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Acidified food help, please!

process authority acidified food challenge testing

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#1 svnh.bell

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Posted 11 January 2016 - 03:55 PM

Good Morning all, 

 

We have a product (dietary supplement ingredient) that will most likely be classified as an acidified food. This is our first foray into this arena of regulation, so any help would be much appreciated.  

 

I'm aware that we need to have our process evaluated by a recognized Process Authority. We have reached out to a few. Several I have not received any follow-up from and another responded, but the challenge testing quote was crazy expensive; 6 times the cost of our normal challenge test costs through another facility.

 

My main question: does the challenge testing need to be performed by a Process Authority, or can we use our normal external lab and send those results to the Process Authority to evaluate? 

 

Additionally, does anyone have recommendations on a Process Authority to use? 

 

Thank you in advance for any help! 


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#2 Simon

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Posted 11 January 2016 - 07:14 PM

If you can give some idea of where you are located it may hep you to get recommendations.

 

Regards,

Simon


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#3 svnh.bell

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Posted 11 January 2016 - 07:23 PM

Yes, Simon. Thank you :) 

 

I am located in NE Ohio. We manufacture various food, beverage, dietary supplement and cosmetic ingredients. 


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#4 Charles.C

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Posted 11 January 2016 - 10:50 PM

Good Morning all, 

 

We have a product (dietary supplement ingredient) that will most likely be classified as an acidified food. This is our first foray into this arena of regulation, so any help would be much appreciated.  

 

I'm aware that we need to have our process evaluated by a recognized Process Authority. We have reached out to a few. Several I have not received any follow-up from and another responded, but the challenge testing quote was crazy expensive; 6 times the cost of our normal challenge test costs through another facility.

 

My main question: does the challenge testing need to be performed by a Process Authority, or can we use our normal external lab and send those results to the Process Authority to evaluate? 

 

Additionally, does anyone have recommendations on a Process Authority to use? 

 

Thank you in advance for any help! 

 

Hi svnh.bell,

 

The question of competency for a Process Authority has come up before here in the context of low acid canning processes. From memory, the appointee was required to personally  inspect all the system / proposed process / data and then cogitate over their validity (specific FDA documents on website were required to be filled in by the PA).

 

The PA was required to be recognized as an "authority" however the definition of "recognized' and by whom seemed somewhat imprecise, ie it might be based on "reputation/status/publications" rather than a specific certification. The "whom" was never exactly resolved but i daresay it is specified somewhere.


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Kind Regards,

 

Charles.C


#5 QAGB

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Posted 12 January 2016 - 12:49 PM

Good Morning all, 

 

We have a product (dietary supplement ingredient) that will most likely be classified as an acidified food. This is our first foray into this arena of regulation, so any help would be much appreciated.  

 

I'm aware that we need to have our process evaluated by a recognized Process Authority. We have reached out to a few. Several I have not received any follow-up from and another responded, but the challenge testing quote was crazy expensive; 6 times the cost of our normal challenge test costs through another facility.

 

My main question: does the challenge testing need to be performed by a Process Authority, or can we use our normal external lab and send those results to the Process Authority to evaluate? 

 

Additionally, does anyone have recommendations on a Process Authority to use? 

 

Thank you in advance for any help! 

 

 

Our company uses NC State's Food Science Lab (Department of Food, Bioprocessing and Nutrition Sciences Extension Program).  We submit an online form with information about the product, and then they reply and tell you what they need you to send. They do the testing, and send back the results (pretty quickly I would add), along with research articles about the testing they've done. You do need to have someone on site that has taken a course on low acid foods and is certified in order to be qualified. Also, please be aware that if you do want a product to be considered low acid, you have to file the scheduled process (once you have it) with the FDA. That's also an interesting process. Hopefully this helps.


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#6 Charles.C

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Posted 12 January 2016 - 01:03 PM

Hi QAGB,

 

Thks for the input and Welcome to the Forum ! 

 

Have one query, the product referenced in OP is most likely to be an Acidified Food rather than "Low Acid"

 

Do you know if the procedure you described for Low Acid has similar steps for AF ? 

 

I got the impression from yr post that the chosen "Process Authority" not required to visit the actual process installation. Really ??


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Kind Regards,

 

Charles.C


#7 QAGB

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Posted 12 January 2016 - 01:28 PM

Hi QAGB,

 

Thks for the input and Welcome to the Forum ! 

 

Have one query, the product referenced in OP is most likely to be an Acidified Food rather than "Low Acid"

 

Do you know if the procedure you described for Low Acid has similar steps for AF ? 

 

I got the impression from yr post that the chosen "Process Authority" not required to visit the actual process installation. Really ??

 

 

I was thinking based on the wording of the post that the OP was referring to a product that isn't naturally at  ≤4.6 pH without the use of acidifying agents, and has a water activity greater than .85. If that is what is being referred to here, then the post would apply. 

 

We've been using the same process authority for a number of years, and to my knowledge have not been to the facility. However, what they do may depend on the product in question.


