14 replies to this topic

[Psych6]

Hello everbody,

 

I was checking regulation about mandatory haccp juice and I read this:

 

120.24 (a) In order to meet the requirements of subpart A of this part, processors of juice products shall include in their Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log (i.e., 10 ⁵) reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism.

 

But it also address "The following juice processors are exempt from this paragraph: (1).... (2) A juice processor using a single thermal processing step sufficient to achieve shelf-stability of the juice or a thermal concentration process that includes thermal treatment of all ingredients, provided that the processor includes a copy of the thermal process used to achieve shelf-stability or concentration in its written hazard analysis required by 120.7. "

 

It that means if I'm pasteurizing food for a time-temperature enough to destroy spoilage microorganism and achieve shelf-stability, I don't have to demonstrate 5-log reduction of pertinent microorganism (pathogen)? 

[Ryan M.]

Correct, but one would think your thermal process to achieve shelf-stability would demonstrate a 5-log reduction of the pathogen.  If you can readily show or demonstrate this then you cover both bases.

[Psych6]

Correct, but one would think your thermal process to achieve shelf-stability would demonstrate a 5-log reduction of the pathogen.  If you can readily show or demonstrate this then you cover both bases.

And how could I prove to FDA that juices are shelf-stable? Conducting a shelf-life study of the juice? 

 

Time/temperature pasteurization are in accordance with recomendations of their guidances for industry.

But we want to set filling temperature slighlty below 70ºC (158 F) to use PET bottles. I haven't found references of filling process at these temperature, but I've found some studies of yeast resistance (D and Z values) in a range of temperatures 60 - 70ºC (140 - 158 F). But I'm not sure if I could use that information to prove stability of fruit juices.

[carinaevora]

Hello. 

 

I did before juice pasteurization and the time/tempertura binomial was higher than you state...although the package used was tetra brik.

You have to perform a study to prove stability and reduction of initial bacteria count. In my opinion the Temperature is low...how long (time) is the holding tube?

The pasteurization process will heat your product to a certain temperature during a certain time and than cool it to a temperture that you can set also: 4, 25 C...

Why do a hot filling in PET? To ensure asseptic filling you could use a bottle washer.

Do you use preservatives? 

[Psych6]

Hello. 

 

I did before juice pasteurization and the time/tempertura binomial was higher than you state...although the package used was tetra brik.

You have to perform a study to prove stability and reduction of initial bacteria count. In my opinion the Temperature is low...how long (time) is the holding tube?

The pasteurization process will heat your product to a certain temperature during a certain time and than cool it to a temperture that you can set also: 4, 25 C...

Why do a hot filling in PET? To ensure asseptic filling you could use a bottle washer.

Do you use preservatives? 

Hello.

 

Wow, I used to think all tetrabrik systems were designed to be filled in aseptic enviroment, at room temperature.

 

Pasteurization temp./time is mín. 84°C x 3 minutes

Yes, in line will be a bottle washer. Target temperature of filling is around 70°C because of the intend to use of PET bottles with lower weight.

Formula includes sodium benzoate (around 200 ppm).

I was thinking of collect data about microbial load in enviroment, surfaces maybe (filler, caps) to have and idea to determine hold time at that temperature in closed bottle (close and invert bottle), maybe doing it only theorytically is a bit risky. Making emphasize in yeast contamination. Since I've read in papers yeast are more resistant than pathogenic bacteria. What's your opinion about?

[Scampi]

USA will require you to have a process authority determine whether or not you have achieved commercial sterility.....that means you need an expert (may have one in your facility) prove that if you follow steps ABCDEFG exactly you will achieve commercial sterility

 

Is your equilibrium pH below 4.6?

 

We process pickles so we are sort of in the same boat

[carinaevora]

Hello.

 

Wow, I used to think all tetrabrik systems were designed to be filled in aseptic enviroment, at room temperature.

 

Pasteurization temp./time is mín. 84°C x 3 minutes

Yes, in line will be a bottle washer. Target temperature of filling is around 70°C because of the intend to use of PET bottles with lower weight.

Formula includes sodium benzoate (around 200 ppm).

