4 replies to this topic

[BakerNat]

Hi all,

 

I have database access through my university, but I am coming up totally short in finding relevant documentation. FSMA Inspectors told us validation studies were online/easy to find; but I am not coming up with any for the product they audited (almond flour based loaf; almonds have a kill step from the supplier but we have eggs in the product, so looking at salmonella largely).

 

I hadn't realized when I went through pcqi training that we needed a validation study in the way they need; we had just sent product off to labs to have it tested for aerobic plate count/ listeria/salmonella/ pH/water etc. That's clearly not what FSMA  meant. So now I am looking for kill step validation studies for the baking process; but I have my doubts that they will accept a study I found for nut-inclusion muffin batter (no eggs; study in 2019) as a replacement for a quick bread size loaf that also has egg-based pathogens. 

 

Any suggestions besides conducting one externally? I know AIB has kill step calculators, but not one that seems to be  the right fit for this product.

Our Internal temperature gets to 200 F, pH post bake is 5.98 and Aw .87. So I have a lot of confidence that we bake well past a kill step// would have nonviable product if it wasn't past. But now just looking for the supporting docs. 

 

Thanks!

 

BN

[Lorem Ipsum]

Hi, we put a button data logger into muffin batter and sent through oven several times in different places of the tray. No issues with any audit, including BRC. When you download your data, you will have a time/temperature graph. We have this one: https://www.klipspri...38,145,160,1073

[Charles.C]

Hi all,

 

I have database access through my university, but I am coming up totally short in finding relevant documentation. FSMA Inspectors told us validation studies were online/easy to find; but I am not coming up with any for the product they audited (almond flour based loaf; almonds have a kill step from the supplier but we have eggs in the product, so looking at salmonella largely).

 

I hadn't realized when I went through pcqi training that we needed a validation study in the way they need; we had just sent product off to labs to have it tested for aerobic plate count/ listeria/salmonella/ pH/water etc. That's clearly not what FSMA  meant. So now I am looking for kill step validation studies for the baking process; but I have my doubts that they will accept a study I found for nut-inclusion muffin batter (no eggs; study in 2019) as a replacement for a quick bread size loaf that also has egg-based pathogens. 

 

Any suggestions besides conducting one externally? I know AIB has kill step calculators, but not one that seems to be  the right fit for this product.

Our Internal temperature gets to 200 F, pH post bake is 5.98 and Aw .87. So I have a lot of confidence that we bake well past a kill step// would have nonviable product if it wasn't past. But now just looking for the supporting docs. 

 

Thanks!

 

BN

Hi BN,

 

Please clarify a little.

 

Afaik the "validation" typically involves only a demonstration of a sufficient "kill" result (eg logD value) which IRC is what most (eg AIB's baking method) do in a generic way. From memory, unless you have a constant product temperature, simply need a T/t profile and the software does the rest.

Why is the AIB-type method not "suitable" for you ? (eg Unusable k value ?. No T/t data ?)

[BakerNat]

Hi all!

Thank you @sjegorov , I reached out to that company. Much much appreciated.

 

Charles, I guess what I was saying is that AIB seems to have calculators for specific lines of product; crispy cookie, hamburger bun, cheesecake, etc. They don't seem to have one for a loaf/ quick bread, so I'm not sure I will be able to use their calculators to demonstrate the sufficient kill result. I am looking into software now though, so potentially that will have its own calculator, or T/t data will be enough. But while we have tracked internal bake temperature, our inspectors said that we need a scientific study that validates our T/t data would be a kill result for each product.

 

I am a little alarmed since we have about 30 SKUs, but I do think that AIB's data will be useful for most of the rest. 

 

  Thanks for the feedback!

[Charles.C]

Hi all!

Thank you @sjegorov , I reached out to that company. Much much appreciated.

 

Charles, I guess what I was saying is that AIB seems to have calculators for specific lines of product; crispy cookie, hamburger bun, cheesecake, etc. They don't seem to have one for a loaf/ quick bread, so I'm not sure I will be able to use their calculators to demonstrate the sufficient kill result. I am looking into software now though, so potentially that will have its own calculator, or T/t data will be enough. But while we have tracked internal bake temperature, our inspectors said that we need a scientific study that validates our T/t data would be a kill result for each product.

 

I am a little alarmed since we have about 30 SKUs, but I do think that AIB's data will be useful for most of the rest. 

 

  Thanks for the feedback!

Hi BakerNat,

 

Re ^^^(red) I haven't looked at the detailed analyses on AIB's site for a long time but I daresay you will only need one Scientific Study if all of them use the same logD / target species (eg Salmonella/L.mono) /average "k" requirements. (Bacillus spores are theoretically also a possible hazard but afaik are not conventionally used as a primary thermal elimination target bur handled separately). (UK usually select L.mono as a (typical) most thermally difficult target species but USA do not always concur with this logic/assumption).

 

Offhand, the only (to me) immediately obvious reason for an exception could be if the k factor for yr product is significantly different to the (I assume) average value probably used by AIB. If FDA do require you to validate your k value and it's not matching any AIB examples then some  serious Literature searching or a Consultant may be required.

 

I anticipate the AIB website addresses all the above comments/caveats.

 

I also anticipate any US bakers reading this thread must have encountered an identical situation ?? Comments welcome.