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RMAV

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Posted 01 February 2016 - 04:23 PM

New product, 100% Single-Strength Lemon Juice.  I've identified the CCP to control biological hazards.  The measurement is pH and hold time.

 

The step where pH is controlled is mixing.  The step where hold time is controlled is storage after filling/packaging, labeling, etc. 

 

My problem:  mixing occurs at step #3.  Storage occurs at step #12.  How should I express this in the HACCP plan?

 

Note: due to our process, the pH must be measured at step 3.  The hold time must be measured at step 12.  The control measure of pH and hold time are tied together as per my justification document. 

 

Thanks!



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Posted 01 February 2016 - 04:45 PM

New product, 100% Single-Strength Lemon Juice.  I've identified the CCP to control biological hazards.  The measurement is pH and hold time.

 

The step where pH is controlled is mixing.  The step where hold time is controlled is storage after filling/packaging, labeling, etc. 

 

My problem:  mixing occurs at step #3.  Storage occurs at step #12.  How should I express this in the HACCP plan?

 

Note: due to our process, the pH must be measured at step 3.  The hold time must be measured at step 12.  The control measure of pH and hold time are tied together as per my justification document. 

 

Thanks!

 

Hi RMAV,

 

The process is rather unobvious (to me). fresh, pasteurised, sterilized, acidified ??

 

What is the relevance of "hold time" ?


Kind Regards,

 

Charles.C


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Posted 01 February 2016 - 06:25 PM

In the U.S., 100% juice is required to undergo a 5-log reduction in the pathogens of concern at the final point of packaging.  In the case of single-strength 100% lemon juice, I have documentation to show a 5-log reduction at a certain pH but only after so-many hours (hold time). 



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Posted 01 February 2016 - 06:29 PM

In the U.S., 100% juice is required to undergo a 5-log reduction in the pathogens of concern at the final point of packaging.  In the case of single-strength 100% lemon juice, I have documentation to show a 5-log reduction at a certain pH but only after so-many hours (hold time). 

 

Hi RMAV,

 

so the hold time is the time at the pasteurizing plateau temperature ? (I presume this is heat-driven?)(or pH?)

 

Regardless, if the process is synergic you can typically declare the 2 interlocked control variables as a combined CCP unless yr particular FS standard does not allow such.


Kind Regards,

 

Charles.C


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Posted 01 February 2016 - 06:34 PM

No heat.  Just pH / acidity.  E.Coli O157:H7 is the "concern" and it is inactivated between 48 - 72 hours.  Here's a link to the study: https://www.research...and_Lime_Juices



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Posted 01 February 2016 - 07:47 PM

No heat.  Just pH / acidity.  E.Coli O157:H7 is the "concern" and it is inactivated between 48 - 72 hours.  Here's a link to the study: https://www.research...and_Lime_Juices

 

Hi RMAV,

 

Thanks for link.

 

Looks like maybe 3 variables (critical limits?) involved - pH, temp., time

 

The "CCP" will logically depend on precisely how/where the >= 5log reduction is achieved/validated. If totally at steps 3,12  can probably either express as 2 CCPs or a combimed CCP.

If contributions to >=5log reduction from steps 4-11, will need to consider those also.


Kind Regards,

 

Charles.C


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Posted 01 February 2016 - 08:17 PM

How would I express it as a "combined" CCP?  Say, on a flow chart, could I call the it CCP 1 at step 3 with a reference to time as well, then again, CCP 1 at step 12 (storage time).  This is what I had been thinking of doing, but I don't know if that's too strange to do it that way.

 

Yes, temperature plays a role in the study but they unfortunately did not study a range of temperatures.  I'm hoping to leave it at "ambient storage" temperature and call it good, but if someone nitpicks, they may require me to show temperature of storage - this will be impossible for me to hold at a precise temperature, but I'll be able to show that it is not in cold conditions.  I have looked for further study regarding the hold temperatures without success.  I am also not keen on doing such challenge studies.



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Posted 01 February 2016 - 08:19 PM

Not sure how to edit my post...

 

I should have added that the combination of steps 3 and 12 is what gives me the 5-log reduction, i.e. CCP, but step 3 alone does not do it, nor step 12 alone.



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Posted 01 February 2016 - 08:57 PM

Not sure how to edit my post...

 

I should have added that the combination of steps 3 and 12 is what gives me the 5-log reduction, i.e. CCP, but step 3 alone does not do it, nor step 12 alone.

 

Hi RMAV,

 

It's all a question of validation, eg  the necessity to demonstrate a >=5log reduction is achieved in step 12, or [step5 + step12] or ....... ?

