Services
Providing Everything You Need
Standard medical grade materials include: polyether block amide (PEBA), polyamide, polyurethane, polyester, and thermoplastic elastomer materials
-
Diameters ranging from 0.003” to 0.400” & tolerance for most polymers and sizes: ± 0.0003"
-
Wall thickness ranging from 0.0005” to 0.035″ & tolerance for most polymers and sizes: ±0.0003"
-
Tolerances may vary depending on the durometer, material, and size of the extrusion
-
Discrete lengths or spools available
-
In-house die design and fabrication
-
Internal annealing advanced measurement systems
-
Critical visual inspection for implantable extrusions
Development
One Medical Extrusion helps our customers with:
-
Material selection
-
Specification requirements
-
Development plan
-
Proof-of-concept prototypes
-
Extrusion iterations for a robust device design verification
-
Process documentation, and
-
Fast–track extrusions
Testing & Validation
Following the development phase, One Medical Extrusion offers our customers:
-
A Tubing is selected from the development phase
-
Focused process control, repeatability, and manufacturability of the selected extrusion
-
Process and Operational qualification (Such as OQ and PQ, if needed)
-
Process and inspection Documentation
-
Inventory security to ensure the long-term availability of raw materials
-
Material identification and traceability functions throughout the extrusion process
-
Process validation (as needed), and
-
SPC and data-based approach to the extrusion process
Production
One Medical Extrusion provides the following production-related information/options for customers:
-
Production quote
-
Lead time
-
Option of a single production order, or a blanket purchase order with multiple scheduled deliveries
-
Record of process and online SPC documentation for all lots, and
-
Quality reports with the shipment of products