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Swabbing using 3M Clean-Trace Luminometer

Swabbing Cleaning Validation

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#1 chrisbird616

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Posted 09 November 2013 - 09:47 PM

Hi all

First topic post so be gentle!

 

I was just wondering if anybody has any experience in using a 3M Clean-Trace Luminometer for microbiological swabbing?

 

We've recently started using a new unit, which (as I understand it) could be markedly different from our old unit in terms of mechanism, sensitivity, etc. 

 

I was basically enquiring if anybody could provide any guidance in two aspects of use.

 

Firstly, in terms of what pass or fail is in the reported SLU count - i.e has cleaning been successful. We used to work to a 'pass' of 150 SLU and a 'concern' limit of 300 SLU, but we have no basis in fact that this continues to be suitable for use. Due to staff turnover we don't even have access to the study that determined these limits.

 

Secondly, (posssibly the same question as above) what validation can we request from our lab to establish that the luminometer is reporting cleaning success accurately?

 

Thx.


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#2 QABMP

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Posted 09 November 2013 - 10:12 PM

NO IDEA


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#3 Slab

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Posted 09 November 2013 - 11:35 PM

Hi all

First topic post so be gentle!

 

I was just wondering if anybody has any experience in using a 3M Clean-Trace Luminometer for microbiological swabbing?

 

We've recently started using a new unit, which (as I understand it) could be markedly different from our old unit in terms of mechanism, sensitivity, etc. 

 

I was basically enquiring if anybody could provide any guidance in two aspects of use.

 

Firstly, in terms of what pass or fail is in the reported SLU count - i.e has cleaning been successful. We used to work to a 'pass' of 150 SLU and a 'concern' limit of 300 SLU, but we have no basis in fact that this continues to be suitable for use. Due to staff turnover we don't even have access to the study that determined these limits.

 

Secondly, (posssibly the same question as above) what validation can we request from our lab to establish that the luminometer is reporting cleaning success accurately?

 

Thx.

 

Hi, Chris;

 

Since the industry is lacking any solid pass/fail criteria, it's best to establish your limits with a statistical model i.e. mean to omega (or average to std deviation formula), and set pass/cautionary/fail limits based upon that.  If your RLU results are beyond the current system parameters, then reassess assuming the following;

 

  • SSOP is proven with systematic validation
  • Your environmental testing and finished product micro is within governmental/customer regulatory limits.

 

Of course there is no "magic" number, as surfaces to be cleaned vary, hence limits will have to be adjusted in your test plan based on this.  Rubber, vinyl, PVC, and composites will not give the same results as well manufactured stainless equipment.

 

As far as your last question, I'm not familiar with the 3M, but I would venture a guess that the manufacturer can provide you with a control kit to ensure your system is properly calibrating on start-up.


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#4 Charles.C

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Posted 10 November 2013 - 12:25 AM

Dear chrisbird,

 

If you look back through other threads here, you will see that many (all?) brands issue their own ranges of recommended values for pass, fail etc. The actual numbers can vary considerably between brands due, as you suggest,  to differences in the  detection/amplification/display stages of the unit. Some brands  (freely) provide actual validation data to support the ranges quoted ( some reports are linked in forum threads [from memory this includes some 3M units but I may be wrong]). There is no absolute standard as noted in previous post.

 

It is possible to set up yr own standards but it will obviously be necessary to decide on a criterion for pass / fail etc. Again there is no absolute standard but you will presumably have to validate yr decision by, for example, comparing results to alternative accepted methods, eg micro.data.

 

Seems easier to initially try the brand manufacturer's own proposals for pass/fail. I am not a user of this method myself but I would be amazed if such information was not available. i suggest you immediately contact the supplier or look it up on the net.

 

I think there are also discussions of yr brand on this forum already, some may well include typical values for  pass/fail ranges.

 

Anyone ?? :smile:

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#5 chrisbird616

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Posted 10 November 2013 - 03:21 PM

@Charles.C

 

Remarkably, the supplier of the kit provide no guidance on recommended values. Partly, because, as Slab pointed out, there are variations/idiosyncracies in different user's individual test surfaces, but also because they state that the user must determine their own values based on corresponding microbial load specifications.

 

I was quite astounded by there being no standardised or generic guidance, however. I mean, after all the manufacturer alone must have performed exhaustive studies during the design process. So why wouldn't they want to supply it as a starting point?!??

 

I was just wondering if anybody could point me in the direction of a study or reference that was freely available. There is nothing unusual about our lines; we are just looking to swab on flat s/s or polythene surfaces.

 

Chris


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#6 Charles.C

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Posted 10 November 2013 - 04:12 PM

@Charles.C

 

Remarkably, the supplier of the kit provide no guidance on recommended values. Partly, because, as Slab pointed out, there are variations/idiosyncracies in different user's individual test surfaces, but also because they state that the user must determine their own values based on corresponding microbial load specifications.

 

I was quite astounded by there being no standardised or generic guidance, however. I mean, after all the manufacturer alone must have performed exhaustive studies during the design process. So why wouldn't they want to supply it as a starting point?!??

