Medical Device Injection Molding & Cleanroom Manufacturing
Precision, particulate-controlled component molding for critical medical consumables, diagnostic cassettes, and surgical devices. We integrate certified USP Class VI & ISO 10993 biocompatible polymers with Class 100k (ISO Class 8) cleanroom production cells, automated optical inspection, and full IQ/OQ/PQ process validation.
Biocompatible & Sterilization-Grade Resins
Every medical batch is backed by comprehensive manufacturer certificates of analysis, guaranteeing zero cytotoxic leaching and full sterilization stability.
Medical PC & Cyclic Olefins (COP/COC)
Exceptional optical clarity (>92% light transmission) and ultra-low autofluorescence for optical diagnostic cassettes, cuvettes, and transparent fluid manifolds.
Medical PEEK & Polyaryletherketone
High mechanical modulus matching cortical bone elasticity, continuous thermal resistance up to 250°C, and exceptional resistance to repeated chemical sterilization.
Medical Polypropylene (PP) & PE
Clean resin formulations with low extractables, no heavy metal catalysts, and exceptional surface hydrophobicity for pipette tips, centrifuge tubes, and luer caps.
Medical TPE & LSR Overmolding
Latex-free and phthalate-free elastomeric seals overmolded onto rigid plastic surgical handles, catheter connectors, and integrated plunger stoppers.
Class 100k (ISO 8) Cleanroom Production Cells
Contamination prevention is non-negotiable in medical manufacturing. Our certified cleanroom cells isolate the entire production cycle from resin handling to packaging.
Medical Quality & Regulatory Dossiers
- Complete DHR (Device History Records): 100% batch traceability from raw polymer pellet lot to final pallet seal.
- Validated Bioburden & Sterility Testing: Routine microbiological testing through certified external partner labs.
- Automated Optical Sorting: High-resolution CCD cameras verify critical dimensions and zero foreign black specks.
Medical Components in Serial Production
From micro-channel lab-on-a-chip cartridges to ergonomic overmolded surgical instruments, we meet rigorous dimensional and clinical criteria.
Microfluidic & IVD Cartridges
Complex micro-channel networks (features <50μm) molded in medical-grade acrylic and COP with high weld-joint sealing for point-of-care testing.
Surgical Instrument Handles
Two-shot overmolded handles combining glass-reinforced PBT cores with anti-microbial soft TPE grips, resistant to aggressive alkaline wash cycles.
Luer Locks & IV Fluid Connectors
Precision ISO 80369-7 compliant threaded fluid connections with zero flash on parting lines, ensuring leak-free performance under pressure.
Inhalation & Drug Delivery Housings
Multi-cavity high-speed molding of inhaler bodies, dose counter mechanisms, and nasal spray actuators with stringent CPK repeatability.
Developing a Medical Device or IVD Diagnostic Consumable?
Submit your part specifications and cleanroom criteria. Our medical tooling engineers and polymer scientists will provide comprehensive DFM analysis and validation roadmaps.