Stainless steel Type for Pharmaceutical equipment

[AdityaPatil (Aditya Ashok Patil)]

Hi,

I have been trying to search for a guidance or any reference to support the use of 316, 316L Stainless steel for product contact and 304 for non product contact parts.

Appreciate any help in advance.

Thank you,
Aditya

[Ankur (Ankur Choudhary)]

It is not written anywhere directly but construction material must not be reactive with drug product.
Check it here
https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment#13

[AdityaPatil (Aditya Ashok Patil)]

Great, Thank you for the response.

[Abiodun_Olupitan]

I do respect Ankur so much. He’s a veteran when it comes to GxP. Thank you for these.

[Girish_Hiremath]

Hi sir
For FDA COS Unit, Can we use brass flow meter for water as media, instead of SS316. FDA will approve?

Thanks
Girish

[sunilrbudhkar]

It is to be ensured that the contact parts of the brass flowmeter should not be reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity (as applicable) of the water which will be in contact with the flowmeter. The brass material may be reactive with the purified water.
Brass is an alloy of copper and zinc. Commonly it contains lead and may include iron, manganese, aluminum, silicon, or other elements.
The CGMPs require that equipment is of appropriate design to facilitate operations for its intended use and for cleaning and maintenance (see 21 CFR 211.63 and 211.67) and, that any equipment surface in contact with components, in-process materials, or drug products 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” (see 21 CFR 211.65).