TPE-KRAIBURG Thermolast M TM6MED
Ensuring uncompromising biological safety and low extraction potentials in clinical fluid-contact pathways and drug-delivery devices requires a premium elastomer, which KRAIBURG TPE’s THERMOLAST® M TM6MED (Series: MC/tl) delivers. Boasting an ultra-pure translucent density of 0.880 g/cm³ and a hardness of 56 Shore A, this medical-grade thermoplastic elastomer is fully certified to USP Class VI and ISO 10993 biocompatibility protocols. Jucheng Precision, under ISO 13485 medical device certified frameworks, specializes in molding TM6MED. Using 5-axis CNC-machined S136 stainless steel molds, we control its high crystallization shrinkage (1.5%-2.5%) and eliminate parting-line micro-flashes, ensuring dynamic seals verified by Zeiss CMM.
THERMOLAST M TM6MED Medical Compliance & Mechanical Profile
THERMOLAST® M TM6MED (Series: MC/tl) is a premium, translucent medical-grade elastomer engineered by KRAIBURG TPE, certified under USP Class VI and ISO 10993 to ensure ultimate biological safety:
| Biocompatibility & Quality Standard | THERMOLAST M TM6MED Metric | Medical Overmolding Advantage |
|---|---|---|
| Tương thích sinh học | USP Class VI / ISO 10993-4, 5, 10, 11 | Đảm bảo hoàn toàn không độc tính (độc tế bào, kích ứng, tan máu) cho tiếp xúc mô người ngắn hạn và các đường dẫn chất lỏng động. |
| Sterilization Adaptability | Autoclave 134°C, EtO & Gamma Resistant | Withstands repeated steam-sterilization without dynamic properties shifting, avoiding leaks or surface sticky degradation. |
| Pure Base Formulation | Free from Latex, PVC, and Phthalates | Manufactured on a dedicated medical unit, ensuring ultra-low volatile outgassing and zero risk of toxic extractables leaching. |
Clinical & Fluid Process Configurations for Biocompatible TM6MED
With its high elastic elongation and standard chemical adhesion, TM6MED is highly suitable for clean, dynamic seals:
| Process Category | Khả năng tương thích Đúc & Chi tiết Vận hành |
|---|---|
| Dynamic Syringe Plunger Tips | Excellent. Molded within our ISO Class 7/8 cleanrooms to produce high-purity sliding seals, gaskets, and syringe plunger tips with optimized compression set. |
| Flexible Peristaltic Pump Connectors | Excellent. Low friction coefficients and standard easy-release characteristics allow automated, high-efficiency ejection of flexible valves and mouthpieces. |
| Soft-Touch Medical Grips | Good. Excellent adhesion to PP and PE substrates. Ideal for overmolding over rigid medical surgical instruments and diagnostic device handles. |
TPE-KRAIBURG Thermolast M TM6MED Tooling & Overmolding Guide
Molding an amorphous medical-grade elastomer like TM6MED requires strict control of parting lines to prevent flash, alongside cleanroom contamination control:
Đúc Phun trong Phòng sạch ISO Class 7/8
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.
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.
Cold Mold Temperature Control
We maintain mold temperatures at 20°C–40°C (68°F to 104°F) using pressurized water chillers. Keeping tools cold is critical to freeze the soft elastomeric phase quickly, allowing for automatic, warp-free ejection. Melt temperatures are controlled at 180°C–220°C (356°F–428°F).
Micron-Level Flash Control (Low Viscosity Shear)
At melt temperatures of 180°C–220°C, soft TPE can easily flash into mold parting line gaps. Jucheng’s tooling division uses 5-axis CNC machines to achieve micro-tolerances, keeping mold parting clearances strictly within 0.005mm on premium S136 stainless steel mold cavity blocks.
Key Application Fields for TPE-KRAIBURG Thermolast M TM6MED
- Medical & Dental Devices (ISO 13485 Certified): High-precision medical dynamic syringe plunger tips, dynamic fluid valves, flexible peristaltic pump connectors, soft-touch handles, and mouthpieces.
- Pharmaceutical Packaging & Seals: High-purity vial closures, infusion stoppers, elastic sealing gaskets, dynamic dosing membranes, and drug-delivery syringe seals.
- Personal Protective Equipment (PPE): Flexible breathing masks, protective goggle seals, face shield sealing strips, and soft-touch dynamic earbud sleeves.
Properties
| Mật độ | 0.880 g/cm³ |
| Hardness (Shore A, 3s) | 56 - |
| Tensile Strength (ISO 37) | 12 MPa |
| Tensile Elongation at Break (ISO 37) | 800 % |
| Tear Resistance (Graves, ISO 34-1) | 18 N/mm |
| Compression Set (23°C, 72h) | 25 % |
| Compression Set (70°C, 24h) | 35 % |
| Compression Set (100°C, 24h) | 51 % |
| Tuân thủ tương thích sinh học | USP Class VI / ISO 10993 - |
| Processing Melt Temperature Range | 180 - 220 °C |
| Mold Temperature Range | 20 - 40 °C |
| Độ co rút khuôn tuyến tính | 1.5 - 2.5 % |
| Kích thước chi tiết tối đa (Giới hạn phòng sạch) | 600 x 400 mm |
| Kích thước chi tiết tối thiểu | 1 x 1 mm |