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#1 KarenMeadowsSIA

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Posted 18 November 2019 - 06:30 PM

HI a company I am working with produces Gin and uses a 5um filter just before bottling.

The SALSA auditors want the filter to be a CCP and want the visual checks verified.

How on earth do you do that for a 5um filter?

 

I dont this this is a CCP.  There is no microbiological risk, no allergenic risk, chemical risk is ruled out by specs and GMPs, which leaves a risk of physical contaminants from a damaged filter.  However the filter is visually checked before and after use. But to see if a 5um filter is damaged in the um spectrum is virtually impossible without huge cost.  The risk of damage to anyone from physical contamination is very low.  If it was large enough to do that it could be seen.  

 

Any suggestions???



#2 QAGB

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Posted 18 November 2019 - 06:39 PM

Perhaps I am missing something here, but it is mentioned that these filters are checked before and after use. How is this not verification? I can understand their want for the filter to be a CCP (in many cases they are).

 

What format is the filter in? Could you measure the size of the holes of any visibly damaged filters, and consider your limit to be quantifiable & measurable based on the size of the damage?



#3 FSQA

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Posted 18 November 2019 - 07:18 PM

I agree with QAGB as mentioned in the above post. You pre and post inspection is your verification. Visual inspection of any ruptures can be a deviation.

 

"The risk of damage to anyone from physical contamination is very low."

I would suggest a risk assessment, based on severity and likelihood of occurrence (historically related to the product in query), which can help to back up in case if it comes up.



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#4 Watanka

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Posted 19 November 2019 - 12:35 AM

Hi Karen,

 

We declared last filtration before bottling to be a CCP (physical) for bottling distilled spirits.  Our filters run from 25-micron to 0.5 micron depending upon the product.  We check the filters at least daily, more often if there is a change-over to another product type.  QC Technicians inspect the filters for visible tears and holes.  FDA declared a limit of 7mm for physical hazards per CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects.  We set critical limits to no visible defects in the filters. Human eye can resolve to about 35-40 microns, so a visual inspection is more than adequate to that task.  We document filter inspection observations.  We conduct challenge studies at least annually as a part of our HACCP reassessment using a 6.5mm object to ensure filtration catches it in each bottling line.  Check your UK regulations to see if there is a physical hazard size limit like FDA's 7mm limit for physical contaminants, or just set a critical limit of no visible defects.  

 

Cheers!



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#5 Charles.C

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Posted 19 November 2019 - 02:37 AM

Hi Karen,

 

We declared last filtration before bottling to be a CCP (physical) for bottling distilled spirits.  Our filters run from 25-micron to 0.5 micron depending upon the product.  We check the filters at least daily, more often if there is a change-over to another product type.  QC Technicians inspect the filters for visible tears and holes.  FDA declared a limit of 7mm for physical hazards per CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects.  We set critical limits to no visible defects in the filters. Human eye can resolve to about 35-40 microns, so a visual inspection is more than adequate to that task.  We document filter inspection observations.  We conduct challenge studies at least annually as a part of our HACCP reassessment using a 6.5mm object to ensure filtration catches it in each bottling line.  Check your UK regulations to see if there is a physical hazard size limit like FDA's 7mm limit for physical contaminants, or just set a critical limit of no visible defects.  

 

Cheers!

 

Hi Watanka,

 

IMO the red^^^  is a popular "quote" but unfortunately lends itself to gross misinterpretation.

For example if you ask the FDA if a food contaminated with ball bearings of diameter 6 mm is acceptable, I am confident they will reply something like "you must be joking !"

It's categorised as adulteration.

 

It sounds like the OP may be slightly confusing hazards, CCPs and validation/verification of control measures.


Kind Regards,

 

Charles.C


#6 KarenMeadowsSIA

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Posted 19 November 2019 - 08:52 AM

Perhaps I am missing something here, but it is mentioned that these filters are checked before and after use. How is this not verification? I can understand their want for the filter to be a CCP (in many cases they are).

 

What format is the filter in? Could you measure the size of the holes of any visibly damaged filters, and consider your limit to be quantifiable & measurable based on the size of the da

HI the auditors wanted verification for the filter which is already being checked visually.  Maybe there was some confusion between the auditor and my client.  I will check..



#7 zanorias

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Posted 19 November 2019 - 09:12 AM

Looking at this at another angle, could it potentially be a case of not needing to change the actual process, but any/all of the procedural and documentation side i.e. a review of the HACCP plan, formally listing the sieving as a CCP and making the necessary amendments to the plan along with the records and documentation? I'm just wondering if the auditor was satisfied with the physical process and checks but wants to see it recognised as a CCP and thus specify and document the verification in that regard.



