Contact
moldeo_hero_alt
ISO 9001 ISO 13485 EN 9100 GMP FDA 21 CFR 177.2600 EC 1935/2004 ISO 10993 USP Class VI EN 45545-2 UL94

LSR, HCR, and Compression Silicone Molding with Certified Precision

At ProSilicones64, we combine the know-how of Progress Silicones (France) and Establecimientos OR64 (Spain) to offer Liquid Silicone Rubber (LSR), HCR, and compression molding with micrometric precision. With 18 presses and segregated workshops, we manufacture everything from medical micro-components to industrial technical seals under ISO 13485, FDA, and EN 45545-2 certifications.

Definition

Silicone molding at ProSilicones64 covers three technologies: Liquid Silicone Rubber (LSR) injection, High Consistency Rubber (HCR) injection, and compression. Progress Silicones (France) has 18 presses and independent ISO 13485 certified workshops, while Establecimientos OR64 (Spain) performs complementary assemblies and verifications. We manufacture technical parts from tenths of a gram to over a kilo with total traceability and external microbiological validation.

Technical Features of LSR and HCR Silicone Molding

  • Processes: LSR injection, HCR injection, compression, overmolding, and dual hardness.
  • ISO 8 and GMP environments with biocontamination validation (NF EN 17141).
  • 18 hydraulic and electric presses with clamping forces from 30 to 250 tons.
  • Part weight: 0.1 g to 1 kg (micro-injection to large format).
  • Molding temperature: 120–220 °C, depending on formulation and catalyst type.
  • Optical grade polished cavities and vacuum-assisted demolding control.
  • Tolerances: ISO 3302-1 M2 / ±0.05 mm.
  • ISO 13485, FDA, EC, ISO 10993, and USP Class VI certification for medical and food applications.
Technical Specifications

Parameters and Capabilities of LSR and HCR Silicone Molding

Property Typical Values Standard
no_data_available
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

Technical Applications of LSR and HCR Silicone Molding

  • LSR parts for sterile medical devices and respiratory valves.
  • Overmolded parts with metal or plastic inserts.
  • Precision O-rings, flat seals, and vulcanized profiles.
  • FDA / EC 1935/2004 certified food-grade components.
  • EN 45545-2 railway parts with fire resistance and low toxicity.
  • Conductive, thermal, or radiopaque silicones for advanced sectors.
Selection Guide

How to Choose the Right Silicone Molding Process

Customer Requirement Recommended Process
Sterile medical parts ISO 13485 / USP VI Medical LSR Molding
Food-grade components FDA / EC 1935/2004 LSR Molding
Prototypes and short runs HCR Compression Molding in Aluminum Mold
Overmolding with inserts Multi-component LSR Molding with Vacuum
Long industrial runs Automated HCR Molding with Hot Runner
Conductive or radiopaque parts LSR Molding with Special Fillers
Competitive Advantage

Why Choose ProSilicones64 for LSR and Compression Molding

Key Benefits

  • Production compliant with ISO 13485, FDA, EC, and EN 45545-2.
  • Total coverage: LSR, HCR, compression, overmolding, and dual hardness.
  • Microbiological validation and ISO 8 biocontamination control.
  • Production capacity: from prototypes to millions of parts.
  • Technical backing from Progress Silicones (France) and Establecimientos OR64 (Spain).

The silicone molding at ProSilicones64 unites precision engineering, environmental control, and international certifications. Every part is the result of a traceable and auditable process that guarantees safety, consistency, and industrial performance.

The silicone molding area at ProSilicones64 consolidates the alliance between Progress Silicones (France) and Establecimientos OR64 (Spain). With 18 presses, certified ISO 8 environments, and complete traceability, we produce critical parts for the medical, food, railway, electronic, and industrial sectors, guaranteeing precision, reliability, and international conformity.

Need a Technical Silicone Solution?

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

Contact Us
Contact us