Hi,
Does anyone know what the requirement for metallic product contact materials during manufacturing for finished solid dose drugs should be? For example the minimum requirements for the product contact area materials in a tablet counter system used as part of the manufacturing process.
Apart from stainless steel is there any other metals that should be accepted and if so what exact specifications must they meet? Is it sufficient for alternate metals to be non-toxic, non-corrosive, non-decomposing and stable?
[quote=csvconsult]Hi,
Does anyone know what the requirement for metallic product contact materials during manufacturing for finished solid dose drugs should be? For example the minimum requirements for the product contact area materials in a tablet counter system used as part of the manufacturing process.
Apart from stainless steel is there any other metals that should be accepted and if so what exact specifications must they meet? Is it sufficient for alternate metals to be non-toxic, non-corrosive, non-decomposing and stable?[/quote]
Dear csvconsult,
there is no universal list of product contact materials, because there are too many cases of materials incompatibility. We have an internal list of materials which we use for equipment qualification, and which differentiates between wet, dry, and potential product contact. The list of approved materials should be made up according to your specific product portfolio, and even the normally accepted “stainless steel” needs evaluation, because there are products extremely sensitive to metal traces that require surgical stainless steel, and react with metal traces from stainless steel of different quality. In my opinion the best approach is to set up a positive list of approved materials based on the current product list, and a procedure that requires product contact material evaluation for every new product manufactured at the site. Take into account that in many cases the material itself is not that important, but the surface treatment or plating makes the difference (anodization, nitride treatment, passivation, hard chrome plating, etc.).
Best regards
Alfred
Nice post Alfred, your input is most appreciated.
Regards
Nice post Alfred, many thanks…this is very interesting thema, pls (to other colleagues) what is your expiriences with inspections??? Is someboddy ask for this questions??? What is more important…material certificate from supplier or treatment of the same?? How many often inspector ask for this??
thx in adv,
rgds,
cubica
2 years back we faced one EU audit for a Pharmaceutical product which is processed halway stage by Biotech processing & later by Chemical synthesis.
We were asked to show material non reactivity certifications
-With SS316 materials we used
-With PEEK material used in Process Scale HPLC.
-Certifications of Joints Including photographs
-Then Filtration of same–Any leachates found from Filtration medium
-Material certification of Gaskets of Centrifugal filters.
We knew these were expected and we were questioned beyond our knowledge about these.
I liked what Mr.Alfred wrote here and its very true.
Unfortunately the whole list of questions will depend up on the regulators previous exposure to the product, Process and also how he dealt with material certifications earlier and his audit training.
To avoid any pit falls these days companies are hiring Metallurgy or Material Science Engineers to understand the whole philosophy. It is slowly becoming another SME.
Regards
The new FDA process validation Guidance speaks about Primary packing materials and also materials in contact and their effects on products.
This will change from product to product and there is no universal thumb rule that fits all products as experts already said here.
This has to be identified at the Stage-1 -Process Design stage.
Hi All,
I do agree with Mr. Alfred, one should evaluate the compatibility based on the process nature.
Hi,
Our company has stablished that the product contact material is the stainless steel, but the most our equipments don’t have any certification of material, so I want to know if there is a non-destructive method to check if a material is made of stainless steel 316L or 304.
thanks a lot