Medical Silicone Manufacturing in ISO 8 Cleanroom
Manufacturing process of medical silicone components in controlled ISO 8 environment with ISO 13485 certification.
Manufacturing of technical silicone components with chemical resistance and thermal stability for analysis, biotechnology, and petrochemical processes. Production under ISO 9001 / ISO 13485 system in a certified ISO 8 Cleanroom environment.
Laboratory and petrochemical environments demand materials with high chemical and thermal resistance, capable of maintaining their properties after prolonged exposure to reagents, oils, or solvents. At ProSilicones64, we develop HTV and LSR silicone compounds manufactured under an ISO 9001 / ISO 13485 system in an ISO 8 cleanroom. Formulations are validated compliant with REACH / RoHS and include ISO 10993 and USP Class VI compatibility testing for biotechnological applications.
Our technical compounds are manufactured and verified under certified systems and tested formulations compliant with the main international safety and chemical compatibility standards.
| Normativa | Ámbito de aplicación |
|---|---|
| ISO 9001 | Quality management system certification (manufacturing process) |
| ISO 13485 | Quality management in critical environments (manufacturing process) |
| ISO 10993 / USP Clase VI | Biocompatibility and chemical compatibility testing (formulation verification) |
| ISO 8 Cleanroom | Certified environment compliant with ISO 14644 for critical components |
| REACH / RoHS | European chemical compatibility and control of restricted substances |
Technical knowledge and application cases in this sector.
Manufacturing process of medical silicone components in controlled ISO 8 environment with ISO 13485 certification.