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#8 svnh.bell

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Posted 12 January 2016 - 02:14 PM

QAQB, 

 

You are correct in your thinking. Before the acidifying agent our product pH is approximately 6.8, then adjusted to 4.2 +/- 0.2.

 

In our initial conversations with the first Process Authority we spoke with, there was no mention of a facility visit. They simply stated they would need to do challenge testing to determine the efficacy of our high pressure processing and subsequent packaging. 

 

Thank you for the recommendation, I will contact NC State today! We have also booked the online course from UC Davis for myself and the QC Manager to complete ASAP. We are aware of the FDA filing, but I was under the impression that we should have the challenge testing completed and the Process Authority letter in hand prior to that filing process. 


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#9 svnh.bell

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Posted 12 January 2016 - 02:15 PM

I should add that we use a preservative system, activated by the addition of the acidifying agent. The aim of the challenge test is to determine how many days it takes our preservative system to exhibit a 5 log reduction. 


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#10 QAGB

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Posted 12 January 2016 - 02:25 PM

QAQB, 

 

You are correct in your thinking. Before the acidifying agent our product pH is approximately 6.8, then adjusted to 4.2 +/- 0.2.

 

In our initial conversations with the first Process Authority we spoke with, there was no mention of a facility visit. They simply stated they would need to do challenge testing to determine the efficacy of our high pressure processing and subsequent packaging. 

 

Thank you for the recommendation, I will contact NC State today! We have also booked the online course from UC Davis for myself and the QC Manager to complete ASAP. We are aware of the FDA filing, but I was under the impression that we should have the challenge testing completed and the Process Authority letter in hand prior to that filing process. 

 

 

I should add that we use a preservative system, activated by the addition of the acidifying agent. The aim of the challenge test is to determine how many days it takes our preservative system to exhibit a 5 log reduction. 

 

 

Hi svnh.bell,

 

Indeed, those would be the proper steps for your product. I know that we've never had our process authority visit our facility, so I would be inclined to think the challenge testing is more on their end. They do ask product specific questions and they want to know the ingredients in the product, ingredient type (aqueous, anhydrous, etc.), and some other information. Once you fill out the online form, they will contact you with what you need. NC State has always been extremely helpful, and will answer any questions you have. I've submitted products on several occasions and haven't had any problems.

 

Yes, you have to go through the process authority steps before you file with the FDA (you'll need that paperwork to file the scheduled process). I just wanted to make sure you knew the extra step. Good luck with your product!

 

QAGB


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#11 Charles.C

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Posted 12 January 2016 - 02:47 PM

Hi QAGB / svnh,

 

No audit required.

 

I find that astonishing.

 

Or is there a  "(re)-validation"  subsequently carried out by FDA ?


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Kind Regards,

 

Charles.C


#12 QAGB

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Posted 12 January 2016 - 03:24 PM

Hi QAGB / svnh,

 

No audit required.

 

I find that astonishing.

 

Or is there a  "(re)-validation"  subsequently carried out by FDA ?

 

We've not had the FDA re-validate the process. They can come inspect at any time, and that could be one of the processes they check, but there hasn't been anything routinely reviewed by the FDA.


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#13 foonie

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Posted 12 January 2016 - 06:49 PM

Interesting thread. I am in the same position but have a different question: We have products that are on the borderline: variation of pH 4.3-4.8 for a single product. We sterilize the product far above low acid F0 values so the pH is not a critical factor. Should we file the process as acidified or low acidified taken into account the variation and high sterilization process?

 

 

 

 


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#14 QAGB

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Posted 12 January 2016 - 07:17 PM

Interesting thread. I am in the same position but have a different question: We have products that are on the borderline: variation of pH 4.3-4.8 for a single product. We sterilize the product far above low acid F0 values so the pH is not a critical factor. Should we file the process as acidified or low acidified taken into account the variation and high sterilization process?

 

Hi Foonie,

 

The two biggest factors in determining would be:

 

1. Is the product ≤ 4.6 naturally without acidifying agents: You've stated it's a borderline product.

2. Is the water activity (aw) of the finished product >0.85: This, based on the question hasn't been determined.

 

You can have an accredited laboratory perform a water activity test on your finished product to determine where you are. If it is less than 0.85, then you are good to go. If it is greater than 0.85, you would most likely have to file with a process authority and the FDA. As a rule of thumb, aw tends to be the driving force in acidified foods. If the water activity is low, then pH isn't so much a worry, and no filing is necessary. Please note that this information is based on US regulations. I'm not certain about the regulations outside of the US.

 

If needed, you could also adjust the water activity by reducing water levels (if possible) in the formulation. Even though you are sterilizing the product, this may not be taken into account based on the above regulations. You could always contact a process authority to be sure you're headed in the right direction.

 

QAGB


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#15 foonie

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Posted 12 January 2016 - 08:06 PM

Hi QAGB,

 

Thanks for your quick response. I forgot to mention that it is a liquid, drinkable product (powders dissolved in water, homogenize, UHT, aseptically filled in tetra cartons)  that we plan on exporting to the US. We have a process authority which advises us and will validate and file the LACF process. and ACF process with the FDA. Don't know the exact aw value though, but I reckon it will be high.They said that these borderline products are probably considered acidified, but since the pH of the product is not a critical factor because we sterilize well above min F0 LACF in stead of pasteurizing I rather have it filed as LACF because FSMA doest not apply to LACF. I looked at the LACF process file form in which you can indicate that pH is not a critical factor. In essence, the pH does not play any role in microbiological reduction. 