 

(I could not find any evidence on  IT that the FDA have so far "approved" this (2008) procedure ?)(ie no official critical limits for pH, time, etc  exist)

 

Re-  format, IMEX the normal hazard analysis presentation is to go step- by- step as the flowchart. Linkages in the hazard analysis between steps can be noted in the "control measure" column and subsequently in the "critical limit" column


Kind Regards,

 

Charles.C


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Posted 01 February 2016 - 09:00 PM

Thank you very much.  I really appreciate your help



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Posted 02 February 2016 - 06:40 AM

Hi RMAV,

 

I'm not sure I like the idea of unpasteurized juice but hopefully you validation data stands up.

 

So to the idea of control, my view of this is that I check the pH and hold the product for 3 days and check the pH prior to release. My pH level is the critical limit at 0 and 72hrs?

 

Two CCP's - one at 0 hrs and one at 72hrs. Some may even argue that 0hrs is not the CCP but I'm more worried about the control.

 

Kind regards,

 

Tony



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Posted 02 February 2016 - 01:47 PM

Hi RMAV,

 

Thanks for link.

 

Looks like maybe 3 variables (critical limits?) involved - pH, temp., time

 

The "CCP" will logically depend on precisely how/where the >= 5log reduction is achieved/validated. If totally at steps 3,12  can probably either express as 2 CCPs or a combimed CCP.

If contributions to >=5log reduction from steps 4-11, will need to consider those also.

 

Hi RMAV,

 

I have a couple of questions. Are you recording temperatures at least daily in your storage using a NIST calibrated thermometer? I'd think that would be really important because the study you linked shows storage conditions at 22C (approx. 71F). I know this is typically room temperature (not always if the room isn't temperature controlled though), but you need to show that the storage is at least 22C. You should also think about having the room temperature controlled, if it isn't currently. We have a lot of warehouse space in my company and storage temperatures can vary from room to room.

 

Have you also been validating your 5-log reduction as well? I know that you have the document, but you should be able to show that you've done some testing as well, and you are indeed getting your needed reduction. CCP validation is extremely important, so you must be able to totally justify your processes.

 

QAGB


Edited by Tony-C, 02 February 2016 - 02:18 PM.
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RMAV

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Posted 02 February 2016 - 05:08 PM

Hi RMAV,

 

I'm not sure I like the idea of unpasteurized juice but hopefully you validation data stands up.

 

So to the idea of control, my view of this is that I check the pH and hold the product for 3 days and check the pH prior to release. My pH level is the critical limit at 0 and 72hrs?

 

Two CCP's - one at 0 hrs and one at 72hrs. Some may even argue that 0hrs is not the CCP but I'm more worried about the control.

 

Kind regards,

 

Tony

The step at 0 hours had me troubled as it is not exactly the step at which control is applied, but also not the 72 hour step by themselves.  That's where I'm leaning toward connecting those two steps in the plan as the CCP.  We definitely must control the step at 0 hours (mixing).



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Posted 02 February 2016 - 05:19 PM

I'd link the CCPs in step 3 and Step 12 by calling them CCP 1. I have two step CCPs in a number of HACCP plans, mind you the steps come directly after one another but are distinctly different steps. So long as you are able to show VALIDATION of the process, which is a study carried out in your plant with your equipment which shows beyond reasonable doubt that you are achieving your 5 log reduction, then after that VERIFICATION comes from the recording of the pH,temperature and the time in and the time out of hold.


I'm entitled to my opinion, even a stopped clock is right twice a day

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RMAV

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Posted 02 February 2016 - 05:20 PM

Hi RMAV,

 

I have a couple of questions. Are you recording temperatures at least daily in your storage using a NIST calibrated thermometer? I'd think that would be really important because the study you linked shows storage conditions at 22C (approx. 71F). I know this is typically room temperature (not always if the room isn't temperature controlled though), but you need to show that the storage is at least 22C. You should also think about having the room temperature controlled, if it isn't currently. We have a lot of warehouse space in my company and storage temperatures can vary from room to room.

 

Have you also been validating your 5-log reduction as well? I know that you have the document, but you should be able to show that you've done some testing as well, and you are indeed getting your needed reduction. CCP validation is extremely important, so you must be able to totally justify your processes.

 

QAGB

Part of the trouble with the study is that I do not have a storage temperature range.  I only know that 0°C took "more than a week."  The conditions of storage are not always dead-on 22°C.  A challenge study here would pose more risk than it is worth as my concentrates come having had a 5-log reduction and none of my other raw materials pose a real risk of introducing pathogens into the environment or process.  That and I think just about all my customers would prohibit this.

