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The use of static filter after a metal detector - Adequate?!


Best Answer , 23 December 2015 - 10:52 AM

Hi vivek,

 

A few comments -

 

(1) it may depend on the FS standard, if any. I assume only safety criteria are involved.

 

(2) The status of the final filter IMO logically depends on a (safety) haccp risk assessment, ie is it likely that any "dangerous" objects will pass the MD but then be stopped by the final filter ?.

 

The answer to (2)  depends on yr product / process, criterion for "dangerous" and possibly Indian Regulations as to the local (safety) assessment of yr finished product if such exist (in which case will take priority).

 

Just as an example, from memory Canada set > 2mm as size criterion for hazardous metallic contamination. So if the MD validatably rejects all Fe items  <=2mm using, say SS 316, as a worst case reference and if only iron is considered a significant FM, then the final filter is simply redundant.

 

In some sectors, from an auditorial POV,  it is apparently acceptable to quote an "Industry Standard" as target critical limit, ie "best practice". Presumably requires some justification though.

 

The USA, as per my understanding, further protect their consumers by invoking adulteration as a FM rejection possibility.

 

So what is yr current, validated, operational MD rejection limit for Stainless Steel ? Or perhaps yr risk-assessed metal ? If  X >1mm and you can support a case for contaminants being hazardous between X and 1mm plus a likely occurrence then the final filter is CCP and the MD is redundant.

Or you could propose that the combination of "MD + sieve" is CCP for operational reasons.

 

Perhaps easier to quote Canada if yr MD passes the requirement and only metallic of significance and throw away the sieve. But perhaps in practice  it does stop something ???


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vivekpadinjat

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Posted 22 December 2015 - 06:49 AM

Hi all,

 

Greetings!!!

 

Myself from a fruit processing industry.

 

We have a line in which the Metal detector and Magnetic trap operates in Series to eliminate the Metal hazards. I have two queries basically:

 

1. Is that ok if I have a Static filter (Sieve size 1.0 mm) after the metal detector. The thing is I canot change the location of the filter as it is an interal part of the steriliser and I cant relocate the metal detector also becuase once the pulp is fed to the steriliser, the complete system is under PLC control until the product gets filled aseptically. Also, in This case Whats my CCP ?? Metal detector or Static filter???

 

 

2. Can you guys help me with some scientific literature proving the metals as a non hazard below specific levels?? (I have read somewhere that there has been some papers presented by Oklahoma University on this).

 

 

Thanks..

 

Regards,

 

Vivek



esquef

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Posted 22 December 2015 - 04:17 PM

To me it sounds like you're in a bit of a predicament. Ideally you'd want your metal detector as your last step of control regarding metal contamination since metal sieves can (and ultimately will break). In your case if this occurs your metal detector will not eliminate (or control to an acceptable level of risk) metal contamination, so in my opinion this fact would eliminate metal detection as a CCP. You could assign the sieve as a CCP, but you'd need to back that up with effective monitoring proceedures, corrective actions, and verification and record keeping/documentation procedures which I personally would find challenging.



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Posted 22 December 2015 - 09:29 PM

I audit many sites that have magnets and metal detection in line, through the process, and just before packing, the product passes through a "security screen" (eg sieve at 1mm) to ensure removal of any FO's that may have found their way into the product stream along the way.  These security screens are invariably CCP's.  The upstream Metal Detectors sometimes are, and sometimes are not.  There is no rule on this but industry practice tends to identify the final MD as a CCP as well.  This decision is made company by company.  What I look for is consistency in the CCP decision making process.  It is important that you get this right.

 

In the case of the security screen being a CCP, there needs to be all the usual CCP management aspects in place, and it's not hard.  The manufacturer monitors at a frequency that has product in it's control, Action limits are in place, as are Verification plans.

 

Hope this helps.



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Posted 22 December 2015 - 09:35 PM

Oh, and this reference may be useful...

 

CPG Sec. 555.425 Foods, Adulteration Involving hard or Sharp Foreign Objects - FDA

 

In terms of size, this reference says in part...

 

"The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly. The scientific and clinical literature supports this conclusion."



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Posted 23 December 2015 - 04:36 AM

To me it sounds like you're in a bit of a predicament. Ideally you'd want your metal detector as your last step of control regarding metal contamination since metal sieves can (and ultimately will break). In your case if this occurs your metal detector will not eliminate (or control to an acceptable level of risk) metal contamination, so in my opinion this fact would eliminate metal detection as a CCP. You could assign the sieve as a CCP, but you'd need to back that up with effective monitoring proceedures, corrective actions, and verification and record keeping/documentation procedures which I personally would find challenging.

 

Thanks for that reply..

