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ISO 9001 ISO 13485 FDA 21 CFR 177.2600 EC 1935/2004 BfR XV EN 45545-2 UL94

Technical Silicone Extrusion with Industrial Precision

ProSilicones64 combines the industrial power of Progress Silicones (France) and Establecimientos OR64 (Spain). Seven extrusion lines —two in an ISO 8 cleanroom and five industrial— enable the manufacturing of everything from sterile medical tubing to complex technical profiles. Every process is executed under international certifications including ISO 13485, FDA, EC 1935/2004, and EN 45545-2, ensuring quality, traceability, and regulatory compliance.

Definition

Silicone extrusion at ProSilicones64 combines French engineering with Spanish industrial agility. Progress Silicones (France) operates seven extrusion and co-extrusion lines —two in an ISO 8 cleanroom— capable of manufacturing everything from tubes and cords to complex technical profiles. This capability is reinforced at Establecimientos OR64 (Spain) with dedicated workshops for ring gasket fabrication, vulcanized frames/seals, and CNC cutting, ensuring short lead times and local technical support.

Technical Features

  • Processes: extrusion, co-extrusion, foam, bi-material, and multi-material with inserts.
  • Dimensions: tubes up to Ø120 mm, profiles up to 100×200 mm.
  • Tolerances: ISO 3302-1 ±0.1 mm / ±0.05 mm precision.
  • Hardness: 20–90 Shore A.
  • Foams: density 0.25–0.53 g/cm³.
  • Colors: translucent, white, black, iron oxide red, custom FDA/EC RAL colors.
  • Services in Spain: vulcanized gasket fabrication and automatic CNC cutting.
Technical Specifications

Physical and Mechanical Properties of Extruded Silicone Profiles

Property Typical Values Standard
Hardness (Shore A) 20 – 90 ISO 7619-1
Tensile Strength 6 – 12 MPa ISO 37
Elongation at Break 200 – 600 % ISO 37
Tear Strength 15 – 30 kN/m ISO 34-1
Density 1.11 – 1.20 g/cm³ ISO 2781
Working Temperature -60 °C to +200 °C
Dimensional Tolerances ±0.05 mm to ±0.1 mm ISO 3302-1
Guaranteed Quality

Certifications and Regulatory Compliance in Silicone Extrusion

Every extrusion process is backed by international certifications that guarantee traceability, safety, and regulatory conformity in highly demanding sectors.

Main Certifications

  • ISO 9001:2015 – Quality Management
  • ISO 13485:2016 – Medical Devices
  • EN 9100 – Aerospace
  • GMP – Good Manufacturing Practices
  • Validated ISO 8 Cleanroom (550 m², ISO 14644-1 to -7)

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

Technical Applications of Silicone Extrusion in Regulated Industry

  • Medical and special tubing (radiopaque, bicomponent, anti-static).
  • Solid or foam silicone cords for sealing.
  • Custom geometric profiles.
  • Closed seals and vulcanized frames/gaskets.
  • Multi-material co-extruded profiles with inserts.
  • Technical profiles for lighting and electronics.
  • EN 45545-2 certified profiles for the railway sector.
Selection Guide

How to Choose the Right Extrusion Process Based on Technical Requirements

Customer Requirement Recommended Process
Sterile medical tubing for cleanroom use ISO 8 Cleanroom Extrusion + USP VI LSR
Precision technical profiles Industrial Extrusion with ±0.05 mm tolerances
Flexible sealing cords Compressible cellular foam extrusion
Fire-retardant railway profiles Extrusion with EN 45545-2 HL2/HL3 silicone
Certified food-grade tubing FDA 21 CFR 177.2600 + EC 1935/2004 Extrusion
Die-cut flat gaskets Flat Extrusion + OR64 (Spain) CNC Cutting
Profiles with metal inserts Multi-material Co-extrusion + Vulcanization/Splicing
Competitive Advantage

Why Choose ProSilicones64 for Certified Silicone Extrusion

Key Benefits

  • Production compliant with ISO, FDA, CE, EN, and UL.
  • Wide range: solid, foam, and multi-material co-extrusion.
  • Capacity from prototypes to long production runs.
  • Flexibility in geometries, colors, and formulations.
  • Backed by Progress Silicones (France) and Establecimientos OR64 (Spain).

Silicone extrusion at ProSilicones64 is not limited to manufacturing profiles: it transforms precision into industrial profitability. Every meter produced complies with certified, auditable, and traceable protocols, ensuring reliability, consistency, and regulatory compliance with every delivery.

The alliance between Progress Silicones (France) and Establecimientos OR64 (Spain) establishes ProSilicones64 as the Iberian benchmark in technical silicone extrusion. With French industrial power and Spanish logistical support, we offer European manufacturers a partner capable of combining productivity, traceability, and regulatory compliance under a single quality standard.

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