I am wondering why yr customer is asking for this info.

IMEX routine, in-plant labs infrequently perform such testing unless there is a specific necessity. Commercial analytical services do offer such facilities, eg

https://www.leatherh...llenge-testing/

http://www.merieuxnu...nge-studies/548

 

A detailed example of the theoretical/practical factors involved is attached -

 

attachicon.gifchallenge testing of micro,safety of raw milk cheeses,2011.pdf

 

and one more -

 

attachicon.gifmicro.challenge testing for L.monocytogenes,2014.pdf

 

It depends.  Is your process and product unique?  If not, you will likely find the regulatory or peer-reviewed documentation to support the validation of your process and product.

 

For example, we produce milk in the US.  Our validation for the milk processing/pasteurization is the FDA pasteurization time and temperature limits.  All we do is reference that standard to validate.

 

Your process could be that simple.

Now i validate shelf life using durability . 

So, are durability study and challenge testing independent?






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