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Validation C.botulinum, Canned, Pasteurized, Chilled Crabmeat


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#1 shanshan15

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Posted 05 July 2019 - 05:44 AM

Good day!

 

i just want to ask how to validate clostridium botulinum? we process Pasteurized Chilled Crabmeat in Can. and our pasteurization time to kill pathogenic bacteria is 86-87C for 2hrs. and 20 minutes by batch (160 cans) then same process in post chilling. what im gonna do to validate that c. botulinum is not present in our product?



#2 mahantesh.micro

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Posted 05 July 2019 - 08:24 AM

Hi Shanshan,

To validate pasteurization process especially a particular pathogen, what we do is we will pasteurize the product at different temperatures and time combination for all kind of product and pack sizes, and then test the pasteurized product for pathogens after 24 hours. At what combination of temperature and time the pathogens found absent we will consider that temperature and time suitable for the destruction of chosen pathogen. Validation is conducted atleast 3 times for confirmation.

 

Regards

Mahantesh



#3 Charles.C

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Posted 05 July 2019 - 09:49 PM

Good day!

 

i just want to ask how to validate clostridium botulinum? we process Pasteurized Chilled Crabmeat in Can. and our pasteurization time to kill pathogenic bacteria is 86-87C for 2hrs. and 20 minutes by batch (160 cans) then same process in post chilling. what im gonna do to validate that c. botulinum is not present in our product?

 

Why do you believe that yr Process will eliminate C.botulinum ? Including Spores ?


Kind Regards,

 

Charles.C


#4 shanshan15

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Posted 06 July 2019 - 03:05 AM

Hi sir charles,

 

Nope, (sorry for the word "kill" in my post). I mean our process probably wont eliminate C. botulinum but we can prevent it's spores to grow. so the thing is, our QA wanted me to do a research on validation of C. botulinum. I write down her instruction

 

-Validation for Clostridium Butolinum. Check F Value.

A. 31 mins. for FDA

B. 45 mins for XXX at 85C

 

Compare and Analyze.

 

will you help me this? I just dont understand.



#5 Ryan M.

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Posted 06 July 2019 - 05:07 AM

If you want to utilize literature that is already out there you will have to conduct thermal death curve calculations.  That's where the F value comes into play.  FDA has a lot of literature about this for various products, but unfortunately each product and pack size is relatively unique.  You can search through the FDA to see if there is an actual study or literature around canned crab meat pasteurization in can with C. Bot as target pathogen.

 

If you can find that then you can verify it with an temperature tracker in your pack size / type in the coldest spot in the process.  I'm assuming a retort?  Generally the centermost unit inside the retort is coolest spot and slowest to rise in temperature.  Links below...

 

https://www.fda.gov/...g-symbols-d-z-f

 

https://www.fda.gov/.../99572/download  (content you want starts on page 4)

 

https://www.fda.gov/.../80310/download

 

There are 3rd party labs who have someone on staff as a "thermal process expert" who can assist with validating your process for your target organisms.



#6 ts33

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Posted 06 July 2019 - 05:58 PM

Finished product would be tested to ensure no pathogens in it and experimenting what time/temperature control works to achieve that.

 

Thanks,

 

ts33



#7 Charles.C

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Posted 06 July 2019 - 09:31 PM

Hi sir charles,

 

Nope, (sorry for the word "kill" in my post). I mean our process probably wont eliminate C. botulinum but we can prevent it's spores to grow. so the thing is, our QA wanted me to do a research on validation of C. botulinum. I write down her instruction

 

-Validation for Clostridium Butolinum. Check F Value.

A. 31 mins. for FDA

B. 45 mins for XXX at 85C

 

Compare and Analyze.

 

will you help me this? I just dont understand.

 

Hi shanshan,

 

Thks for data.

 

Ryan's Post 5 has well-covered a lot of the FDA's work/analysis on this topic.

 

To develop a thermal process, some typical required information includes items like (a) Packing style,notably whether ROP (eg canned) or not, (b) species (eg  "XXX") to be pasteurized, (c) storage conditions, eg chilled/frozen, and shelf life.

 

A comment from 3rd link/Post5 illustrates the situation -

 

Refrigerated (not frozen), reduced oxygen packaged, pasteurized fishery products

 

Refrigerated, reduced oxygen packaged, pasteurized fishery products fall into two categories:

(1) those which are pasteurized in the final container; and
(2) those which are cooked in a kettle and then hot filled into the final container in a continuous, closed filling system (e.g., heat-and-fill soups, chowders, and sauces).

In both cases, ordinarily [it is necessary that] the heating process should be sufficient to destroy the spores of C. botulinum type E and non-proteolytic types B and F. [However]  In neither case is it likely that the heating process will be sufficient to destroy the spores of C. botulinum type A and proteolytic types B and F.  Therefore, strict refrigeration control (i.e., at or below 40°F (4.4°C)) should be maintained during storage and distribution to prevent growth and toxin formation by C. botulinum type A and proteolytic types B and F.
(Pg 252)
[  ] = "added"

 

 

 

The "FDA"  F value of 31min (@85degC) noted in yr Post is maybe "borrowed" from the ROP Process/blue crabmeat example in 3rd link of Post 5 (Pg 252).

 

As Ryan noted you need a process expert to determine whether Literature reference values may be applicable or a separate validation study is required. An example of latter is attached.

 

Attached File  Heat pasteurization Process for Dungeness Crabmeat.pdf   2.75MB   10 downloads

 

PS - Note that FDA (Pg 423 source document above) also provide a Generic seafood (Lethality/Temperature/Time) table which is more conservative than the 31min datum mentioned above,ie -

 

Attached File  Inactivation (6D) Non-Proteolytic C.botulinum Type B.pdf   83.31KB   15 downloads

 

PPS - also see para. 4.2.1 in -

 

https://www.inspecti...0/1412623333845


Edited by Charles.C, 08 July 2019 - 06:02 AM.
expanded

Kind Regards,

 

Charles.C





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