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#8 KarenMeadowsSIA

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Posted 19 November 2019 - 09:22 AM

Hi Karen,

 

We declared last filtration before bottling to be a CCP (physical) for bottling distilled spirits.  Our filters run from 25-micron to 0.5 micron depending upon the product.  We check the filters at least daily, more often if there is a change-over to another product type.  QC Technicians inspect the filters for visible tears and holes.  FDA declared a limit of 7mm for physical hazards per CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects.  We set critical limits to no visible defects in the filters. Human eye can resolve to about 35-40 microns, so a visual inspection is more than adequate to that task.  We document filter inspection observations.  We conduct challenge studies at least annually as a part of our HACCP reassessment using a 6.5mm object to ensure filtration catches it in each bottling line.  Check your UK regulations to see if there is a physical hazard size limit like FDA's 7mm limit for physical contaminants, or just set a critical limit of no visible defects.  

 

Cheers!

 

Looking at this at another angle, could it potentially be a case of not needing to change the actual process, but any/all of the procedural and documentation side i.e. a review of the HACCP plan, formally listing the sieving as a CCP and making the necessary amendments to the plan along with the records and documentation? I'm just wondering if the auditor was satisfied with the physical process and checks but wants to see it recognised as a CCP and thus specify and document the verification in that regard.

HI visual checks of the 5 micron filter before and after production is a CCP in the HACCP plan.  On reflection is may be simply that this wasn't identified on the start/finish due diligence checks as a CCP (fliter check was on there).  I have amended the sheet to make it obvious.  Thank you.


Edited by KarenMeadowsSIA, 19 November 2019 - 09:23 AM.


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#9 mahantesh.micro

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Posted 19 November 2019 - 11:37 AM

Hi Karen,

I dont know which standard you have been certified.. But as per ISO 22000 CCP should be measurable and OPRP should either be measurable or observable. If you want to make your filteration (5um) as your CCP, then its very difficult to make it measurable one.

In my opinion it can be made as OPRP (operational prerequisite programme).

 

Regards

Mahantesh



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#10 kingstudruler1

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Posted 20 November 2019 - 05:19 PM

Record review is a form of verification (review / sign / date the monitoring record(s)).  Is it as simple as this not being done?



#11 QAGB

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Posted 21 November 2019 - 03:38 PM

Hi Karen,

I dont know which standard you have been certified.. But as per ISO 22000 CCP should be measurable and OPRP should either be measurable or observable. If you want to make your filteration (5um) as your CCP, then its very difficult to make it measurable one.

In my opinion it can be made as OPRP (operational prerequisite programme).

 

Regards

Mahantesh

 

Hi Mahantesh,

 

Actually, filtration is a very common CCP and is measurable. Watanka's post (#4) explains it pretty accurately. If you really want to challenge your filters, aside from putting foreign objects in the line (not my favorite tool), you can also measure the sizes of any particles captured by the filters. In this case, I presume that might be more difficult for the types of particulate captured in the OPs process, but in other products with a coarser filter, this can be achieved.



#12 Matthew Fuller

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Posted 21 November 2019 - 09:14 PM

In our plant we have 5 micron polish filters as a CCP, the last step of filtration prior to dispatch (edible oils). 

Verification for us is differential pressure, every load dispatched (bulk tankers) inlet and outlet pressure are observed and recorded. 

This CCP is validated by purposefully damaging filter bags and observing when the differential pressure is affected etc. This is obviously infrastructure dependant and does require some good calibrated gauges. 

This process is a bit tedious for load-out staff but we have never had an issue with an auditor. 



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#13 BostonCream

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Posted 21 November 2019 - 09:41 PM

We have couple filters though the whole process, and we did not assign any of them to be a CCP. Reason is that by going through all these 150 mesh screens, the chance of any physical hazard reaching the last filter is very low, and if yes, the size will be much less than 1mm.  



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#14 mahantesh.micro

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Posted 22 November 2019 - 05:06 AM

Hi Mahantesh,

 

Actually, filtration is a very common CCP and is measurable. Watanka's post (#4) explains it pretty accurately. If you really want to challenge your filters, aside from putting foreign objects in the line (not my favorite tool), you can also measure the sizes of any particles captured by the filters. In this case, I presume that might be more difficult for the types of particulate captured in the OPs process, but in other products with a coarser filter, this can be achieved.

