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#1 QA_123

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Posted 11 August 2020 - 01:32 PM

Hello,

I know this has been asked but I have not seen an answer yet.  I am looking on some documentation on holding hydrated batter at 60 degrees F. or less for more than 12 hours.  I was told by an Inspector that the data is out there but he can't give it to me.  He said I have to find it on my own.  All I can find is the link below.  I know that exposure times greater than 12 hours at temperatures between 50 degrees F. and 70 degrees F. could result in toxin formation according to the following link but is there anything that is more specific?  If you can hold it at 50 degrees and 70 degrees for 12 hours how long can you hold it at 50 or 60 degrees for longer than 12 hours?  

 

Thank you in advance for any help.

 

 

https://www.fda.gov/.../80319/download



#2 Charles.C

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Posted 11 August 2020 - 06:56 PM

Hello,

I know this has been asked but I have not seen an answer yet.  I am looking on some documentation on holding hydrated batter at 60 degrees F. or less for more than 12 hours.  I was told by an Inspector that the data is out there but he can't give it to me.  He said I have to find it on my own.  All I can find is the link below.  I know that exposure times greater than 12 hours at temperatures between 50 degrees F. and 70 degrees F. could result in toxin formation according to the following link but is there anything that is more specific?  If you can hold it at 50 degrees and 70 degrees for 12 hours how long can you hold it at 50 or 60 degrees for longer than 12 hours?  

 

Thank you in advance for any help.

 

 

https://www.fda.gov/.../80319/download

 

Hi QA,

 

Why do you want to hold it so long ?

 

IMEX most batter coating operations get through substantial volumes of batter like lightning.

 

I have seen some small volume processes where a large sealed bag of ice was immersed in the container since surrounding with ice took too long to cool.


Kind Regards,

 

Charles.C


#3 QA_123

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Posted 11 August 2020 - 07:11 PM

We do not actually "hold" it that long.  We run two shifts and replenish the machines throughout the day.  So, its not just sitting there for that long and the temps are kept below 60 degrees F.  



#4 Charles.C

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Posted 12 August 2020 - 03:24 AM


 

Hello,

I know this has been asked but I have not seen an answer yet.  I am looking on some documentation on holding hydrated batter at 60 degrees F. or less for more than 12 hours.  I was told by an Inspector that the data is out there but he can't give it to me.  He said I have to find it on my own.  All I can find is the link below.  I know that exposure times greater than 12 hours at temperatures between 50 degrees F. and 70 degrees F. could result in toxin formation according to the following link but is there anything that is more specific?  If you can hold it at 50 degrees and 70 degrees for 12 hours how long can you hold it at 50 or 60 degrees for longer than 12 hours?  

 

Thank you in advance for any help.

 

 

https://www.fda.gov/.../80319/download

 

The quoted time criteria are probably based on Predictive Modelling using data generated by internal/literature studies (eg the refs in yr FDA link).

 

The limits are presumably based on (assumed) initial values  of S.aureus / characteristics of hydrated batter mix followed by calculation of time(s)  to reach levels of S.aureus which are "considered" to potentially enable generation of toxin. I assume conservative values / limits were applied. The full details may not have been published.

 

An illustrative, semi-worked out, example (2018) of one possible Predictive  approach is given in attachment below (see pages 58-64/69)

Attached File  Uses of microbial modelling, 2018.pdf   2.42MB   5 downloads

 

Re ^^^^(red) -  As I understand the intention of the quoted FDA critical limits are that the batter should not be held any longer than FDA's values (eg the haccp plan in yr link), ie such an occurrence would require a corrective action as per the haccp plan in yr link.


Kind Regards,

 

Charles.C


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#5 moskito

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Posted 14 August 2020 - 11:47 AM

Hi,

 

I have had a long discussion with a UK private label customer on exactly this topic (but shorter time), presenting predictive modelling results. At this time the models/tools and existing data were not applicable for our situation. In our case we havn't stored the batter (why we should do that?). We are producing batter batchwise in 3 vessels which are completely emptied (but not cleaned). Cleaning at the end of a shift. And we have process-related a partial recirculation of batter, what the auditor wanted to eliminate. His advise was based on a simple model.

I have been using models several times for cross check in risk assessments, but not for such type of unusual "fed-batch" (not nutrient, but microorganisms).

We are using the process since many years in this manner. I have monitored bacterial growth and possible toxin production several times over the years and never found an indication for unacceptable conditions.

I agree to apply modelling, but you should look how much your tool is able to model the conditions to be assessed.

 

Rgds

moskito



#6 QA_123

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Posted 14 August 2020 - 01:22 PM

Hello,

We do not "hold" it either.  I think I worded that wrong.  It sounds like we have close to the same process.  We have 2 - 3 vessels also.  They are not completely emptied but added to.  






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