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 |
|---|---|---|
| Biocompatibility | USP Class VI / ISO 10993-4, 5, 10, 11 | Guarantees complete non-toxicity (cytotoxicity, irritation, hemolysis) for short-term human tissue contact and dynamic fluidic pathways. |
| 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 | Molding Compatibility & Operational Details |
|---|---|
| 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:
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.
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
| Density | 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 % |
| Biocompatibility Compliance | USP Class VI / ISO 10993 - |
| Processing Melt Temperature Range | 180 - 220 °C |
| Mold Temperature Range | 20 - 40 °C |
| Linear Mold Shrinkage | 1.5 - 2.5 % |
| Maximum Part Size (Cleanroom limit) | 600 x 400 mm |
| Minimum Part Size | 1 x 1 mm |