Metallurgical, manufacturing and surface finish requirements for high purity stainless steel system components.

The stainless steel piping systems that distribute water for injection (WFI) and other critical fluids in pharmaceutical and biotechnology plants will be the subject of this paper. We will confine our focus to the two major components of such systems--tubing and fittings. It should be noted that the discussions here can certainly be applied in the selection of other components such as valves, filter housings, pumps, and tanks used in these industries. The purpose of this paper will be to guide user choices with regard to raw material selection, surface preparation, and surface analysis within the context of system requirements. A suggested material specification for stainless steel tubing and fittings will also be presented.