Medical-grade thermoplastic tubing is heat-formed, flared, necked, sealed, welded, or bonded to create catheter shafts, joints, and functional end features, and balloon components are assembled according to the product design. Select an application below to review its process and control points.
Forming
Catheter Forming and Balloon Assembly
Two Applications
Select an application to compare its control points and performance targets.
Catheter
Catheter Forming and Composite Processing
Based on drawings and risk analysis, medical-grade thermoplastic tubing is heat-formed, flared, necked, sealed, welded, or bonded to create catheter shafts, joints, and functional end features. Bioteque’s published capabilities include composite processing, custom precision extrusion, micro-injection/overmolding, and polymer welding. Key controls include dimensions, concentricity, appearance, bond strength, and functional performance.
Balloon
Medical Balloon Assembly
Balloon and catheter components are positioned and assembled according to the product design, including mounting components on or within the balloon, distal/proximal bonding, folding/wrapping, and final assembly. Bioteque’s published capability includes pressure, leak and vacuum testing, final lot inspection, labeling, and final packaging inspection. Burst pressure and dimensional acceptance criteria should follow customer specifications and validated methods.