Characterization and Extrusion Qualification Process of Introducers/Dilators at Edwards Lifesciences Puerto Rico

Abstract

Edwards Lifesciences is experiencing a high demand for Introducers/Dilators. The company decided to produce the Introducers/Dilators single lumen catheters shafts tubing in Añasco, Puerto Rico site. To implement this new production, a qualification process needed to be conducted, involving characterization study to demonstrate equivalency of the material used for component, as well as the qualification of an extrusion process for the catheter’s shafts tubing at Puerto Rico. After several iterations, the study of the material demonstrated the equivalence for its use. Also, as results the new extrusion process was achieved to sustain demand. Key Terms ⎯ Introducers/Dilators, sheath, FTIR, 4-point bending, Surface Roughness, Dimension, Concentricity, OQ, PQ, Validations.