I don’t know if someone else have crossed the same question, but when you verify the material the of construction for contact surfaces, how do you do it. I always have the doubt with the poor links between what the manufacturer tells you it is, and what it actually is.
Not claiming any expertise here but maybe a few thoughts to stimulate discussion.
Would it be possible to get the manufacturer to supply a Certificate of Compliance (or such) that provides sufficient information to trace the material used to the source? Sometimes signing a document attesting something pushes them to a little more diligence.
The other thing I could think of was testing. You might contact someone like NAMSA (I have no affiliation with them) to see what they could do.
I also have this question/concern. I think yodon’s idea of a certificate is good. This may get overwhelming to the manufacture if there are many different surfaces to verify etc., so make sure that you select the high risk materials only (definitely contact surfaces).
Regarding MOC:
My company manufacturers pharmaceutical equipment (Bottle Fillers & Custom Feed Systems).
I am responsible for obtaining product contact certifications from all our vendors.
Our vendors provide technical information, MSDS and a company letter stating which CFR the product contact material conforms to.
Also, we periodically audit our material vendors.
I have been involved in the specification, purchase, FAT and IOQ of equipment for 15 years. Our process has evolved over the years and in one situation where we helped a small fabrication shop become a pharma-acceptable supplier, they supply a CoC that lists a description of the component or machine, the alloy, the heat numbers of the raw material and a passivation date. This CoC is then signed by their QC manager attesting to its accuracy.
In an IOQ, it is typically a paper exercise reviewing the supplied mill report or CoC. It can be a daunting task as many suppliers don’t link their MOC reports to the actual part or component well. This is why we helped this fab shop set up their procedures.
We also had purchased a portable XRF alloy analyzer and used this during FAT to verify that materials are what they are supposed to be. It wasn’t often, but a few times we found 304 when the part should have been 316. It wasn’t the manufacturer that was at fault but their raw material supplier.
During FAT of bioreactors we require material certs for all product contact parts. Manufacturers should supply certs, as well as material samples for all contact parts. In my opinion this is the easy part. The larger question is what data do you have to say that any component is compatible with your product?