Hi all!
We are looking for clarification on CPG Sec. 555.425 (commonly referenced for physical contaminates in relevance to choking hazards). We've historically held ourselves to fragments above 1/32", but we want to place on file any improved regulations.
CPG Sec. 555.425 specific below...
"Products are considered adulterated if the physical contaminate is <7mm and for a special risk group."
"The product contains a hard or sharp foreign object less than 7 mm in length and if a special-risk group, as defined in the background section, is among the intended consumers of the product."
So accepting that we wish to comply with this to market the product in question is for a special-risk group, how do others validate an x-ray system or metal detection for a range with no bottom? I have seen test cards and wands that contain 2.0 mm, 1.0 mm, but I have not seen one for 0.00009 mm.
How would you validate an in-line screen for <6mm? How would you validate an x-ray or metal detector for <6mm?
The receptacle is glass. So glass is capable of making debris of any size. Wouldn't I need a microscope?