10 replies to this topic

[latchaporn]

Dear all,

 

Could anyone helps me? My boss asked me to do a validation of a new process, he used this words

 

"FDA would like to see a 5 log reduction of Clostridium botulinum, we probably need to inoculate the Clostridium botulinum for this test. We need to demonstrate that neither the bacteria nor spores are passing this process."

 

So what should I start? I think Clostridium botulinum is very dangerous to do an enrichment to get log 5. Is FDA really wants a 5 log reduction of Clostridium botulinum not a TPC?

 

Thank you in advance

 

Bew

[cazyncymru]

Hi Bew

 

if I remember rightly (and it's been a while) In the UK there are very few laboratories that are accredited (or permitted) to test for Clostridium Botulinum. They have to be tested at a laboratory that is at biosafety Level 4. The only place that I'm aware of that tests in UK is Porton Down. I looked when I worked in canning, so that we could also do some validation tests, and cost is so prohibitive!

 

http://en.wikipedia....Biosafety_level

 

There are rapid methods available; but again you have to demonstrate that you have adequate bio security measures.

 

http://www.rapidmicr...toxins-in-food/

 

It's a long time ago, but I think we did our validation using theoretical models. We validated the temperature reached in the can and the time it was at that temperature using dataloggers, then had a model for calculating the log reduction for botulinum. But like I say, it was so long ago, and I've slept since then!

 

Caz x

[Charles.C]

Dear all,

 

Could anyone helps me? My boss asked me to do a validation of a new process, he used this words

 

"FDA would like to see a 5 log reduction of Clostridium botulinum, we probably need to inoculate the Clostridium botulinum for this test. We need to demonstrate that neither the bacteria nor spores are passing this process."

 

So what should I start? I think Clostridium botulinum is very dangerous to do an enrichment to get log 5. Is FDA really wants a 5 log reduction of Clostridium botulinum not a TPC?

 

Thank you in advance

 

Bew

 

Dear latchaporn,

 

You need to add some context to get directly relevant responses, eg -

 

Is this the USFDA or local FDA ?

 

5log sounds like some form of pasteurization rather than sterilization ? Yes ?

 

 

What kind of product / process is being studied ?  if Pasteurization for C.bot. a certain range of products / processes are usually involved ?

 

Various approaches to validating pasteurizations exist which may depend on the specific situation, eg local (?) FDA requirement. It is possible that a substitute, non-pathogenic species for C.bot type XYZ exists or perhaps you can validate the maximum existing level of C.bot in yr input material and then validate the thermal process applied / level in finished product (this is a common approach for L.mono.) It all depends on the specific case.

 

FDA would like to see a 5 log reduction of Clostridium botulinum, we probably need to inoculate the Clostridium botulinum for this test. We need to demonstrate that neither the bacteria nor spores are passing this process."

 

The last sentence looks confused. The usual pasteurization requirement is to demonstrate that the population count of target species is reduced by >=5log or whatever the standard requires. This procedure does not prove that there is no residual C.bot. ( typically the objective of sterilization via  >= 12 log reduction).

 

Please clarify a little.

 

Rgds / Charles.C

[Slab]

Hi, latchaporn;

 

A 5D doesn't sound very aggressive for C-Bot.  I have found a reference for 6D and 12D (FDA 6D insufficient for some products).  A bit more information on your product and process would help. I'm no microbiologist but I believe the only viable method to validate your process would be the adoption of a scientifically proven thermal treatment model or bioassay from a certified lab.

 

Here are some attachments that may help;

 

 Chapter 13 C-Bot.pdf   888.07KB   68 downloads

 

 Appendix 4 Bacterial Pathogen Growth and Inactivation.pdf   2.08MB   83 downloads

 

Table A-1 and A-4

[latchaporn]

My product is fresh coconut water so, that meant we are not using any thermal processes in the production. Is it possible to inoculate C. bot in the product and pass the process to see the reduction's result? My process to be used for reduction is filtration.

 

Thank you all for your help in advance

 

Best regards,

Bew

[latchaporn]

How can we validate 12 log reduction of Clostridium botulinum

[Charles.C]

How can we validate 12 log reduction of Clostridium botulinum

 

Process ? heat ? filtration ?

 

for latter, a process maybe like - 

 

http://www.criticalp...m/food/wine.php

 

 sterile filtration, alfa-laval.pdf   1.32MB   60 downloads

 

Rgds / Charles.C

[campbell]

C.bot comes in two varieties.  There is the one which grows at ambient temperatures and then there is one which grows at chill temperatures.  Both require different growing conditions.  You need to decide your product storage conditions and then select the type.

You cannot validate your process as the organism can produce a toxin that can (& does) kill.  Talk to a recognised laboratory to assist but get help.

I work in a facility in UK which has test facilities for C Bot but I am sure if I mention name Charles/Simon will edit out.

[Simon]

I work in a facility in UK which has test facilities for C Bot but I am sure if I mention name Charles/Simon will edit out.

 

Once you have reached 10 posts on the forum you can edit your profile signature and that appears underneath every post you make.  In your signature you can include your name, company name, address, contact details including web link address etc.  The only constraint is it should be discrete and not massive font etc.  If you need help doing it send me a PM.

[Charles.C]

Dear latchaporn,

 

here is one, non-thermal, commercial pasteurization process for coconut water based on HPP - 

 

http://www.foodengin...healthier-foods

 

and here is another patent for a process designed to allow milder thermal sterilization -

 

http://www.google.co...1523248A1?cl=en

 

Rgds / Charles.C

 

PS - there are numerous papers** describing the production of "filtration sterilized" coconut water but so far have not seen any claiming to have validation against C.botulinum.

 

The intended shelf-life is also clearly relevant.

 

** for example -

 Sterilized Coconut water - technical details.pdf   238.49KB   35 downloads

 

I noticed this comment in a micro. text for thermally pasteurized, low acid, fruit juices and vegetable juices required to be kept chilled for safety - 

 

Validated control measures for all C. botulinum spores should be incorporated into HACCP plans to ensure that C. botulinum growth and toxin production will not occur should the juice be kept unrefrigerated in distribution or by consumers

 

.

[Slab]

Good finds, Charles.