With today’s emphasis on process and product safety and compliance to Federal
Regulations such as Title 21, CFR 211.65, selection of suitable materials of construction for
the bio-technology and pharmaceutical industries is a critical step in designing or modifying
plant equipment. Selecting the material of construction is only the first step, ensuring that the
selected material meets the metallurgical and corrosion resistance performance that is
expected is a very important second step. This paper discusses the reason for the high quality
microstructural requirements for equipment destined for the bio-pharmaceutical industry. This
paper also discusses some of the problems that have been encountered during the fabrication
of high performance corrosion resistance equipment and provides guidelines to ensure that the
equipment meets the required expectations.