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Is inversion of Hot-Filled package a CCP?

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onascaleofonetobotulism

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Posted 19 June 2018 - 06:37 PM

Is inverting of the bottles or other packages that have been hot-filled with a product according to the appropriate Process Schedule, considered a CCP in its own right?

 

If so, what are the critical limits? I know about the length of time that it should be inverted, but what about he time between filling and inversion? If product is filled, then immediately capped, how long is too long before being inverted? 

 

For context: this is a small process, maybe 100 bottles in one batch; filling is done by machine, but capping and inversion is manual. We have obtained a letter from a Process Authority, and I have already reached out to them about this, but wanted to cast a wide net as a backup.



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Posted 19 June 2018 - 06:42 PM

These steps will need to immediately concurrent.

 

If you don't cap and invert AQAP, the temperature will not be hot enough to pasteurize the neck and cap and you risk spoilage

 

What does your PA say?


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onascaleofonetobotulism

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Posted 19 June 2018 - 06:52 PM

Scampi-

 

PA has yet to reply to me (only been an hour, not too worried yet).

 

Our bottles and jugs don't have much of a "neck"-- very minimal.

 

We currently sample at least one bottle/jug for temperature retention during each cycle--i.e. we hot fill, invert for the PA-required time, then set it down for 5-10 minutes, open and check the temp, which is always still 180. Since the 5-10 minutes encompasses the 2-3 minutes we sometimes have between the usual capping and inversion, would that not be verification of the heat effectiveness for the latter?



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Posted 19 June 2018 - 07:21 PM

The schedule you've been provided with should tell you what your critical limits are for steps that are indeed critical, and inversion will probably be one of those

 

What temp are you filling at?


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onascaleofonetobotulism

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Posted 19 June 2018 - 07:48 PM

Our PA mandated cook temps/times, equilibrium pH, and a minimum filling temp, which is 180 Fahrenheit. Inversion must be at least 6 seconds. They did not specify in the letter, however, how long is too long between filling and inversion.



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Posted 19 June 2018 - 07:55 PM

So your six second inversion is based on 180F temperature I would assume which means that time between isn't your Critical Factor, heat is. So the only way to really know  how long is too long is to VALIDATE your process by taking temperatures repeatedly/constantly after a hot fill to see how long it takes to cool below 180, don't do this just once, but a multitude of times to be sure, then take the statistical average to create your critical length of time.

 

If your equilibrium pH is below 4, you should ok to have a little flexibility, if it's not, then your process should only allow you to hot fill as many as you can reasonably cap and invert while still maintaining 180.  That temperature really needs about 5 minutes of contact time to pasteurize the neck/lid

 

You also should record the room temperature and any air movement velocity as that information will change the amount of time you have until they container must be inverted


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onascaleofonetobotulism

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Posted 19 June 2018 - 08:08 PM

Any idea why the PA mandated 6 seconds of contact time for inversion?

 

For a small operation, how many data points would constitute an acceptable average? 20-25? 50? 100+? 

 

Currently, we fill 4 at a time, cap immediately, then when we have 8-12 on the roundtable at the end of the conveyor, we start laying them down in an inverted position. (And they stay that way for far longer than the minimum 6 seconds, too--call it operational limits if you'd like.)



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Posted 19 June 2018 - 08:14 PM

Nope, but it sounds a bit off to me

 

whats your finished pH?


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onascaleofonetobotulism

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Posted 19 June 2018 - 08:17 PM

Equilibrium pH must be 4.3 or below, according to PA. We actually average 3.7 to 3.9; haven't had one go over 4.01 since beginning equilibrium sampling.

 

We are cooking at an initial 200 degrees, before hot filling. And there aren't really any proteins, fats, etc.

 

It's a bottled chai tea, intended for reheating before serving--I guess you could try drinking it RTD, but, uh, gross.



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Posted 19 June 2018 - 08:20 PM


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onascaleofonetobotulism

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Posted 19 June 2018 - 08:27 PM

I have the NCSU info on file--they're also our Process Authority, so it lines up. I guess the goal is to minimize the fill-to-invert time to something that doesn't compromise the 180 minimum, then.

 

The team has already tested 40+ jugs/bottles at 5-10 minutes after closing, and temp is above 180 in all. That, to me, signals that our "comfort zone" of 2-3 minutes is acceptable.



