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HACCP in Fermentation Process

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ganeshkashinath

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Posted 03 February 2015 - 09:09 AM

Hi All,

 

I need a second opinion on the Hazard Analysis I am doing  for fermentation process . 

 

Basically , the process of fermentation consists of fermenting rice bran with a fungal culture . 

 

The steps involved are 

 

1. Autoclaving of substrate(Proposed CCP)

2. Mixing of starter culture and substrate.

3.Fermentaion

4.Drying

5. Milling

6. Blending.

 

The starter culture is prepared by taking spores and inoculating it with media  to get enough spores and use it as starter culture . 

 

My risk assessment says , autoclaving will be a CCP . The question is , when preparing starter culture  the initial spores are transferred to autoclaved media , will this autoclaving will also be a CCP ?Can a single CCP be enough to mitigate the hazard in two different process having common hazard. 

 

As in,if I make my autoclaving as CCP, so when ever I autoclave something will it be attributed to CCP 

 

Please let me know , if I am wrong in my understanding . 

 

Thanks and Regards,

Ganesh 



michaelgaspard

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Posted 03 February 2015 - 02:54 PM

Hi Ganesh,

just to share my opinion,

if there is a second Autoclaving to get rid of the hazard, i think that the first one becomes a control point, unless you will consume the product at the first autoclaving also from time to time, then it becomes a CCP. see your decision tree, the 5 steps in codex alimetarius.

 

I think you will not start Autoclaving everything in the same autoclave you are having your CCP!!!

 

Please let me know if I have understood your questions,

kind regards,

Michael G



Mr. Incognito

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Posted 03 February 2015 - 03:03 PM

A critical control point is the last place that control can be applied to remove a hazard or reduce it to an acceptable level.

 

So if what you are autoclave the first time is also involved in the 2nd autoclave application and isn't going to be used without the 2nd application then the 2nd one is the CCP the first one could be a control point.


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ganeshkashinath

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Posted 04 February 2015 - 10:23 AM

Thanks everyone for replying . 

 

Basically my process involves addition of inoculum(Live Microorganism) into a autoclaved substrate. Will the  quality of the inoculum be a CCP. My hazard analysis says , there could be microbial contamination , but yet again following all GMPS, I should not have any contamination . 

 

My enemy in this case would be time , as culturing the microorganism(Determining contamination ) will take time and the technology is so that I have to use it the very same day. 

 

Preparation of inoculum 

1. Mother culture 

2. Production of  first & second generation ( Includes autoclaving of media) 

3. Preparation of inoculum 

4.This inoculum is mixed with a autoclaved substrate.

 

Deriving from Hazard analysis , I presume the autoclaving  at 2 step and 4 step would be CCPs. using laminar air flow and other things could be PRPs.

 

I thank you again for taking time to go through this and responding . 

 



Mr. Incognito

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Posted 04 February 2015 - 12:07 PM

your determination of what should be a CCP should come from a thorough risk analysis of the frequency and severity that a hazard could occur at that step that is a risk to illness or injury to someone using the product.

 

like I said before a CCP is nearly always the final step that control can be applied that will eliminate or reduce a hazard to an acceptable level.

 

Beyond that I don't know your process or product well enough to give you a direct answer on where your CCP(s) should be.


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ganeshkashinath

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Posted 07 February 2015 - 08:43 AM

Thank you for your inputs .

 

In one of my process , my hazard analysis is directing me towards a microbial contamination. I did a  "what If " analysis  assuming I have a contaminant , in this regard  I risk my product with microbial toxin contamination .  But  according to regulation my product will still be safe to be consumed(Because of the contaminant limit ) . In this case , this will not be a CCP , right ? 

 

The contamination cannot occur because of the physiology  of the microorganism and product characteristics which will prevent any further harm to the product.Can I refer to  a scientific paper to prove it is not a CCP

 

Thanks and Regards,



Charles.C

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Posted 07 February 2015 - 09:58 AM

Dear ganeshkashinath,

 

The hazard analysis requires knowledge of, for example, the product, process, intended use, (eg how [RTE} and by whom). (eg as per Codex)

 

The first step is typically to define the hazards, ie "microbial contamination" is an inadequate concept  unless the product specification requires sterility which seems improbable in this case.

 

The decision as to PRPs / CCPs etc may also depend on yr intended use of the result, ie audited or not ?

 

It might help if you could provide a link to a related process since i daresay many people here, including myself, are unfamiliar with your process (and unknown product).

 

Rgds / Charles.C


Kind Regards,

 

Charles.C




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