What's New Unreplied Topics Membership About Us Contact Us Privacy Policy
[Ad]

Determine of critical limits Foreign Material -> SS 5.0 mm in sachet products?

Started by , Jul 04 2023 08:07 AM
10 Replies

Hi All, 

 

Do you think it is possible to specify a CL of 5.0 mm on a sachet product, even though the FDA sets a size limit that has a serious impact on human health? -- > Min. 7.0 mm

 

This means that the detector can only detect SS at a minimum size of 5.0 mm, if the size is smaller, isn't that also dangerous? At least it will cause process failure if it reaches the customer. 
 
Sachet packaging is generally coated with aluminum foil, so that some tools can only detect Ferrous only, while non-fe metals and SS cannot be detected or SS can be detected with a larger size. 
 
Is there a provision for determining the type of metal in the CL determination? for example only Fe? or must be Non FE and SS? 
 
I need the best views from my colleagues here. 
 
Thank you 
Share this Topic
Topics you might be interested in
Questions used to determine the critical control point Risk assessment to determine frequency of ATP swabbing How to determine tolerance How to quantitatively determine when a beard net must be worn? How do you determine parameters and what type of testing needs to be completed by a lab for your finished product?
[Ad]

 

Hi All, 

 

Do you think it is possible to specify a CL of 5.0 mm on a sachet product, even though the FDA sets a size limit that has a serious impact on human health? -- > Min. 7.0 mm

 

This means that the detector can only detect SS at a minimum size of 5.0 mm, if the size is smaller, isn't that also dangerous? At least it will cause process failure if it reaches the customer. 
 
Sachet packaging is generally coated with aluminum foil, so that some tools can only detect Ferrous only, while non-fe metals and SS cannot be detected or SS can be detected with a larger size. 
 
Is there a provision for determining the type of metal in the CL determination? for example only Fe? or must be Non FE and SS? 
 
I need the best views from my colleagues here. 
 
Thank you 

 

Hi cici,

 

A detailed study of FDA's  foreign body compliance requirements reveals that in addition to limits based on earlier (US) safety statistics there is an, additiional focus on adulteration and it's rejection consequences..

The latter aspect significantly boosts the rigor of the nominal implied limits in the context of yr (^red) query above.

The 7mm guidance that the FDA put out it is the dumbest document IMO.   Certainly 6 mm pieces can be a health risk.  As you stated, product with 6mm metal shards is not going to go well for anyone.   Due to orientation issues, setting a metal detector / xray sensitivity too high could lead to disaster.   Most metal detectors will not find a piece of metal that is 1/3 the size of the test piece if the metal if ran parallel through the center of the head.

 

You should use test pieces made of metal that are consistent with risk.   Using FE, Non FE, and SS is the normally accepted practice.   There are also AL and Bronze specific standards available that might make sense to incorporate.   

 

I believe there detectors that are designed for foil use.  

Hi Cici,

 

Not sure of the product inside and sachet size you have.  But in general, sachets are smaller in size, you can detect 1mm or even smaller size of stainless steel with x-ray inspection system.

1 Thank

 

Hi All, 

 

Do you think it is possible to specify a CL of 5.0 mm on a sachet product, even though the FDA sets a size limit that has a serious impact on human health? -- > Min. 7.0 mm

 

...
 
Is there a provision for determining the type of metal in the CL determination? for example only Fe? or must be Non FE and SS? 
 
...

 

You don't mention what kind of detector you're using, but yes it is possible to detect a variety of metals in the 0.5-1.5mm size range, even inside a metallized film pouch.  Especially if you're using an x-ray and don't have other components to ignore like an oxygen absorber or high density product.  We occasionally see birdshot pellets in subprimal cuts of beef this size.

 

The kinds of metal you're looking for are determined by what kind of equipment you use, or foreign material that is likely to occur in your raw materials.  The reason ferrous and stainless steels, and copper alloys are used by so many companies is because those are what many types of food processing equipment are made of.

We used common Metal detector, NOT X-Ray. 

 

Is there any metal detector type can only detected for FE and SUS ? why SUS ? due to potentially comes from process and equipment . So we need to verified it . 

