20 replies to this topic

[amdtarmizi]

hello guys,

 

i need a help regarding the ccp validation. Can anyone explain what the procedure and documents needed to validate the cooking temperature-( 85degC -30mins ) and pasteurization(85degC-5min, 25degC-5mins).We are producing pudding and jelly in cups.

[Charles.C]

hello guys,

 

i need a help regarding the ccp validation. Can anyone explain what the procedure and documents needed to validate the cooking temperature-( 85degC -30mins ) and pasteurization(85degC-5min, 25degC-5mins).We are producing pudding and jelly in cups.

Dear amdtarmizi,

 

It is probable that there is a local legislatory requirement for the product / process you are referring. This usually refers to a core temperature and minimum time or similar.

 

It is unclear to me what product / process / location yr temperature/time data actually refers to but it appears rather atypical.

 

I presume the 25degC is a cooling step ?

 

Maybe you can provide more details.

 

Rgds / Charles.C

[amdtarmizi]

Dear amdtarmizi,

 

It is probable that there is a local legislatory requirement for the product / process you are referring. This usually refers to a core temperature and minimum time or similar.

 

It is unclear to me what product / process / location yr temperature/time data actually refers to but it appears rather atypical.

 

I presume the 25degC is a cooling step ?

 

Maybe you can provide more details.

 

Rgds / Charles.C

Dear Charles

many thanks for yor reply, FYI we are producing pudding and jelly and now in the process to get an iso 22000.The auditor ask to validate all the ccp and oprp. we have 3 ccp, cooking,pasteurization and metal detector. Could you explain in detail how to validate,what are the  documents involved which i need to keep in a validation file.

Thanks

 

[Charles.C]

Dear amdtarmisi,

 

thks yr flowchart.

 

i appreciate yr difficulty but it's rather difficult to analyse a flow chart / hazards without knowledge of the type of ingredients.

 

I'm not immediately familiar with this type of process but other people here hopefully may be.

 

Rgds / Charles.C

[Tony-C]

Dear amdtarmisi,

 

For this process as you are cooking then pasteurizing (in pack) it seems that you are likely to need to validate yourself!

You will need to validate that at maximum load for your ingredients (as per your agreed specifications) the minimum cooking temperature/time combination (80C 40 mins) and the minimum pasteurization temperature/time (75C 10 mins) produce a product that is microbiologically sound. If developing a product I would be doing this on at least 3 separate production runs.

I am assuming that OPRP 1 is a sealing temperature.

Regards,

Tony

[George @ Safefood 360°]

There are a number of factors to be considered when validating CCP’s such as cooking and pasteurisation. The information required to do this properly is not present in your post so much of what will follow in speculative at best. Firstly, validation of a CCP or oPRP means proving objectively that the control(s) employed are in fact capable of eliminating or reducing the hazard to an acceptable level. As you might begin to see, proper validation requires clear identification of the hazards concerned. In the case of heat treatment ccp’s this usually means the identification of ‘target pathogens’. If you do not clearly identify the target pathogens then there is no basis for any subsequent validation work.

The target pathogens, as Charles indicates, are based on those which are associated with the ingredients used and those potentially introduced in the process prior to the control step i.e. thermal treatment, cooling. If the puddings are rice based you will have one set of characteristic pathogens. If the pudding is cream based there will be another set. Your post does not provide sufficient information on this.

For heat treatment controls you are usually seeking to validate the process time and temp combination regarding its ability to achieve a log reduction of the target pathogen. This can be obtained from guidance documents or through challenge testing. You also need to validate that the process under maximum load and conditions is capable of achieving the required time/temp in all parts of the cooking vessel. This is often validated using a multi-point probe survey of the cooking vessel, or in the case of sealed containers going through a water bath, checking multiple packs across multi cycles to determine the ‘cold spot’ which then becomes the point you monitoring the CCP subsequently. In terms of documentation, simply produce a report which sets out your methodology, basis of validation and all associated data and keep on file with your written conclusions

Finally, just one comment. Your process has two CCP points which are based on heat treatment. This would imply that the risks require two lethal steps. The question is why? In terms of HACCP principles the final heat treatment step would be a CCP since in the decision tree for the first it would emerge that a subsequent step will address the hazard. There may be good reason for this but it is not immediately obvious.

