PPSU-Solvay Radel R-5100
Enabling flawless visual color-coding for surgical sizing trials while maintaining exceptional resistance to repeated autoclaving and high impact forces requires an advanced biocompatible polymer, which Syensqo’s Radel R-5100 (formerly Solvay) delivers through its unreinforced, opaque, pre-colored polyphenylsulfone (PPSU) matrix. Certified to USP Class VI, ISO 10993, and FAA FAR 25.853a flammability standards, this tough thermoplastic resists environmental stress cracking under aggressive clinical detergents. Jucheng Precision, under strict ISO 13485 and IATF 16949 certified frameworks, specializes in micro-molding Radel R-5100 in dedicated ISO Class 7/8 cleanrooms. Utilizing 5-axis CNC-machined S136 stainless steel molds, we control internal stresses and ensure zero particulate contamination, delivering high-purity medical assemblies verified by Zeiss CMM.
Radel R-5100 Opaque Medical Pre-Colors & Flame Compliance
Radel® R-5100 is an unreinforced amorphous Polyphenylsulfone (PPSU) resin, certified to deliver outstanding impact strength, low smoke density, and multiple medical-grade pre-colors under ISO/ASTM standards:
| Material & Flammability Class | Radel R-5100 Standard Metric | Molding & Assembly Advantage |
|---|---|---|
| Certified Pre-Colors | Opaque Blue, Grey, Red, Bone & Black | Provides permanent and biocompatible color-coding options, allowing surgeons to identify exact instrument sizes quickly during dynamic trials. |
| FAA FAR Flammability | FAR 25.853a Compliance (60-sec vertical burn) | Inherently flame retardant without modifiers, complying with aircraft safety standards for low smoke toxicity and OSU heat release. |
| Impact Toughness | Notched Izod Impact 690 J/m (ASTM D256) | Delivers virtual indestructibility and structural toughness under repeated drops or dynamic impacts. |
Structural Process & Color-Coding Configurations for Radel R-5100
With its stable melt viscosity and amorphous consistency, Radel R-5100 processes reliably inside high-heat systems:
| Processing Method | Molding Compatibility & Operational Details |
|---|---|
| Color-Coded Surgical Sizing Trials | Excellent. Molded within our ISO Class 7/8 cleanrooms using pristine colored pellets to prevent cross-color contamination in surgical trials and spacer blocks. |
| High-Impact Orthopedic Instrument Handles | Excellent. High impact strength and exceptional chemical resistance prevent stress cracking under continuous autoclaving and dynamic surgical load. |
| Structural Aviation Enclosures | Good. High specific modulus and low outgassing enable lightweight aircraft cabin structures complying with strict FAR fire and smoke safety. |
PPSU-Solvay Radel R-5100 Cleanroom Tooling & Processing Guide
Molding an amorphous high-performance colored blend like Radel R-5100 requires strict thermal boundaries and full-contamination prevention protocols:
ISO Class 7/8 Cleanroom Injection Molding
Medical-grade colored resins must be protected from any airborne particulates or dust. Jucheng operates dedicated injection molding machines inside fully enclosed, positive-pressure ISO Class 7/8 cleanrooms. Raw material feeding, plastication, and robot part-ejection are completely automated and isolated.
Mirror-Polished S136 Tooling (Purity Preservation)
To prevent tissue irritation from microscopic surface micro-roughness, we build molds using high-chromium S136 stainless steel. Cavities are mirror-polished to a high level using clean diamond paste, ensuring non-porous biocompatible part surfaces with no dynamic release drag marks.
Pressurized Oil Mold Temperature Control
Pressurized oil heaters are utilized to maintain mold temperatures at 140°C–180°C (284°F to 356°F). Maintaining high mold temperatures is critical to minimize molded-in stress, optimize surface gloss, and completely prevent weld-line stress cracking near intricate snap-fits.
Desiccant Pre-Drying Protocol
PPSU is highly hygroscopic. Moisture causes cosmetic splay, bubbles, and loss of transparent optical quality. We dry raw material in desiccant hopper dryers at 150°C (302°F) for 4 hours to keep moisture levels below 0.02% before molding, protecting dynamic mechanical tensile bonds.
Key Application Fields for PPSU-Solvay Radel R-5100
- Medical & Dental Sizing Trials (ISO 13485): Autoclavable colored orthopedic sizing trials, surgical instrument handles, implant alignment guides, and dental spacer blocks.
- Aviation & Passenger Transit: Aircraft cabin passenger service units, structural window bezels, commercial ventilation duct fittings, and heavy-duty connectors.
- Plumbing & Fluid Delivery: High-temperature residential water manifold fittings, boiler water mixing connectors, chemical-resistant fluid couplers, and pump impellers.
Properties
| Density | 1.3 g/cm³ |
| Melt Mass-Flow Rate (MFR) (365°C/5.0kg) | 14.0 - 20.0 g/10 min |
| Tensile Modulus | 2,410 MPa |
| Tensile Strength at Yield | 69.6 MPa |
| Tensile Elongation at Break | 60 % |
| Flexural Modulus | 2,410 MPa |
| Flexural Strength | 91 MPa |
| Izod Notched Impact Strength (1/8, 23°C) | 690 J/m |
| Vicat Softening Point | 218 °C |
| Heat Deflection Temperature (HDT @ 1.82 MPa) | 207 °C |
| Linear Mold Shrinkage | 0.7 % |
| Dielectric Strength | 18 kV/mm |
| Volume Resistivity | 1.0E+16 Ohm-cm |
| Maximum Part Size (Cleanroom limit) | 600 x 400 mm |
| Minimum Part Size | 1 x 1 mm |