304 vs 316l in pharma

GOOD ENGINEERING PRACTICE (cGEP)
1

Dear All
Hello.
I would like to know that-

  1. what type of equipment must be constructed of 316l in pharma industry?
  2. For the autoclave cart used to load different loadings like dress, contact parts wrapped in Tyvek is it mandatory to use 316l? or 304 is acceptable?Should the other equipments like waste bin, microbiological agar plate stand inside the aseptic area be made of 316l or 304 is acceptable?

thanks

2

There are some specific things you need to look after discussing with your own people by looking Internal quality procedures you have.

Always a product contact part will have a higher quality of Stainless steel. This is to prevent any change to the critical quality attribute to product by way of process contact material. You need to identify what is critical and non critical to you.

If your loads are packed in tyvek what is the criticality of such contact you need to assess.
At times the 304 steel will generate rouge and it will produce an yellow or orange color on the surface of the steel. At times it can seep into those bags and color the materials of interest. You need to take a call on this issue now with your QA team.

Bins are normally 304.