Approved construction materials for product contact parts

Dear colleagues,

I would appreciate if someone can help me on issue of acceptable materials for product contact parts. EU cGMP in Annex 15, point 12-d states: ” IQ should include, but not be limited to the following:… (d) verification of materials of construction.”. This should include verification that materials of construction are as specified in vendor documentation and acceptable according to regulatory requirements.
For non-metal parts, 21CFR177.2600 is possible to use for evaluation, if some material is acceptable/unacceptable. What is for stainless steel/metal parts? List of acceptable materials I was not able to find in official regulatory documents. In EHEDG document, “Hygienic equipment design criteria” (Second edition, 2004), it is stated that 304, 316, 409, 410, 329 SS are recommended… what is with other types of Stainless steel (303, 321 etc.). For example, tooling for tablet press could not be made of this materials (or can? :confused: ).
Could anyone help me on finding the official requirements for stainless steel/metal materials, acceptable for constructing the parts, in contact with product, of pharmaceutical equipment?

Thanks in advance :slight_smile:

Hi “Del boy”…

It is common to find many different steel types in the pharmaceutical industry… you have to check if that kind of steel is appropriated (is not additive, reactive… etc.) for your needs.

Normally “tooling for tablet press” are made by steel AISI D3 and steel AISI D2 (TOOL GRADE STAINLESS STEEL). You can find a lot of information related with these types of steel in many different sources.

Check the article: “tool steels, compression forces, and fatigue Failure” in the American pharmacist Association site (unfortunately I don´t have the pdf file) also check the site of “the Elizabeth companies”.

Hope this will be useful…

Best regards,
Qfb. Pablo Muñoz Gardea