Surface finish requirements of Stainless steel parts used in disposables (GMP applications)

[champ01752]

Question regarding the surface finish of a 316 stainless part that is used in a disposable bag chamber set. In the past I would machine the parts to a .4Ra (micrometers) surface finish and EP the surface. This was in a non-disposable application that parts would be post cleaned after every run. (CIP an or SIP) Now the set (sst part) will be used once and disposed of. My plan was to target a .6Ra and passivate the part. Trying to make sure I don't get push back from the customers or QA after the fact.

 

[EdStainless]

If you have data to show that you can sterilize them I don't see why not.
Why do you machine?
We used to take annealed and pickled material and EP it. It was not smooth, about 2.5 um, but it cleaned better than a machined or mechanically polished surface at 0.5 um without EP.

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