What is a High Purity ball valve?
High Purity ball valves are flow control devices that meet the industry criteria for purity of materials and design. Valves in high purity processes are used in two broad areas of application: • Valves that are in direct contact with the final (or intermediate) product • Valves that are not in contact with the final (or intermediate) product. These applications are in “support systems” such as handling clean steam for cleaning and temperature control. In the pharmaceutical industry ball valves are never used in applications or processes where they may be in direct contact with the final product. • What are the industry criteria for high purity valves? The pharmaceutical industry derives the valve selection criteria from two sources: • ASME/BPE-1997 (Specifications for Bioprocessing Equipment) • FDA material and design specifications • What is ASME/BPE-1997? ASME/BPE-1997 is the evolving specification document that addresses the design and use of equipment for the pharmaceutical industr