I was thinking of collect data about microbial load in enviroment, surfaces maybe (filler, caps) to have and idea to determine hold time at that temperature in closed bottle (close and invert bottle), maybe doing it only theorytically is a bit risky. Making emphasize in yeast contamination. Since I've read in papers yeast are more resistant than pathogenic bacteria. What's your opinion about?

 

Hello again

 

The juice we made was Pasteurized at 94 C/15 seg than cooled to 25 C and was kept in Asseptic tank during fillling...the filling machine was Tetra TBA that is used for asseptic filling (packaging material pass through a H2O2 hot bath before formation and receiving the product).

 

Normally, due the low pH of juice, you will have problems with yeast and moulds. The first to grow will be yeast. If you have yeast contamination in your final product it can mean a poor sanitary condition or bad quality raw material. 

It is a good ideia to collect all the data you pretend to, because you will validate at the same time your HACCP system or any quality control system you are using. Collect samples in all the location you stated and also in your bottle washer (water etc.), all the raw material; the juice before pasteurization and after; etc. etc. Like that you will have an ideia if your initial microbial load is reduced due to pasteurization. Also perform a shelflife study...our product had one year.

[Psych6]

USA will require you to have a process authority determine whether or not you have achieved commercial sterility.....that means you need an expert (may have one in your facility) prove that if you follow steps ABCDEFG exactly you will achieve commercial sterility

 

Is your equilibrium pH below 4.6?

 

We process pickles so we are sort of in the same boat

As part of the R&D team, we are supposed to be the experts  They will require a validation by a process authority? I think is only for low acid canned food and acidified food. I consider this juices (fruit) acid food.

 

Yes, happily, pH is below 4.6

Oh, I've worked with acidified food (sauces), too. PCC were Time/temp and pH

Hello again

 

The juice we made was Pasteurized at 94 C/15 seg than cooled to 25 C and was kept in Asseptic tank during fillling...the filling machine was Tetra TBA that is used for asseptic filling (packaging material pass through a H2O2 hot bath before formation and receiving the product).

 

Normally, due the low pH of juice, you will have problems with yeast and moulds. The first to grow will be yeast. If you have yeast contamination in your final product it can mean a poor sanitary condition or bad quality raw material. 

It is a good ideia to collect all the data you pretend to, because you will validate at the same time your HACCP system or any quality control system you are using. Collect samples in all the location you stated and also in your bottle washer (water etc.), all the raw material; the juice before pasteurization and after; etc. etc. Like that you will have an ideia if your initial microbial load is reduced due to pasteurization. Also perform a shelflife study...our product had one year.

[Charles.C]

And how could I prove to FDA that juices are shelf-stable? Conducting a shelf-life study of the juice? 

 

Time/temperature pasteurization are in accordance with recomendations of their guidances for industry.

But we want to set filling temperature slighlty below 70ºC (158 F) to use PET bottles. I haven't found references of filling process at these temperature, but I've found some studies of yeast resistance (D and Z values) in a range of temperatures 60 - 70ºC (140 - 158 F). But I'm not sure if I could use that information to prove stability of fruit juices.

 

Hi Psyche,

 

I guess the ability to answer red question will be one of the minimum requirements for  The "Expert".

 

Knowledge as to whether the Regulations in Peru follow US Guidelines will presumably be a 2nd criterion.

 

Lacking an "approved" Process Authority,  perhaps yr customer may know the precise Local requirements ? (assuming product is for local distribution).

[Scampi]

Just as an FYI, salmonella in orange juice was the reason the FDA changed the rules for shelf stable products

 

In order to prove a 5 log reduction, you would have to plate the juice before and after processing and document all findings. This validation would need to be done under the "worst possible" set of parameters (i.e no chlorine in wash water (if using), the quickest possible pasteurization time etc)  This has nothing to do with a shelf life study, that would only be to validate the best before date on the package

[TruAseptics]

I have always sited the following references and it has never been questioned by GFSI Auditors, FDA or AIBI:

 