Hi Karen,

 

We declared last filtration before bottling to be a CCP (physical) for bottling distilled spirits.  Our filters run from 25-micron to 0.5 micron depending upon the product.  We check the filters at least daily, more often if there is a change-over to another product type.  QC Technicians inspect the filters for visible tears and holes.  FDA declared a limit of 7mm for physical hazards per CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign ObjectsWe set critical limits to no visible defects in the filters. Human eye can resolve to about 35-40 microns, so a visual inspection is more than adequate to that task.  We document filter inspection observations.  We conduct challenge studies at least annually as a part of our HACCP reassessment using a 6.5mm object to ensure filtration catches it in each bottling line.  Check your UK regulations to see if there is a physical hazard size limit like FDA's 7mm limit for physical contaminants, or just set a critical limit of no visible defects.  

 

Cheers!

 

Hi QAGB,

Mr. Watanka clearly mentioned (marked in red-above) which says it is visual inspection and i dont think he has mentioned anywhere measuring of the CCP except annual challenge test (which we also do for 20 mesh sieve in my Organization). Big task is 5um filter!!!. 

Currently we are measuring the 20 mesh sieve at random places every 4 hours and limit i have set for this CCP is 0.841 mm to 0.905 mm. We also have metal detector before sieving which i made it as OPRP.

 

CCP is fine if the filter mesh size is bigger (below 20 mesh) i.e. openings above 0.841 mm. But the filter mesh size is too small such as 5um, then it is very difficult to measure and also it is time consuming.

 

 

Thank you..



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#15 KarenMeadowsSIA

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Posted 22 November 2019 - 08:45 AM

In our plant we have 5 micron polish filters as a CCP, the last step of filtration prior to dispatch (edible oils). 

Verification for us is differential pressure, every load dispatched (bulk tankers) inlet and outlet pressure are observed and recorded. 

This CCP is validated by purposefully damaging filter bags and observing when the differential pressure is affected etc. This is obviously infrastructure dependant and does require some good calibrated gauges. 

This process is a bit tedious for load-out staff but we have never had an issue with an auditor. 

 

Hi Matthew thanks.  This distiller is a 1 man operation who works from a converted garage at this home.  A very small production unit.  However he has big plans hence the 3rd party audit.  The risk of anything getting through the previous filters is very low.  Bottles are filled using a small filling machine not from a bulk tank so i don't know about the practicality of measuring pressure.



#16 QAGB

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Posted 22 November 2019 - 01:32 PM

 

Hi Karen,

 

We declared last filtration before bottling to be a CCP (physical) for bottling distilled spirits.  Our filters run from 25-micron to 0.5 micron depending upon the product.  We check the filters at least daily, more often if there is a change-over to another product type.  QC Technicians inspect the filters for visible tears and holes.  FDA declared a limit of 7mm for physical hazards per CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign ObjectsWe set critical limits to no visible defects in the filters. Human eye can resolve to about 35-40 microns, so a visual inspection is more than adequate to that task.  We document filter inspection observations.  We conduct challenge studies at least annually as a part of our HACCP reassessment using a 6.5mm object to ensure filtration catches it in each bottling line.  Check your UK regulations to see if there is a physical hazard size limit like FDA's 7mm limit for physical contaminants, or just set a critical limit of no visible defects.  

 

Cheers!

 

Hi QAGB,

Mr. Watanka clearly mentioned (marked in red-above) which says it is visual inspection and i dont think he has mentioned anywhere measuring of the CCP except annual challenge test (which we also do for 20 mesh sieve in my Organization). Big task is 5um filter!!!. 

Currently we are measuring the 20 mesh sieve at random places every 4 hours and limit i have set for this CCP is 0.841 mm to 0.905 mm. We also have metal detector before sieving which i made it as OPRP.

 

CCP is fine if the filter mesh size is bigger (below 20 mesh) i.e. openings above 0.841 mm. But the filter mesh size is too small such as 5um, then it is very difficult to measure and also it is time consuming.

 

 

Thank you..

 

 

 

Hi Mahantesh,

 

I can't speak to your process, but we used many filters and sieves in our process, and were audited by customers, BRC, and FDA. Here's the process thought for our filtration CCPs, which were satisfactory to our auditors.

