|Username||Post: FDA approved materials?|
03-04-09 09:25 PM - Post#5536
Ok, so 316L is the stainless steel to use for pharma/medical project. And I understand from this forum and others that there is no written recommandation/guideline from well established authorities (FDA...) for using this specific stainless steel or an other. This statement comes mainly from experience and is commonly accepted accross the pharma/medical industry, am I right here?
For other materials in contact, as you mentioned, it must be proven that the material used is fit for purpose. Since we had to do some research to respond to our customers requirements regarding materials in contact with their products, I just would like to share my experience and explain how we are handling it. That might just be common sense for most of you, but it was all new for me!
In our case, other materials for wich we need to prove it is fit for purpose are generally polymers. In many cases, often for cosmetic reasons, the hardness of 316L or most SS is not suitable for product handling. In this situation, since we are subcontracting most of our machine parts, we had to define with our plastic parts manufacters a list of materials for which they would be able to deliver a "certificate of conformity". This certificate would state the material used for manufacturing the part and its conformity with a 21 CFR 177.xxxx.
The difficulty in getting this certificate comes from the fact that it can only be supplied if the raw material manufacturer is able to supply a similar certificate of conformity for the raw material. And then the manufacturing process of the part may affect the validity of the certificate delivered by the raw material manufacturer.
And it is getting even more fun if we have to include a sub-system in the assembly process which will have to handle the customer product!
Now, if you have an opinion about our way to do, please feel free to comment, I would be very interested to know about your experience on this matter.