George

Edited by George Howlett, 13 February 2014 - 09:45 PM.

[Charles.C]

Hi George,

 

Thanks for the elaboration of the principles involved.

 

Finally, just one comment. Your process has two CCP points which are based on heat treatment. This would imply that the risks require two lethal steps. The question is why? In terms of HACCP principles the final heat treatment step would be a CCP since in the decision tree for the first it would emerge that a subsequent step will address the hazard. There may be good reason for this but it is not immediately obvious.

 

And this was where I got a bit lost also.

in fact i am unsure as to the purpose of the "cooking" step altogether.

Is this a sous-vide process so a sort of combined CCP ?

 

Maybe the OP / any pudding experts here can donate some light into the darkness ?

 

Rgds / Charles.C

[swanswal]

Hi.  I am not an expert on puddings specifically, but thermal process in general.  So me more questions....

 

After cooking, is there an intermediate storage step prior to filling?  What is your filling temp?  Answers may help explain the pasteurisation step.  This is most puzzling to me and I am speculating that it is to deal with the potential risk of packaging micro contamination.

 

I suggest that the purpose of the cooking step is to 'activate' the thickening agents in your mixes.  It is coincidental that the temps would also be a reasonable pathogenic kill step.

[amdtarmizi]

Hi.  I am not an expert on puddings specifically, but thermal process in general.  So me more questions....

 

After cooking, is there an intermediate storage step prior to filling?  What is your filling temp?  Answers may help explain the pasteurisation step.  This is most puzzling to me and I am speculating that it is to deal with the potential risk of packaging micro contamination.

 

I suggest that the purpose of the cooking step is to 'activate' the thickening agents in your mixes.  It is coincidental that the temps would also be a reasonable pathogenic kill step.

Hi,

after cooking direct pump to filling and sealing machine, no intermediate storage.Filling temp, i assumed 80degC because after cooked immediately pump to filling machine.

 

"I suggest that the purpose of the cooking step is to 'activate' the thickening agents in your mixes.  It is coincidental that the temps would also be a reasonable pathogenic kill step." - Yes it is

 

and the purpose of water bath pasteurization  are to  eliminate microbial contamination on sealed cups and wash the mixes residue after sealing.

Our process has 2 ccp based on  thermal, it's reasonable. Should i remove either one.Pls advise

[swanswal]

IF, all products are going through the cook step to the temps you have described, this is an effective pathogenic kill step (which you will validate), which effectively eliminates the 'pasteurisation step' as a CCP.

 

I am suspicious of why the pasteurisation step is there though.....  Does the jelly product go through the 'cooking' step to similar temps?  I suspect it may not, but the cooking vessel simply be used as a blending/mixing step, with no heat (read no kill step).  If this is the case, then that is the reason for the pasteurisation step.

 

Can you comment on this.....

[amdtarmizi]

There are a number of factors to be considered when validating CCP’s such as cooking and pasteurisation. The information required to do this properly is not present in your post so much of what will follow in speculative at best. Firstly, validation of a CCP or oPRP means proving objectively that the control(s) employed are in fact capable of eliminating or reducing the hazard to an acceptable level. As you might begin to see, proper validation requires clear identification of the hazards concerned. In the case of heat treatment ccp’s this usually means the identification of ‘target pathogens’. If you do not clearly identify the target pathogens then there is no basis for any subsequent validation work.

The target pathogens, as Charles indicates, are based on those which are associated with the ingredients used and those potentially introduced in the process prior to the control step i.e. thermal treatment, cooling. If the puddings are rice based you will have one set of characteristic pathogens. If the pudding is cream based there will be another set. Your post does not provide sufficient information on this.

For heat treatment controls you are usually seeking to validate the process time and temp combination regarding its ability to achieve a log reduction of the target pathogen. This can be obtained from guidance documents or through challenge testing. You also need to validate that the process under maximum load and conditions is capable of achieving the required time/temp in all parts of the cooking vessel. This is often validated using a multi-point probe survey of the cooking vessel, or in the case of sealed containers going through a water bath, checking multiple packs across multi cycles to determine the ‘cold spot’ which then becomes the point you monitoring the CCP subsequently. In terms of documentation, simply produce a report which sets out your methodology, basis of validation and all associated data and keep on file with your written conclusions

Finally, just one comment. Your process has two CCP points which are based on heat treatment. This would imply that the risks require two lethal steps. The question is why? In terms of HACCP principles the final heat treatment step would be a CCP since in the decision tree for the first it would emerge that a subsequent step will address the hazard. There may be good reason for this but it is not immediately obvious.