 

I was just wondering if anybody could point me in the direction of a study or reference that was freely available. There is nothing unusual about our lines; we are just looking to swab on flat s/s or polythene surfaces.

 

Chris

Dear chrisbird,

 

Try this maybe -

 

http://www.ifsqn.com...its/#entry61440

 

Rgds / Charles.C


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Charles.C


#7 chrisbird616

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Posted 11 November 2013 - 07:56 AM

Once again, thanks Charles.C !!


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#8 cazyncymru

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Posted 11 November 2013 - 09:17 AM

Chris

 

First thing is, get your rep in, they do "free" training, so that everyone knows how to use the machine correctly. Also make sure you have the trending software on your PC.

 

I've attached a couple of documents for you

 

Caz x

 

Attached Files


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#9 chrisbird616

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Posted 11 November 2013 - 09:59 AM

@cazyncymru

 

Deepest thanks from this Wales-based numpty!

 

We did have two reps in to do some initial training; the issue was we didn't really know what questions to ask back them, compounded by the fact that (for various reasons) we didn't get the swabber out of the box again for another three months!

 

Thanks again

Chris


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#10 cazyncymru

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Posted 11 November 2013 - 10:14 AM

Where in Deepest Darkest (and dampest) Wales are you Chris?

 

Cazx


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#11 George @ Safefood 360°

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Posted 12 November 2013 - 01:12 PM

Hi Chrisbird,

 

As I'm sure you are aware the test is based on an indirect measurement of ATP a chemical component in respiration. The test unlike standard swabbing and plating tests measure the presence of protein and from this an assumption is made about the hygienic standard of the surface or sample etc. Standard methods measure the viable numbers of micro-organisms which is a different thing. As a manager and auditors I view these rapid tests as being an excellent indicator of hygienic practices and standards. Even where the result is expressed in RLU's, SLU's as a specific value or number, I still deal with the test as a qualitative test i.e. pass/fail; go/no go. Without knowing the specific process and product risk I can only provide some general advise.

 

Validation is important. If we take cleaning as the specific area of interest you need to effectively conduct a study or experiment. In other words in the specific context of your process, products and operations you need to know what 100, 200, 300 slu's tells you. What is this saying about your procedures and activities. For example:

 

1. Take a cleaning procedure as document

2. Confirm through visual observing that the procedure is being carried out as defined. (Steps, chemical make up, usage etc)

3. If not, does the procedure need to be changed or the operator trained? Close this out.

4. Once the above is confirmed, conducted the documented procedure a number of times and conduct standard micro testing for TVC's, pathogens etc.

5. Also conduct the Clean Trace swabbing at the same time under identical conditions, sample points etc

6. Develop a correlation graph between the two sets of results

7. Document all the above and file for inspection/review by your auditors. Show you methodology, results and conclusions clearly. 

 

This will tell you what the SLU results actual reflect and from this you can make validated decisions. I hope this help and it should be sufficient for most auditors.

 

George


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#12 Katja

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Posted 15 November 2013 - 07:32 PM

I wholeheartedly agree with George.  We have used both the Hygiena and 3m luminometer and have validated it use.  From meomory of the 3m model it came with standard pass fail  but we chose our own based on a study.  You cannot compare lumnometer because it all depends on the technology and reagents used. For us the pass for hygiena was 4RLU and for the 3m it was equivalent to 35 RLU.  I contacted the sales rep who sent me a document on setting pass fail levels.  Unfortunately i did not keep it as our 3m luminometer was a lemon.  it never worked properly it always failed its auto calibration and after replacing it 3 times we had enough.ask for the 3m clean-trace hygiene management guide.


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#13 bactrol

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Posted 15 November 2013 - 10:30 PM

Hello

The figures you quote are used by a number of food producers. Your initial figures may not meet the 300/150 levels but treat what ever you get as a starting point to move forward from. I have seen some really good improvements just by hygiene teams being able to see these results. You may find that you get better results on some surfaces rather than others e.g. stainless steel will generally give a better result than plastic (all other things being equal). But what ever you get ATP gives you a good measure of your progress and helps you quantify the results of any changes you make to your leaning methods.

One final point you can get some references solutions to check you meter is producing accurate readings - these are not expensive and worth considering. Good luck.


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#14 Charles.C

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Posted 16 November 2013 - 06:02 AM

Dear Chrisbird,

 

Regarding the setting of Pass/fail levels, this document (different system) may be of interest. Most general procedures in use are inevitably semi-quantitative and may hv to be (validatably) modified.

 

Attached File  Guide to ATP Hygiene Monitoring.pdf   1.61MB   57 downloads

 

Some of the data is interesting to compare with Caz's earlier attachments, eg in respect to actual machine responses.

 

As a comparison, here is an example of a  FSIS (2009) regulatory procedure for sanitation control utilising microbiological evaluations.

 

Attached File  FSIS baseline-ongoing sanitation control procedure.pdf   84.32KB   40 downloads

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C






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