Services
Providing Everything You Need
Standard medical grade materials include: polyether block amide (PEBA), PET, polyurethane, polycarbonate, and thermoplastic elastomer materials
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Diameters ranging from 0.003” to 0.450” & tolerance for most polymers and sizes: ± 0.0003"
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Wall thickness ranging from 0.0005” to 0.035″ & tolerance for most polymers and sizes: ±0.0003"
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Tolerances may vary depending on the durometer, material, and size of the extrusion
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Discrete lengths or spools available
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In-house die design and fabrication
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Internal annealing advanced measurement systems
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Critical visual inspection for implantable extrusions
Development
One Medical Extrusion helps our customers with:
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Material selection
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Specification requirements
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Development plan
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Proof-of-concept prototypes
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Extrusion iterations for a robust device design verification
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Process documentation, and
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Fast–track extrusions
Testing & Validation
Following the development phase, One Medical Extrusion offers our customers:
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A Tubing is selected from the development phase
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Focused process control, repeatability, and manufacturability of the selected extrusion
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Process and Operational qualification (Such as OQ and PQ, if needed)
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Process and inspection Documentation
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Inventory security to ensure the long-term availability of raw materials
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Material identification and traceability functions throughout the extrusion process
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Process validation (as needed), and
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SPC and data-based approach to the extrusion process
Production
One Medical Extrusion provides the following production-related information/options for customers:
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Production quote
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Lead time
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Option of a single production order, or a blanket purchase order with multiple scheduled deliveries
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Record of process and online SPC documentation for all lots, and
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Quality reports with the shipment of products