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SEBASTIANRD

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Posted 23 October 2015 - 09:39 PM

Hi,

I'm developing a HACCP plan for a rawhide plant with the following manufacturing process:

Delivery of Raw material (CCP1) --> Cleaning---> Splitting ---> Bleaching (CCP2- We use peracetic acid 100ppm as a sanitizer and hydrogen peroxide) --->

 Mechanical drain --> Cutting --> Shaping --->

Drying (CCP3?- 40ºC:12 hours -> 45ºC:12hours_50ºC:14 hours) Max humidity 11% -->

Quality control & classification ---> Packing.

 

So my main concern is the CCP 2 and 3, can I define the bleaching process as a CCP? I validate the CCP by measuring the amount of peracetic acid that goes into the mixture, do you consider this is correct?

 

I read in another post that the following steps might be considered as CCP as well, like "drain" or Cutting, at the time I just considered those proceses in my pre-requisites program.

 

With this in mind, should I considered the drying step as only a CP?.

 

Well, as you can read in my post I'm kind of lost and there isn't a lot of information about this process anywhere, so I would really appreciate any comment, advise or solution, anyone could give. 

 

Attached Files



Charles.C

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Posted 25 October 2015 - 03:30 AM

Hi Sebastian,

 

Thks for yr query and welcome to the Forum !   :welcome:

 

I presume this is a process to manufacture commercially sterile petfood, eg dog “treats”.

 

Unfortunately I am not directly familiar with yr process but can offer a few general comments.

 

The basic answer to yr queries likely depends on –

 

(a) any relevant local Regulatory haccp control requirements for the process.

(b) whether the HACCP Plan for yr process is to be audited / certified to any particular FS Standard.

© risk assessment / hazard analysis applied to the various steps of the process.

 

I assume you are familiar with the typical procedure for developing a haccp plan, eg Codex methodology.

 

The answers to yr CCP queries are delivered by a hazard analysis / risk assessment. This requires yr specifying the hazards existing at the steps you mention and their intended control, eg by Prerequisite programs or additional controls such as at a CCP.

 

Any specific haccp requirements for (a,b) will take priority over the following comments.

 

Based on yr flowchart the sterilization step is likely to be a CCP  for controlling XYZ micro.hazards. From a micro. POV, the steps (CCP1-3) you mention are unlikely to control / generate CCPs IMO assuming that temperature/time process conditions are not “excessive”, GMP is satisfactory and approved chemicals are used.

Metal/bone fragments might be 2 possible Physical hazards in this type of process (eg cutting step).

Discussion of other Chemical / Physical (and conceivably micro.) hazards probably requires more information, eg dried how, what temperature, how long ?

 

Other posters may have more direct knowledge on rawhide.

 

The attached document may be of some interest.

 

Attached File  Global petfood process requirements.xls   192.5KB   30 downloads


Kind Regards,

 

Charles.C


SEBASTIANRD

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Posted 26 October 2015 - 05:17 PM

Hi Charles, Thanks for the feedback and the document it sure has been helpful!

 

We are aiming towards a HACCP certification to begin with then scale up to a FSSC 22000, it's easier this way right?

 

The risk assement shows that we need a CCP during reception of raw materials because of any foreign objects such as wood splinters or metal fragments or even chemical contamination, and it also helps us to only obtain rawhide that comes from a certified slaughter house (so no rawhide from "sick" cows)

 

After some steps, we reach the bleaching part, and the main objective of this step is to slow down the natural decomposition process of the rawhide by controlling the microorganisms present in the rawhide and also to give that white color to the roll or bone. The peracetic acid provider states that at a 100ppm concentration the p.a. has a germicidal effectiveness of 99.99%. 

 

The following steps are mainly done by hand and the best way to avoid re-contamination it's through GMP (or at least IMO). 

 

Then the product is placed in "shelves" then dried in an oven like the one in the picture it's just an air blower with a gas burner attached to it, during 12 hours at 40ºC then another 12 hours but at 45ºC and last, 12 hours at 50ºC. We do this process mainly to obtain a <11% humidity. (are the temperatures to low? or does it compensate with the time in the oven?)

 

 In the risk assessment I did  there is not an actual risk (pathogens) that needs to be controlled during this step because of the bleaching step, the product just needs to achieve a low humidity percentage to be a shelf stable food.

 

So, if the humidity it's not controlled effectively there is a chance of re-contamination? making this a CCP?

 

Metal fragments are considered as potential risks but controlled only as GMP (the blades are sharpened outside the process line and checked regularly). For the bone fragments I think I failed to explain that during the cutting step the rawhide is still soft and flexible so its easy to cut and shape as a "bone" or "roll" depending the product.

