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FDA Position about Stainless Steel & Ra?

C

cisko

#11
#11
meddevuser said:
What FDA is really saying is that it is up to you to verify that the stainless steel that you choose to use has no adverse effect on safety, quality, identity, potency or purity for the product that you manufacture using your materials, machines, and methods. Testing to verify non-impact should be part of your process validation requirements.
Click to expand...
Yep ok

& what I also wanted to check it's why we can find on many websites "stainless steel is GRAS" but it's not mentioned on FDA website :frust:
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#12
#12
cisko said:
Yep ok

& what I also wanted to check it's why we can find on many websites "stainless steel is GRAS" but it's not mentioned on FDA website :frust:
Click to expand...
a. The FDA is in charge of several fields - pharmaceuticals, medical devices etc. Not necessarily the same statements apply to all fields.

b. "Generally Regarded As Safe" - Please note the term "generally". This may very well be the case in many situations, but as long as it isn't so in *all*, I wouldn't expect the FDA to make the sort of declarations you're looking for.

c. Further, "Generally Regarded As Safe" - safe for what? The FDA typically works on an intended-use basis, so as long as this is kept vague, I wouldn't expect the FDA to be very clear.

Cheers,
Ronen.
 
L

Lugog

#13
#13
cisko said:
Hi Ronen, thanks for your useful answer!

The flowchart is interesting but in date of 1995 :(

Currently we ask the EN 10204 2.1 or 3.1 certificat for alloy 316/316L, of course it's enough but we are looking further that

Any other ideas or opinions ? Also about the rugosity coefficient (Ra)

Cheers,
Cisko
Click to expand...
Hi all,

Coming back on this one, is the 3.1 certificate or EN110204 2.1 really enough thought?

I am working on a similar definition for our plant (pharma industry) and am being asked again and again by my management if this is really sufficient.

What was your position in the end?

Regards
Lugog
 
C

cisko

#14
#14
Hi Lugog,

We decided to ask a 3.1 certificat for all metals/polymer & 2.1 for ceramic & glass materials

Is it enought ? actually It depends of far do you trust your supplier :caution:

We know that chineses certificates are often suspects .. so we might use a PMI analyser for metals products & conducts internal tests on polymerics materials...
 
V

v9991

Trusted Information Resource
#15
#15
1) asking for certificate is not adequate...especially for product contact surfaces, there ought to be a Inhouse test. ( i believe that even EN 10204 also outlines the need for "specific inspection"and "manufacturers" validation.
and its certainly not for your to depend on supplier...rather what are the processes in place to rely on supplier...and in some circumstances, limitations of performing certain tests!!!

2) as has been said, the suitability/compatibility has to be established through product specific challenges/studies.(which is part of your validations of equipment or process as appropriate)
this could b some times as simple identification of the specified grade of steel toverify the supplier certificate or in other cases, the hold time study/compatibility study on specific product.
 
L

Lugog

#16
#16
Hi V9991

I'm interested in which kind of testing you'd suggest to perform.
We could not perform test for every material we are receiving even if they have product contact. The approach we took is to perform testing for polymeric components (leachability and extractability) as there is a confirmed risk.

For metal components we check the supplier qualification and material certificate for each incoming part. No further testing afterwards.

Would you have a reference to recommand?
 
J

JeantheBigone

Quite Involved in Discussions
#17
#17
You might want to consider verifying your supplier cert at least occasionally. And if you are getting material that originates in China, I'd verify each and every batch.

Material downgrades on stainless are rampant, not only in China. You specify 316 but you get 304, they figure no one will notice.

I wonder if the surface roughness requirement on stainless is a carryover from food production? :cool:
http://www.foodquality.com/details/article/813533/Go_With_the_Flow.html?tzcheck=1
 
V

v9991

Trusted Information Resource
#18
#18
Lugog said:
We could not perform test for every material we are receiving even if they have product contact. The approach we took is to perform testing for polymeric components (leachability and extractability) as there is a confirmed risk.
Click to expand...
:yes:
Lugog said:
For metal components we check the supplier qualification and material certificate for each incoming part. No further testing afterwards.
Click to expand...
although there are many references, its always required to confirm/sync with the manufacturer;s procedure. (cause, even if either of you are not following standard procedure, the exercise would not serve purpose)
anyways, here's few
ASTM A493-95 :- Corrosion Resistance
Molybdenum test
http://www.fumeanddust.com.au/manuals/clinox/Easy Test_presentazione ENG.pdf
http://www.koslow.com/metal_test_kits/1542c.html
http://www.eng-tips.com/viewthread.cfm?qid=78040
:2cents:

though a little far fetched,, here's one reference where compatiblity is demonstrated in this protocol...
http://www.xcellerex.com/pdf/XDA-Biocompatibity.pdf
 
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