5 replies to this topic

[jjpfdf]

Hi, I am looking if anyone can provide some guidance on F value calculation for FDA approval? The products are ambient stable sauces (hot fill and hold method) and apparently F value is needed to get it approved by FDA. Can anyone provide some guidance for the formula to use or signpost to any other thread already been discussed on it? Thanks, J

[Scampi]

Hey J   

 

https://foodsafety.w...osing a Hot.pdf

 

https://foodsafety.w...ty_TimeTemp.pdf

 

These are both a huge help

 

 

Also, you may be able to get some great LIVE help from either Nebraska State or North Carolina State University if you can't find anyone close to assist

 

Canada also requires the calculation---ideally you'll have an entire scheduled process that includes, recipe/cook time/temp/package size(s)/ and the hot fill temp and hold time

[jjpfdf]

_{@ Scampi}

 

_{Hi , thanks for your reply.}

 

_{The above two looks are useful and can be used to support FDA files and just need to ensure the processing parameters matching to this articles. Just wonder if sauces (hot fllled and hold method) will target pathogen - clostridium botulim or the three common - Listeria, salmonella and E. coli ...}

 

_thanks

_J

[Scampi]

How is this pathogen controlled in foodstuffs?
Control of C. botulinum in foods requires destruction of the spores through processing (e.g. effective canning at high temperatures for long periods of time) or prevention of bacterial growth through product formulation (e.g. keeping pH below 4.6, reducing the amount of available water), temperature control, or a combination of these factors. Failure of one or more of these control measures, (e.g. cans not being heated sufficiently to kill the spores of Cl. botulinum) may enable the organism to grow and produce the toxin in the food.

 What foods are at risk?
Foods that are not acidic (above pH 4.6), have enough available water and have little or no air in them (e.g. certain canned or jarred foods) are susceptible to Cl. botulinum growth. Outbreaks have been recorded in canned food, jarred foods in oil, some fish products and meat/blood sausages amongst other foods. Nearly always, there is a failure of processes like heat or acidification during the production of foods that would normally be expected to make the food safe. Sometimes post-heat process contamination is responsible.

 Does cooking kill Cl. botulinum and its toxin?
Normal thorough cooking (pasteurisation: 70°C 2min or equivalent) will kill Cl.botulinum bacteria but not its spores. To kill the spores of Cl.botulinum a sterilisation process equivalent to 121°C for 3 min is required. The botulinum toxin itself is inactivated (denatured) rapidly at temperatures greater than 80°C . 

The goal with a hot fill and hold is kill the bacteria AND render the environment such that the spores that have not been killed CANNOT reproduce

 

FYI the FDA is probably going to also ask for a scheduled process and not just an F value

[Charles.C]

A variety of F-data, calculation methods in attachment below. The exact figure obviously depends on yr own process.

 

 heat-process-values-pasteurization-sterilization.pdf   2.68MB   64 downloads

 

As per previous post, approval of a scheduled process involves a detailed process feasibility assessment.

 

PS - here is a detailed analysis for tomato sauce -

 

 thermal_treatment_parameters_for_tomato sauce.pdf   273.84KB   49 downloads

[kfromNE]

Yeast and mold will be your biggest concerns for items with a low pH and high cooking temp. Make sure you also test your pH of your final product and keep records. For the pH - I made an excel document and set it up to all I had to do was put in the pH and excel calculated the average.

 

The articles Scampi referenced - my old job uses these to validate their process.

 

For the FDA either you have to have your process validated by doing your own 5-log reduction study or finding a credible source.

Edited by kfromNE, 26 January 2021 - 08:24 PM.