PC-Covestro Makrolon Rx1805
Maintaining absolute structural clarity and high impact strength under repeated gamma-radiation sterilization and aggressive clinical lipid exposure requires a specialized amorphous polymer, which Covestro’s Makrolon Rx1805 delivers through its unreinforced, medical-grade polycarbonate matrix. Certified to USP Class VI and ISO 10993 biocompatibility standards, this premium easy-release resin provides outstanding tensile yield strength (66 MPa) and a high heat deflection temperature (HDT) of 125°C. Jucheng Precision, operating under strict ISO 13485 medical device certified frameworks, specializes in cleanroom molding of Makrolon Rx1805. Utilizing 5-axis CNC-machined S136 stainless steel tooling and pressurized water controllers, we eliminate internal residual molding stresses, delivering high-purity medical components verified by Zeiss CMM.
Makrolon Rx1805 Biocompatibility & Gamma-Radiation Profile
Makrolon® Rx1805 is an unreinforced amorphous medical-grade Polycarbonate (PC) resin engineered by Covestro, certified to deliver outstanding light transmission, low yellowing under radiation, and lipid-resistant toughness under ISO/ASTM standards:
| Surgical Compliance Factor | Makrolon Rx1805 Spec Metric | MedTech Component Advantage |
|---|---|---|
| Gamma Radiation Stability | Resists yellowing under Gamma / E-beam sterilization | Maintains glass-like optical clarity and structural transmission values, avoiding the rapid embrittlement typical of standard PC resins. |
| Lipid & Chemical Resistance | High environmental stress crack resistance (ESCR) | Resists stress cracking under constant exposure to surgical lipids, disinfectants, and aggressive drug carriers. |
| Biocompatibility Certifications | ISO 10993 & USP Class VI Certified | Guarantees complete non-toxicity (cytotoxicity, irritation, hemolysis) for short-term human tissue contact and dynamic fluidic pathways. |
Clinical Device Process Suitability for Makrolon Rx1805
With its high-flow melt performance and low mold shrinkage, Makrolon Rx1805 processes consistently inside precise molds:
| Molding Process Class | Molding Compatibility & Operational Details |
|---|---|
| Hemodialysis Dialyzer Housings | Excellent. Molded within our ISO Class 7/8 cleanrooms to produce high-purity clear blood dialyzers, oxygenators, and IV drip chambers. |
| Surgical Tool Interfaces | Excellent. High toughness and low outgassing prevent structural warping, making it ideal for surgical cutter housings and dynamic medical handles. |
| Diagnostic Fluid Connections | Good. Outstanding dimensional stability, low outgassing, and excellent high-temperature creep resistance prevent structural distortion. |
ISO 13485 Cleanroom Tooling & Processing Guide
Molding an amorphous medical-grade resin like Makrolon Rx1805 requires strict thermal boundaries and low-stress mold setups to prevent stress-cracking:
ISO Class 7/8 Cleanroom Injection Molding
Medical-grade 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
We maintain mold temperatures at 80°C–120°C (176°F to 248°F) using pressurized temperature controllers. 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 Drying Protocol (Hydrolysis Prevention)
PC is highly hygroscopic. Moisture causes cosmetic splay, bubbles, and loss of transparent optical quality. We dry raw material in desiccant hopper dryers at 120°C (248°F) for 3–4 hours to keep moisture levels below 0.02% before molding, protecting dynamic mechanical tensile bonds.
Key Application Fields for PC-Covestro Makrolon Rx1805
- Cardiovascular Systems & Dialysis (ISO 13485 Compliant): Hemodialysis dialyzer housings, blood oxygenators, clear blood filter casings, arterial filters, and surgical connectors.
- Surgical & Dental Instruments: Surgical cutter housings, medical ventilator manifolds, pharmaceutical filtration housings, dental trial guides, and endoscopic tool handles.
- Clinical Fluid Management & Diagnostics: IV drip chambers, clear fluid connectors, diagnostic device covers, pharmaceutical valves, and disposable pipettes.
Properties
| Density | 1.2 g/cm³ |
| Melt Volume-Flow Rate (MVR) (300°C/1.2kg) | 6 cm³/10min |
| Tensile Modulus (1mm/min) | 2,400 MPa |
| Tensile Stress at Yield (50mm/min) | 66 MPa |
| Tensile Strain at Yield (50mm/min) | 6.1 % |
| Nominal Tensile Strain at Break | >50 % |
| Tensile Strain at Break | 115 - 130 % |
| Flexural Strength (2mm/min) | 97 MPa |
| Flexural Modulus (2mm/min) | 2,350 MPa |
| Charpy Notched Impact Strength (23°C, 3mm) | 70 kJ/m² |
| Glass Transition Temperature (Tg) | 145 °C |
| Vicat Softening Point (50N, 50°C/hr) | 144 °C |
| Heat Deflection Temperature (HDT @ 1.80 MPa) | 125 °C |
| Linear Mold Shrinkage | 0.50 - 0.70 % |
| Maximum Part Size (Cleanroom limit) | 600 x 400 mm |
| Minimum Part Size (Micro Medical limit) | 1 x 1 mm |