 

  • We used the justification that hazard limits are set at 7mm, like Watanka. We also noted that as Charles mentioned earlier, this limit can be subject to misinterpretation.
  • Filter validation was conducted by measuring the size of particulate remaining in the filters.
  • Therefore, we tried to use the finest filters that our products could tolerate for filtration, which kept us well below 7mm. We ranged anywhere from 0.15mm to 2.4mm filters depending on product type.
    • Any foreign material that was not organic to a product still was considered adulteration and required investigation and actions.
  • For verification - filters were checked at least twice per shift, not only for the foreign material, but also to ensure filters were not damaged (hence a visual inspection).
    • If foreign materials were found or filters were damaged, QA was notified for further corrective actions (product placed on hold and production stopped).
    • If filters were damaged due to wear and tear, we would re-filter the product with a good filter.

 

Back to Watanka's statement on visual verification by human eye, 35-40 microns would be extremely small; <0.05mm. I would think this is more than enough for a verification to determine when damage is found.

 

I can't quite grasp the reason for physically measuring your 20 mesh sieve every 4 hours, unless you expect your sieve to change sizes. Is it difficult to spot damage or holes in your sieve by the human eye?



#17 mahantesh.micro

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Posted 23 November 2019 - 08:31 AM

Hi Mahantesh,

 

I can't speak to your process, but we used many filters and sieves in our process, and were audited by customers, BRC, and FDA. Here's the process thought for our filtration CCPs, which were satisfactory to our auditors.

 

  • We used the justification that hazard limits are set at 7mm, like Watanka. We also noted that as Charles mentioned earlier, this limit can be subject to misinterpretation.
  • Filter validation was conducted by measuring the size of particulate remaining in the filters.
  • Therefore, we tried to use the finest filters that our products could tolerate for filtration, which kept us well below 7mm. We ranged anywhere from 0.15mm to 2.4mm filters depending on product type.
    • Any foreign material that was not organic to a product still was considered adulteration and required investigation and actions.
  • For verification - filters were checked at least twice per shift, not only for the foreign material, but also to ensure filters were not damaged (hence a visual inspection).
    • If foreign materials were found or filters were damaged, QA was notified for further corrective actions (product placed on hold and production stopped).
    • If filters were damaged due to wear and tear, we would re-filter the product with a good filter.

 

Back to Watanka's statement on visual verification by human eye, 35-40 microns would be extremely small; <0.05mm. I would think this is more than enough for a verification to determine when damage is found.

 

I can't quite grasp the reason for physically measuring your 20 mesh sieve every 4 hours, unless you expect your sieve to change sizes. Is it difficult to spot damage or holes in your sieve by the human eye?

Hi QAGB,

I agree that whatever left on filters can be measured and record it. Coming to your last point, yes we can spot damage with our eyes and record as "no damage" but it becomes qualitative inspection and not measurable. Earlier we were recording like this only, but our auditor questioned it. Then we started measuring the mesh size and recording each random measurements.



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#18 Charles.C

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Posted 23 November 2019 - 12:55 PM

iso22000:2005 actually accepted visually implemented criteria as a CL (albeit not in the CL definition) but this option was seemingly removed in the 2018 version along with the creation of "action criteria". Semantic manouevrings. :smile:

 

I daresay, if in UK,  the applicable Standard is unlikely (but not impossible) to be ISO22000.

 

> Karen ????

 

afaik ISO's version is currently the only haccp system which imposes this (quantitative) limitation. In fact sieve visual integrity has a long history of being set as a CL for a CCP's  filtration control measure.


Kind Regards,

 

Charles.C


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#19 mahantesh.micro

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Posted 25 November 2019 - 04:44 AM

iso22000:2005 actually accepted visually implemented criteria as a CL (albeit not in the CL definition) but this option was seemingly removed in the 2018 version along with the creation of "action criteria". Semantic manouevrings. :smile:

 

I daresay, if in UK,  the applicable Standard is unlikely (but not impossible) to be ISO22000.

 

> Karen ????

 

afaik ISO's version is currently the only haccp system which imposes this (quantitative) limitation. In fact sieve visual integrity has a long history of being set as a CL for a CCP's  filtration control measure.

This is what i was trying to explain, ISO 22000 mandates measurable critical limits for CCP and Measurable or observable action criterion for OPRPs. I dont know about the other standards. IMO it depends on the standard -SQF, BRC, IFS, FSSC etc.



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#20 Charles.C

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Posted 25 November 2019 - 01:02 PM

This is what i was trying to explain, ISO 22000 mandates measurable critical limits for CCP and Measurable or observable action criterion for OPRPs. I dont know about the other standards. IMO it depends on the standard -SQF, BRC, IFS, FSSC etc.

 

I predict ISO, (and therefore fssc) is unique although IFS is often a "loose cannon"


Kind Regards,

 

Charles.C






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