 

Kind Regards,

 

Sebastian R



Charles.C

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Posted 26 October 2015 - 07:04 PM

Hi Charles, Thanks for the feedback and the document it sure has been helpful!

 

We are aiming towards a HACCP certification to begin with then scale up to a FSSC 22000, it's easier this way right?

 

Yes, probably easier but it may depend on the level required to get a haccp certificate. FSSC22000 is a big step up IMO and you might find it helpful to align some things in advance, eg Prequisites.

 

The risk assement shows that we need a CCP during reception of raw materials because of any foreign objects such as wood splinters or metal fragments or even chemical contamination, and it also helps us to only obtain rawhide that comes from a certified slaughter house (so no rawhide from "sick" cows)

This would all be handled by Prerequisites in some haccp presentations.

 

After some steps, we reach the bleaching part, and the main objective of this step is to slow down the natural decomposition process of the rawhide by controlling the microorganisms present in the rawhide and also to give that white color to the roll or bone. The peracetic acid provider states that at a 100ppm concentration the p.a. has a germicidal effectiveness of 99.99%.

Probably 99.99% under laboratory conditions for a specific micro.target(s).

The practical efficiency will be defined by yr measurements.

I assume the peracetic acid is approved for RTE food use. 

 

The following steps are mainly done by hand and the best way to avoid re-contamination it's through GMP (or at least IMO). 

 

Then the product is placed in "shelves" then dried in an oven like the one in the picture it's just an air blower with a gas burner attached to it, during 12 hours at 40ºC then another 12 hours but at 45ºC and last, 12 hours at 50ºC. We do this process mainly to obtain a <11% humidity. (are the temperatures to low? or does it compensate with the time in the oven?)

Sorry, no experience this process. You need some data and hopefully some documentation. Offhand the temperatures seem low but i I imagine the (humidity) effectiveness will relate to the thickness of the product, etc. Residual micro-undesirables are another aspect. Picture ??

 

 In the risk assessment I did  there is not an actual risk (pathogens) that needs to be controlled during this step because of the bleaching step, the product just needs to achieve a low humidity percentage to be a shelf stable food.

See my comment on bleaching step above.

So, if the humidity it's not controlled effectively there is a chance of re-contamination? making this a CCP?

Yes, i expect this will be a CCP. A sufficiently low humidity stops microbial growth but does not eliminate any survivors from earlier steps. And similarly, afaik, a temperature of 50degC.

 

Metal fragments are considered as potential risks but controlled only as GMP (the blades are sharpened outside the process line and checked regularly). For the bone fragments I think I failed to explain that during the cutting step the rawhide is still soft and flexible so its easy to cut and shape as a "bone" or "roll" depending the product.

Auditors often look for a metl detector. It's become sort of traditional and especially for RTE products.But maybe not in Mexico. :whistle:

 

Kind Regards,

 

Sebastian R

 

Hi Sebastian,

 

The critical bit is that the drying stage is designed to give a RTE, shelf-stable, product.

Auditors will usually expect to see detailed haccp validation material for this step.

Unfortunately I have no experience this process. I suggest some reliable professional advice + literature back-up + pilot trial/measurement.

 

Maybe other posters will have some experience / advice.


Kind Regards,

 

Charles.C


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SEBASTIANRD

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Posted 26 October 2015 - 08:37 PM

Hi Sebastian,

 

The critical bit is that the drying stage is designed to give a RTE, shelf-stable, product.

Auditors will usually expect to see detailed haccp validation material for this step.

Unfortunately I have no experience this process. I suggest some reliable professional advice + literature back-up + pilot trial/measurement.

 

Maybe other posters will have some experience / advice.

Hi Charles,

 

Some of the validation material I have is the logs where we register the humidity of the inside of the "bone" or "roll" after the drying step. (If the humidity doesn't meet our critical limit we put it back in the oven).

 

Another validation are the results from a laboratory in which they show the humidity of the product, and also the CFU of different pathogens (everything meets the legal requirements). The product seems to be very safe at least on paper.  I don't know if the product is safe thanks to the bleaching process and gmp afterwards or due to an sterilization in the oven (because it's a really long time at 45-50 degrees). Is there a chart or something where I can check the time-temperature relation for sterilization?

 

Thanks a lot for your help Charles! :spoton:

 

pd. Sorry I forgot to post the url of the oven image. 

