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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 = ?


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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.


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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






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