 

 

We dont used X-Ray due to currently regarding high cost and budget. 

 

Is it OK if we only verify Fe piece in metalized sachet ? 

Metal detectors are not really selective for certain metals.   That is how the technology currently works.   They detect and measure the interference of the magnetic field.  Doesnt matter what the cause is (copper, al, brass, stainless, iron, rocks , water, product, etc.) 

 

 

"Is it OK if we only verify Fe piece in metalized sachet ? "

 

probably not.   Most of the risk of metal is going to be from non ferrous (Al) and stainless.     this is what most food production equipment is made from.   You need to ask yourself "where might the metal be coming from and what type of metal is it?"   Most metal detectors will easily find ferrous and non ferrous.   Stainless is usually harder for them to "find".  You need to validate that it is capable of finding and removing all hazard material.   

 

GM is talking about a common metal detector.   They are now capable of finding metal in pouches.  

You MUST be detecting the type of metal you processing equipment is made from otherwise why bother?

 

Generally speaking, outside of live animals, SS is what you're actually looking for and i doubt very much that your equipment is made of iron

...

Is there any metal detector type can only detected for FE and SUS ? why SUS ? due to potentially comes from process and equipment . So we need to verified it . 

...

Is it OK if we only verify Fe piece in metalized sachet ? 

 

Most "metal detectors" can detect a variety of metals, including stainless and ferrous steels.  You'll want to talk with the manufacturer or a good service provider about what your machine is capable of.  They can also help you determine approximately how small a verification seed your machine can detect with/without your product present.  

 

If your process (or that of your suppliers) includes any machinery with parts that are not ferrous steel, such as stainless steel, brass/bronze or aluminum, you will need to perform your verification testing with a metal seed that has similar electromagnetic properties.  -- Notably, stainless steel, which is what a lot of food manufacturing equipment is made of, will have a different kind of effect on the magnetic field inside metal detectors - so you will probably want to also test with SS.

We used common Metal detector, NOT X-Ray. 

 

Is there any metal detector type can only detected for FE and SUS ? why SUS ? due to potentially comes from process and equipment . So we need to verified it . 

 

 

We dont used X-Ray due to currently regarding high cost and budget. 

 

Is it OK if we only verify Fe piece in metalized sachet ? 

We are a metal detector service company, we support most of the well-known companies in China. The standards we have achieved may surprise many.

Here is a little bit of my opinion that you can refer to:

1, If a metal detector based on balanced coil technology is used to detect aluminum foil products directly, you should hardly expect it to perform well.

There are two core reasons here:
1), it is based on electromagnetic induction technology.
2), your metal packaging further exacerbates the uncertainty of this induction.

There is almost no way to avoid these two reasons at all, unless new technologies emerge in the future.

You can certainly use it, but its purpose may be to detect large metal bodies left behind such as scissors.

 

2, Currently, if detection with packaging is a must and acceptable sensitivity is expected, it is almost exclusively X-ray;

It's hardly something to hesitate about. I'm pretty sure of that.

 

3, So, your product has to go through a metal detector with its packaging?

Since the existing technology can’t achieve the purpose of detection, why do we still insist on doing so?

Otherwise, only X-Ray.

 

4, A previous member mentioned that the use of a metal detector must maintain its detection capability and that the direct use of a test stick alone is not sufficient. A simple diagram is shared here:

Detection capability.jpg   98.94KB   0 downloads

We are more than happy with any extreme challenge and share them here.

Thanks.

Is metal detection the right solution?  depending on what is in the sachet, viscosity and particle size, then what about filtering in the filler?  The requirement is to control foreign bodies.  There are several different ways to do that  


Similar Discussion Topics
Questions used to determine the critical control point Risk assessment to determine frequency of ATP swabbing How to determine tolerance How to quantitatively determine when a beard net must be worn? How do you determine parameters and what type of testing needs to be completed by a lab for your finished product? Risk assessment to determine if recall necessary Technical considerations to determine whether a product was suitable for dual supply? How to determine a recall standard? Sterile water sampling to determine the potability How to determine a false reject rate acceptability threshold?