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. |
| Khả năng chống hóa chất | 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:
Đúc Phun trong Phòng sạch ISO Class 7/8
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.
Khuôn S136 đánh bóng gương (Bảo toàn độ tinh khiết)
Để ngăn ngừa kích ứng mô do độ nhám bề mặt vi mô, chúng tôi chế tạo khuôn bằng thép không gỉ S136 hàm lượng crom cao. Các khoang được đánh bóng gương đến mức cao bằng bột kim cương sạch, đảm bảo bề mặt chi tiết tương thích sinh học không xốp, không có vết kéo nhả động.
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.
Quy trình sấy khô bằng chất hút ẩm mở rộng
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
| Mật độ | 1.27 g/cm³ |
| Hấp thụ nước (Bão hòa) | 1.25 % |
| Hấp thụ độ ẩm | 0.5 % |
| Mô đun kéo | 3,200 MPa |
| Ứng suất kéo tại điểm chảy | 110 MPa |
| Ứng suất kéo tại điểm đứt | 85 MPa |
| Độ giãn dài khi đứt | 60 % |
| Độ bền uốn | 165 MPa |
| Mô đun uốn | 3,300 MPa |
| Độ bền va đập có khía Izod (23°C) | 50 J/m |
| Glass Transition Temperature (Tg) | 217 °C |
| Điểm hóa mềm Vicat | 211 °C |
| Heat Deflection Temperature (HDT @ 1.80 MPa) | 200 °C |
| Độ co rút khuôn tuyến tính | 0.50 - 0.70 % |
| Kích thước chi tiết tối đa (Giới hạn phòng sạch) | 600 x 400 mm |
| Minimum Part Size (Micro Medical limit) | 1 x 1 mm |