 

Any thoughts/advise?

 

Rgds,

 

Foonie


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#16 foonie

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Posted 12 January 2016 - 08:14 PM

I forgot to add: pH varies naturally between 4.4 and 4.8. We do not add an acidification agent for the sake of obtaining a specific pH. The nature of ingredients just result in that pH


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#17 QAGB

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Posted 12 January 2016 - 08:35 PM

Hi QAGB,

 

Thanks for your quick response. I forgot to mention that it is a liquid, drinkable product (powders dissolved in water, homogenize, UHT, aseptically filled in tetra cartons)  that we plan on exporting to the US. We have a process authority which advises us and will validate and file the LACF process. and ACF process with the FDA. Don't know the exact aw value though, but I reckon it will be high.They said that these borderline products are probably considered acidified, but since the pH of the product is not a critical factor because we sterilize well above min F0 LACF in stead of pasteurizing I rather have it filed as LACF because FSMA doest not apply to LACF. I looked at the LACF process file form in which you can indicate that pH is not a critical factor. In essence, the pH does not play any role in microbiological reduction. 

 

Any thoughts/advise?

 

Rgds,

 

Foonie

 

 

I forgot to add: pH varies naturally between 4.4 and 4.8. We do not add an acidification agent for the sake of obtaining a specific pH. The nature of ingredients just result in that pH

 

Hi Foonie,

 

I see what you're saying. Without knowing the entire process, it looks like you would be filling out the FDA Form 2541g for Low-Acid Aseptic Systems (which is what I believe you are referring to). Some of our products are under the Acidified Foods category, so it is treated differently. I'd definitely say you're headed in the right direction because that is indeed a borderline product and should be filed. In that case, it's certainly better to play it safe than sorry (especially with exporting). If you file the Form 2541g, you shouldn't have to file one for the Acidified Foods category, because the parameters won't pertain to your product.

 

QAGB


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#18 foonie

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Posted 12 January 2016 - 08:55 PM

Hi QAGB,

 

Indeed, we will use 2541g. The products we intend to export are clearly LACF and one or two that are borderline acidified. However, they all are processed, sterilized (overkill) and aseptically filled in the same manner like I described. Thanks for your input. I will start up discussions with our Process Authority. My main aim is to steer away from FSMA as much as possible as it does not (fully) apply to aseptic LACF.

 

I do have one concern: if we file the borderline products as LACF and the FDA comes back to us and states that it has to be filed as acidified we have a major delay in product launch. Can I get your view on this one more time....? I appreciate that I can finally ask these things with someone actually based in the US :-)

 

Foonie


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#19 QAGB

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Posted 12 January 2016 - 09:26 PM

Hi QAGB,

 

Indeed, we will use 2541g. The products we intend to export are clearly LACF and one or two that are borderline acidified. However, they all are processed, sterilized (overkill) and aseptically filled in the same manner like I described. Thanks for your input. I will start up discussions with our Process Authority. My main aim is to steer away from FSMA as much as possible as it does not (fully) apply to aseptic LACF.

 

I do have one concern: if we file the borderline products as LACF and the FDA comes back to us and states that it has to be filed as acidified we have a major delay in product launch. Can I get your view on this one more time....? I appreciate that I can finally ask these things with someone actually based in the US :-)

 

Foonie

 

 

Hi Foonie,

 

In summary, you would still use water activity and pH to determine your first course of action when making the product. If when formulating, the water activity is less than 0.85, you don't need to file. However if it is greater than 0.85, you would look at your pH. If it is less than or equal to 4.6 naturally, you don't need to file. If it is above 4.6, then you need to file. Based on the information given, your water activity is probably going to be fairly high, so then you would look at your pH. Your pH is borderline, so then you would need to file (regardless of whether it will be critical to the process).

 

After that point, you would be looking at the different FDA Forms. One form is for the retort method, one form is for the acidified method (acidifying a food and adjusting fill temperatures), water activity/formulation control method (adding an ingredient to bind to water), and then the form for low acid aseptic systems. You're using UHT and filling into tetra cartons, which tells me: 1. It isn't the retort method. 2. You aren't adding any acid to lower the pH, so this wouldn't be the acidified method. 3. You're not adding any ingredients specifically to bind to water (at least that I'm aware of). Therefore, the best choice you have and what looks to be suited to your product is the form 2541g for low acid aseptic systems.

 

Our process is simply acidified foods. We adjust pH to a certain level, and fill at a certain temperature. I can't necessarily comment to the low acid aseptic systems, but from a process of elimination standpoint, form 2541g is what I would suggest. Hopefully there are some others on here that have more experience with UHT and can confirm. You could also go about directly contacting the LACF group at the FDA to find out exactly what form you should use, if you have significant time constraints.

 

I hope this helps!

 

QAGB


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