FDA Position about Stainless Steel & Ra?

[cisko]

Hello everybody,

I am looking for more information about stainless steel and regulation.

The stainless stell will be in "contact product" for vaccine production.

On FDA 21 CFR I couldn't find anything about stainless steel and on the web, some ppl just say it's GRAS (generally recocgnized as safe) but there is no link with an official doc from the FDA.

So what is exactly the position of the FDA about steel in contact product ?

And I also would like to know what is the regulation about rugosity ? On most certificats it's seem that 0,5µm is required but where this value comes from ?

Regards
Cisko

 

[Marc]

A quick "Bump". Can anyone help with this one? My Thanks in advance!

 

[Ronen E]

Hello everybody,

I am looking for more information about stainless steel and regulation.

The stainless stell will be in "contact product" for vaccine production.

On FDA 21 CFR I couldn't find anything about stainless steel and on the web, some ppl just say it's GRAS (generally recocgnized as safe) but there is no link with an official doc from the FDA.

So what is exactly the position of the FDA about steel in contact product ?

And I also would like to know what is the regulation about rugosity ? On most certificats it's seem that 0,5µm is required but where this value comes from ?

Regards
Cisko

Hello and welcome to the cove

Can't help you right away from a pharma perspective, however, the following seems to support the GRAS approach towards Stainless Steel, as long as it's heavy metals free, for medical devices:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm

Look at the flowchart at the bottom (Attachment C).

Other than that, you better be using a certified medical grade (e.g. 316 etc.) from a reliable source, and make yourself comfortable regarding the purity / cleanliness of the material you get. Further, you should be making sure your production process has not left any unwanted substances on/at the contact surface by the time your product is finished.

Cheers,
Ronen.

 

[cisko]

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

 

[Ronen E]

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

Hi,

Don't worry about the year; it's still current and there is no superseding document from the FDA on this subject.

Re. surface finish - it makes sense to have it on a high polish level but unfortunately I can't point out a regulation requiring the value you mentioned. Sorry.

Ronen.

 

[MIREGMGR]

There are several US FDA Recognized Consensus Standards for stainless steel grades. But, does CDER recognize CDRH's Recognized Consensus Standards program for materials as relevant to pharma production equipment?

If I were you, I'd call up FDA CDER and ask them your question.

 

[cisko]

There are several US FDA Recognized Consensus Standards for stainless steel grades. But, does CDER recognize CDRH's Recognized Consensus Standards program for materials as relevant to pharma production equipment?

If I were you, I'd call up FDA CDER and ask them your question.

They just send me a general e-mail ....


Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER).

FDA does not approve or prohibit specific materials used in contact with pharmaceutical products or maintain a schedule or list of approved materials. 21 CFR 211.65 requires equipment (surfaces that contact) components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. 21 CFR 211.63 requires that equipment (surfaces that contact) be of appropriate design to facilitate operations for its intended use and for cleaning and maintenance. 21 CFR 211.67 requires firms to clean, maintain, and sanitize equipment (surfaces that contact) at appropriate intervals to prevent malfunctions or contamination that would adversely affect product quality.

Here is a link to 21 CFR 211, http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr211_04.html.

Firms are afforded the flexibility to select the materials and grade that best satisfies the needs of their particular application. CGMP regulations do not include specifics on stainless steel.

In choosing materials or components involves evaluating whether there is any potential for an adverse impact on drug product quality. In this respect, various compatibility considerations (leachables, interaction with formulations/sanitizers, ability of material to withstand sterilization) can often take on the most CGMP significance.


Which isn't really useful

 

[Marc]

Thanks for posting their feedback to you.

 

[MIREGMGR]

Which isn't really useful

You did get an answer to your question.

Certainly you'd have less work to do if they'd responded in the affirmative, i.e. CDER recognized CDRH's standards approach.

But since they don't, you have to prove suitability from first principles.

Yeah, it's a zillion times harder, but apparently that's the rule and the answer to the question.

 

[meddevuser]

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.