Hi all,
I work for a company that manufactures assembly machines for different sectors of the industry, including pharmaceutical. For such projects, we provide a validation package, where sometime, we are asked to attach the list of materials used in the construction of the machine. We had a question recently from a customer concerning that list, and I am transmitting that question in this forum as I do not have the answer and could not find a reliable enough source to confirm it, so there it is:
Does FDA provides a list of materials that are stamped FDA approved?
If yes, where can it be found?
And if not, how can I prove it to my customer?
Many thanks for your help,
Antares
Edited by Antares on 06-08-08 09:38 PM. Reason for edit: No reason given.
The quick answer is No, they don't. The reason is that noo matter what material you mention it is the use and application of that material that dictates it suitability.
The FDA does have an extensive list of rubber materials, but thus crosses over to profolactics as well as seals.
The thing to do is relate the suitability of the material to its useage. This should include that it is not reactive, addative, absoptive, shedding. etc.
depending on the product you want to transport you need to find the appropriate material to transport it.
SS316 is commonly used as it has very inert characteristics and is easy to maintain.
I would not be myself if I could not say BUT. So here we go, following example can help you to not think in standards: Water systems can also be made entirely out of PVC or PE.
Different studies are available to prove that these materials are OK and do not interfere woth quality, yet in GMP companies you will find the water systems in 316L.
Look at RO/CDI skids, you will see that nowadays the greater part of such a skid are made of PVC or PE, but from the point where the client deems the system GMP critical the system then changes over to SS316.
On one project we had quite a big debate with a RO/CDI supplier cause they made everything in PE/PVC till after the CDI unit. They didn't see the sense of the client's demands (specs) to have 316L as from after RO part.
So there is a difference in what is the industry standard, and what is good enough to use. I think companies rather go by general standards instead of looking into the detail of product vs transportation medium.
Luckily standards are based on experience so you can do little wrong by following them.
But as you can see nowadays, it takes a long time for a new technology to settle or even to proof that alternative methods are as good as the common standard.
I know this doesn't answer your question, but I hope it gives you a sense of technology wisdom.
The general norm is that all product contact parts must be 316L or a written justification for the choice of material must be supplied.
So you can build your machines in the conventional manner using 316L only where product contact is made. If you chose to use other than 316L material, then you must validate the long term effect of product contact with it.
Hello Alex,
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.
Hi Antares
I agree with nearly all you have stated. This is the simply reason that in design we will use 316 for all product contact parts. Just simply because the regulators will accept it without question.
If you opt to use another material then you have to go through all the environmental studies to validate that your material of choice is safe to use.
You have to have these studies to hand, and you have to supply them to all third parties that are going to buy your equipment. It is an expensive and time consuming task, especially if you have several variations.
Incidentally the FDA do list basic material types that are incompatible with product contact. I would have to trawl through our old files to retrieve details on that.
12-01-08 09:18 PM -