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Constructed from corrosion-resistant stainless steel (e.g., 1.2344 or 1.4034), the mold ensures compliance with strict medical standards (ISO 10993, FDA 21 CFR Part 878) while processing polypropylene (PP) materials optimized for sterilization resistance and chemical compatibility.
Medical-Grade Material Compatibility: Specifically engineered for PP grades compliant with USP Class VI, EU MDR 2017/745, and ISO 13485, ensuring no leachable contaminants.
Precision Engineering: Utilizes CNC-machined cavities with surface roughness ≤0.2μm to meet tight tolerances (±0.02mm) for critical medical components.
Sterilization-Ready Design: Mold surfaces are polished to prevent bacterial adhesion, compatible with ethylene oxide (EtO), gamma radiation, and autoclave sterilization methods.
Anti-Corrosion Construction: Hardened stainless steel inserts and electroless nickel plating protect against degradation from medical disinfectants (e.g., hydrogen peroxide, alcohol).
Multi-Cavity Flexibility: Available in 1-64 cavity configurations for high-volume production of uniform parts, with automated ejection systems to minimize cycle times.
Syringes & Needle Components: Produces plungers, barrels, and safety shields with smooth surfaces to ensure precise fluid measurement.
Diagnostic Devices: Manufactures microfluidic cartridges, test tube racks, and reagent reservoirs with leak-proof seals and chemical resistance.
Surgical Instruments: Creates lightweight handles for scalpels, forceps, and retractors with ergonomic designs and biocompatible finishes.
Medical Packaging: Forms sterile containers, blister packs, and vial stoppers with hermetic seals and tamper-evident features.
Q: What is the minimum wall thickness achievable for medical PP parts?
A: Our molds can produce wall thicknesses as thin as 0.3mm while maintaining structural integrity, ideal for microfluidic applications.
Q: How do you ensure compliance with FDA biocompatibility standards?
A: All molds undergo material traceability audits, and PP compounds are tested for cytotoxicity, hemocompatibility, and extractable chemicals through accredited labs.
Q: Can the mold be modified for different sterilization methods?
A: Yes, surface treatments (e.g., PTFE coatings) can be customized to enhance resistance to specific sterilization processes, such as steam autoclaving at 134°C.
Q: What is the typical mold lifespan for medical applications?
A: With proper maintenance, molds can produce 500,000-1,000,000 cycles, depending on part complexity and material abrasiveness.
Constructed from corrosion-resistant stainless steel (e.g., 1.2344 or 1.4034), the mold ensures compliance with strict medical standards (ISO 10993, FDA 21 CFR Part 878) while processing polypropylene (PP) materials optimized for sterilization resistance and chemical compatibility.
Medical-Grade Material Compatibility: Specifically engineered for PP grades compliant with USP Class VI, EU MDR 2017/745, and ISO 13485, ensuring no leachable contaminants.
Precision Engineering: Utilizes CNC-machined cavities with surface roughness ≤0.2μm to meet tight tolerances (±0.02mm) for critical medical components.
Sterilization-Ready Design: Mold surfaces are polished to prevent bacterial adhesion, compatible with ethylene oxide (EtO), gamma radiation, and autoclave sterilization methods.
Anti-Corrosion Construction: Hardened stainless steel inserts and electroless nickel plating protect against degradation from medical disinfectants (e.g., hydrogen peroxide, alcohol).
Multi-Cavity Flexibility: Available in 1-64 cavity configurations for high-volume production of uniform parts, with automated ejection systems to minimize cycle times.
Syringes & Needle Components: Produces plungers, barrels, and safety shields with smooth surfaces to ensure precise fluid measurement.
Diagnostic Devices: Manufactures microfluidic cartridges, test tube racks, and reagent reservoirs with leak-proof seals and chemical resistance.
Surgical Instruments: Creates lightweight handles for scalpels, forceps, and retractors with ergonomic designs and biocompatible finishes.
Medical Packaging: Forms sterile containers, blister packs, and vial stoppers with hermetic seals and tamper-evident features.
Q: What is the minimum wall thickness achievable for medical PP parts?
A: Our molds can produce wall thicknesses as thin as 0.3mm while maintaining structural integrity, ideal for microfluidic applications.
Q: How do you ensure compliance with FDA biocompatibility standards?
A: All molds undergo material traceability audits, and PP compounds are tested for cytotoxicity, hemocompatibility, and extractable chemicals through accredited labs.
Q: Can the mold be modified for different sterilization methods?
A: Yes, surface treatments (e.g., PTFE coatings) can be customized to enhance resistance to specific sterilization processes, such as steam autoclaving at 134°C.
Q: What is the typical mold lifespan for medical applications?
A: With proper maintenance, molds can produce 500,000-1,000,000 cycles, depending on part complexity and material abrasiveness.
