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? ).
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