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#1 Multivits

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Posted 18 March 2021 - 01:10 AM

When performing a sanitation validation exercise using either ATP or Microbe enumeration what microbe would be recommended as the marker for the validation of the sanitation process? e.g. if we use the definition of sanitized that would require a reduction of 99.9% (log 3) of microbes, therefore it is assumed that a control substrate surface is used (e.g. 10 cm x 10 cm) and is spiked with a known microbe and there is a known starting enumeration. After spiking a second substrate surface and performing the sanitation process and enumeration could then establish if we have a reduction of 99.9% (log 3) and could verify the sanitation process is effective. However, if no spiking occurred prior to the sanitation process and ATP or microbe enumeration was done afterwards there is no guarantee that the substrate had anything on it and thus the sanitation can't be proven to be effective. Can we get advice on what method to validate the sanitation process can be used given we need to prove a 99.9% reduction? TIA

 



#2 Slab

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Posted 18 March 2021 - 01:13 PM

Hi, Multivits;

 

The procedure really depends on your product and process and surfaces being cleaned. Pathogens (or any microorganisms) of concern vary greatly between industries. A dairy plant is not the same as produce...

 

As far as inoculation of the environment, I don't have any experience there, however I know it is done under extremely controlled conditions, even with analogous organisms. Introducing something like this into your facility is a huge risk.

 

I would recommend from experience to not use ATP in validation activities. It's perfectly fine to use as a verification tool, since adenosine triphosphate is not a measure of any specific microorganism but the "currency" microorganisms use for growth. 

 

My approach to hand washing and cleaning validation in the past was to do before and after swabs for indicators (EB, yeast, mold, APC, E. coli). I would usual get some elevated  indicator before and if all goes well acceptable levels post clean. It always satisfied 3rd party or regulatory body audits. Not sure about Australian standards however.

 

Additionally, many chemical manufacturers publish kill studies such as:

 

Attached File  PAA-Efficacy-Time-Temp.pdf   195.01KB   19 downloads

 

And your chemical provider should be able to provide you with tons of technical data

 

Here are a few threads discussing the topic;

 

https://www.ifsqn.co...on-process-cip/

 

https://www.ifsqn.co...not-applicable/

 

https://www.ifsqn.co...ixing-blending/

 

 


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#3 Charles.C

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Posted 18 March 2021 - 01:36 PM

When performing a sanitation validation exercise using either ATP or Microbe enumeration what microbe would be recommended as the marker for the validation of the sanitation process? e.g. if we use the definition of sanitized that would require a reduction of 99.9% (log 3) of microbes, therefore it is assumed that a control substrate surface is used (e.g. 10 cm x 10 cm) and is spiked with a known microbe and there is a known starting enumeration. After spiking a second substrate surface and performing the sanitation process and enumeration could then establish if we have a reduction of 99.9% (log 3) and could verify the sanitation process is effective. However, if no spiking occurred prior to the sanitation process and ATP or microbe enumeration was done afterwards there is no guarantee that the substrate had anything on it and thus the sanitation can't be proven to be effective. Can we get advice on what method to validate the sanitation process can be used given we need to prove a 99.9% reduction? TIA

 

Hi Multivits,

 

Unless you are following a specific requirement, you may be overthinking the situation.

 

Some Standards consider that Validation of PRPs like this is unnecessary and may be replaced by Verification. In the latter's context, see -

 

http://www.ifsqn.com...ces/#entry60958


Kind Regards,

 

Charles.C


#4 Multivits

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Posted 18 March 2021 - 08:51 PM

Thank you for the replies, since I didn't want to complicate the question I left off the sanitation process method.

 

The sanitation process is for equipment parts and is done in an automated cleaning and sanitation washer, sanitation is supposed to be achieved through thermal exposure vs time i.e. A0.

 

I can use thermo strips with LCD temperature indication attached to the equipment parts, but I can't get inside the machine (obviously) to measure the actual time 70 degrees C (wash tank temperature) is reached, the process is 6 minutes from entry to exit, with a heighted 80 degrees C rinse water temperature from an RO unit.

 

Could we use a probiotic as the marker?

 

TIA



#5 Slab

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Posted 19 March 2021 - 03:03 AM

I see (I think);

 

Your cleaning process is time/temp control CIP, can you use a data logger for this purpose?

 

https://www.madgetec...ucts/hitemp140/


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#6 Multivits

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Posted 19 March 2021 - 03:59 AM

Not actually CIP, as the equipment parts are run on a conveyor through the machine, Thanks for the suggestion and I am looking into using data loggers which can withstand the harsh environment and will look at the device you posted, thanks.



#7 Slab

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Posted 19 March 2021 - 05:36 PM

I have used this particular data logger in boiling water for 30-40 minutes for cook studies if that helps in the decision. The software and support are also very good, however the version of software I used in 2015 the analytics were meh...


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#8 majoy

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Posted 19 March 2021 - 07:28 PM

Honestly, I have worked with thermal sanitation machines and have never done any validation micro or have an auditor asked for any validation. As long as the chemicals, and temperatures are being monitored, recorded and thermolabels are being activated to confirm that temp are reached, I have not encountered an auditor questioning the effectiveness of these machines in cleaning and sanitation.

 

We did verification though, using ATP (weekly) and monthly micro swabs of newly washed equipment to show that micro limits are met.


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#9 Charles.C

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Posted 20 March 2021 - 02:26 PM

Hi Multivits,

 

a little context might be helpful, eg -

 

Standard = ?

Product = ?

Process = ?


Kind Regards,

 

Charles.C


#10 Multivits

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Posted 21 March 2021 - 09:30 PM

Standard = Code of GMP for Complimentary Medicines

Product = Curcumin, Fish Oil, Vitamin D, Royal Jelly

Process = Auto washing Meiko MiQ ware washer, set for thermo label sanitation, wash tank Suma Opal L9 70 degree C, Rinse tank RO water 80 degrees with RinseIT rinse aid, hot air blast for drying, cycle time 6 minutes for entry to exit.


The Meiko MiQ ware washer is a commercial kitchen grade continuous cycle machine, under the Code of GMP we have to validate cleaning and sanitation, and the QA Manager is pushing for this also. The installers are not used to a GMP environment however they set the machine to thermo label sanitation according to an Australian Standard, which I will enquire about.

TIA



#11 De Lucia

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Posted 01 April 2021 - 07:12 PM

Dear Multivit,

for verify the disinfection of dishwashing machine in the airline catering we use the thermolabel test. Normaly the standard is 71°C for 1 second on the surface and the rinse water temperature is 82°C. I enclose to you the link https://www.tiptemp....perature-Label/.

If you need additional information don't hesitate to contact me.

Regards

Giuseppe



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#12 Charles.C

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Posted 01 April 2021 - 07:55 PM

Note that the OP was seeking a specific  "Validation" methodology for any quoted  temp/time washing process (offerings 1 sec to 4 min).

 

So far it seems "No Cigar" albeit thanks for the various inputs. :thumbup:


Kind Regards,

 

Charles.C


#13 Multivits

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Posted 18 May 2021 - 11:22 PM

Thanks to all, other factors have come to bear such that the high temperature within the Meiko Machine is stripping a PTFE coating off some parts and the requirement for this machine to perform sanitation has now been removed and sanitation will be done manually using 70/30 IPA and distilled water.

 

FYI - The closest I got to a solution was to use Biological Indicators, which I have used for Autoclave validations, since the manufactures do provide a viable organisms count (provided they are stored correctly) theoretically a Log 3 reduction (sanitation) should be able to be established.

 

case is now closed. Thanks.






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