George

 

IF, all products are going through the cook step to the temps you have described, this is an effective pathogenic kill step (which you will validate), which effectively eliminates the 'pasteurisation step' as a CCP.

 

I am suspicious of why the pasteurisation step is there though.....  Does the jelly product go through the 'cooking' step to similar temps?  I suspect it may not, but the cooking vessel simply be used as a blending/mixing step, with no heat (read no kill step).  If this is the case, then that is the reason for the pasteurisation step.

 

Can you comment on this.....

HI,

the cooking temp must reach 85degC then go to Hot filling step.

[swanswal]

HI,

the cooking temp must reach 85degC then go to Hot filling step.

 

So, if it has been determined that all products going through this process must go through a cooker which brings the material up to 85 deg C, and then the product is immediately filled into sanitary packaging, to me there is no sense that I can see (from a Food Safety point of view) in having a pasteurisation step immediately after that.  This cooking step is far more lethal than the pasteurisation step.

 

And this is the bit that intrigues me....    Regular 2 step heat kill steps usually increase in temps as they go.  I have never seen a second heat step cooler than a previous one if there has been no other ingredients added or hold steps.  Who designed this process?

 

I definately agree that based on the information presented so far, the second (pasteurisation ccp) is superfluous as a kill step.  In fact the pasteurisation step is superfluous from a Food Safety standpoint.

[amdtarmizi]

There are a number of factors to be considered when validating CCP’s such as cooking and pasteurisation. The information required to do this properly is not present in your post so much of what will follow in speculative at best. Firstly, validation of a CCP or oPRP means proving objectively that the control(s) employed are in fact capable of eliminating or reducing the hazard to an acceptable level. As you might begin to see, proper validation requires clear identification of the hazards concerned. In the case of heat treatment ccp’s this usually means the identification of ‘target pathogens’. If you do not clearly identify the target pathogens then there is no basis for any subsequent validation work.

The target pathogens, as Charles indicates, are based on those which are associated with the ingredients used and those potentially introduced in the process prior to the control step i.e. thermal treatment, cooling. If the puddings are rice based you will have one set of characteristic pathogens. If the pudding is cream based there will be another set. Your post does not provide sufficient information on this.

For heat treatment controls you are usually seeking to validate the process time and temp combination regarding its ability to achieve a log reduction of the target pathogen. This can be obtained from guidance documents or through challenge testing. You also need to validate that the process under maximum load and conditions is capable of achieving the required time/temp in all parts of the cooking vessel. This is often validated using a multi-point probe survey of the cooking vessel, or in the case of sealed containers going through a water bath, checking multiple packs across multi cycles to determine the ‘cold spot’ which then becomes the point you monitoring the CCP subsequently. In terms of documentation, simply produce a report which sets out your methodology, basis of validation and all associated data and keep on file with your written conclusions

Finally, just one comment. Your process has two CCP points which are based on heat treatment. This would imply that the risks require two lethal steps. The question is why? In terms of HACCP principles the final heat treatment step would be a CCP since in the decision tree for the first it would emerge that a subsequent step will address the hazard. There may be good reason for this but it is not immediately obvious.

George

hi George,

 

FYI the ingredients are(water, milk powder, sugar,carrageenan,cmc gum, flavour, colour, acidity regulator), and the product pH is 3.8-4.2. Based on the ingredient and pH what are the susceptible pathogen.

I need to find any journal/reference regarding the temp and time for target pathogen.

[swanswal]

Is the product a Commercially Sterile product or short shelf life?  This will dictate the log reduction required.  You will also need to know worst case initial micro loads.

[amdtarmizi]

Is the product a Commercially Sterile product or short shelf life?  This will dictate the log reduction required.  You will also need to know worst case initial micro loads.

yes it's commercially sterile. thanks

[Charles.C]

yes it's commercially sterile. thanks

 

Dear amdtarmizi,

 

I suppose you realise that the thermal requirements for pasteurisation are totally different to sterilisation (added later - but not necessarily to "commercially sterile" )?

 

Are you familiar with the typical thermal theory for sterilisation requirements, eg 12D + ?

