PEI-SABIC Ultem HU1000
Maintaining absolute biological safety under aggressive clinical lipid exposure and enduring over 1,000 steam autoclaving sterilization cycles without physical degradation requires a highly pure, high-temperature polymer, which SABIC’s Ultem HU1000 delivers through its unreinforced, healthcare-grade amorphous polyetherimide (PEI) matrix. Compliant with USP Class VI and ISO 10993, this transparent amber resin boasts an outstanding glass transition temperature (Tg) of 217°C and a density of 1.27 g/cm³. At Jucheng Precision, an ISO 13485 and ISO 9001 certified medical device contract manufacturer, we specialized in high-temperature cleanroom molding of Ultem HU1000. Supported by certified ISO Class 7 and Class 8 cleanrooms and 5-axis CNC-machined S136 stainless steel tooling, we ensure zero particulate contamination, delivering flawless medical components verified by Zeiss CMM.
Ultem HU1000 Medical Biocompatibility & Autoclave Specs
SABIC™ ULTEM™ Resin HU1000 is an unreinforced amorphous Healthcare-grade Polyetherimide (PEI) resin, certified to deliver outstanding biocompatibility and high-heat sterilization resistance under ISO/ASTM standards:
| Biocompatibility / Sterilization Spec | SABIC Ultem HU1000 Value | MedTech Assembly Benefit |
|---|---|---|
| Biocompatibility Certification | ISO 10993 & USP Class VI Compliant | Guarantees complete non-toxicity and biological safety for short-term human tissue contact and dynamic fluidic pathways. |
| Autoclave Hydrolysis Life | Retains 100% Structural Properties | Withstands repeated steam-sterilization at 134°C without cracking, structural warping, or loss of aesthetic transparency. |
| Chemical Resistance | High resistance to clinical lipids & sanitizers | Resists stress cracking under constant contact with surgical disinfectants, clinical hydrocarbons, and aggressive bodily lipids. |
Clinical Process Configurations for Biocompatible Ultem HU1000
With standard melt viscosity and high thermal stability, SABIC Ultem HU1000 processes reliably inside high-heat medical systems:
| Clinical Application Category | Process Compatibility & Operational Details |
|---|---|
| Autoclavable Surgical Trays | Excellent. Run inside our ISO Class 7/8 cleanrooms to mold highly complex surgical instrument sterilization trays, cassettes, and brackets. |
| High-Viscosity Medical Manifolds | Excellent. Highly optimized for transparent medicine delivery manifolds, dialyzer housings, pharmaceutical fluidic valves, and diagnostic tubes. |
| Diagnostic Device Shells | Good. Outstanding structural strength and low outgassing enable clean, high-precision housings for surgical optical devices and clinical tools. |
ISO 13485 Healthcare Molding & Purity Matrix
Molding an amorphous medical-grade resin like Ultem HU1000 requires strict thermal controls and full-contamination prevention protocols:
ISO Class 7/8 Cleanroom Injection Molding
Medical-grade PEEK and PEI 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 Matrix
To minimize internal thermal stresses, mold temperatures are maintained continuously at 140°C–180°C (284°F to 356°F) using pressurized oil temperature controllers. Cold molds cause high internal stresses, which severely compromises environmental stress-crack resistance (ESCR) under aggressive clinical fluid exposure.
Extended Desiccant Pre-Drying Protocol
PEI 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 PEI-SABIC Ultem HU1000
- Surgical & Orthopedic Systems: Autoclavable surgical sterilization trays, instrument brackets, dental trial guides, surgical drill guides, and laser diagnostic manifolds.
- Clinical Fluid Management: Hemodialysis dialyzer housings, pharmaceutical fluidic valves, IV drip chambers, fluid connectors, and catheter adapters.
- Advanced MedTech Enclosures: Surgical optical tool casings, medical monitor bezels, diagnostic device covers, and hospital electrical switch terminals.
Properties
| Density | 1.27 g/cm³ |
| Water Absorption (Saturation) | 1.25 % |
| Moisture Absorption | 0.5 % |
| Tensile Modulus | 3,200 MPa |
| Tensile Stress at Yield | 110 MPa |
| Tensile Stress at Break | 85 MPa |
| Tensile Strain at Break | 60 % |
| Flexural Strength | 165 MPa |
| Flexural Modulus | 3,300 MPa |
| Izod Notched Impact Strength (23°C) | 50 J/m |
| Glass Transition Temperature (Tg) | 217 °C |
| Vicat Softening Point | 211 °C |
| Heat Deflection Temperature (HDT @ 1.80 MPa) | 200 °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 |