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About metal detector used on compression machine

Dear All,

For Tablet compression machine we use metal detector, for detection of any metal particles in product. For this we challange the metal detector by using some standard pieces of ferrous, Non-ferrous and Stainless steel (FE.NFE & SS), acceptance criteria for FE- 0.15MM, NFE-0.20MM and SS-0.3MM.

My question is - On which basis these criteria was fixed?? and if metal particles occurs in the product which is less than above mention size then it is accetable??

Regards

Prashant Mhetre

Dear Prashant Mhetre,

i don´t think this standards come from the pharmaceutical industry, it is only a functional check for the metal detector and not a pharmaceutical criterion. Actually, the danger from a metal particle is more related to the shape than to the size (a chip or splinter seems to be more dangerous than a spheric particle). In general, and without justifying metallic scrap in the tablets, i think the risk from these particles is somewhat overestimated, and there are a lot of metallic surgical implants in spheric and rod shape that are completely harmless.

Best regards

Alfred

What should be a part of PQ protocols for metal detector?
How do you check it’s function?