 

In that case what about hazards less than my sieve size of 1.0 mm.??



vivekpadinjat

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Posted 23 December 2015 - 04:38 AM

Oh, and this reference may be useful...

 

CPG Sec. 555.425 Foods, Adulteration Involving hard or Sharp Foreign Objects - FDA

 

In terms of size, this reference says in part...

 

"The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly. The scientific and clinical literature supports this conclusion."

 

Thanks for the reply..

 

Actually I had a discussion on this point of the 7 mm particle. 

 

But there is another side of it also. If a sieve particle of say 3 mm comes to ur mouth and bruise ur mouth, the same is hazardous right..

 

Correct me If I am wrong!!



vivekpadinjat

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Posted 23 December 2015 - 04:43 AM

I audit many sites that have magnets and metal detection in line, through the process, and just before packing, the product passes through a "security screen" (eg sieve at 1mm) to ensure removal of any FO's that may have found their way into the product stream along the way.  These security screens are invariably CCP's.  The upstream Metal Detectors sometimes are, and sometimes are not.  There is no rule on this but industry practice tends to identify the final MD as a CCP as well.  This decision is made company by company.  What I look for is consistency in the CCP decision making process.  It is important that you get this right.

 

In the case of the security screen being a CCP, there needs to be all the usual CCP management aspects in place, and it's not hard.  The manufacturer monitors at a frequency that has product in it's control, Action limits are in place, as are Verification plans.

 

Hope this helps.

 

Thanks for the reply..

 

Can you just give me more details on this "SECURITY SCREEN"

 

Thanks.. 



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Posted 23 December 2015 - 09:12 AM

Hi,

 

I you have installed a sieve, why do you have done an investment for a metal detector. A sieve does not only remove metal foreign bodies, i.e. if you are able to sieve your product that is the better choice. The last stage to control the risk is the CCP, i.e. the sieve.

Metal detector would make sense in my opinion in another order: sieve for the liquid/powdered product before packaging and the metall detector for the packed goods.

 

Rgds

moskito



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Posted 23 December 2015 - 10:52 AM   Best Answer

Hi vivek,

 

A few comments -

 

(1) it may depend on the FS standard, if any. I assume only safety criteria are involved.

 

(2) The status of the final filter IMO logically depends on a (safety) haccp risk assessment, ie is it likely that any "dangerous" objects will pass the MD but then be stopped by the final filter ?.

 

The answer to (2)  depends on yr product / process, criterion for "dangerous" and possibly Indian Regulations as to the local (safety) assessment of yr finished product if such exist (in which case will take priority).

 

Just as an example, from memory Canada set > 2mm as size criterion for hazardous metallic contamination. So if the MD validatably rejects all Fe items  <=2mm using, say SS 316, as a worst case reference and if only iron is considered a significant FM, then the final filter is simply redundant.

 

In some sectors, from an auditorial POV,  it is apparently acceptable to quote an "Industry Standard" as target critical limit, ie "best practice". Presumably requires some justification though.

 

The USA, as per my understanding, further protect their consumers by invoking adulteration as a FM rejection possibility.

 

So what is yr current, validated, operational MD rejection limit for Stainless Steel ? Or perhaps yr risk-assessed metal ? If  X >1mm and you can support a case for contaminants being hazardous between X and 1mm plus a likely occurrence then the final filter is CCP and the MD is redundant.

Or you could propose that the combination of "MD + sieve" is CCP for operational reasons.

 

Perhaps easier to quote Canada if yr MD passes the requirement and only metallic of significance and throw away the sieve. But perhaps in practice  it does stop something ???


Kind Regards,

 

Charles.C


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Posted 23 December 2015 - 01:43 PM

Thanks for that reply..
 
In that case what about hazards less than my sieve size of 1.0 mm.??


1.0 mm Fe is a fairly standard minimum critical limit here in the U.S., so that wouldn't be my concern. I'd be worried that the sieve would be compromised (damaged) and metal wire would be introduced into the product and by the nature of your process flow wouldn't be caught by a metal detector. This would force you (at least in my opinion) to hold all product that went through the sterilizer/metal detector and then the screen to be put on hold until the screen integrity could be verified.


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Posted 24 December 2015 - 02:01 AM

Hi esquef,

 

I agree with yr logic.

 

IMEX, unless infeasible, the usual "end" location of a MD is such that it is not followed by any potentially significant sources of metallic contamination. For obvious reasons.

 

I have no idea what PLC control means but offhand the design layout of the line seems questionable from a haccp/MD POV. 

 

I'm less sure regarding the capability of  MDs to consistently detect 1mm of 316 SS (or Fe). Units i have used not possible. Relates to the product/price/aperture of course.


Kind Regards,

 

Charles.C





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