Certified ISO 8 Cleanroom for Silicone Extrusion and Molding
At ProSilicones64, purity is an engineering standard. The cleanroom facility at Progress Silicones (France) —550 m² with ISO 8 validation— allows us to manufacture medical, pharmaceutical, and food products with total traceability. Every process complies with ISO 14644-1 to -7, NF EN 17141, and certifications including ISO 13485, FDA, EC 1935/2004, USP Class VI, and EN 45545-2.
Definition
The ISO 8 cleanroom at Progress Silicones (France) is the core sterile production facility for ProSilicones64. Designed for the manufacturing of medical, pharmaceutical, and food-grade silicone, it combines extrusion and LSR molding in a controlled environment with BMS (Building Management System) monitoring, HEPA H14 filtration, particle monitoring, and regular external audits.
ISO 8 Cleanroom Technical Features
- Total Area: 550 m² (200 m² extrusion / 350 m² molding).
- ISO 8 Classification according to ISO 14644-1 to -7, annual external validation.
- Processes: extrusion, co-extrusion, multi-component LSR molding, and overmolding.
- Equipment: 2 extrusion lines, 3 LSR presses, 3 ventilated stainless steel ovens.
- Catalysis: Platinum (Medical / Food) or Peroxide (Industrial).
- Particulate and microbiological control testing (NF EN 17141).
- BMS management with monitoring of pressure, temperature, and laminar flow.
Properties and Production Capabilities in ISO 8 Cleanroom
| Property | Typical Values | Standard |
|---|---|---|
| Area | 550 m² (200 m² extrusion / 350 m² molding) | ISO 14644-1 |
| Classification | Validated ISO 8 | ISO 14644-1 to -7 |
| Processes | Extrusion, co-extrusion, multi-component LSR molding, overmolding | Internal |
| Catalysis | Platinum / Peroxide | ISO 10993 |
| Working Temperature | -60 °C to +250 °C (peaks +315 °C) | Internal Testing |
| Sterilization | Autoclave, EtO, gamma | ISO 11135 / ISO 11137 |
| Personnel | 12 Qualified Operators | ISO 13485 Training |
Certifications and Standards Applicable to the ISO 8 Cleanroom
The ISO 8 cleanroom operates under a certified management system that complies with the most demanding international standards for biocontamination, traceability, and environmental control.
Main Certifications
- ISO 9001:2015 – Quality Management
- ISO 13485:2016 – Medical Devices
- ISO 14644-1 to -7 – Cleanroom Design and Control
- NF EN 17141:2020 – Biocontamination Control
- GMP – Good Manufacturing Practices
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
Industrial Sectors Where We Apply Cleanroom Production
Technical Applications Manufactured in ISO 8 Cleanroom
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Peristaltic and short-term implantable medical tubing.
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High-precision multi-component and overmolded LSR parts.
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CNC / die-cut flat gaskets for food and pharmaceutical use.
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Extruded profiles for food-grade and railway applications.
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Inflatable seals for autoclaves and airlocks.
Tubes, Seals, and LSR Components Manufactured in Certified Cleanroom
Medical Tubing
Biocompatible medical tubes conforming to ISO 10993 and FDA CFR 177.2600.
Medical LSR
Certified biocompatible LSR silicone for medical devices.
Food-Grade LSR
Food-grade LSR silicone compliant with FDA and Regulation (EU) 1935/2004.
Overmolding
Silicone overmolding onto metal, plastic, and other substrates.
How to Select the Right Process Within the ISO 8 Cleanroom
| Customer Requirement | Recommended Process |
|---|---|
| Sterile medical tubing | ISO 8 Cleanroom Extrusion + USP Class VI LSR |
| High-precision multi-component parts | ISO 13485 Certified Multi-component LSR Molding |
| Metal-silicone integration | Overmolding with position-controlled inserts |
| Short-term implantables (< 29 days) | ISO 10993 Biocompatible Medical LSR Molding |
| Food-grade applications | FDA 21 CFR 177.2600 + EC 1935/2004 Extrusion |
| Railway applications | EN 45545-2 HL2 / HL3 Extrusion or Molding |
Why Choose ProSilicones64 for Certified Cleanroom Production
Key Benefits
- Guaranteed international compliance (ISO, FDA, EC, EN, USP).
- Controlled environment that minimizes particulate and biological contamination.
- Integral traceability of materials and processes validated by external audits.
- Flexibility from prototypes to long production runs in certified environments.
- Backed by Progress Silicones (France) and Establecimientos OR64 (Spain).
The ISO 8 cleanroom at ProSilicones64 guarantees the manufacturing of critical components in controlled environments according to international standards. We combine advanced infrastructure, validated protocols, and highly qualified personnel to ensure regulatory conformity, safety, and reliability in audits.
The ISO 8 cleanroom infrastructure makes ProSilicones64 the Iberian benchmark in silicone production in controlled environments. With 550 m² certified, periodic audits, and an alliance between Progress Silicones (France) and Establecimientos OR64 (Spain), we guarantee components of maximum purity, biocompatibility, and traceability for the medical, pharmaceutical, food, and aerospace sectors.
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