Medical plastic injection molded parts require uncompromising material traceability, tight dimensional repeatability, and strict cleanroom production controls. We partner with medical device OEMs to transition complex CAD designs into validated, high-integrity polymer components.
Our operations integrate multi-cavity precision tooling, automated micro-molding cells, and validation-ready manufacturing lines to support prototyping, bridge tooling, low-to-medium volume pilot runs, and high-volume commercial production.
Technical Specifications
|
Parameter |
Standard Capability |
High-Precision Capability |
|
Dimensional Tolerance |
± 0.05 mm |
± 0.01 mm (application-dependent) |
|
Clamping Force |
50 T to 500 T |
Micro-molding down to 30 T |
|
Shot Weight Capacity |
0.1 g to 1200 g |
- |
|
Cleanroom Environment |
ISO Class 8 (Class 100,000) |
ISO Class 7 (Class 10,000) |
|
Cavitation |
Single cavity to 64-cavity tooling |
Hot-runner and cold-runner systems |
|
Metrology & Inspection |
CMM, Optical Comparator, Vision System |
100% automated vision inspection for critical dimensions |
Key Features
Biocompatible Resin Compliance:
Molded strictly using FDA-listed, USP Class VI, and ISO 10993 compliant engineering thermoplastics.
Advanced DFM & Mold Flow Analysis:
Computer-aided engineering (CAE) mitigates warpage, volumetric shrinkage, and sink marks in complex thin-wall geometries.
Controlled Cleanroom Assembly:
Post-molding operations, ultrasonic welding, and sub-assembly executed inside ISO-classified cleanrooms to minimize particulate contamination.
Complete Lot Traceability:
Resin lot numbers, process parameter logs, and inspection archives maintained per production run to support FDA 21 CFR Part 820 regulatory audits.
Materials & Options
Polymer selection dictates chemical resistance, sterilization durability, and mechanical performance. We process a wide portfolio of medical-grade resins:
• ABS / PC / ABS-PC Blends: High impact resistance and dimensional stability; utilized for equipment housings and monitor bezels.
• Polycarbonate (PC): Superior optical clarity and impact strength; applied in transparent fluid reservoirs and optical diagnostic windows.
• Polypropylene (PP): Excellent chemical resistance and fatigue endurance; standard for living hinges, test vials, and disposable labware.
• Polyetheretherketone (PEEK): Exceptional strength-to-weight ratio, radiolucent, withstands repeated steam autoclaving; deployed in surgical instruments.
• Thermoplastic Elastomers (TPE / TPU): Variable durometer flexibility; chosen for dynamic seals, gaskets, and soft-touch device grips.
Sterilization Compatibility Profile:
• Ethylene Oxide (EtO): Broadly compatible with standard medical polymers.
• Gamma / Electron Beam: Requires radiation-stabilized grades to prevent yellowing or polymer embrittlement.
• Autoclave (Steam): Restricted to high-temperature polymers like PEEK, PSU, and specific PPSU formulations.
Manufacturing Process
Design for Manufacturability (DFM) Analysis: Engineering review evaluating wall thickness consistency, draft angles, gate location optimization, and sink-mark prevention prior to cutting steel.
Tooling Fabrication: Precision CNC milling, high-speed machining, and wire EDM utilized to build hardened steel or aluminum production molds.
Resin Drying & Conditioning: Materials dried to strict moisture content thresholds to prevent polymer degradation, voids, and structural weakness.
Injection Molding: Closed-loop electric and hybrid presses execute programmable injection velocity, packing pressure, and cooling profiles.
Secondary Operations: Controlled de-gating, laser marking, ultrasonic welding, and cleanroom packaging.
Quality Control
Certifications: ISO 13485:2016 certified quality management system.
Process Validation Packages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation support available.
Metrology Verification: Coordinate Measuring Machines (CMM) and non-contact optical multi-sensor systems verify complex GD&T features.
In-Process Monitoring: Press sensors track cavity pressure and melt temperature profiles in real time, automatically diverting out-of-tolerance parts.
Customization
Custom Color Matching:
FDA-compliant masterbatch colorants or pre-colored resins matched precisely to Pantone or RAL standards.
Insert & Over-Molding:
Injection molding plastic around metal inserts (brass, stainless steel) or over-molding soft TPE grips onto rigid substrates.
Surface Finishes:
VDI 3400 and SPI surface finish standards applied directly to mold cavities, ranging from high-gloss optical finishes to matte textures.
Custom Packaging & Labeling:
Cleanroom-grade barrier bags, custom carton labeling, and barcoding for automated inventory tracking.
Applications
In-Vitro Diagnostics (IVD): Micro-fluidic cartridges, test strip housings, multi-well plates, and sample collection tubes.
Surgical & Dental Instruments: Single-use surgical handles, trocar housings, and protective device covers.
Drug Delivery Devices: Auto-injector internal functional components, inhaler mouthpieces, and metered-dose parts.
Medical Equipment Hardware: Diagnostic monitor enclosures, cable management clips, and complex fluid management manifolds.
Packaging & Delivery
Cleanroom-grade polyethylene bags heat-sealed under controlled conditions; corrugated outer master cartons labeled with part numbers, lot codes, and quantities.
Secure international freight handling via air or sea with complete customs documentation, including Certificates of Conformance and Material Test Reports.
Flexible order scaling supporting low-volume prototype builds (MOQs starting from 500–1,000 units depending on tooling) up to millions of units per year via Kanban programs, safety stock agreements, and scheduled blanket orders.
FAQ
Q: What 3D CAD formats do you accept for quotation and DFM analysis?
A: We accept STEP, IGES, Parasolid (.x_t), and SolidWorks formats, alongside 2D engineering drawings detailing critical tolerances and GD&T requirements.
Q: Do you provide tool steel certifications and material data sheets?
A: Yes. Full material data sheets (CoA) from resin manufacturers and steel certificates for mold tooling are supplied with every project handover.
Q: Can you assist with mold flow analysis before cutting steel?
A: Yes. Every custom tooling project undergoes computer-aided engineering (CAE) mold flow simulation to evaluate fill patterns, weld lines, air traps, and volumetric shrinkage.
Q: What is the typical lead time for prototype tooling versus production tooling?
A: Prototype aluminum tooling generally requires 2 to 3 weeks. Production-grade hardened steel multi-cavity tools typically range from 4 to 8 weeks based on geometry complexity.
Q: Are your injection molding machines operated in a cleanroom?
A: Production can be routed to our ISO Class 7 or ISO Class 8 cleanrooms depending on customer particulate control and contamination mitigation standards.
Q: How do you handle validation documentation for regulated medical devices?
A: We provide comprehensive validation packages containing protocol templates and execution data for Installation Qualification (IQ) and Operational Qualification (OQ).
Q: What are your minimum order quantities (MOQs) for medical molding projects?
A: We support scalable production from low-volume clinical trial runs (prototype/bridge tooling) to high-volume commercial manufacturing. Minimum order quantities vary based on resin type and tool cavitation, typically starting around 500 to 1,000 parts for custom runs.
Request a Quote
Ready to move your medical component from design to production? Submit your CAD models, estimated annual volume, material requirements, and target timeline directly to our engineering team to receive a formal DFM feedback report and commercial quotation within 24 hours.
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