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Posted 19 June 2018 - 08:30 PM

Ok gotcha

 

If you look at that first link, that's where they got the 6 second hold time, BUT THAT IS THE BEAR MINIMUM

 

I wouldn't be comfortable with 6 seconds at all.  We are about the same pH, but we still water bath because of the heat penetration (pickled veg) to kill the vegetative pathogens and spoilage organisms and to inactive the botulism spores

 

Makes much more sense to me now.  So,  yes the inversion time/temperature combination should be the CCP along with the cooking temperature

 

For me the time/temperature combination in the water bath pasteurizer is my CCP, although when I got here, there were 6!!! The poultry plant I left didn't have 6 in the whole place!!!


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onascaleofonetobotulism

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Posted 19 June 2018 - 08:38 PM

Yeah, 6 seconds seems minimal, but the PA has it as their official minimum--like I said, we have operational limits well in excess of that.

 

Our Chai is almost entirely liquid, with just some minimal fragments of spices/tea in the liquid. Heat is pretty homogenous throughout.

 

The CCPs I'm outlining in the HACCP, and building monitoring record templates for, are: 1. Cook Time/Temp; 2. pH of Acidified product, pre-fill; 3. Hot fill/hold/invert time and temp; and 4. Equilibrium pH.



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Posted 20 June 2018 - 03:45 PM

Yeah, 6 seconds seems minimal, but the PA has it as their official minimum--like I said, we have operational limits well in excess of that.

 

Our Chai is almost entirely liquid, with just some minimal fragments of spices/tea in the liquid. Heat is pretty homogenous throughout.

 

The CCPs I'm outlining in the HACCP, and building monitoring record templates for, are: 1. Cook Time/Temp; 2. pH of Acidified product, pre-fill; 3. Hot fill/hold/invert time and temp; and 4. Equilibrium pH.

 

The above are, i guess, numerical Operational limits, possibly Critical Limits but not CCPs.

 

I suggest you need to do a risk assessment/HA for Safety/CCPs. ie What is the SIGNIFICANT HAZARD(S) ? eg Post 12 perhaps.

 

(Not my area but i thought hot-fill was supposed to be relatively simple process compared to a full-blown retort sterilisation)


Kind Regards,

 

Charles.C


onascaleofonetobotulism

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Posted 20 June 2018 - 03:59 PM

Critical Limits are the quantitative values defining a CCP's execution vs. failure, no?
 

Critical limit: A criterion which separates acceptability from unacceptability.

Critical limits are established to determine whether a CCP remains in control. If a critical limit is exceeded or violated, the products affected are deemed to be potentially unsafe.

(iso22000, IMO it should have preferably stated that it is the control measure associated with the CCP which is relevant.)

 

I am conducting the Hazard Analysis, but it is assumed to include, at the least, microbiological contamination of product. This is intended to be controlled by a. initial cooking, b. acidification, and c. hot fill sterilization of container.

 

That's really 3 CCPs, so I guess the Equilibrium pH check is actually the monitoring of one of those CCPs, but not the CCP itself (though it does determine 100% whether or not a batch is good to go.)

 

So how to validate the critical limits ? (requires a specific target for the pasteurization process, eg worst case scenario)



Scampi

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Posted 20 June 2018 - 04:37 PM

Your scheduled process is your validation!  Lucky you

 

The validation simply means that under conditions X, Y and Z, the critical limits will ALWAYS work, 

 

You know that is you do not hit any of your CCP's (1 or more) your product either needs reprocessed or condemnded

 

OR you could call the equilibrium pH plus a review of the daily batch records your validation of the process and it's CCPs


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Posted 20 June 2018 - 07:18 PM

Your scheduled process is your validation!  Lucky you

 

The validation simply means that under conditions X, Y and Z, the critical limits will ALWAYS work, 

 

You know that is you do not hit any of your CCP's (1 or more) your product either needs reprocessed or condemnded

 

OR you could call the equilibrium pH plus a review of the daily batch records your validation of the process and it's CCPs

 

Hi Scampi,

 

Thks.

 

I am curious, does the provided "scheduled process" include an explanation/reference of how the "CLs" were arrived at ?


Kind Regards,

 

Charles.C


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Posted 20 June 2018 - 07:32 PM

Oh heavens No Charles, why would they want us to find errors in the work!!

 

It's a big calculation like this

www.fedegari.com/wp-content/uploads/2016/07/ST19_EBook_F0-What-it-means-How-to-calculate-it-How-to-use-it.pdf

 

My process is so massive and incomplete that we are over processing substantially so I've found someone who's willing and able to help me sort out the mess, but in the mean time, we follow the schedule we have


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