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Cleaning verification for basic GMP audits


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L. Mathies

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Posted 19 March 2014 - 04:45 PM

Does anyone know if a visual inspection will suffice for verification of equipment cleaning in a facility that blends and packages spice blends?



Tony-C

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Posted 19 March 2014 - 04:58 PM

Does anyone know if a visual inspection will suffice for verification of equipment cleaning in a facility that blends and packages spice blends?

 

This would depend on your products, any hazards identified, method of cleaning (& it's validation) and the risk of cross-contamination particularly with regards to allergens.

 

Regards,

 

Tony



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Posted 19 March 2014 - 05:25 PM

Because of the high biological loads that many spices have, I would think you would want to verify with ATP. 


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Tony-C

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Posted 19 March 2014 - 05:36 PM

Because of the high biological loads that many spices have, I would think you would want to verify with ATP. 

 

If they do have 'high loading' can I ask why you would want to verify with ATP?

 

Regards,

 

Tony



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Posted 19 March 2014 - 06:49 PM

If they do have 'high loading' can I ask why you would want to verify with ATP?

 

Regards,

 

Tony

 

While many of the organisms associated with spices are not pathogenic, still many have concerns about high micro counts.  It has been a struggle for many outside of the produce industry to understand that a high APC or SPC is not necessarily a problem or a concern. 

 

The value of ATP is that you get an immediate result.  You won't know what kind of cell you have but you at least know there are cells present.  So if your value is high or out of range you can re-clean.  Micro results take a bit longer, but the cells present may not even be microorganisms, but cells from the spices themselves.  ATP lets you demonstrate that you have eliminated cells (be they microorganisms  or otherwise) from the equipment.  You can't verify that visually.  While I understand there is a lot of debate as to what an acceptable limit is, customers and regulators like ATP. Visual is still important but based on the product would  have other methods of verification.

 

Allergens are a different issue. 


Edited by Snookie, 19 March 2014 - 09:02 PM.

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Slab

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Posted 19 March 2014 - 07:55 PM

Personally I would not rely on a visual only but proper environmental testing by a 3rd party or in house lab that is accredited.

 

If you're looking for quick positive release (not recommended) then testing instead for indicator organisms over ATP may be a better option.  The assay is a bit more complicated than ATP but it may give you a better reading of the procedure.

Not a "spice man" myself, just saying...

Here are a few lengthy documents from the FDA:

 

 

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Snookie

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Posted 19 March 2014 - 08:12 PM

Personally I would not rely on a visual only but proper environmental testing by a 3rd party or in house lab that is accredited.

 

If you're looking for quick positive release (not recommended) then testing instead for indicator organisms over ATP may be a better option.  The assay is a bit more complicated than ATP but it may give you a better reading of the procedure.

Not a "spice man" myself, just saying...
 

 

L. Mathies is talking about verification of cleaning.  Not a positive release.  For a positive release then micro would be better suited. 


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tanyac

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Posted 19 March 2014 - 08:16 PM

I don't think a visual inspection alone is sufficient.  We use ATP in my spice company along with the 3m allergen swabs.  We want to make sure your preventing cross contamination of products.



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Posted 19 March 2014 - 08:58 PM

Because of the high biological loads that many spices have, I would think you would want to verify with ATP. 

 

I think I know where Tony's question is going.  ATP seems magic to many, but it seems few realize ATP has not been demonstrated to directly correlate to microbial counts, in fact it has demonstrated little/no correlation.

 

While I think ATP has come a long way in the past few years, I still believe it should not be the end-all to proper inspection and testing.  I have seen even modern ATP machines do too many weird things for me to completely trust it.

 

In my view, though it is not my specific field, I would be more comfortable using ATP for cleanliness on a daily pre-op basis followed up with a weekly pre-op and operational TPC and coliform testing of the equipment.  Indeed, as Snookie stated, we see some high loads with spice blends.  The spice folks ought to ensure they're ridding those loads from the equipment during sanitization operations.



Taste Maker

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Posted 19 March 2014 - 09:02 PM

Hello,

 

Good afternoon, I would refer to your HACCP Plan for any hazard (s) associated with your specific blends. However, spices are generally considered to be safe per validated treatment process. In this way most hazards are eliminated or reduced to an acceptable level. I would do the range of micro testing on the blender every two weeks depending on your volume and risk. That is, how much product are you willing to lose and the associated risk involved would determine the actual frequency. We also blend spices and have never had a recall for a pathogen.Of course, visual is one of the ways in which we MONITOR the cleaning process by scheduling an "observation" to aid in detecting any deviations from the critical limit. Furthermore, you might want to establish a "clean" baseline with the ATP and validate with micro after establishing critical limits for any potential hazards. Remember, a high ATP does not mean there is a pathogen present and should be used as tool in the monitoring to ensure that the process is under control by asking, "who, what, when and where". Also, remember to document the inspections along with any corrective actions taken and revise the HACCP Plan when a failure occurs or anything in the process changes. You might want to look back at any consumer complaints from the past few years as well to determine the risk. Please see the attachment for an overview of hazards in spices.

