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Sample analysis using Process Control Testing (PCT)


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#1 Jewl578

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Posted 22 June 2018 - 01:35 PM

We have a customer who is requiring our facility to test our finished product and perform environmental swabbing (no problem, it's expected, we'd perform these regardless) then have the samples analyzed using Process Control Testing (PCT). 

We send samples out to an external lab. This is for an RTE FDA product.

This type of analysis is new to our facility and am wondering if anyone has experience or knowledge of it.

Advantages/Disadvantages?

I'm simply trying to gather more information and anyone's thoughts on the process.

We haven't started production on the product yet, but will be soon, so I have no reference to taking this approach.

 

PCT Description:

 

Test Method:

Process Control Testing = Process Control Testing MB491.01-4(PCR)(GNGC), EHEC /pSTEC = EHEC Molecular Indicators MB491.01-MI(PCR), LM = Listeria monocytogenes Molecular Indicators MB491.01MI(PCR), SAL = Salmonella spp. Molecular Indicators MB491.01-MI(PCR)

 

Target & Action Limits: 

PCT Critical Limit:  Process Control Testing (PCT) detects the presence of groups of organisms which share a common genetic target.  All samples with a Process Control Index (PCI) <10 are deemed acceptable.  When the PCT score is ≥10, the sample is considered Out of Specification, and actions are taken. PCT Upper Control Limit: Although Process Control Index (PCI) <10 are deemed acceptable, PCI scores between 5 and 9 require some investigative and sanitation activities to be conducted.

 

Thanks,

JBickle

 

 

 



#2 Scampi

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Posted 22 June 2018 - 05:22 PM

When i google PTC, it appears to be a KPI used in making 'stuff' as apposed to food........

 

Ae you looking at finished goods testing, or are you needing to sample throughout the process

 

Just wondering if your customer is using verbage that we're all not familiar with to mean something else

 

I've not heard of this type in all my food processing experience


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#3 jdpaul

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Posted 22 June 2018 - 05:36 PM

Scampi,

 

IEH Laboratories and Testing has created a method called PCT; however, on their website, there is not much documentation aside from this:

PCT™ is a rapid, customizable assay which shows possible microbiological process control deviations (Food Safety & Spoilage).

 

I reached out to them because I was interested in learning more about the process. I will share when I get more information.

 

Edit: PCT not 'PTC'

 

 

I'm assuming it allows the customer to monitor, so to speak, your sanitation of overall organisms that share genetic characteristics with the target ones (different strains?) 'share similar genetic target' could also mean groups of organisms that use the same genetic mechanisms, chaperone proteins, etc to carry out their activity. Not sure.


Edited by jdpaul, 22 June 2018 - 05:45 PM.


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#4 Scampi

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Posted 22 June 2018 - 05:49 PM

Thaks jd

 

I just don't understand how in gods name an assay is going to tell you anything worth knowing mid process

 

Let's assume you're making tv dinners (lol I know who eats that stuff) and you cook the protein on site.........one would assume that at some point you will get a positive on ecoli or salmonella or both

 

So what?  That's taking the entire HACCP program and throwing it out the window........it's just data, but not really helpful data.........you know where to expect hits mid-process, that's what the hazard anaylisis is for??

 

I went to the website jd, and it actually reads like a gimmic to me.  Who cares about micro, if you're oven was too cool, you should have at least 2 seperate checks plus maintenance records to show you that upon record review even if the operator didn't say anything

 

OR, i'm missing something on this chain in which case I will quietly slink to the back of the room and be quiet


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#5 jdpaul

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Posted 22 June 2018 - 07:31 PM

See attachments and quotes:

 

 


Thanks for your inquiry. We offer both AOAC pathogen tests and the Process Control Test Platform (PCT). The PCT is considered an indicator platform; an analogy would be total coliform testing.    The coliforms are not considered pathogenic in and of themselves however, over a certain level is associated with a higher risk of the presence of pathogens. For example, some have a TCC threshold and over is considered adulterated, below is considered ok. The PCT is a similar approach however, instead of looking for the group of coliforms it detects a target panel of genes, some found in broad groups of organisms, some semi specific to pathogens (EHEC, Salmonella & Listeria).  The score is based on the presence and combination of the genes that are a detected. 

 

The PCT results fall into three categories:

•             0 to 8: pass (process under control)

•             9: indicates non-mono Listeria is present

•             10 and above: fail (process temporarily out of control, either EHEC, Salmonella of L mono markers detected)

 

Also, just as there is no table as to what a count of 1, 2, 3….. coliform mean, there is no table for  PCT = 0, 1, 2, 3….   The reaction to a PCT = 1 is the same as a PCT = 3, just like the reaction to TCC = 1CFU/unit is the same as TCC = 3 CFU/unit. Furthermore, the PCT targets 10 genes so there are 1,024 possible combinations: a PCT = 1 could be achieved 10 different ways and a PCT = 3; 120 different ways.

 

Regards,

Sam

 

From what I understand from the call with Sam;

 

Advantage; this method acts as a indicator test and thus when dealing with regulatory = less problems

another is that the test is more cost effective since it uses PCR and DNA to detect presence of genes related to the pathogens in question. To do all the testing for each organism by itself would be expensive, etc. He mentioned trend analysis capabilities to show when you start approaching the 8 score.

 

I haven't read material yet so this is just from the phone conversation

Attached Files


Edited by jdpaul, 22 June 2018 - 07:41 PM.


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#6 Scampi

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Posted 22 June 2018 - 08:00 PM

Thanks for the follow up jd

 

So this isn't a "process control testing"; the name is a misnorer I think

 

I know that the University of Guelph in Ontario is working feverishly to produce real time pathogen detection to the subtype, so I would wait for that (next 3-5 years)

 

"semi specific"  it sounds like alot of explaining to auditors about what you're really finding and perhaps hitting the panic button too soon, although if you had a high risk/care product it might be useful. I know with my experiece with CFIA they would be as likly to get confused by an "indicator" as by the findings and corrective actions


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#7 Jewl578

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Posted 25 June 2018 - 01:52 PM

Thanks for the comments everyone.

I had goggled as well and did not find much.

jdpaul the information you supplied is great, we are in fact going to be using IEH labs for these tests. I've been in contact with them, but wasn't given the information you supplied.

This is going to be a RTE product with daily environmental testing as well.

PCT is new to us so am looking forward to seeing how this all plays out.

Scampi, we had never heard of it either, was beginning to wonder if the customer was just wanting to use us as guinea pigs  :headhurts:

 

Once again, thank you all!

 

jbickle



#8 BuckeyeGal

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Posted 30 December 2019 - 06:08 PM

The main issue with this method is the total lack of transparency.  Anyone who has designed PCR primers knows that you have to know exactly what genes you are looking for and they should be specific so that you aren't rejecting product based on non-pathogenic relatives. They are testing for pathogens.






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