4 replies to this topic

[Plastic Ducky]

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? 

[PQAManager]

I found these, they may help:

 

Metal Detector Validation:

FDA’s
Health Hazard Evaluation Board has supported
regulatory action against products with metal
fragments 0.3 inch (7 mm) to 1 inch (25 mm) in
length.
 

CHAPTER 20: Metal Inclusion - US Food and Drug ...

https://www.fda.gov › media › download

 

PDF

 

Screen Validation:

From 1972 through 1997, the FDA Health Hazard Evaluation Board
evaluated approximately 190 cases of hard or sharp foreign objects in food. These include cases
of both injury and non-injury reported to FDA. 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.

CPG Sec. 555.425 Foods, Adulteration Involving hard or ...

https://www.fda.gov › media › download

 

PDF

 

[G M]

Might I ask what special risk group you've identified for you product, and generally what type of product it is?

 

The less than part of the statement isn't without bounds.  It is determined by you based on your intended consumers and the size of FM that is specifically of concern for people in that group.  The FDA has to some degree acknowledged that their 7mm limit is still hazardous to someone, but they aren't officially setting the requirement any lower.  It is left up to you to identify your consumer, and propose what that limit should be for them and support your reasoning with some evidence.

[kingstudruler1]

I hate the FDA document.   Glass pieces less than 7 mm are a risk for any population.  They will cause injury to nearly everyone.  Do not use or validate with a 6mm test piece.  You want to use the smallest test piece possible that you are capable of detecting and removing.   

 

Most people would validate an x-ray or MD by using a third-party company.   Screen - in place and intact.  screens may have certs as to opening size and they are either recertified and/or replaced at "x" frequency.   the concern is holes or oversized openings. 

 

You need to do some research and understand the MD and X-ray technology.   Most MFGs will have some resources.  Due to material composition, size and orientation through the device, MD and X-rays are not 100% effective at detecting and removing everything.  The will in most cases alert you a possible issue that you an act upon.   

[Plastic Ducky]

HI all,

 

The product is for the risk group "infant". And it is a puree in a glass jar.

 

The CPG document states <7mm for a special risk group. 

 

My experience is that in order to validate a control (whether x-ray, or screen) you must rely on the range as a reference. As in, it is easy to validate an x-ray as an effective control when the target of obligation is "7-25mm" as stated in the CPG document. So i would validate the x-ray using a test piece of 6mm and if the challenge is successful, then my control is successfully controlling the hazard. But it would seem that the x-ray cannot be used as a CCP at all in this circumstance, because I cannot get the x-ray, or screen, or metal detector, or ANYTHING validated to control a physical hazard that has no bottom to the range. How would you validate a screen to control a physical contaminate hazard .001 mm in length?

 

For those of you who manufacture for any special risk group, elderly, surgery patients, infants, what is the control that you have for physical contaminates? How would I validate anything for a range with no bottom?

 

I have researched and found several professional pediatric publications noting that for neonatal and other infants, 3mm is the choking hazard reference. Is this the missing piece? Since the FDA refuses to identify the range acceptable for special risk groups, can I reference several of these pediatric publications for the size of a choking hazard?

 

Please advise.