Cleanroom Injection Molding Services
Absolute Purity. Zero Contamination.
Cleanroom injection molding is the process of manufacturing plastic components in an enclosed, environmentally controlled facility. High-Efficiency Particulate Air (HEPA) filters strictly regulate the concentration of airborne particles, temperature, and humidity.
For invasive medical devices, fluid delivery systems, and advanced optical lenses, standard molding environments introduce unacceptable risks of particulate contamination, bio-burden, or static dust attraction.
At Jucheng, our ISO Class 8 (Class 100,000) cleanroom facility operates under strict ISO 13485 quality protocols, ensuring your sensitive parts are molded, handled, and packaged with absolute sterility and full lot traceability.
The Secret to Clean Molding: Precision Tooling
In-House 5-Axis CNC Mastery
We do not outsource medical molds. Utilizing our tool room’s 25+ advanced 5-axis CNC machines (Haas/Mazak), we cut mold steel to micron-level tolerances. This ensures perfect parting line shut-offs, guaranteeing flash-free parts and eliminating particulate shedding during the molding cycle.
All-Electric Injection Presses
Standard hydraulic injection machines pose a severe risk of aerosolized oil mist contaminating a cleanroom. Jucheng utilizes highly precise, all-electric injection molding machines (from our fleet of 35+ presses) inside our cleanroom to ensure a 100% oil-free, sterile manufacturing environment.
High-Polish Mold Finishes
Rough mold surfaces harbor bacteria and particulates. Our expert polishers finish medical and optical cavities up to SPI A-1 / A-2 Diamond Polish standards. This prevents contamination and ensures optically clear, flawless surfaces for diagnostic and lens components.
Rapid Medical Tooling (10 Days)
Clinical trials cannot wait. By keeping all tooling in-house, we can deliver high-precision T1 samples for your medical or biotech prototypes in as fast as 10 business days, allowing you to validate your device and secure FDA approval faster.
Medical Grade Materials & Traceability
High-Performance Biocompatible Polymers
We expertly mold Medical Grade PEEK, PEI (Ultem), and PPSU (Radel). These materials can withstand repeated autoclave sterilization cycles without degrading, making them perfect for reusable surgical instruments and implantable device housings.
Optical & Clear Resins
For diagnostic cuvettes, microfluidics, and automotive/optical lenses, we mold high-purity Polycarbonate (PC), PMMA (Acrylic), and COP/COC. Our strict cleanroom environment prevents static dust from compromising optical clarity.
Commodity Medical Plastics
For high-volume, single-use consumables like syringes, IV components, and centrifuge tubes, we process high-flow medical grades of PP (Polypropylene), PE, and ABS efficiently and cost-effectively.
Full Lot Traceability (ISO 13485)
Every batch of raw material is verified using our in-house spectrometer. From the resin certificate of analysis (CoA) to the final Zeiss CMM inspection report, we provide 100% end-to-end documentation for your regulatory submissions.
Cleanroom Applications Across Industries
Surgical & Dental Instruments
Overmolded scalpel handles and PEEK targeting guides that demand absolute sterility, biocompatibility, and flash-free ergonomics.
Microfluidics & Diagnostics
Transparent, micro-molded testing cartridges and cuvettes where even a microscopic dust particle could invalidate medical test results.
Optical Lenses & Sensors
Under IATF 16949 standards, we mold optically clear LiDAR covers and automotive lighting lenses free of dust inclusions and flow marks.