 

It appears that the flowchart may have been analysed by someone who was not familiar with technical terminologies.

 

I presume there was some original logic applied in the labelled designations of CCP1, CCP2, OPRP ? Do you know what that was ?

 

It may be useful for you to supply the finished product specification (without revealing the product identity if necesary), eg shelf stable or,  if not, storage requirements, ie temp. / time.

 

Rgds / Charles.C

[amdtarmizi]

hello guys,

any validation docs sample, related to heat treatment.

[Charles.C]

Dear amdtarmizi,

 

Ignoring the uncertainties in the flowchart, I assume the primary  FS-related thermal process is a variation of  "hotfill".

I suggest -

(1)  see the linked post below and   

(2) see the sublinked post, and especially the attachment indicated which explains the operational interface between sterilization and pasteurization. I hope this will have some relevance to yr system (especially Pg2,right-hand column et seq). Yr feedback might then be helpful.

 

http://www.ifsqn.com...ces/#entry46598

 

It is easier to suggest validation material when one knows what is being required to validate.

 

Rgds / Charles.C

[Tony-C]

 

Your process has two CCP points which are based on heat treatment. This would imply that the risks require two lethal steps. The question is why? In terms of HACCP principles the final heat treatment step would be a CCP since in the decision tree for the first it would emerge that a subsequent step will address the hazard. There may be good reason for this but it is not immediately obvious.

 

And this was where I got a bit lost also.

in fact i am unsure as to the purpose of the "cooking" step altogether.

Is this a sous-vide process so a sort of combined CCP ?

 

Maybe the OP / any pudding experts here can donate some light into the darkness ?

 

Rgds / Charles.C

 

IME of similar products second step is to ensure there is no contamination from the packaging although if the filling temperature is sufficient then it may not be necessary.

 

Regards,

 

Tony

[genebartholomew]

While it is nice to have all of the details for a particular heat treatment so one can tailor the cook to suit all of the parameters of product, such as expected pathogen load, etc., it is my opinion that we are overdoing it in this case. This is vey similar to a hot fill cook, as the pH is below that which would support growth of most spore formers of health significance. That being the case, you can pick some of the usual food borne pathogens such as Salmonella, pathogenic E. coli, coagulase positive staphylococcus, etc as the target organisms for lethality. It would be highly unlikely that any of these organisms would be present at greater than 10 million per gram. If you use AMIF.org's process lethality schedule and plug in a hold time of 30 minutes at 85°C (185°F, and enter it every two minutes to add up to 30), you get a log reduction of at least 25,000 for Salmonella (using a very conservative D value of 1.4 min at Tref145. Similar food borne pathogens would be show similar declines, although Listeria may be an order of magnitude less. Bottom line is, without knowing anything about ingredients going into the pudding, you can use this data as a validation. People have looked at die off of bacteria by heat in many systems and there are some differences, but they are not huge. This calculation shows you have a huge overkill, so go with it.

[Tony-C]

While it is nice to have all of the details for a particular heat treatment so one can tailor the cook to suit all of the parameters of product, such as expected pathogen load, etc., it is my opinion that we are overdoing it in this case. This is vey similar to a hot fill cook, as the pH is below that which would support growth of most spore formers of health significance. That being the case, you can pick some of the usual food borne pathogens such as Salmonella, pathogenic E. coli, coagulase positive staphylococcus, etc as the target organisms for lethality. It would be highly unlikely that any of these organisms would be present at greater than 10 million per gram. If you use AMIF.org's process lethality schedule and plug in a hold time of 30 minutes at 85°C (185°F, and enter it every two minutes to add up to 30), you get a log reduction of at least 25,000 for Salmonella (using a very conservative D value of 1.4 min at Tref145. Similar food borne pathogens would be show similar declines, although Listeria may be an order of magnitude less. Bottom line is, without knowing anything about ingredients going into the pudding, you can use this data as a validation. People have looked at die off of bacteria by heat in many systems and there are some differences, but they are not huge. This calculation shows you have a huge overkill, so go with it.

 

 

Whilst I understand your comments regarding overkill in the heat treatment I am sure an auditor would find your validation more than a little lacking in depth. It also does not consider contamination post heat treatment.

 

By carrying out product trials as per my previous post the whole process is validated.

 

Regards,

 

Tony