 

Taste Maker

Memphis, TN

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jenky

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Posted 19 March 2014 - 09:11 PM

We manufacture spice blends, and you must know the hazard of your ingredients to determine how to monitor your sanitation.  Visual examination may be suitable for regular, changeover sanitation if you know your spices and ingredients are treated per a validated process.  ATP is also suitable verification of sanitation, but as others have suggested - ATP results cannot be correlated to microorganisms present, and therefore is not a subsitute for a solid environmental monitoring program.  A good enviromental monitoring program in a spice blending plant should include indicator organisms and Salmonella testing. 

 

Regarding the references to FDA's Risk Profile, I would caution readers that the study has large number of gaps.  The study failed to collect data and test in spices in commerce and at the retail level.  The study relied on import data to make conclusions about the entire farm-to-fork continuum.   I could go on with the failings of this study ... but I will spare everyone my rant.   


Edited by Jennifer B., 19 March 2014 - 09:30 PM.


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Kellio

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Posted 19 March 2014 - 10:46 PM

Basically, you need record of verification and  validation for GMP's inspections. Whatever process you use for inspection for certain procedures, the verification and validation should be documented.  One way to cut in paper is to design a form for GMP's and load it in a Ipad or Tablet in to a secure server or computer.

 

Visual Inspections not documented. It never happened. :) 

 

I hope this helps.



Bhawani Gorti

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Posted 20 March 2014 - 01:07 AM

The most appropriate way to address this - pre and post cleaning microbiological swab test and cleaning efficiency through various appropriate cleaning procedure. Keep changing the cleaning procedure and check the swab test results.

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Charles.C

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Posted 20 March 2014 - 01:50 AM

The most appropriate way to address this - pre and post cleaning microbiological swab test and cleaning efficiency through various appropriate cleaning procedure. Keep changing the cleaning procedure and check the swab test results.

thanks

 

And establish applicable standards.

 

Data / specifications. chicken or egg ? :smile:

 

Unfortunately the OP gave no (intended) auditory context.

 

A publication ca.5-6 years back containing a detailed "industry" appraisal implied that visual was the clear majority for validation purposes. Verification undisclosed. Presumably GFSI would not applaud this routine datum.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


Tony-C

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Posted 20 March 2014 - 07:52 AM

I think I know where Tony's question is going.

 

No you don't

 

While many of the organisms associated with spices are not pathogenic, still many have concerns about high micro counts.  It has been a struggle for many outside of the produce industry to understand that a high APC or SPC is not necessarily a problem or a concern. 

 

The value of ATP is that you get an immediate result.  You won't know what kind of cell you have but you at least know there are cells present.  So if your value is high or out of range you can re-clean.  Micro results take a bit longer, but the cells present may not even be microorganisms, but cells from the spices themselves.  ATP lets you demonstrate that you have eliminated cells (be they microorganisms  or otherwise) from the equipment.  You can't verify that visually.  While I understand there is a lot of debate as to what an acceptable limit is, customers and regulators like ATP. Visual is still important but based on the product would  have other methods of verification.

 

Allergens are a different issue. 

 

I might know the value of ATP technology given I pioneered the use of ATP swabs to positively release filling machines (cleaning verification) and product in the UK dairy industry 20 years ago.

 

My question was if the product has a 'high loading' why do you need to make sure the equipment is 'spotless'? Why isn't a visual check adequate? Get it?

 

Regards,

 

Tony



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cazyncymru

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Posted 20 March 2014 - 09:35 AM

Does anyone know if a visual inspection will suffice for verification of equipment cleaning in a facility that blends and packages spice blends?

 

 

I would assume you were dry cleaning? ATP might not be much use if you were.



Jairajmarcose

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Posted 20 March 2014 - 11:43 AM

microbiological swabs or ATP with defined criteria i think. what is the industry practice.??? 



Tony-C

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Posted 21 March 2014 - 03:33 AM

microbiological swabs or ATP with defined criteria i think. what is the industry practice.??? 

 

Well industry code of practice will depend on the sector of the industry!

 

For high risk products for sure use ATP swabs and back up with periodic micro swabs but would you use routinely on product that already has a 'high microbiological loading'? I might want to check cleaning periodically but I think my money would be better spent elsewhere as my first off product checks would indicate if there was a problem with cleaning.

 

Regards,

 

Tony



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Posted 24 March 2014 - 12:57 AM

I think visual inspecion is enough only for cleaning (clean from dust) but to verify  sanitize ( clean from micro), you need objective result such ATP method or Swab Test method.

 

 

Rgds

AS Nur



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Posted 24 March 2014 - 06:29 AM

Various safety meassures are followed when it comes to food packaging. In my opinion, as spice blends are tangible, many more safety meassures should be followed apart from visual inspection. Making sure that the right form of packaging is used is also important.






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