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ISO 9001 ISO 13485 FDA 21 CFR 177.2600 EC 1935/2004 EN 45545-2 ISO 3302-1

Cutting, Assembly, and Splicing/Vulcanization of Certified Technical Silicone

ProSilicones64 integrates the capacity of Progress Silicones (France) and Establecimientos OR64 (Spain) to offer a complete service for final fabrication, precision cutting, and vulcanization/splicing of technical seals and profiles. This process combines industrial precision, certified traceability, and local support under ISO 13485, FDA, and EC 1935/2004 standards.

Definition

The cutting, assembly, and vulcanization/splicing process at ProSilicones64 represents the final stage of the production cycle. In the workshops of Progress Silicones (France) and Establecimientos OR64 (Spain), CNC cutting, technical assembly, and vulcanization are performed to transform extruded profiles and molded parts into certified and traceable final products.

Technical Features of Silicone Cutting and Assembly

  • Processes: CNC cutting, hot vulcanization/splicing, cold or RTV adhesive welding, technical assembly.
  • Workshops: 3 in France and 1 in Spain for manual and mechanized fabrication.
  • Capacity: closed seals, frames, inflatable seals, and assemblies with integrated valves.
  • Cutting Tolerance: ±0.2 mm (ISO 3302-1 M2/E2).
  • Maximum Dimensions: up to 2000 × 2000 mm.
  • Labeling and batch traceability (NF L17-103).
  • Production in certified environments ISO 9001, ISO 13485, FDA, EC 1935/2004, and EN 45545-2.
Especificaciones técnicas

Propiedades y capacidades de fabricación en corte y ensamblaje

Property Typical Values Standard
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Quality and Compliance

Certifications and Standards Applicable to Cutting and Vulcanization/Splicing

All final fabrication processes are carried out under international standards that guarantee traceability, reproducibility, and compliance in regulated 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 Cutting, Assembly, and Vulcanization/Splicing

  • Closed seals and hot vulcanized frames.
  • Inflatable seals with valves and pressure plugs.
  • Profiles assembled via cold welding or structural RTV adhesive.
  • Technical seals for pharmaceutical or food equipment.
  • Precision CNC cutting and custom final fabrication.
Selection Guide

How to Choose the Right Cutting and Assembly Process Based on Project Type

Customer Requirement Recommended Process
Joining extruded profiles Cold or hot welding depending on silicone type
Custom closed seals/gaskets Certified hot vulcanization/splicing
Inflatable seals with valve Assembly + tightness testing
Rapid prototypes Manual assembly or RTV adhesive
Long production runs CNC mechanized assembly
Competitive Advantage

Why Choose ProSilicones64 for Technical Cutting and Vulcanization/Splicing

Key Benefits

  • Manufacturing compliant with ISO 9001, ISO 13485, FDA, and EC.
  • Custom solutions: vulcanized seals, inflatable seals, and technical frames.
  • Total flexibility: from prototypes to long production runs.
  • Workshop in Spain that optimizes lead times and strengthens local support.
  • Direct integration with extrusion and molding for complete solutions.

The cutting, assembly, and vulcanization/splicing process at ProSilicones64 transforms extruded profiles and molded parts into certified and traceable final solutions. Thanks to the Spanish workshop of Establecimientos OR64, lead times are reduced without losing the technical and regulatory backing of Progress Silicones in France.

The alliance between Progress Silicones (France) and Establecimientos OR64 (Spain) makes ProSilicones64 the Iberian benchmark in technical silicone fabrication. With certified processes, strict dimensional control, and complete traceability, we offer high-performance seals and components for the medical, food, pharmaceutical, railway, and industrial sectors.

Need a Technical Silicone Solution?

Our team is ready to analyze your case and design a custom-tailored technical response.

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