Technical Reference:                                                   Relevant Biological Pathogens for Juice products:                   ·        E. coli O157:H7                     ·        Salmonella Species                   ·        Listeria Species                     ·       Cryptosporidium parvum                                               Validation Statement: Critical limits for Pasteurization within Juice HACCP plans                  To fulfill the requirements of 21 CFR Part 120, the minimum "pathogen cook" prescribed by the U.S. Food and Drug Administration (CFSAN) for heat-treated, non-shelf stable juices is a minimum 6-second pasteurization process at 160ºF (71ºC). This corresponds to a 5-log reduction of the parasite Cryptosporidium parvum (all forms) and a >5-log reduction of E. coli 0157:H7, Salmonella spp. and Listeria monocytogenes in juices. The research on which this is based (Mazzotta, 2001) was carried out using fruit juices adjusted to pH 3.9.  In response to inquiries from the juice beverage industry, an FDA official has stated that the aforementioned process (6 sec at 160ºF) is adequate to assure the microbiological safety of juices with pH values as high as 4.50 (Kashtock, 2004).

An example of a higher temperature / shorter time process that also meets the above criteria is a pasteurization hold time of 1 second (fastest moving particle) at a minimum temperature of 180ºF (82.2ºC)                                             References:
Kashtock, M.E. (June 21, 2004). Personal communication. Note: Dr. Kashtock is Senior Advisor, Division of Plant Product Safety, Office of Plant and Dairy Foods, with the FDA's Center for Food Safety and Applied Nutrition (CFSAN).

Mazzotta, A.S. (2001). Thermal Inactivation of Stationary-Phase and Acid-Adapted Escherichia coli O157:H7, Salmonella, and Listeria monocytogenes in Fruit Juices. Journal of Food Protection, 64, 315-320.

Guidance for Industry:  Juice HACCP Hazards and Controls Guidance First Edition; Final Guidance
5.2 Validated Pasteurization Treatments for Juice
Study #1 Summary: A study done by the NFPA(7) has resulted in a recommended general thermal process of 3 seconds at 71.1 degrees C (160 degrees F), for achieving a 5-log reduction for E. coli O157:H7, Salmonella, and Listeria monocytogenes in fruit juices. The efficacy of this process was measured using single strength apple, orange, and white grape juices adjusted to a pH of 3.9. The authors noted that a pH in the range of 3.6 to 4.0 has been reported as a non-significant variable in the heat resistance of E. coli O157:H7

Study #2 Summary: A study done at the University of Wisconsin(8) has shown that treatments of 68.1 degrees C (155 degrees F) for 14 seconds (recommended treatment conditions in Wisconsin) and 71.1 degrees C (160 degrees F) for 6 seconds (recommended treatment conditions in New York) are capable of achieving a 5-log reduction of acid adapted E. coli O157:H7 in apple cider (pH values of 3.3 and 4.1). The Wisconsin study also confirmed the adequacy of the treatment conditions of the NFPA study (71.1 degrees C (160 degrees F) for 3 seconds) for achieving a 5-log reduction for E. coli O157:H7 in apple cider.                                          

 

[TruAseptics]

My apologies for the formatting.  In the preview it was formatted properly.

[dameafr6183]

Hi morning from Malaysia. I am Damea working on food manufacturing company for Frozen fruit puree product and fruit puree drink concentrate.

If I may, could I request a reference of time/temperature for Pasteurization di you have before?

Thank so much

And how could I prove to FDA that juices are shelf-stable? Conducting a shelf-life study of the juice? 
 
Time/temperature pasteurization are in accordance with recomendations of their guidances for industry.
But we want to set filling temperature slighlty below 70ºC (158 F) to use PET bottles. I haven't found references of filling process at these temperature, but I've found some studies of yeast resistance (D and Z values) in a range of temperatures 60 - 70ºC (140 - 158 F). But I'm not sure if I could use that information to prove stability of fruit juices.

[pHruit]

The details given in post #11 are all good reference sources and I've used them previously.
One further link that may be useful for some juice products: https://jfoodprotect...028X-64.11.1679

 

N.B. These are all focussed on food safety, so if you're aiming for ambient-stable product you'll likely need a higher temp / longer time.

[Psych6]

Hi morning from Malaysia. I am Damea working on food manufacturing company for Frozen fruit puree product and fruit puree drink concentrate.

If I may, could I request a reference of time/temperature for Pasteurization di you have before?

Thank so much
 

Hi

 

Pasteurization was set at 94-95°C x 3 min for fruit juices, except for orange juice due to sensory quality (85° x 10 min)