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At what point is a foreign material contamination so small it is not a contamination?


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#1 burilini55

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Posted 02 August 2020 - 03:09 PM

In my career of many years I have never run into this extreme a question. If an object, EPDM, is found at 0.5 x .01 mm per 5 tons of final product, is that contamination? I am curious what you all think. At what point is a contamination so small it isn’t a contamination? Is the presence of it ever “too low”? I am generally a “any contamination is unacceptable”, but this seems extreme to me in any production line..Thoughts?



#2 Charles.C

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Posted 03 August 2020 - 11:41 AM

In my career of many years I have never run into this extreme a question. If an object, EPDM, is found at 0.5 x .01 mm per 5 tons of final product, is that contamination? I am curious what you all think. At what point is a contamination so small it isn’t a contamination? Is the presence of it ever “too low”? I am generally a “any contamination is unacceptable”, but this seems extreme to me in any production line..Thoughts?

EPDM = ?


Kind Regards,

 

Charles.C


#3 burilini55

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Posted 03 August 2020 - 11:45 AM

It’s an ethlyproplene polymer rubber used in gaskets and o-rings. It is a little spongy, but food grade. This wouldn’t be a hard/sharp issue.



#4 Charles.C

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Posted 03 August 2020 - 12:13 PM

It’s an ethlyproplene polymer rubber used in gaskets and o-rings. It is a little spongy, but food grade. This wouldn’t be a hard/sharp issue.

Thanks.

 

Presumably this qualifies as a Foreign Material (FM).

 

I guess it depends on the FDA's definition/interpretation of adulteration in the (unknown) context ?

 

Specifications of  food products IMEX usually have zero tolerances for FM as against inadvertent/adventitious quality contaminants although FDA do have limits for certain "unpleasant"  items, eg rodent hairs.


Kind Regards,

 

Charles.C


#5 burilini55

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Posted 03 August 2020 - 12:41 PM

Hi Charles

 

Thanks for your input!  These are the regulations I know as well.  I just thought there might be something out there that defined something that small as trace or inconsequential.  Thanks again for your input.

 

Tasha



#6 PQEdwards

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Posted 06 August 2020 - 12:05 PM

Although not applicable to food directly the IPEC guidance on TUPP (Technically Unavoidable Particle Profile) sometime referred to as TUVP (Technically Unavoidable Visible Partlcies) relating to exipients for pharmaceuticals might be an interesting read.  

 

My company produces the same ingredients that can be used in food and cosmetic products and have been asked by several cosmetic customers to use this approach, which is quite forward thinking in getting away from the expectation/specification of zero contaminants. Of course you have to be able to define that what is typical and that it is not harmful (based on size and composition)



#7 Quality & Food Safety

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Posted 06 August 2020 - 02:53 PM

Hello,

 

While I was at my PCQI Course this is something that my instructor touched base on briefly, and I found it quite interesting  CPG Sec 555.425 Foods, Adulteration Involving hard or Sharp Foreign Objects (click on link)

 

In there it reads the below:

 

Hard or sharp natural components of a food ( e.g. bones in seafood, shell in nut products) are unlikely to cause injury because of awareness on the part of the consumer that the component is a natural and intrinsic component of a particular product. The exception occurs when the food="s" label represents that the hard or sharp component has been removed from the food, e.g., pitted olives. The presence of the naturally occurring hard or sharp object in those situations (e.g., pit fragments in pitted olives) is unexpected and may cause injury. FDA has established Defect Action Levels for many of these types of unavoidable defects in other Compliance Policy Guides and therefore they are not subject to the guidance in this document.

 

It also gives further guidance in there, like for example, the material can't be a deleterious substance which may render it injurious to health (well, duh.) but at least they spell it out really well :)

 

I hope you find this helpful!






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