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YIXUN mold
8480419090
At Yixun, we understand that medical device manufacturing carries lives in the balance. Beyond precision machining, we provide full regulatory partnership—from material selection to validation protocols—ensuring your devices meet FDA, CE, and global regulatory requirements.
1. Surgical & Diagnostic Instrumentation
Endoscope components, housing assemblies, disposable surgical tools
Key Capability: Micro-molding for sub-gram components with ±0.005mm tolerances
Materials Expertise: PEEK, PEI (Ultem), Radel, medical-grade PP/PC
2. Drug Delivery Systems
Inhaler components, auto-injector assemblies, nebulizer parts
Key Capability: Multi-material overmolding for seals, grips, and flexible hinges
Validation: Full IQ/OQ/PQ documentation packages provided
3. Implantable & Long-Term Contact Devices
Orthopedic trial components, dental healing caps, wearable sensor housings
Key Capability: Cleanroom molding (ISO Class 7), ultrasonic welding, laser marking
Materials: USP Class VI resins, biocompatible grades, color masterbatches
| Standard Practice | Our Enhanced Protocol |
|---|---|
| Basic material certification | Full traceability: Lot-to-part tracking with material genealogy |
| Standard cleaning | Validated cleaning process per ASTM F2459 with residue analysis |
| General QC inspection | Statistical process control (SPC) with CpK >1.67 on critical dimensions |
| Mold maintenance as needed | Predictive maintenance schedule based on cavity pressure & wear sensors |
Environment: ISO Class 7 Cleanroom (option for ISO Class 5 workstations)
Quality Systems: ISO 13485:2016 certified, FDA-registered establishment
Documentation: Electronic Device History Records (eDHR), cloud-based revision control
Testing Partners: Third-party biocompatibility (ISO 10993), E&L studies, sterilization validations
Precision Levels:
Micro-molding: Parts as small as 0.01g, tolerances to ±0.002mm
High-volume: 64+ cavity molds with hot runner balancing
Complex geometries: Undercuts, thin walls (0.15mm), micro-fluidic channels
Surface Finishes:
SPI A-1 (Mirror) for optical clarity
Textured surfaces (VDI 3400) for grip and aesthetics
Passivation for corrosion resistance in surgical steel components
We don't just make parts—we build your regulatory submission:
Design Phase: Risk analysis (ISO 14971), FMEA documentation
Prototyping: Build summary reports, design verification testing
Production: Process validation packages (IQ/OQ/PQ), sampling plans
Post-Market: Change control documentation, periodic process reviews
Challenge: A pharmaceutical company needed complex auto-injector components with strict particulate requirements (<100 particles >10µm/mL).
Our Solution:
Designed mold with positive pressure cavities and automated part handling
Implemented in-mold particulate monitoring with real-time alerts
Developed extraction-resistant POM formulation
Results:
✅ 99.98% particulate compliance rate
✅ 30% faster cycle time through conformal cooling
✅ 6-month faster regulatory submission with our documentation package
High-Frequency Materials:
PEEK, PEI, PPSU, PC, COP/COC
Liquid silicone rubber (LSR) for seals and gaskets
Bio-absorbable polymers (PLA, PGA)
Special Processes:
In-mold assembly for multi-component devices
Two-shot molding for soft-touch surfaces
In-line plasma treatment for improved adhesion
Phase 1: Complimentary Design Review
Submit your CAD file for a:
Design for Manufacturability (DFM) report
Preliminary cost and timeline analysis
Phase 2: Prototype & Validation
5-10 working day rapid prototyping
Design verification testing support
Material compatibility studies
Phase 3: Production & Sustaining
Full validation protocol execution
Lot-controlled production with eDHR
Annual process review and improvement
At Yixun, we understand that medical device manufacturing carries lives in the balance. Beyond precision machining, we provide full regulatory partnership—from material selection to validation protocols—ensuring your devices meet FDA, CE, and global regulatory requirements.
1. Surgical & Diagnostic Instrumentation
Endoscope components, housing assemblies, disposable surgical tools
Key Capability: Micro-molding for sub-gram components with ±0.005mm tolerances
Materials Expertise: PEEK, PEI (Ultem), Radel, medical-grade PP/PC
2. Drug Delivery Systems
Inhaler components, auto-injector assemblies, nebulizer parts
Key Capability: Multi-material overmolding for seals, grips, and flexible hinges
Validation: Full IQ/OQ/PQ documentation packages provided
3. Implantable & Long-Term Contact Devices
Orthopedic trial components, dental healing caps, wearable sensor housings
Key Capability: Cleanroom molding (ISO Class 7), ultrasonic welding, laser marking
Materials: USP Class VI resins, biocompatible grades, color masterbatches
| Standard Practice | Our Enhanced Protocol |
|---|---|
| Basic material certification | Full traceability: Lot-to-part tracking with material genealogy |
| Standard cleaning | Validated cleaning process per ASTM F2459 with residue analysis |
| General QC inspection | Statistical process control (SPC) with CpK >1.67 on critical dimensions |
| Mold maintenance as needed | Predictive maintenance schedule based on cavity pressure & wear sensors |
Environment: ISO Class 7 Cleanroom (option for ISO Class 5 workstations)
Quality Systems: ISO 13485:2016 certified, FDA-registered establishment
Documentation: Electronic Device History Records (eDHR), cloud-based revision control
Testing Partners: Third-party biocompatibility (ISO 10993), E&L studies, sterilization validations
Precision Levels:
Micro-molding: Parts as small as 0.01g, tolerances to ±0.002mm
High-volume: 64+ cavity molds with hot runner balancing
Complex geometries: Undercuts, thin walls (0.15mm), micro-fluidic channels
Surface Finishes:
SPI A-1 (Mirror) for optical clarity
Textured surfaces (VDI 3400) for grip and aesthetics
Passivation for corrosion resistance in surgical steel components
We don't just make parts—we build your regulatory submission:
Design Phase: Risk analysis (ISO 14971), FMEA documentation
Prototyping: Build summary reports, design verification testing
Production: Process validation packages (IQ/OQ/PQ), sampling plans
Post-Market: Change control documentation, periodic process reviews
Challenge: A pharmaceutical company needed complex auto-injector components with strict particulate requirements (<100 particles >10µm/mL).
Our Solution:
Designed mold with positive pressure cavities and automated part handling
Implemented in-mold particulate monitoring with real-time alerts
Developed extraction-resistant POM formulation
Results:
✅ 99.98% particulate compliance rate
✅ 30% faster cycle time through conformal cooling
✅ 6-month faster regulatory submission with our documentation package
High-Frequency Materials:
PEEK, PEI, PPSU, PC, COP/COC
Liquid silicone rubber (LSR) for seals and gaskets
Bio-absorbable polymers (PLA, PGA)
Special Processes:
In-mold assembly for multi-component devices
Two-shot molding for soft-touch surfaces
In-line plasma treatment for improved adhesion
Phase 1: Complimentary Design Review
Submit your CAD file for a:
Design for Manufacturability (DFM) report
Preliminary cost and timeline analysis
Phase 2: Prototype & Validation
5-10 working day rapid prototyping
Design verification testing support
Material compatibility studies
Phase 3: Production & Sustaining
Full validation protocol execution
Lot-controlled production with eDHR
Annual process review and improvement
