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MOLDED PRODUCT

Food-Grade Liquid Silicone Rubber (LSR)

Food-grade LSR liquid silicone compounds for injection molding. Compliance with FDA 21 CFR 177.2600, EC 1935/2004, and BfR XV. Suitable for prolonged contact with food and beverages. Production in ISO 8 cleanroom under ISO 9001 and ISO 13485 control.

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Food-grade Liquid Silicone Rubber (LSR)
FDA 21 CFR §177.2600
Europe CE 1935/2004 · BfR
Catalysis Platinum
Hardness 20–90 Shore A

Material Principle

Food-grade LSR liquid silicone is a two-component, platinum-cured elastomer that offers exceptional purity, thermal stability, and chemical resistance. Its liquid nature allows for automated injection molding with high precision and repeatability.

Formulation and Certifications

Formulated for direct contact with food and beverages, compliant with FDA 21 CFR 177.2600, EC 1935/2004, BfR XV, and EU 10/2011. Free of byproducts, plasticizers, and volatile compounds. Sterilizable by steam, autoclave, or gamma radiation.

Technical Properties

Available in hardnesses from 20 to 90 Shore A, with excellent thermal resistance (-60 °C to +230 °C), stability against oils, fats, and detergents, and great elasticity at low temperatures. Totally odorless, tasteless, and transparent.

Production Environments

Production in a certified ISO 8 cleanroom, under ISO 9001 and ISO 13485 quality systems. All batches are traceable, analyzed, and accompanied by certificates of conformity and raw material datasheets.

Product Gallery

Technical Specifications

Key Technical Data

Typical values obtained according to series datasheets (17, 30) and indicated standards. May vary based on hardness, formulation, and application. Final validation is the customer's responsibility.

Property Typical Values Standard
Hardness (Shore A) 20 – 70 (núcleo habitual: 40–60) ISO 7619-1
Tensile Strength 7 – 11 MPa ISO 37
Elongation at Break 400 – 1200 % ISO 37
Tear Resistance (Type C) 17 – 47 kN/m ISO 34-1
Density 1,11 – 1,20 g/cm³ ISO 2781
Working Temperature –60…+200 °C (up to +215 °C in some formulations)
Tolerances Molding Class M2 (LSR Injection) ISO 3302-1
Sectoral (On Request) FDA / CE 1935/2004 / USP VI / ISO 10993 / RoHS / REACH
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

  • Hardness: 10 to 80 Shore A
  • Colors: Translucent, white, pigmented, or custom RAL
  • Formulation: 100% platinum cure, byproduct-free
  • Certifications: FDA, EC 1935/2004, BfR XV, EU 10/2011
  • Production: Validated ISO 8 Cleanroom
  • Delivery: Traced, tested, and certified material for food contact
  • Entrega: material trazado, ensayado y certificado
Selection Guide

Product Selection Matrix

Customer Requirement Recommended Solution
Medical or pharmaceutical use componentsLSR Injection Molding
High-precision technical partsHCR Injection Molding
Food-contact seals or valvesFood-Grade LSR
Integration with other materialsOvermolding
Integración con otros materialesOvermolding
In Summary

Technical Conclusion and Recommendations

Food-grade LSR liquid silicone from ProSilicones64 guarantees purity, thermal stability, and sanitary safety for applications in contact with food and beverages.

Produced in an ISO 8 cleanroom under ISO 9001 and ISO 13485 control, it complies with all European and American regulations for direct food contact.

A solution of high performance and total traceability, designed for demanding industrial processes where hygiene and reliability are non-negotiable.

Una solución de alto rendimiento y trazabilidad total para procesos industriales exigentes.

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