What valve types does ASME/BPE address?
Valves typically used in bio-pharm process systems include ball, diaphragm and check valves. This engineering document will be limited to discussions on ball valves. What is “validation”? Validation is a regulatory procedure that intends to assure repeatability of a processed product or formulation. The procedure indicates that mechanical process components, formulation times, temperatures, pressures and other conditions be measured and monitored. Once a system and the product of that system have proven repeatable, all components and conditions are deemed validated. No changes may be made to the final “package” (process system and procedures) without re-validating. There is also the related issue of material verification. Material Test Report (MTR) is a statement from casting producers that documents the composition of the casting and verifies that it has come from a specific run in the casting process. This degree of traceability is desirable in all critical piping component installat