 

I do have the benefit of some history behind this.  It is a product for which I have records of having been produced before with four different FDA inspections over that time frame.  The CCP was the same as I am proposing, but it was not spelled out very well.

 

Single-strength lemon juice has a pH of 2.4-2.6 or so.  Pretty tough material for pathogens to survive in and very unlikely to be introduced into the material in the first place at this facility.  Yet, as it is 100% juice, it must be considered high risk according to our regulatory body.



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Posted 02 February 2016 - 05:23 PM

I'd link the CCPs in step 3 and Step 12 by calling them CCP 1. I have two step CCPs in a number of HACCP plans, mind you the steps come directly after one another but are distinctly different steps. So long as you are able to show VALIDATION of the process, which is a study carried out in your plant with your equipment which shows beyond reasonable doubt that you are achieving your 5 log reduction, then after that VERIFICATION comes from the recording of the pH,temperature and the time in and the time out of hold.

So far, validation using the scientific justification has been adequate for our processes in 3rd party audits and regulatory inspections.  Our products are pretty low-risk and, in the case of a couple of other processes, we're able to test and show the equipment does what it is supposed to do to control the identified hazard.



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Posted 02 February 2016 - 05:26 PM

So far, validation using the scientific justification has been adequate for our processes in 3rd party audits and regulatory inspections.  Our products are pretty low-risk and, in the case of a couple of other processes, we're able to test and show the equipment does what it is supposed to do to control the identified hazard.

On the other hand, when I was in RTE meats, we changed the process for, for lack of a better term, listeria control.  We had scientific justification, but you'd better believe we completed challenge studies under very careful and controlled conditions. 



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Posted 02 February 2016 - 05:26 PM

Oh well you're flying then... I'd link the two steps as one CCP but that's just my opinion.


I'm entitled to my opinion, even a stopped clock is right twice a day

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Posted 02 February 2016 - 05:39 PM

Oh well you're flying then... I'd link the two steps as one CCP but that's just my opinion.

I'm continuing to research.  It's turned into a big month-long headache so far!



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Posted 02 February 2016 - 06:57 PM

The step at 0 hours had me troubled as it is not exactly the step at which control is applied, but also not the 72 hour step by themselves.  That's where I'm leaning toward connecting those two steps in the plan as the CCP.  We definitely must control the step at 0 hours (mixing).

 

I'm struggling here as you seem to be contradicting yourself 'The step at 0 hours had me troubled as it is not exactly the step at which control is applied' & 'We definitely must control the step at 0 hours (mixing).'

 

:uhm:



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Posted 02 February 2016 - 08:08 PM

I'm struggling here as you seem to be contradicting yourself 'The step at 0 hours had me troubled as it is not exactly the step at which control is applied' & 'We definitely must control the step at 0 hours (mixing).'

 

:uhm:

Sorry for the confusion.  Both steps together is the hazard control, but Mixing (step at 0 hours) controls pH, Storage controls the hold time (step at 72 hours). it's pH plus hold time that controls the hazard, but not pH alone and not time alone.  At least that's how it is in my mind - which I admit I may be losing.



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Posted 02 February 2016 - 10:04 PM

Hi RMAV,

 

Out of curiosity, why do you not run the ("CCP") steps in sequence ?. Seems the most logical control procedure.

 

There are analogous processes elsewhere in which the control of 2 variables "boosts" the reduction (= synergy),  but IMEX, as per Trubertq, the activities are usually closely "combined" eg see the short attachment in this post -

 

http://www.ifsqn.com...indpost&p=85830


Kind Regards,

 

Charles.C


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Posted 03 February 2016 - 07:55 AM

I think from the definition of a CCP, It should be clear that the last stage, 12 is the one that result in the control of the pathogen(s) being dealt with. So Step 12 is the CCP despite that you have created conditions(pH) that you require to achieve a 5-log reduction.



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Posted 03 February 2016 - 08:08 AM

I think from the definition of a CCP, It should be clear that the last stage, 12 is the one that result in the control of the pathogen(s) being dealt with. So Step 12 is the CCP despite that you have created conditions(pH) that you require to achieve a 5-log reduction.

 

hi Imugs,

 

Try this link (see step 7) -

 

http://www.fao.org/d...9e/y1579e03.htm

 

But perhaps you have a different definition.

 

Logically, it comes back to risk assessment.


Kind Regards,

 

Charles.C


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Posted 03 February 2016 - 02:56 PM

Just a thought, since the actual control is being at the correct pH for the specified time you could call the mixing step a control point (CP) and the holding time the CCP





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