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MOLDED PRODUCT

HCR Silicone Injection Molded Parts

High Consistency Rubber (HCR) silicone injection molding. Production of precise, repeatable, and high-performance parts. Hardness 30–90 Shore A. Automated process under ISO 9001 and ISO 13485. FDA, EC 1935/2004, EN 45545-2, UL94, and USP VI formulations.

View Technical Data
HCR silicone injection molded parts
Tolerance ISO 3302-1 · M2
Hardness 10–90 Shore A
Temperature –60 °C to +200 °C
Certifications Per formulation
Formulations available up to +300 °C continuous

Process Principle

HCR injection molding uses high-consistency silicone compounds fed by a cold extruder and dosed directly into the mold. Vulcanization is achieved via controlled heat and pressure, resulting in precise, repeatable parts with great dimensional stability even in long runs.

Materials and Formulations

Solid or reinforced VMQ HCR silicones with hardnesses between 30 and 90 Shore A are used. Available formulations: food-grade, medical-grade, fire-retardant, antistatic, and high-temperature. Peroxide or platinum cure depending on the application. All raw materials comply with FDA, EC 1935/2004, UL94, EN 45545-2, and USP VI.

Dimensions and Finishes

Process suitable for precision technical parts, complex geometries, and thin walls. Allows for tight tolerances according to ISO 3302-1 M1/F. Smooth, satin, or micro-textured finishes according to drawing. Wide chromatic range available in standard or custom RAL colors.

Production Environments

Manufacturing in an automated industrial environment or an ISO 8 cleanroom for the medical, pharmaceutical, and food sectors. Processes validated under ISO 9001 and ISO 13485 with control of traceability, hardness, tensile strength, tear strength, and thermal aging testing.

Product Gallery

Technical Specifications

Key Technical Data

Typical values obtained according to series datasheets (1, 2, 9, 12) and indicated standards. May vary based on hardness, formulation, and raw material. Final validation is the customer's responsibility.

Property Typical Values Standard
Hardness (Shore A) 20 – 90 (núcleo habitual: 40–70) ISO 7619-1
Tensile Strength 6 – 9 MPa (según dureza) ISO 37
Elongation at Break 300 – 700 % (blandos hasta 1000 %) ISO 37
Tear Resistance (Type C) 15 – 30 kN/m (alto desgarro hasta 40 kN/m) ISO 34-1
Density 1,11 – 1,20 g/cm³ (extremos 1,07 – 1,23) ISO 2781
Working Temperature –60…+200 °C (up to +300 °C in thermal series)
Tolerances Molding Class M2 ISO 3302-1
Sectoral (On Request) FDA / CE 1935/2004 / BfR / EN 45545-2 / RoHS / REACH / UL94
Guaranteed Quality

Certifications and Regulatory Compliance in Silicone Molding

Every molding batch is manufactured under strict validation protocols, guaranteeing conformity with international standards and integral traceability of the material and the mold.

Main Certifications

  • ISO 9001:2015 – Quality Management System
  • ISO 13485:2016 – Medical Devices
  • EN 9100 – Aerospace and Defense
  • GMP – Good Manufacturing Practices
  • ISO 10993 – Medical Biocompatibility
  • USP Class VI – Pharmaceutical Biocompatibility

Regulatory Compliance

  • FDA 21 CFR 177.2600 – Food Contact
  • EC 1935/2004 – Materials in Contact with Food
  • EN 45545-2 – Railway Fire Protection
  • UL94 – Material Flammability
  • ISO 10993 and USP Class VI – Medical and Pharmaceutical Biocompatibility
  • REACH (1907/2006) and RoHS (2015/863) – Chemical and Electrical Substances

Key Applications

Certified Production

Manufacturing and Delivery Options

  • Geometries: Simple, complex, or thin-walled
  • Volumes: Medium or large series
  • Materials: Solid or reinforced VMQ HCR silicone
  • Formulations: Food-grade, Medical-grade, Fire-retardant, Antistatic, High-temperature
  • Production: Industrial or ISO 8 Cleanroom
  • Delivery: Tested, certified, and traced parts
  • Entrega: piezas ensayadas, certificadas y trazadas
Selection Guide

Product Selection Matrix

Customer Requirement Recommended Solution
Prototypes or short runsCompression Molding
High-volume runs with dimensional precisionHCR Injection Molding
Medical or optical microcomponentsLSR Injection Molding
Integration with metallic or plastic insertsOvermolding
Integración con insertosOvermolding
In Summary

Technical Conclusion and Recommendations

HCR silicone injection molding from ProSilicones64 enables the production of high-precision and repeatable technical parts with excellent mechanical and thermal performance.

Certified formulations (FDA, EC 1935/2004, UL94, EN 45545-2, USP VI) and controlled manufacturing in ISO 9001 and ISO 13485 environments ensure total traceability and regulatory compliance.

Thanks to its automation, stability, and versatility, this process represents the best option for series production within the industrial and medical sectors in Europe.

Este proceso representa la mejor opción para producción en serie dentro del sector industrial y médico en Europa.

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