 

export-industrial-oven.jpg



Charles.C

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Posted 27 October 2015 - 04:05 AM

Hi Sebastian,

 

There are many variations around the basic process you are talking about. . As you already know, 2 basic micro. requirements are (a) ensure microbiological safety, (b) ensure ambient shelf stability. I have attached a couple of documents giving a general analysis of some  "related" human products / processes below.

 

Attached File  d1 - Principles for preservation.pdf   175.62KB   23 downloads

Attached File  d2 -compliance_guideline_jerky.pdf   195.41KB   21 downloads

 

Is it possible to post a URL link to yr own intended process or attach a more detailed description of the overall process / microbiological / validation aspects ?

 

PS - some D values for beef-type matrices/Salmonella/L.mono species around 50degC here -

 

http://www.ncbi.nlm....pubmed/17186675

Attached File  d3 - D values some pathogens in beef matrix, 55 - 60 degC.pdf   116.61KB   19 downloads

 


Kind Regards,

 

Charles.C


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Posted 28 October 2015 - 09:50 PM

Hi Charles!

 

Thanks for the documents I think they have the info I was looking for  :spoton:

Mmm we don't have a webpage yet,  but what kind of info do you need? (I want to be sure before I translate it haha)



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Posted 29 October 2015 - 12:33 AM

Hi Sebastian,

 

The reason for my request is –

 

I doubt that the process as described will achieve sterilization.

I have been unable to find any similar commercial system claimed to achieve sterilization.

I would like to see some evidence.

 

It’s as simple as that. :smile:

 

PS – No need to translate if only a few pages and is accepted by Google Translate.


Kind Regards,

 

Charles.C


Charles.C

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Posted 31 October 2015 - 04:24 AM

Hi Sebastian,

 

My concerns regarding the safety of yr process are related to its partial similarity to the manufacture of beef jerky and the various reported safety caveats for the latter item.

An obvious difference is your initial treatment with  peracetic acid but the impact of this stage and also the subsequent drying is, IMO, impossible to predict without data/evaluation/validation.

 

I enclose 3 articles on beef jerky to illustrate my reservations –

 

Attached File  Jerky and Food Safety.pdf   21.5KB   24 downloads

Attached File  jerky - Compliance-Guideline-Jerky-2014-1.pdf   852.11KB   23 downloads

Attached File  jerky - Uncooked RTE dried meat and Salmonella.doc   78.5KB   16 downloads


Kind Regards,

 

Charles.C


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Posted 31 October 2015 - 05:08 PM

Hi Sebastian,

 

My concerns regarding the safety of yr process are related to its partial similarity to the manufacture of beef jerky and the various reported safety caveats for the latter item.

An obvious difference is your initial treatment with  peracetic acid but the impact of this stage and also the subsequent drying is, IMO, impossible to predict without data/evaluation/validation.

 

I enclose 3 articles on beef jerky to illustrate my reservations –

 

attachicon.gifJerky and Food Safety.pdf

attachicon.gifjerky - Compliance-Guideline-Jerky-2014-1.pdf

attachicon.gifjerky - Uncooked RTE dried meat and Salmonella.doc

Hi Charles,

 

I agree with you, It's impossible to predict if the peracetic acid  + hydrogen peroxide  is a crucial step in the process, we are sending the rawhide (without any processing) to see what kind of microorganisms are we dealing here and another sample of the rawhide after the bleaching step. This should be enough as a way to evaluate and validate, right? 

If you know any complimentary ways of validating, I would really appreciate it.

Thanks a lot for your help! 



Charles.C

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Posted 31 October 2015 - 09:17 PM

Hi Charles,

 

I agree with you, It's impossible to predict if the peracetic acid  + hydrogen peroxide  is a crucial step in the process, we are sending the rawhide (without any processing) to see what kind of microorganisms are we dealing here and another sample of the rawhide after the bleaching step. This should be enough as a way to evaluate and validate, right? 

If you know any complimentary ways of validating, I would really appreciate it.

Thanks a lot for your help! 

 

Hi Sebastian,

 

Actually the PA/h2o2 mix is a well-known sanitizer, eg this thread -

 

http://www.ifsqn.com...are-experience/

 

From memory to be officially listed as a sanitizer in USA, the chemical must be capable of achieving a 5-6log reduction of a specific bacterium under standardized lab. test conditions. Its effect on actual products will vary of course. I daresay it's capability for reducing bacterial loads on meat is quite well documented in the literature.

 

Micro. laboratories probably have standard procedures for doing this kind of evaluation. Your method should give you an idea of the average total effect if you use several samples but you will probably get a wide range of data. :smile:


Kind Regards,

 

Charles.C




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